Omnitrope

Growth Hormones

Administer somatropin by intramuscular or subcutaneous injection. Do NOT administer intravenously.
Monitor height, weight and bone age. Discontinue therapy if final height is achieved or epiphyseal fusion occurs.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
 
Accretropin:
This product does not require reconstitution. Prior to administration, swirl the contents of the vial with a gentle rotary motion; do not shake. The solution should be clear. Store unopened vials under refrigeration at 2 to 8 degrees C (36 to 46 degrees F). Do not freeze. Protect from light. Once opened, the vial may be stored under refrigeration for up to 14 days. After 14 days, discard unused portion.
 
Genotropin:
This product is supplied as a powder, filled in a two-chamber cartridge with the active substance in the front chamber and the diluent in the rear chamber. The product is available in a 5 mg cartridge (green tip) and a 12 mg cartridge (purple tip). The 5 and 12 mg cartridges can be used with the Genotropin Pen or the Genotropin Mixer. Genotropin is also available, in various doses ranging from 0.2 mg to 2 mg, in single use, auto-mix devices called Genotropin Miniquicks.
Cartridges: Store cartridges in the refrigerator at 2 to 8 degrees C (36 to 46 degrees F) prior to reconstitution. Do not freeze; protect from light. A reconstitution device supplied by the manufacturer is used to mix the powder and the diluent. After the powder and diluent are mixed, gently tip the cartridge upside down a few times until completely dissolved. DO NOT SHAKE; this may cause denaturation of the protein. If the solution is cloudy, do not use. Following reconstitution, the 5 mg cartridge will contain a 5 mg/mL solution and the 12 mg cartridge will contain a 12 mg/mL solution; both the 5 mg and 12 mg cartridges contain overfill. The cartridges contain diluent with preservative (m-cresol) and may be stored under refrigeration for up to 28 days after reconstitution. Do not use the 5 mg and 12 mg cartridges in patients with m-cresol hypersensitivity
Genotropin Minquicks: After dispensing, but prior to reconstitution, store at or below 25 degrees C (77 degrees F) for up to 3 months. A reconstitution device supplied by the manufacturer is used to mix the powder and diluent. Ten different strengths are available that each deliver a fixed volume of 0.25 mL. This product contains a diluent with no preservative, therefore, refrigerate after reconstitution and use within 24 hours. Use the reconstituted solution only once and discard any remaining solution.
 
Humatrope:
Prior to reconstitution, store under refrigeration at 2 to 8 degrees C (36 to 46 degrees F).
Vials: Reconstitute each 5-mg vial with 1.5 to 5 mL of the supplied diluent (contains m-cresol as a preservative) or Bacteriostatic Water for Injection (contains benzoyl alcohol as a preservative); sterile water for injection can be used for patients with a hypersensitivity to both m-cresol and benzoyl alcohol. Direct the liquid against the glass vial wall. Swirl vial with a gentle rotary motion until contents are dissolved completely. Do not shake. If the solution is cloudy, do not use. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins. Vials reconstituted with the diluent or bacteriostatic water are stable for 14 days when stored under refrigeration at 2 to 8 degrees C (36 to 46 degrees F). For vials reconstituted with sterile water, use the vial only once and discard the unused portion; if not used immediately, refrigerate (2 to 8 degrees C) and use within 24 hours. Avoid freezing reconstituted solutions.
Cartridges: Reconstitute cartridges using ONLY the supplied diluent syringe; the cartridges are designed for use only with the Humatrope injection device. Once reconstituted, the cartridges are stable for up to 28 days when stored under refrigeration at 2 to 8 degrees C (36 to 46 degrees F). Store the injection device without the needle attached. Avoid freezing reconstituted solutions.
 
Norditropin:
Do not use reconstituted solution if cloudy or contains particulate matter.
Prior to use, store under refrigeration at 2 to 8 degrees C (36 to 46 degrees F).
Once a Norditropin pen is in use, the pen should be stored in the refrigerator (2 to 8 degrees C; 36 to 46 degrees F), and used within 4 weeks. Alternatively, the Norditropin pens may be stored in the pen at room temperatures, no higher than 25 degrees C (77 degrees F), for up to 3 weeks. NovoFine needles are recommended for administration. Wipe the stopper on the needle thread with rubbing alcohol to prevent contamination.
 
Nutropin:
Prior to reconstitution, store under refrigeration, 2 to 8 degrees C (36 to 46 degrees F).
Reconstitute each 5-mg vial with 1 to 5 mL Bacteriostatic Water for Injection, USP (benzyl alcohol preserved) and each 10-mg vial with 1 to 10 mL of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). If using for newborns, reconstitute with sterile water for injection. Direct the liquid against the glass vial wall. Swirl vial with a gentle rotary motion until contents are dissolved completely. Do not shake. If the solution is cloudy after reconstitution or refrigeration, do not use. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins. The pH after reconstitution with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved) is approximately 7.4.
Solutions reconstituted with Bacteriostatic Water for Injection are stable for 14 days under refrigeration, 2 to 8 degrees C (36 to 46 degrees F). Solutions reconstituted with sterile water for injection should be used immediately and only once; discard any unused portions. Avoid freezing reconstituted solutions.
 
