Miacalcin

Calcitonins

Calcitonin-salmon injection is administered intramuscularly or subcutaneously. If the volume of the injection exceeds 2 mL, intramuscular injection is preferable and multiple injection sites should be used.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
With chronic use, ensure adequate intake of calcium and vitamin D to reduce the risk of treatment-related hypocalcemia.
 
Skin Testing prior to treatment:
In patients with a suspected sensitivity to salmon calcitonin, a skin test using a diluted injection concentration should be performed.
A detailed skin testing protocol is available from the manufacturer's product safety department. Healthcare providers may wish to refer patients who require skin testing to an allergist.
Prepare testing solution in a tuberculin syringe by diluting 10 International Units (0.05 mL) of the calcitonin salmon injection to 1 mL with 0.9% Sodium Chloride injection. Mix thoroughly.
Discard 0.9 mL of the diluted test injection and administer the remaining 0.1 mL intracutaneously on the flexor surface of the forearm.
Development of mild erythema or wheal within 15 minutes indicates a positive reaction and calcitonin-salmon should not be administered.

Inject into a large muscle. Aspirate prior to injection to avoid injection into a blood vessel. If the volume of the injection exceeds 2 mL, the IM route is preferred and multiple injection sites should be used.
Rotate sites of injection.
Dispose of the used syringe and needle in an FDA-cleared sharps disposal container after use.

Subcutaneous administration is preferred for outpatient self-administration.
If calcitonin is to be self-administered, instruct the patient and/or caregiver on aseptic technique and the proper subcutaneous injection technique.
Inject subcutaneously taking care not to inject intradermally.
Rotate injection sites.
Dispose of the used syringe and needle in an FDA-cleared sharps disposal container after use.

Calcitonin-salmon Nasal Spray:
Before the first dose, the nasal spray should be at room temperature. Remove the unopened bottle from the refrigerator and allow the spray to reach room temperature.
Remove the protective cap.
To prime the pump bottle, the bottle should be held upright and the 2 side arms of the pump depressed toward the bottle until a full spray is produced. The pump is primed once the first full spray is emitted.
The nasal spray pump only requires priming before the first dose.
To administer, carefully place the nozzle into the nostril with the patient's head in the upright position. Depress the pump firmly toward the bottle.
Alternate the nostril used for administration each day.
To avoid the spread of infection, do not use the sprayer for more than 1 person.
Fortical Nasal Spray Storage: After opening, store bottle in use in an upright position at 20 to 25 degrees C (68 to 77 degrees F). Discard the bottle after 30 doses.[57624]
Miacalcin Nasal Spray Storage (or generic equivalent): After opening, store bottle in use at room temperature between 20 and 25 degrees C (68 and 77 degrees F) in an upright position, for up to 35 days. Each bottle contains at least 30 doses. Discard the bottle after 30 doses.[27980]
Ensure adequate intake of calcium and vitamin D during osteoporosis treatment and prevention.[27980] [57624]

new primary malignancy / Delayed / 4.1-4.1
bronchospasm / Rapid / 1.0-3.0
stroke / Early / 0-1.0
myocardial infarction / Delayed / 0-1.0
hearing loss / Delayed / 0-1.0
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
laryngeal edema / Rapid / Incidence not known
seizures / Delayed / Incidence not known

lymphadenopathy / Delayed / 1.0-3.0
constipation / Delayed / 1.0-3.0
depression / Delayed / 1.0-3.0
hypertension / Early / 1.0-3.0
angina / Early / 1.0-3.0
cystitis / Delayed / 0-3.0
conjunctivitis / Delayed / 1.0-3.0
skin ulcer / Delayed / 0-1.0
anemia / Delayed / 0-1.0
dyspnea / Early / 0-1.0
gastritis / Delayed / 0-1.0
migraine / Early / 0-1.0
palpitations / Early / 0-1.0
sinus tachycardia / Rapid / 0-1.0
bundle-branch block / Early / 0-1.0
phlebitis / Rapid / 0-1.0
cholelithiasis / Delayed / 0-1.0
hepatitis / Delayed / 0-1.0
hyperthyroidism / Delayed / 0-1.0
goiter / Delayed / 0-1.0
nephrolithiasis / Delayed / 0-1.0
hematuria / Delayed / 0-1.0
peripheral edema / Delayed / 0-1.0
edema / Delayed / 0-1.0
blurred vision / Early / 0-1.0
antibody formation / Delayed / 10.0
hypotension / Rapid / Incidence not known
hypocalcemia / Delayed / Incidence not known
tetany / Early / Incidence not known

