Somatuline Depot

Somatostatin and analogs

For storage information, see specific product information within the How Supplied section.

Visually inspect parenteral products for particulate matter and discoloration prior to administration, whenever solution and container permit.

Lanreotide depot injection is administered via deep subcutaneous (SC) injection only.
Preparation:
30 minutes prior to injection, remove the sealed syringe pouch from the refrigerator and allow it to come to room temperature. Keep pouch sealed until just before injection.
The content of the prefilled syringe should have a viscous, gel-like appearance and may also contain micro bubbles that can clear up during injection. This is normal and does not interfere with the quality of the product.
Product left in its sealed pouch may be returned to the refrigerator for continued storage and later use if kept at room temperature (less than 104 degrees F or 40 degrees C) for up to 72 hours.
 
Administration:
Inject and administer medication slowly over 20 seconds via deep subcutaneous injection into the superior external quadrant (outer area) of the buttock.
Alternate injection sites between the right and left sides of the buttocks with each injection.

bradycardia / Rapid / 2.2-23.0
abdominal pain / Early / 0-6.0
vomiting / Early / 0-2.0
musculoskeletal pain / Early / 0-2.0
cholelithiasis / Delayed / 0-1.0
pancreatitis / Delayed / 0-1.0
hypertension / Early / 0-1.0
cholecystitis / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
hypertensive crisis / Early / Incidence not known

hyperglycemia / Delayed / 0-14.0
diabetes mellitus / Delayed / 0-14.0
anemia / Delayed / 5.0-14.0
antibody formation / Delayed / 0-11.0
constipation / Delayed / 5.0-8.0
hypoglycemia / Early / 0-7.0
depression / Delayed / 0-7.0
dyspnea / Early / 0-6.0
hypothyroidism / Delayed / 0-1.0
cholangitis / Delayed / Incidence not known
hematoma / Early / Incidence not known

diarrhea / Early / 26.0-65.0
injection site reaction / Rapid / 6.0-17.0
headache / Early / 5.0-16.0
flatulence / Early / 0-14.0
weight loss / Delayed / 8.0-11.0
nausea / Early / 9.0-11.0
arthralgia / Delayed / 7.0-10.0
dizziness / Early / 0-9.0
steatorrhea / Delayed / Incidence not known
pruritus / Rapid / Incidence not known
rash / Early / Incidence not known
myalgia / Early / Incidence not known
back pain / Delayed / Incidence not known

Somatuline Depot

Rx

Subcutaneous, long-acting analog of somatostatin given as depot injection
Used for the treatment of acromegaly, gastroenteropancreaticneuroendocrine tumors (GEP-NETs), and carcinoid syndrome
May decrease gallbladder motility and lead to gallstone formation; may also affect blood glucose and thyroid function tests, and may cause bradycardia

Initially, 90 mg via deep subcutaneous injection every 4 weeks for 3 months. After 3 months, adjust dose based on growth hormone (GH) concentration, insulin growth factor-1 (IGF-1), and clinical symptoms. In patients with a GH concentration more than 1 ng/mL but 2.5 ng/mL or less, and clinical symptoms are controlled, continue administering 90 mg subcutaneously every 4 weeks. In patients with a GH concentration more than 2.5 ng/mL, IGF-1 is elevated, and/or clinical symptoms are uncontrolled, increase dose to 120 mg subcutaneously every 4 weeks. In patients with a GH concentration 1 ng/mL or less, IGF-1 is normal, and clinical symptoms are controlled, decrease the dose to 60 mg subcutaneously every 4 weeks. Thereafter, adjust the dose based on patient response, serum GH or IGF-1 concentrations, and/or changes in symptoms of acromegaly. Patients who are controlled on 60 mg or 90 mg may be considered for an extended dosing interval of 120 mg every 6 or 8 weeks. Obtain GH and IGF-1 concentrations 6 weeks after this change in dosing regimen to evaluate persistence of patient response.

120 mg by deep subcutaneous injection every 4 weeks. In a multicenter, randomized, double-blind, placebo-controlled clinical trial of patients with unresectable, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (NET), treatment with lanreotide (n = 101) was compared to placebo (n= 103). Lanreotide was associated with a significant improvement in median progression-free survival compared with placebo (not reached at 22 months vs. 16.6 months). In clinical studies of patients with these tumors, symptom reduction is often evident; in patients with flushing as the target symptom, 65% experienced at least a 50% reduction in symptoms, as did 18% of patients with diarrhea as the target symptom.