Nutropin AQ:
Does not require reconstitution. Solution should be clear. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins. Allow vial or pen cartridge to come to room temperature and gently swirl. If solution is cloudy, do not use.
Vials: Before needle insertion, wipe the vial septum with rubbing alcohol or antiseptic solution to prevent contamination by microorganisms that may be introduced by repeated needle insertions. Administer using sterile, disposable syringes and needles. Use syringes with small enough volume that the prescribed dose can be drawn from the vial with reasonable accuracy.
Pen cartridge: Two strengths are available, 10 mg and 20 mg; intended for use only with Nutropin AQ Pen. Each pen and cartridge are color coded to ensure accurate placement of the 10 mg or 20 mg cartridge into the appropriate pen. Do not use the 20 mg cartridge in the pen intended for the 10 mg cartridge, and vice versa. Wipe septum of pen cartridge with rubbing alcohol or antiseptic solution to prevent contamination by microorganisms that may be introduced by repeated needle insertions. Administered using sterile, disposable needles. Follow the directions provided in the Nutropin AQ Pen Instructions for Use. The Nutropin AQ 10 pen allows for administration of a minimum 0.1 mg dose to a maximum 4 mg dose, in 0.1 mg increments. The Nutropin AQ 20 pen allows for administration of a minimum 0.2 mg dose to a maximum 8 mg dose, in 0.2 mg increments.
Prefilled device: A prefilled multi-dose, dial a dose device is available in 3 strengths. Administer using disposable needles. Follow the directions provided in the Nutropin AQ NuSpin Instruction for Use. The Nutropin AQ Nuspin 5 allows for administration of a minimum dose of 0.05 mg to a maximum dose of 1.75 mg, in increments of 0.05 mg. The Nutropin AQ Nuspin 10 allows for administration of a minimum dose of 0.1 mg to a maximum dose of 3.5 mg, in increments of 0.1 mg. The Nutropin AQ Nuspin 20 allows for administration of a minimum dose of 0.2 mg to a maximum dose of 7 mg, in increments of 0.2 mg.
After initial use, vials, cartridges, and prefilled devices are stable for 28 days when stored under refrigeration, 2 to 8 degrees C (36 to 46 degrees F); avoid freezing. Vials, cartridges, and prefilled devices are light sensitive; protect from light.
 
Omnitrope:
Prior to reconstitution, store vials under refrigerations at 2 to 8 degrees C (36 to 46 degrees F). Do not freeze. Store in the carton; Omnitrope is sensitive to light.
Vials: Reconstitute the vial with diluent provided using a sterile, disposable syringe. Swirl the vial gently, but do not shake. If the solution is cloudy after reconstitution, the contents must not be injected. After reconstitution, the 1.5 mg vial may be stored under refrigeration, 2 to 8 degrees C (36 to 46 degrees F), for up to 24 hours. The 1.5 mg vial does not contain a preservative and should only be used once; discard any remaining solution. The 5.8 mg vial diluent contains benzoyl alcohol as a preservative. After reconstitution, the contents must be used within 3 weeks. After the first injection, store the 5.8 mg vial in the carton, to protect from light, in the refrigerator at 2 to 8 degrees C (36 to 46 degrees F). Avoid freezing.
Omnitrope Pen 5 cartridge: Each 5 mg cartridge must be inserted into the Omnitrope Pen 5 delivery system. Follow the directions provided in the Omnitrope Instructions for Use. The cartridge contains benzoyl alcohol as a preservative. Once initially used, store under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) for up to 28 days. Protect from light. Avoid freezing.
Omnitrope Pen 10 cartridge: Each 10 mg cartridge must be inserted into the Omnitrope Pen 10 delivery system. Follow the directions provided in the Omnitrope Instructions for Use. Once initially used, store under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) for up to 28 days. Protect from light. Avoid freezing.
 
Saizen:
Prior to reconstitution, store at room temperature (15 to 30 degrees C; 59 to 86 degrees F).
Vials: Reconstitute each 5 mg vial with 1 to 3 mL bacteriostatic water for injection; reconstitute each 8.8 mg vial with 2 to 3 mL bacteriostatic water for injection (benzoyl alcohol preserved). In patients with hypersensitivity to benzyl alcohol, the vials can be mixed with sterile water for injection. Direct the liquid against the glass vial wall. Swirl vial with a gentle rotary motion until contents are dissolved completely. Do not shake. The solution should be clear; if it is cloudy immediately after reconstitution or refrigeration, do not use. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins. After reconstitution, store vials mixed with bacteriostatic water for injection under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) and use within 14 days. For vials mixed with sterile water for injection, the solution should be used immediately, and any unused portion should be discarded. Avoid freezing.
Cartridges: Available in 4 mg and 8.8 mg click.easy cartridges for use in a compatible injection device. A reconstitution device supplied by the manufacturer is used to mix the Saizen with accompanying diluent containing metacresol. Cartridges reconstituted with the diluent containing metascresol are stable under refrigeration for up to 21 days. Avoid freezing.
 