rhinitis / Early / 0-12.0
injection site reaction / Rapid / 10.0-10.0
vomiting / Early / 1.8-10.0
nausea / Early / 1.8-10.0
flushing / Rapid / 0-5.0
back pain / Delayed / 5.0-5.0
arthralgia / Delayed / 3.8-3.8
epistaxis / Delayed / 3.5-3.5
headache / Early / 3.2-3.2
rash / Early / 1.0-3.0
infection / Delayed / 1.0-3.0
sinusitis / Delayed / 1.0-3.0
diarrhea / Early / 1.0-3.0
abdominal pain / Early / 1.0-3.0
dyspepsia / Early / 1.0-3.0
dizziness / Early / 1.0-3.0
paresthesias / Delayed / 1.0-3.0
myalgia / Early / 1.0-3.0
fatigue / Early / 1.0-3.0
lacrimation / Early / 1.0-3.0
alopecia / Delayed / 0-1.0
pruritus / Rapid / 0-1.0
parosmia / Delayed / 0-1.0
nasal congestion / Early / 0-1.0
sneezing / Early / 0-1.0
cough / Delayed / 0-1.0
pharyngitis / Delayed / 0-1.0
appetite stimulation / Delayed / 0-1.0
flatulence / Early / 0-1.0
dysgeusia / Early / 0-1.0
xerostomia / Early / 0-1.0
weight gain / Delayed / 0-1.0
agitation / Early / 0-1.0
insomnia / Early / 0-1.0
anorexia / Delayed / 0-1.0
anxiety / Delayed / 0-1.0
vertigo / Early / 0-1.0
tremor / Early / 0-1.0
diaphoresis / Early / 0-1.0
fever / Early / 0-1.0
tinnitus / Delayed / 0-1.0
otalgia / Early / 0-1.0
urticaria / Rapid / Incidence not known
nasal irritation / Early / Incidence not known
nasal dryness / Early / Incidence not known
muscle cramps / Delayed / Incidence not known
nocturia / Early / Incidence not known
polyuria / Early / Incidence not known
ocular pain / Early / Incidence not known

Fortical, Miacalcin

Rx

Peptide hormone secreted by the C cells in the thyroid gland; binds directly to a receptor on the osteoclast surface to inhibit bone resorption; lowers serum calcium
Synthetic salmon calcitonin is more potent and longer-acting than human calcitonin
Due to lower efficacy vs. other agents, not routinely used in Paget's disease or postmenopausal osteoporosis; indicated in regimens for hypercalcemic emergencies

Initially, 4 International Units/kg given IM or subcutaneously every 12 hours. If the response is not satisfactory after 1 to 2 days, increase the dose to 8 International Units/kg IM or subcutaneously every 12 hours. May further titrate. Max: 8 International Units/kg IM or subcutaneously every 6 hours. Decreases in serum calcium are usually noted within 2 hours of a single dose; however, the hypocalcemic response to calcitonin therapy usually only lasts 4 to 7 days despite continued therapy.

100 International Units given IM or subcutaneously once daily is the recommended dose.[52559] Per treatment guidelines for Paget's disease, the use of injectable calcitonin-salmon leads to partial radiographic healing of lytic lesions, but most patients do not achieve normalization of bone turnover, and thus calcitonin has limited use versus newer, more effective agents (i.e., bisphosphonates).[63474] Calcitonin should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).[52559]

100 International Units IM or subcutaneously once daily. Give with supplemental calcium and vitamin D if dietary intake is inadequate. Reserve use for patients that are more than 5 years postmenopause in whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). A controlled study, which was prematurely discontinued, failed to demonstrate any benefit of calcitonin-salmon on fracture rate. Guidelines recommend against calcitonin-salmon for the treatment of osteoporosis; the efficacy of calcitonin in preventing vertebral and non-vertebral fractures is not established, and the increase in bone mineral density observed is less than that reported for other agents (e.g., bisphosphonates). Calcitonin may be considered for women who can not or will not take more effective agents; do not prescribe in early menopause as benefit/efficacy has not been observed within the first 5 years of menopause onset.