120 mg by deep subcutaneous injection every 4 weeks. If patients are already receiving lanreotide for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), do not administer an additional dose for the treatment of carcinoid syndrome. In a multicenter, randomized, double-blind clinical trial, patients treated with lanreotide (n = 59) experienced significantly fewer days on rescue medication compared with patients in the placebo arm (n = 56) (34% vs. 49% of days). Patients treated with lanreotide also had fewer average daily frequencies of diarrhea and flushing events compared with those who received placebo.

NOTE: This dosage form is not available in the US. Initially, 30 mg via IM injection once every 14 days; if the therapeutic response is inadequate, as measured by thyroid hormone concentrations and TSH, the dose may be increased to 30 mg every 10 days. In an open label trial, 18 patients with hyperthyroidism secondary to a TSH-secreting pituitary tumor received 30 mg every 14 days for 1 month; after 1 month and based on free T3 concentrations, 7 patients required injections every 10 days while the remainder continued to receive lanreotide every 14 days. Within 1 month, the clinical signs of hyperthyroidism improved; furthermore, by 6 months, both TSH and thyroid hormone concentrations were reduced, with 13 patients achieving concentrations within the normal range.

60 mg to 120 mg subcutaneously every 4 to 6 weeks has been associated with significant improvement in mean hemoglobin. Guidelines recommend somatostatin analogs for red blood cell transfusion-dependent bleeding secondary to GI angioectasias that cannot be adequately controlled with endoscopic therapy; however, octreotide appears to be more effective than lanreotide.

†Indicates off-label use

Acromegaly:
Mild hepatic impairment: No dosage adjustment is recommended.
Moderate to severe hepatic impairment (Child-Pugh Class B or C): Reduce the starting dose to 60 mg by deep subcutaneous injection once every 4 weeks. After 3 months of treatment, adjust the dose based on clinical response.

Acromegaly:
CrCL 60 mL/min or higher: No dose adjustment is recommended.
CrCL less than 59 mL/min: Reduce the starting dose to 60 mg by deep subcutaneous injection once every 4 weeks. After 3 months, adjust the dose based on clinical response. Caution should be exercised when considering these patients for an extended dosing interval (e.g., 120 mg subcutaneously every 6 or 8 weeks).
 
Neuroendocrine Tumors: It appears that dosage adjustments for renal impairment are not necessary.