Serostim:
Prior to reconstitution, store vials and diluent at room temperature (15 to 30 degrees C; 59 to 86 degrees F).
Vials: Reconstitute the 5 mg or 6 mg vials with 0.5 to 1 mL of supplied diluent (sterile water for injection). Reconstitute the 4 mg vial with 0.5 to 1 mL of bacteriostatic water for injection (benzoyl alcohol preserved) and the 8.8 mg vial with 1 to 2 mL of bacteriostatic water for injection (benzoyl alcohol preserved). Direct the liquid against the glass vial wall. Swirl vial with a gentle rotary motion until contents are dissolved completely. Do not shake. The solution should be clear; if it is cloudy immediately after reconstitution or refrigeration, do not use. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins. If reconstituted with sterile water for injection, use within 24 hours. If reconstituted with bacteristatic water for injection (benzoyl alcohol preserved), the solution is stable for up to 14 days under refrigeration (2 to 8 degrees C or 36 to 46 degrees F). Avoid freezing.
Cartridges: Available in 8.8 mg click.easy cartridges for use in a compatible injection device. A reconstitution device is supplied by the manufacturer and is used to mix the Serostim with accompanying diluent containing metacresol. After reconstitution, cartridges are stable under refrigeration for up to 21 days. Avoid freezing..
 
Serostim LQ:
Prior to use, store under refrigeration (2 to 8 degrees C; 36 to 46 degrees F).
Available in 6 mg single-use cartridges that do not require reconstitution. Administer using sterile, disposable syringes and needles.
Bring to room temperature prior to injecting the dose. Discard single-use cartridge after use, even if some drug remains. Discard cartridges after the expiration date stated on the product. Do not freeze. Protect from light.
 
Valtropin:
Prior to dispensing, store vials and diluent under refrigeration (2 to 8 degrees C or 36 to 46 degrees F). After dispensing to patients, may be stored at or below 25 degrees C (77 degrees F) for up to 3 months.
Reconstitute each 5 mg vial with the entire contents of the accompanying diluent, which contains metacresol as a preservative. If patients are allergic to metacresol, sterile water for injection can be used. Direct the liquid against the glass vial wall. Swirl vial with a gentle rotary motion until contents are dissolved completely. Do not shake. The solution should be clear; if it is cloudy or contains particulate matter immediately after reconstitution or after refrigeration, do not inject. The final concentration of the reconstituted solution is 3.33 mg/mL.
After reconstituted with the provided diluent, solutions can be stored under refrigeration (2 to 8 degrees C or 36 to 46 degrees F) for up to 14 days. After reconstituted with sterile water for injection, use only one dose of Valtropin® per vial and discard the unused portion if not used immediately.
 
Zomacton:
Reconstitute each 5 mg vial with 1 to 5 mL bacteriostatic 0.9% NaCl Injection and each 10 mg vial with 1 mL bacteriostatic water for injection (containing 0.33% metacresol as a preservative). When reconstituting for newborns, use sterile 0.9% Sodium Chloride Injection (unpreserved). Direct the liquid against the glass vial wall to prevent foaming. Swirl vial gently until contents are dissolved completely. Do not shake. The solution should be clear; if it is cloudy immediately after reconstitution, do not inject. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins.
Zomacton may be administered using a standard sterile disposable syringe or a Zoma-Jet Needle-Free injection device; refer to the User's Manual provided with the administration device.
Storage: After reconstitution with bacteriostatic 0.9% NaCl Injection, the solution may be stored under refrigeration (2 to 8 degrees C or 36 to 46 degrees F) for up to 14 days. After reconstitution with bacteriostatic water for injection (containing 0.33% metacresol), the solution may be stored under refrigeration (2 to 8 degrees C or 36 to 46 degrees F) for up to 28 days. Solution reconstituted using sterile normal saline (containing no preservative) should be used only once, with any remaining solution discarded. Do not freeze reconstituted solutions.
 
Zorbtive:
Unreconstituted vials of drug and diluent may be stored at room temperature (15 to 30 degrees C; 59 to 86 degrees F) until expiration date.
Reconstitute each vial of 4 mg, 5 mg, or 6 mg with 0.5 to 1 mL sterile water for injection, USP. Reconstitute each 8.8 mg with 1 to 2 mL bacteriostatic water for injection (0.9% benzyl alcohol preserved); in newborns or patients with a benzoyl alcohol hypersensitivity, sterile water for injection can be used. Review manufacturer's labeling for expected concentrations. Direct the liquid against the glass vial wall. Swirl vial with a gentle rotary motion until contents are dissolved completely. Do not shake. The solution should be clear; if it is cloudy after reconstitution or refrigeration, do not use. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins.
After reconstitution with sterile water for injection, use the solution immediately and discard any unused portion. When using bacteriostatic water for injection, reconstituted solutions are stable for up to 14 days under refrigeration (2 to 8 degrees C; 36 to 46 degrees F). Avoid freezing vials of drug or diluent, or reconstituted vials.