200 International Units (1 spray) intranasally in 1 nostril once daily. Give supplemental calcium and vitamin D if dietary intake is inadequate. Alternate the nostril used daily. Fracture reduction efficacy has not been demonstrated. Reserve use for patients that are more than 5 years postmenopause in whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).[27980] [57624] The PROOF study indicates a potential reduction in new vertebral fractures with use.[24299] Guidelines recommend against calcitonin-salmon for the treatment of osteoporosis; the efficacy of calcitonin in preventing non-vertebral fractures is not established, and the increase in bone mineral density observed is less than that reported for other agents (e.g., bisphosphonates). Calcitonin may be considered for women who can not or will not take more effective agents; do not prescribe in early menopause as benefit/efficacy has not been observed within the first 5 years of menopause onset.

Safety and efficacy not established; off-label use reported. 100 International Units calcitonin-salmon injection given IM or subcutaneously once daily or 200 International Units (1 spray of nasal spray) intranasally in 1 nostril once daily, given for up to 30 days post event, have provided symptomatic relief and facilitated mobility in small studies. For short-term use only. Although calcitonin may help relieve acute back pain associated with a recent osteoporotic vertebral compression fracture, one metanalysis found that there is no sufficient data for effectiveness against chronic pain associated with older vertebral fracture.

100 to 300 units/day intranasally.

†Indicates off-label use

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.

Calcifediol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcitriol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcium Acetate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcium Carbonate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcium Carbonate; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcium Chloride: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcium Gluconate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Calcium; Vitamin D: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Chromium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Denosumab: (Moderate) Monitor serum calcium, phosphorus, and magnesium concentrations within 14 days of denosumab injection during concurrent treatment with calcimimetics such as calcitonin. The risk for hypocalcemia and other disturbances of mineral metabolism may increase during coadministration. Monitor serum calcium concentrations closely in patients with severe renal impairment (CrCl less than 30 mL/minute) or renal failure (and/or on dialysis) receiving calcimimetics. An increased risk of hypocalcemia was seen in clinical trials involving patients with renal dysfunction. Instruct patients to seek medical care if symptoms of hypocalcemia develop.
Doxercalciferol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Folic Acid, Vitamin B9: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Lithium: (Moderate) Reduced serum lithium concentrations have been observed in previously stabilized patients who initiated daily calcitonin salmon subcutaneous injections for osteoporosis. The mechanism is not clear, but serum lithium concentrations were reduced to 30% of the baseline value in all patients studied, and fell below normal therapeutic ranges. Increased urinary lithium clearance is a proposed mechanism for the interaction.
Paricalcitol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Pyridoxine, Vitamin B6: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.
Vitamin D analogs: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels.

Calcitonin/Calcitonin (Salmon)/Fortical/Miacalcin Nasal Spray Met: 1actuation, 200IU
Calcitonin/Calcitonin (Salmon)/Miacalcin Intramuscular Inj Sol: 1mL, 200U
Calcitonin/Calcitonin (Salmon)/Miacalcin Subcutaneous Inj Sol: 1mL, 200U

200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously.

200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously.

Safety and efficacy have not been established; off-label use reported for selected conditions.

Safety and efficacy have not been established; off-label use reported for selected conditions.

Safety and efficacy have not been established.

Calcitonin is a is a peptide hormone secreted by the C-cells of the thyroid gland endogenously; calcitonin-salmon is a calcitonin receptor agonist. Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin-salmon appears to have actions essentially identical to endogenous calcitonin of mammalian origin, but its potency per mg is greater than endogenous calcitonin, and it has a longer duration of action. The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts.[27980] [52559] [57624]
 