Acarbose: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Acebutolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Alogliptin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Alogliptin; Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Alogliptin; Pioglitazone: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Amlodipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Amlodipine; Atorvastatin: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Amlodipine; Benazepril: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Amlodipine; Celecoxib: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Amlodipine; Olmesartan: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Amlodipine; Valsartan: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Antidiabetic Agents: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Atenolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Atenolol; Chlorthalidone: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Beta-adrenergic blockers: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Betaxolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Bisoprolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Brimonidine; Timolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Bromocriptine: (Moderate) Monitor for an increase in bromocriptine-related adverse reactions if coadministration with lanreotide is necessary. Limited published data indicate that concomitant administration of a somatostatin analog and bromocriptine may increase the absorption of bromocriptine.
Calcium-channel blockers: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Canagliflozin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Canagliflozin; Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Carteolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Carvedilol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Chlorpropamide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Clevidipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Cyclosporine: (Moderate) Monitor cyclosporine levels if coadministration of cyclosporine with lanreotide is necessary; adjust the dose of cyclosporine as necessary to maintain therapeutic drug concentrations. Concomitant administration of lanreotide with cyclosporine may decrease the absorption of cyclosporine.
Dapagliflozin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Dapagliflozin; Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Dapagliflozin; Saxagliptin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Dextromethorphan; Quinidine: (Major) Monitor ECGs for QT prolongation and watch for an increase in quinidine-related adverse reactions if coadministration with lanreotide is necessary. Quinidine is a CYP3A4 substrate with a narrow therapeutic range. Limited published data available indicate that somatostatin analogs may decrease the metabolic clearance of CYP3A4 substrates, which may be due to the suppression of growth hormone; it cannot be excluded that lanreotide has this effect.
Diltiazem: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Dorzolamide; Timolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Dulaglutide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Empagliflozin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Empagliflozin; Linagliptin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Empagliflozin; Linagliptin; Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Empagliflozin; Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Ertugliflozin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Ertugliflozin; Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Ertugliflozin; Sitagliptin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Esmolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Exenatide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Felodipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Gallium Ga 68 Dotatate: (Moderate) Image patients with gallium Ga 68 dotatate just prior to dosing with non-radioactive, long-acting somatostatin analogs. Short-acting analogs of somatostatin can be used up to 24 hours before imaging with gallium Ga 68 dotatate. These drugs may competitively bind to the same somatostatin receptors.
Glimepiride: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Glipizide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Glipizide; Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Glyburide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Glyburide; Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Insulin Aspart: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Insulin Aspart; Insulin Aspart Protamine: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Insulin Degludec; Liraglutide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Insulin Detemir: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Insulin Glargine: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Insulin Glargine; Lixisenatide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Insulin Glulisine: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Insulin Lispro: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Insulin Lispro; Insulin Lispro Protamine: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Insulin, Inhaled: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Isophane Insulin (NPH): (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Isradipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Labetalol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Levamlodipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Levobunolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Linagliptin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Linagliptin; Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Liraglutide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Lixisenatide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Lutetium Lu 177 dotatate: (Major) Discontinue long-acting lanreotide at least 4 weeks prior to beginning treatment with lutetium Lu 177 dotatate. A short-acting somatostatin analog may be administered as-needed, but must be discontinued at least 24 hours prior to each lutetium Lu 177 dotatate dose. Somatostatin and its analogs, such as lanreotide, competitively bind to somatostatin receptors and may interfere with the efficacy of lutetium Lu 177 dotatate.
Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Metformin; Repaglinide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Metformin; Rosiglitazone: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Metformin; Saxagliptin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Metformin; Sitagliptin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Metoprolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Metoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Miglitol: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Nadolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Nateglinide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Nebivolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Nebivolol; Valsartan: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Nicardipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Nifedipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Nimodipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Nisoldipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Perindopril; Amlodipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Pindolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Pioglitazone: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Pioglitazone; Glimepiride: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Pioglitazone; Metformin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Pramlintide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Propranolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Propranolol; Hydrochlorothiazide, HCTZ: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Quinidine: (Major) Monitor ECGs for QT prolongation and watch for an increase in quinidine-related adverse reactions if coadministration with lanreotide is necessary. Quinidine is a CYP3A4 substrate with a narrow therapeutic range. Limited published data available indicate that somatostatin analogs may decrease the metabolic clearance of CYP3A4 substrates, which may be due to the suppression of growth hormone; it cannot be excluded that lanreotide has this effect.
Regular Insulin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Regular Insulin; Isophane Insulin (NPH): (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Repaglinide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Rosiglitazone: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Saxagliptin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Semaglutide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Sitagliptin: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Sotalol: (Moderate) Concomitant administration of bradycardia-inducing drugs such as sotalol may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the dose of sotalol if necessary.
Telmisartan; Amlodipine: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Timolol: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., beta-adrenergic blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the beta-blocker dose if necessary.
Tolazamide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Tolbutamide: (Moderate) Monitor blood glucose levels regularly in patients with diabetes, especially when lanreotide treatment is initiated or when the dose is altered. Adjust treatment with antidiabetic agents as clinically indicated. Lanreotide inhibits the secretion of insulin and glucagon. Patients treated with lanreotide may experience either hypoglycemia or hyperglycemia.
Trandolapril; Verapamil: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.
Verapamil: (Moderate) Concomitant administration of bradycardia-inducing drugs (e.g., calcium-channel blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Adjust the calcium-channel blocker dose if necessary.

Lanreotide/Somatuline Depot Subcutaneous Inj Sol: 0.2mL, 0.3mL, 0.5mL, 60mg, 90mg, 120mg

120 mg/dose subcutaneously every 4 weeks.