Inject somatropin deeply into a large muscle. Aspirate prior to injection to avoid injection into a blood vessel. Rotate injection sites daily.

Subcutaneous injection of somatropin volumes greater than 1 ml of reconstituted solution is not recommended. Inject subcutaneously taking care not to inject intradermally.
Allow refrigerated solutions to come to room temperature prior to injection.
Subcutaneous injections may be given in the thigh, buttocks, or abdomen. Rotate injection sites daily.

seizures / Delayed / 0-1.0
pancreatitis / Delayed / 0-1.0
new primary malignancy / Delayed / Incidence not known
increased intracranial pressure / Early / Incidence not known
papilledema / Delayed / Incidence not known
diabetic ketoacidosis / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known

peripheral edema / Delayed / 3.0-45.0
edema / Delayed / 3.0-45.0
hypothyroidism / Delayed / 5.0-16.0
elevated hepatic enzymes / Delayed / 6.0-13.0
eosinophilia / Delayed / 12.0-12.0
hematoma / Early / 9.0-9.0
hyperlipidemia / Delayed / 8.0-8.0
hypertension / Early / 3.0-8.0
gastritis / Delayed / 6.0-6.0
anemia / Delayed / 6.0-6.0
hypertriglyceridemia / Delayed / 1.0-5.0
depression / Delayed / 5.0-5.0
chest pain (unspecified) / Early / 5.0-5.0
antibody formation / Delayed / 2.0-2.0
hematuria / Delayed / 0-1.0
hyperglycemia / Delayed / 10.0
fluid retention / Delayed / Incidence not known
hypoglycemia / Early / Incidence not known
diabetes mellitus / Delayed / Incidence not known
bleeding / Early / Incidence not known
erythema / Early / Incidence not known
psoriasis / Delayed / Incidence not known

arthralgia / Delayed / 11.0-37.0
infection / Delayed / 32.0-32.0
myalgia / Early / 3.0-30.0
headache / Early / 6.0-18.0
paresthesias / Delayed / 2.0-17.0
fever / Early / 16.0-16.0
hypoesthesia / Delayed / 2.0-15.0
musculoskeletal pain / Early / 5.0-14.0
rhinitis / Early / 5.0-14.0
back pain / Delayed / 3.0-11.0
fatigue / Early / 4.0-9.0
cough / Delayed / 6.0-9.0
diaphoresis / Early / 8.0-8.0
gynecomastia / Delayed / 3.0-8.0
abdominal pain / Early / 7.0-7.0
weakness / Early / 3.0-6.0
asthenia / Delayed / 3.0-6.0
acne vulgaris / Delayed / 6.0-6.0
maculopapular rash / Early / 6.0-6.0
carpal tunnel syndrome / Delayed / 1.0-5.0
insomnia / Early / 5.0-5.0
diarrhea / Early / 5.0-5.0
nausea / Early / Incidence not known
vomiting / Early / Incidence not known
dizziness / Early / Incidence not known
pruritus / Rapid / Incidence not known
injection site reaction / Rapid / Incidence not known
skin hyperpigmentation / Delayed / Incidence not known
rash / Early / Incidence not known
alopecia / Delayed / Incidence not known

Genotropin, Genotropin MiniQuick, Humatrope, Norditropin FlexPro, Nutropin AQ NuSpin, Omnitrope, Saizen, Saizen Saizenprep Cartridge, Serostim, ZOMACTON, Zorbtive

Rx

Recombinant growth hormone; less immunogenic than somatrem
Used for growth hormone deficiency (GHD), growth failure, or short stature; also used for treating cachexia and AIDS wasting; also used for adults with short bowel syndrome
Several brands are available with varying indications and dosage regimens

Initially, not more than 0.04 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections. Increase dose, as needed, at 4 to 8 week intervals. Max: 0.08 mg/kg per week as 6 or 7 equal daily injections. Alternatively, 0.2 mg/day subcutaneously (range 0.15 to 0.3 mg/day subcutaneously) can be administered without consideration of body weight. Gradually increase the dose by 0.1 to 0.2 mg/day every 1 to 2 months as needed. Obese patients are more likely to experience adverse effects when dosed by weight.

Initially, not more than 0.006 mg/kg (0.018 International Units/kg/day) subcutaneously once daily. The dose may be increased based on individual patient requirements. Max: 0.0125 mg/kg/day (0.0375 International Units/kg/day).