Calcitonin is a hypocalcemic hormone whose effects are generally opposite those of parathyroid hormone (PTH). Calcitonin helps maintain calcium homeostasis. Secretion of calcitonin is regulated by serum calcium; high serum calcium increases the release of calcitonin. Catecholamines, glucagon, gastrin, or cholecystokinin may stimulate calcitonin secretion. Calcitonin directly inhibits osteoclasts, binding to plasma membrane receptors and increasing intracellular cyclic adenosine monophosphate (cAMP), as well as interfering with the membrane transport mechanisms of phosphate and calcium. Calcitonin lowers serum calcium concentrations by inhibiting bone resorption with subsequent decreases in elevated serum alkaline phosphatase concentrations and urinary hydroxyproline levels. The release of calcium and phosphate from bone is reduced, and the extent of collagen breakdown is decreased. Calcitonin antagonizes the actions of PTH, but concentrations of PTH do not increase significantly in response to calcitonin therapy. Calcitonin also has activity outside the bone. In the kidney, calcitonin increases the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption. In some patients, the inhibition of bone resorption is of such a magnitude that the consequent of reduction of filtered calcium load more than compensates for the decrease in tubular reabsorption of calcium. The result is a decrease in urinary calcium. Short-term administration results in a marked transient decrease in the volume and acidity of gastric secretions and the volume and the trypsin and amylase content of pancreatic secretions.
 
Calcitonin has an antinociceptive activity that is independent of its action on bone resorption; the mechanism is not explicitly known. The analgesic effect appears to be evident for acute vertebral fractures due to osteoporosis; there is no sufficient evidence that the drug has effectiveness for pain due to prior fracture.[24558] [24298]

Calcitonin is given parenterally (preferably by subcutaneous or intramuscular injection) or intranasally since calcitonin is destroyed in the GI tract.
 
It is not known whether calcitonin crosses the blood-brain barrier or if it distributes into breast milk. Calcitonin does not appear to cross the placenta. The metabolic fate of calcitonin has not been clearly established, but it is believed to be rapidly degraded by the kidneys, blood, and peripheral tissues into smaller inactive fragments. The half-life of salmon calcitonin is about 1 hour. Elimination half-life of intranasal salmon calcitonin is approximately 43 minutes. Calcitonin is excreted primarily in the urine as inactive metabolites.

Onset of action of calcitonin is immediate following IV administration. Peak effects are observed within 4 hours after parenteral administration. The duration of effect is 0.5—12 hours after IV administration.

Following IM administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. Peak effects are observed within 4 hours after parenteral administration. The duration of effect is 8—24 hours after intramuscular administration.

Following subcutaneous administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. Peak effects are observed within 4 hours after parenteral administration. The duration of effect is 8—24 hours after subcutaneous administration.

Intranasal Route
Absorption through the nasal mucosa is rapid, with peak plasma concentrations achieved in 31—39 minutes. The bioavailability of intranasal calcitonin-salmon appears to be variable. In normal volunteers, bioavailability of the intranasal formulation compared to the parenteral product is 3%, with a range of 0.3—30.6%.

Calcitonin-salmon should be used during pregnancy only if the potential benefit justifies the use versus potential risks to the patient or fetus. There are no adequate studies of calcitonin-salmon injection during pregnancy to inform a drug associated risk for birth defects or miscarriage. Based on animal data, calcitonin-salmon nasal spray is predicted to have a low probability of increasing the risk of adverse developmental outcomes above background risk. When studied in rabbits, salmon calcitonin-salmon decreased fetal birth weights when given by subcutaneous injection in doses 4 to 18 times the recommended human parenteral dose and 70 to 278 times the recommended human intranasal dose (based on body surface area). No embryo/fetal toxicities related to calcitonin-salmon were reported from maternal subcutaneous daily calcitonin-salmon doses in rats up to 80 International Units/kg/day from gestation day 6 to 15.[27980] [52559] [57624]

Use calcitonin with caution during breast-feeding. There is no information on the presence of calcitonin in human milk, the effects on the breast-fed infant, or the effects on milk production. Calcitonin-salmon has been shown to inhibit lactation in rats.[27980] [52559] [57624] Due to species-specific differences in lactation physiology, animal data may not reliably predict human response. Human milk naturally contains some calcitonin and its precursor, procalcitonin. Because it is a large peptide, any systemic absorption by the infant is unlikely because it is probably destroyed in the infant's gastrointestinal tract.[62369] The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for calcitonin and any potential adverse effects on the breast-fed infant from calcitonin or the underlying maternal condition.[27980] [52559] [57624]