120 mg/dose subcutaneously every 4 weeks.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Lanreotide is an analog of somatostatin, and is believed to have a mechanism of action similar to that of endogenous somatostatin. Lanreotide has a high affinity for human somatostatin receptors (SSTR) 2 and 5 and a reduced binding affinity for human SSTR 1, 3, and 4. Activity at SSTR 2 and 5 is the primary mechanism believed to be responsible for growth hormone (GH) inhibition. Clinically, lanreotide reduces GH and insulin growth factor-1 (IGF-1) concentrations allowing for normalization of these hormones in patients with acromegaly. Lanreotide reductions in GH are dose-dependent, and the reductions are sustained for at least 28 days after a single injection of the depot formulation. In addition, lanreotide inhibits various endocrine, neuroendocrine, exocrine, and paracrine functions including the basal secretion of motilin, gastric inhibitory peptide, and pancreatic polypeptide as well as inhibition of the postprandial secretion of pancreatic polypeptide, gastrin, and cholecystokinin. Lanreotide also modifies glucose hemostasis; it reduces and delays the secretion of post-prandial insulin secretion, which results in a transient, mild glucose intolerance. In addition, non-significant reductions in glucagon concentrations may occur after lanreotide administration, which temporarily decreases glucose concentrations by 20—30%. Other effects include inhibition of meal-stimulated pancreatic secretions, reduction in duodenal bicarbonate and amylase concentrations, reduction in gastric acidity, inhibition of gallbladder contractility and bile secretion, inhibition of meal-induced increases in superior mesenteric artery and portal venous blood flow, and inhibition of the nocturnal increase in thyroid-stimulating hormone secretion. Finally, long-term lanreotide also decreases prolactin concentrations in patients with acromegaly.

Lanreotide depot is administered via deep subcutaneous injection. Lanreotide depot is thought to form a drug depot at the injection site by interacting with physiological fluids. The most likely mechanism of drug release is a passive diffusion of the precipitated drug from the depot towards the surrounding tissues, followed by absorption into the blood stream. Less than 5% of lanreotide is excreted in the urine and less than 0.5% is recovered unchanged in the feces, indicative of some biliary excretion.
 
Affected Cytochrome P450 (CYP450) enzymes and drug transporters: CYP3A4
Lanreotide suppresses growth hormone secretion, which may cause a decrease in the metabolic clearance of drugs metabolized by CYP3A4. There is potential for drug-drug interactions with medications that are metabolized by CYP3A4 and also have a narrow therapeutic index.

After a single, deep subcutaneous depot injection, the mean absolute bioavailability in healthy subjects is 73.4%, 69%, and 78.4% for the 60, 90, and 120 mg doses, respectively. Mean Cmax values range from 4.3 to 8.4 ng/mL during the first day in healthy volunteers, and 3.8 +/- 0.5 ng/mL to 7.7 +/- 2.5 ng/mL in patients with acromegaly. Single-dose linearity occurs with respect to AUC and Cmax, although there is high inter-subject variability. Lanreotide depot demonstrates sustained release of lanreotide with a half-life of 23 to 30 days. Mean serum concentrations are greater than 1 ng/mL throughout 28 days after 90 mg and 120 mg injections; mean serum concentrations are greater than 0.9 ng/mL through 28 days after a 60 mg injection. In patients with acromegaly, the accumulation ratio index was 2.7, and the steady state trough concentrations when administered every 28 days were 1.8 +/- 0.3 ng/mL (60 mg), 2.5 +/- 0.9 ng/mL (90 mg), and 3.8 +/- 1 ng/mL (120 mg). A limited initial burst of effect and a low peak-to-trough fluctuation (81% to 108%) of the serum concentration at the plateau were observed. Pharmacokinetic data from studies evaluating extended dosing of lanreotide depot 120 mg demonstrated a mean Cmin of 1.6 ng/mL for the 8-week interval and 2.3 ng/mL for the 6-week interval. Steady state concentrations were reached after 4 to 5 injections in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), with mean trough concentrations of 5.3 to 8.6 ng/mL.

Use lanreotide with caution in females of reproductive potential. Although there are no adequately controlled studies in pregnant women, decreased embryofetal survival and increased fetal skeletal/soft tissue abnormalities were observed in pregnant rats and rabbits at exposures equivalent to 5-times and 2-times the maximum recommended human dose of 120 mg. Limited data based on postmarketing case reports with lanreotide use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. Women who are pregnant or who become pregnant while receiving lanreotide should be apprised of the potential hazard to the fetus.

Due to the potential for serious adverse reactions in nursing infants from lanreotide, including effects on glucose metabolism and bradycardia, advise women to discontinue breast-feeding during treatment and for 6 months after the final dose. It is not known whether lanreotide is present in human milk, although many drugs are excreted in human milk.