Initially, not more than 0.004 mg/kg subcutaneously per day. After 6 weeks, the dose may be increased, as tolerated, to a maximum of 0.016 mg/kg per day. Alternatively, the following non-weight based approach may be used: initially, 0.2 mg subcutaneously per day (0.15 to 0.30 mg subcutaneously per day); increase dose gradually by increments of approximately 0.1 to 0.2 mg/day every 1 to 2 months based on clinical response and serum insulin-like growth factor I (IGF-I) concentrations. Decrease the dose as necessary based on the adverse events and/or serum IGF-I concentrations above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person and between male and female patients. Obese patients are more likely to experience adverse effects when dosed by weight.

Initially, not more than 0.006 mg/kg subcutaneously once daily. The dose may be increased according to individual patient requirements to a maximum of 0.025 mg/kg once daily in patients younger than 35 years or 0.0125 mg/kg once daily in patients 35 years and older.

Initially, not more than 0.04 mg/kg subcutaneously per week divided into 7 equal daily injections, preferably administered in the evening. Increase dose as needed at 4 to 8 week intervals to a maximum of 0.08 mg/kg per week as 7 equal daily injections. Alternatively, 0.2 mg/day subcutaneously (range 0.15 to 0.3 mg/day subcutaneously) can be administered without consideration of body weight. Gradually increase the dose by 0.1 to 0.2 mg/day every 1 to 2 months as needed. Obese patients are more likely to experience adverse effects when dosed by weight.

Initially, not more than 0.005 mg/kg subcutaneously per day. After 4 weeks, the dose may be increased to a maximum of 0.01 mg/kg per day.

Initially, 0.006 mg/kg subcutaneously once daily. Using patient's clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations, titrate dose. Max: 0.0125 mg/kg once daily. This dosage regimen is not recommended for obese patients. Alternatively, 0.2 mg/day subcutaneously (range 0.15 to 0.3 mg/day) can be given initially; the dose can be increased by 0.1 to 0.2 mg/day every 1 to 2 months as clinically indicated. Decrease the dose if needed based on adverse reactions and/or serum IGF-1 concentrations above the age- and gender- specific normal range.

0.16 to 0.24 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections.

0.18 mg/kg/week (0.54 International Units/kg) subcutaneously or IM divided into equal doses given either on 3 alternate days, 6 times per week, or daily. The maximum replacement dosage is 0.1 mg/kg (0.3 International Units/kg) given 3 times per week. Dosage should be individualized for each patient.

0.024 to 0.034 mg/kg/dose subcutaneously given 6 to 7 times a week. Dosage should be individualized for each patient.

0.3 mg/kg/week (approximately 0.9 International Units/kg) subcutaneously divided into daily injections is recommended. In pubertal patients, a weekly dosage of up to 0.7 mg/kg divided daily may be used. Dosage should be individualized for each patient.

Initially, 1.5 mg/kg subcutaneously on the same day each month or 0.75 mg/kg twice each month on the same days of each month (e.g., days 1 and 15).

0.16 to 0.24 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections, preferably administered in the evenings.

0.18 mg/kg/week subcutaneously or IM; the dose can be divided into equal injections administered daily, 3 times/week, or 6 times/week.

0.18 mg/kg to 0.3 mg/kg subcutaneously per week, divided into equal injections given 3, 6, or 7 times per week. Individualize dosage for each patient based on the growth response. If poor growth persists during the first year of treatment, assess compliance and evaluate other causes such as hypothyroidism, under-nutrition, advanced bone age, and antibodies to recombinant human GH.

Generally, 0.24 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections. Genotropin or Omnitrope should only be used in Prader-Willi syndrome patients who have a diagnosis of growth hormone deficiency.

Generally, 0.48 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections for children who have not manifested catch-up growth by age 2. For younger children with a baseline HSDS between -2 and -3, the initial dose is 0.24 mg/kg/week subcutaneously with upwards titration as needed. For children with a baseline HSDS less than -3 or for older/prepubertal children, the recommended initial dose is 0.48 mg/kg/week subcutaneously with a reduction in dosage towards 0.24 mg/kg/week subcutaneously if substantial catch-up growth is seen during the first few years of treatment.

Up to 0.067 mg/kg/day subcutaneously (0.47 mg/kg/week) is recommended. For younger children with a baseline HSDS between -2 and -3, the initial dose is 0.033 mg/kg/day subcutaneously with upwards titration as needed. For children with a baseline HSDS less than -3 or for older/prepubertal children, the recommended initial dose is 0.067 mg/kg/day subcutaneously with a reduction in dosage towards 0.033 mg/kg/day subcutaneously if substantial catch-up growth is seen during the first few years of treatment.

0.48 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections for children who have not manifested catch-up growth by age 2.

Up to 0.47 mg/kg subcutaneously per week, divided into equal injections given 3, 6, or 7 times per week. For younger children with a baseline HSDS between -2 and -3, the initial dose is 0.033 mg/kg/day subcutaneously with upwards titration as needed. For children with a baseline HSDS less than -3 or for older/prepubertal children, the recommended initial dose is 0.067 mg/kg/day subcutaneously with a gradual reduction in dosage if substantial catch-up growth is seen during the first few years of treatment.

0.35 mg/kg (approximately 1.05 International Units/kg) subcutaneously per week divided into daily injections (0.05 mg/kg/day). Dosage should be individualized for each patient. Hemodialysis patients should receive their injection at night just prior to going to sleep or at least 3 to 4 hours after hemodialysis to prevent hematoma formation due to the heparin. Chronic cycling peritoneal dialysis patients should receive their injection in the morning after they have completed dialysis. Chronic ambulatory peritoneal dialysis patients should receive the injection in the evening at the time of the overnight exchange. Nutropin may be continued up to the time of renal transplantation. There are insufficient data regarding the benefit of treatment beyond 3 years. No studies have been completed in patients who have received renal transplants and the use of Nutropin in patients with functioning renal allografts is not indicated.

0.33 mg/kg subcutaneously per week divided into equal doses given 6 or 7 times/week. Discontinue treatment with Genotropin or Omnitrope when epiphyses are fused.

Up to 0.375 mg/kg (1.125 International Units/kg) subcutaneously per week divided into equal doses given either daily or on 3 alternate days.

Up to 0.067 mg/kg/day subcutaneously is recommended.

Up to 0.375 mg/kg subcutaneously per week divided into equal doses given 3 to 7 times per week.

Up to 0.375 mg/kg subcutaneously per week, divided into equal injections given 3, 6, or 7 times per week.

0.35 mg/kg subcutaneously per week divided into daily injections.

0.35 mg/kg subcutaneously per week, divided into equal injections given 3, 6, or 7 times per week.

Up to 0.066 mg/kg/day subcutaneously is recommended. Prior to initiating somatropin, ensure that the patient has short stature. Not all children with Noonan syndrome have short stature. Twenty-four children aged 3 to 14 years of age received doses of 0.033 mg/kg/day subcutaneously or 0.066 mg/kg/day subcutaneously for 2 years; after 2 years, the dose was adjusted based on growth response and continued until final height was achieved. Using the national reference, height gain from baseline increased 1.5 SDS (mean height gain of 9.9 cm in males and 9.1 cm in females at 18 years of age). Using the Noonan reference, height gain from baseline increased 1.6 SDS (mean height gain of 11.5 cm in males and 11 cm in girls at 18 years of age) was noted. During the first 2 years of treatment, height velocity was greater in the group receiving 0.066 mg/kg/day subcutaneously.

Up to 0.47 mg/kg subcutaneously per week divided into equal doses given 6 to 7 times per week. Discontinue treatment with Genotropin, Omnitrope, or Norditropin when epiphyses are fused.

Up to 0.37 mg/kg subcutaneously per week divided into equal doses given 6 to 7 times per week.

Up to 0.3 mg/kg subcutaneously per week divided into equal doses given once daily every day (i.e., 7 times/week).

Up to 0.37 mg/kg subcutaneously per week, divided into equal injections given 3, 6, or 7 times per week.

Dosage is based on weight; 0.1 mg/kg subcutaneously once daily at bedtime, not to exceed 6 mg/day. For patients weighing more than 55 kg: 6 mg subcutaneously once daily at bedtime. For 45 to 55 kg: 5 mg subcutaneously once daily at bedtime. For 35 to 45 kg: 4 mg subcutaneously once daily at bedtime. If weight is less than 35 kg: 0.1 mg/kg subcutaneously once daily at bedtime.

Safety and efficacy in pediatric patients with HIV have not been established. The manufacturer reports that in 2 small studies, 11 children with HIV associated failure to thrive received human growth hormone. In one study, a dose of 0.04 mg/kg/day subcutaneously for 26 weeks was used in 5 children (6 to 17 years). A second study used a dose of 0.07 mg/kg/day subcutaneously for 4 weeks in 6 children (8 to 14 years). Treatment was reported to be well tolerated and consistent with safety observations in growth hormone treated adults with AIDS wasting.

0.1 mg/kg subcutaneously once daily for 4 weeks. Max: 8 mg/day subcutaneously. Dosage selection for the elderly should usually start at the lower end of the dosage range. Discontinue Zorbtive for up to 5 days to reduce severe toxicities, if needed. Upon resolution of symptoms, resume Zorbtive at 50% of the original dose. Permanently discontinue treatment if severe toxicity recurs or does not disappear within 5 days. Moderate fluid retention and arthralgias may respond to symptomatic treatment initially. In clinical trials, Zorbtive (plus a specialized oral diet without glutamine) vs. diet alone significantly decreased the total amount of intravenous parenteral nutrition (TPN) by 2.1L/week. The addition of glutamine to the diet/Zorbtive group resulted in a significant decrease in IPN of 3.9 L/week. Frequency of TPN (days/week) was reduced by 1 day in the Zorbtive/diet group and by 2.2 days in the Zorbtive/diet/glutamine group, although significance was not reported. Other clinical reports have also documented a reduction in TPN usage. Somatropin effects on body weight, lean body mass, essential fatty acid status, stool mass and macronutrient absorption have been positive when compared to baseline (but not placebo) in some studies; the effect of somatropin on these endpoints is controversial.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Acarbose: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Albuterol; Budesonide: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Alogliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Alogliptin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Alogliptin; Pioglitazone: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Antidiabetic Agents: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Azelastine; Fluticasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Beclomethasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Betamethasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Budesonide: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Budesonide; Formoterol: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Canagliflozin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Canagliflozin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Chlorpropamide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Ciclesonide: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Corticosteroids: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Cortisone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Cyclosporine: (Moderate) Somatropin may increase the activity of cytochrome-mediated metabolism of cyclosporine clearance.
Dapagliflozin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Dapagliflozin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Dapagliflozin; Saxagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Deflazacort: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Dexamethasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Dulaglutide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Empagliflozin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Empagliflozin; Linagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Empagliflozin; Linagliptin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Empagliflozin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Ertugliflozin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Ertugliflozin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Ertugliflozin; Sitagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Estrogens: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered.
Exenatide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Fludrocortisone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Flunisolide: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Fluticasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Fluticasone; Salmeterol: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Fluticasone; Umeclidinium; Vilanterol: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Fluticasone; Vilanterol: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Formoterol; Mometasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Glimepiride: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Glipizide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Glipizide; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Glyburide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Glyburide; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Hydrocortisone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Insulin Aspart: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Insulin Aspart; Insulin Aspart Protamine: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Insulin Degludec; Liraglutide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Insulin Detemir: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Insulin Glargine: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Insulin Glargine; Lixisenatide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Insulin Glulisine: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Insulin Lispro: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Insulin Lispro; Insulin Lispro Protamine: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Insulin, Inhaled: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Isophane Insulin (NPH): (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Levothyroxine: (Minor) Excessive use of thyroid hormones with growth hormone (somatropin, rh-GH) may accelerate epiphyseal closure. However, untreated hypothyroidism may interfere with growth response to somatropin. Patients receiving concomitant therapy should be monitored closely to ensure appropriate therapeutic response to somatropin.
Levothyroxine; Liothyronine (Porcine): (Minor) Excessive use of thyroid hormones with growth hormone (somatropin, rh-GH) may accelerate epiphyseal closure. However, untreated hypothyroidism may interfere with growth response to somatropin. Patients receiving concomitant therapy should be monitored closely to ensure appropriate therapeutic response to somatropin.
Levothyroxine; Liothyronine (Synthetic): (Minor) Excessive use of thyroid hormones with growth hormone (somatropin, rh-GH) may accelerate epiphyseal closure. However, untreated hypothyroidism may interfere with growth response to somatropin. Patients receiving concomitant therapy should be monitored closely to ensure appropriate therapeutic response to somatropin.
Linagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Linagliptin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Liothyronine: (Minor) Excessive use of thyroid hormones with growth hormone (somatropin, rh-GH) may accelerate epiphyseal closure. However, untreated hypothyroidism may interfere with growth response to somatropin. Patients receiving concomitant therapy should be monitored closely to ensure appropriate therapeutic response to somatropin.
Liraglutide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Lixisenatide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Macimorelin: (Major) Avoid use of macimorelin with drugs that directly affect pituitary growth hormone secretion and may blunt the growth hormone response to macimorelin, such as somatropin (recombinant rhGH). Healthcare providers are advised to discontinue growth hormone therapy at least 1 week before administering macimorelin. Use of these medications together may impact the accuracy of the macimorelin growth hormone test.
Mecasermin, Recombinant, rh-IGF-1: (Major) Use caution in concomitant use of mecasermin and somatropin. Both agents are used in the treatment of growth disorders and share feedback and pathway systems. Their additive use has not been studied.
Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Metformin; Repaglinide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Metformin; Rosiglitazone: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Metformin; Saxagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Metformin; Sitagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Methylprednisolone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Miglitol: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Mometasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Nateglinide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Olopatadine; Mometasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Pioglitazone: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Pioglitazone; Glimepiride: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Pioglitazone; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Pramlintide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Prednisolone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Prednisone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.
Regular Insulin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Regular Insulin; Isophane Insulin (NPH): (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Repaglinide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Rosiglitazone: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Saxagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Semaglutide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Sitagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Testosterone: (Moderate) Somatropin can induce (i.e., increase) the activity of cytochrome-mediated metabolism of antipyrine clearance in man. Thus, this predicts that somatropin may affect other drugs metabolized via this pathway, like testosterone.
Thyroid hormones: (Minor) Excessive use of thyroid hormones with growth hormone (somatropin, rh-GH) may accelerate epiphyseal closure. However, untreated hypothyroidism may interfere with growth response to somatropin. Patients receiving concomitant therapy should be monitored closely to ensure appropriate therapeutic response to somatropin.
Tolazamide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Tolbutamide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus.
Triamcinolone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted.

Genotropin/Genotropin MiniQuick/Humatrope/Omnitrope/Saizen/Serostim/ZOMACTON/Zorbtive Subcutaneous Inj Pwd F/Sol: 0.2mg, 0.4mg, 0.6mg, 0.8mg, 1mg, 1.2mg, 1.4mg, 1.6mg, 1.8mg, 2mg, 4mg, 5mg, 5.8mg, 6mg, 8.8mg, 10mg, 13.8mg, 24mg
Humatrope Oral Inj Pwd F/Sol: 12mg
Humatrope/Saizen Intramuscular Inj Pwd F/Sol: 5mg, 6mg, 8.8mg, 24mg
Norditropin FlexPro/Nutropin AQ NuSpin/Omnitrope Subcutaneous Inj Sol: 1mL, 1.5mL, 2.5mg, 3mL, 5mg, 10mg, 15mg, 30mg

Somatropin, rh-GH doses must be individualized and are highly variable depending on the nature and severity of the disease, the formulation being used, and on patient response.

Mechanism of Action: Endogenous growth hormone is responsible for stimulating normal skeletal, connective tissue, muscle, and organ growth in children and adolescents. It also plays an important role in adult metabolism. Recombinant products mimic all of these actions. Somatropin binds to growth hormone (GH) receptors and produces a variety of physiologic effects that can be classified as being direct or indirect. The direct effects include antagonism of the peripheral action of insulin and the subsequent stimulation of insulin secretion; stimulation of the production of somatomedins or insulin-like growth factors (IGFs) in the liver and other tissues; stimulation of triglyceride hydrolysis in adipose tissue; stimulation of hepatic glucose output; induction of a positive calcium balance; and retention of sodium and potassium. These effects oppose the action of insulin on fat and carbohydrate metabolism and are potentiated by glucocorticoids.Somatomedins or insulin-like growth factors (IGFs) indirectly mediate the anabolic and growth-promoting effects of somatropin. IGFs circulate throughout the body and bind to specific IGF receptors. Two IGFs have been identified, IGF-1 and IGF-2. IGF-1 appears to be the principal mediator of the action of growth hormone, whereas IGF-2 has more insulin-like activity. The principal anabolic actions of IGFs include stimulation of amino acid transport, stimulation of DNA, RNA, and protein synthesis, and induction of cell proliferation and growth. IGF-1 is directly responsible for chondrogenesis, skeletal growth, and the growth of soft tissue. Linear growth is stimulated by affecting cartilaginous growth areas of long bones. Growth is also stimulated by increasing the number and size of skeletal muscle cells, influencing the size of organs, and increasing red cell mass through erythropoietin stimulation. The actions of growth hormone on the gut may be direct or mediated via the local or systemic production of IGF. In-vivo studies have shown that growth hormone enhances transmucosal transport of water, electrolytes, and nutrients. These indirect effects are inhibited by glucocorticoids.

Somatropin is administered by intramuscular or subcutaneous injection. Peak plasma concentrations of somatropin are reached in 2—6 hours following administration. About 20% of the circulating somatropin is bound to growth hormone-binding protein. Peak plasma concentrations of IGF-1 occur about 20 hours after administration of somatropin. Somatropin is metabolized by the liver, kidney, and other tissues. Somatropin undergoes glomerular filtration and the molecule is cleaved in the kidney. Once cleavages occurs in the renal cells, the peptides and amino acids are returned to the systemic circulation. Little excretion occurs via the urine. The plasma elimination half-life is approximately 20—30 minutes. Because of continued release of somatropin from the intramuscular or subcutaneous site, serum concentrations decline with a half-life of about 3—5 hours. Because of the slow induction and clearance of IGF-1, the effects of somatropin last much longer than its elimination half-life.

Following subcutaneous injection of the depot formulation, somatropin is released from the microspheres initially by diffusion, followed by both polymer degradation and diffusion. The estimated bioavailability following a single dose of Nutropin Depot ranges from 33—38% when compared to single dose Nutropin AQ and from 48—55% when compared to chronically dosed Protropin. Once released and absorbed, somatropin is believed to distributed and eliminated in a manner similar to somatropin formulated for daily administration. Both the Cmax and AUC are proportional to the dose. Serum growth hormone levels > 1 mcg/l persist for approximately 11—14 days following single doses of 0.75 or 1.5 mg/kg.

No adequate and well controlled studies have been conducted in pregnant humans, and the potential for somatropin to cause adverse effects on the fetus or reproductive system is unknown. In animal studies that have been performed, differing doses exceeding the regular human dose revealed no evidence of impaired fertility or harm to the fetus. Inform females of childbearing age that use of somatropin during pregnancy has not been studied in humans, therefore, the effects of the drug on the fetus are unknown.

No data are available regarding the presence of somatropin in human milk, the effects of somatropin on the breast-fed infant, or the effects of somatropin on milk production. Limited published literature reports no adverse effects on breast-feeding infants with maternal administration of somatropin and no decrease in milk production or change in milk content during treatment with somatropin. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.