Dosing & Uses
Dosage Forms & Strengths
injection solution
- 60mg/0.2mL
- 90mg/0.3mL
- 120mg/0.5mL
Acromegaly
Indicated for acromegaly in patients with failed or contraindicated radiation/surgery
90mg SC q4Week for 3 months; THEN adjust based on GH and/or IGF-1 levels
Dose adjustments after 3 months
- GH >1 to ≤2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: Maintain dose at 90 mg q4Week
- GH >2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled: Increase dose to 120 mg q4Week
- GH ≤1 ng/mL, IGF-1 normal and clinical symptoms controlled: Reduce dose to 60 mg q4Week
- Patients controlled on 60-90 mg q4Week may be considered for an extended dosing interval of 120 mg q6-8Week
Gastroenteropancreatic Neuroendocrine Tumors
Indicated for unresectable, well-or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival
120 mg SC q4Week
Carcinoid Syndrome
Indicated for carcinoid syndrome
120 mg SC q4Week
Dosage Modifications
Renal impairment
Acromegaly
- Mild: Safety and efficacy not established
- Moderate-severe: 60 mg deep SC q4Week for 3 months initially; adjust based on GH and/or IGF-I levels thereafter
Gastroenteropancreatic neuroendocrine tumors
- Mild-moderate: No dosage adjustment necessary
- Moderate-severe: Safety and efficacy not established
Hepatic impairment
- Gastroenteropancreatic neuroendocrine tumors: Safety and efficacy not established
Acromegaly
- Mild: Safety and efficacy not established
- Moderate-severe (Child Pugh B or C): 60 mg deep SC q4Week for 3 months initially; adjust based on GH and/or IGF-I levels thereafter
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- ponesimod
ponesimod, lanreotide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Consult cardiologist if considering treatment. Coadministration of ponesimod with drugs that decrease HR may have additive effects on decreasing HR and should generally not be initiated in these patients.
- vilazodone
lanreotide increases levels of vilazodone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If intolerable adverse effects occur when coadministered with moderate CYP3A4 inhibitors, reduce daily dose to 20 mg.
Monitor Closely (23)
- bromocriptine
lanreotide increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Somatropin may increase CYP450 enzymes and, therefore, suppression of growth hormone secretion by somatostatin analogs including pasireotide may decrease the metabolic clearance of compounds metabolized by CYP450 enzymes.
- copper CU 64 dotatate
lanreotide decreases effects of copper CU 64 dotatate by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as CU 64 dotatate and may affect imaging. Image patients just prior to dosing with somatostatin analogs. Washout period of 28 days recommended for patients on long-acting somatostatin analogs before imaging; whereas, 2 days washout recommended for short-acting somatostatin analogs.
- cyclosporine
lanreotide decreases levels of cyclosporine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- dienogest/estradiol valerate
lanreotide will increase the level or effect of dienogest/estradiol valerate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor for potential adverse effects such as nausea, irregular uterine bleeding, breast tenderness and headache.
- gallium Ga 68 dotatate
lanreotide decreases effects of gallium Ga 68 dotatate by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatate and may affect imaging. Image patients with Ga 68 dotatate PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatate.
- gallium Ga 68 dotatoc
lanreotide decreases effects of gallium Ga 68 dotatoc by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatoc and may affect imaging. Image patients with Ga 68 dotatoc PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatoc.
- insulin aspart
lanreotide increases effects of insulin aspart by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- insulin aspart protamine/insulin aspart
lanreotide increases effects of insulin aspart protamine/insulin aspart by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- insulin degludec
lanreotide, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
lanreotide increases effects of insulin degludec by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring. - insulin degludec/insulin aspart
lanreotide, insulin degludec/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
- insulin detemir
lanreotide increases effects of insulin detemir by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- insulin glargine
lanreotide increases effects of insulin glargine by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- insulin glulisine
lanreotide increases effects of insulin glulisine by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- insulin inhaled
lanreotide, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
lanreotide increases effects of insulin inhaled by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring. - insulin isophane human/insulin regular human
lanreotide increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- insulin lispro
lanreotide increases effects of insulin lispro by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- insulin lispro protamine/insulin lispro
lanreotide increases effects of insulin lispro protamine/insulin lispro by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- insulin NPH
lanreotide increases effects of insulin NPH by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- insulin regular human
lanreotide increases effects of insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- lurasidone
lanreotide increases levels of lurasidone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Manufacturer recommends decreasing starting dose of lurasidone to 20 mg/day and maximum daily dose of lurasidone 80 mg when coadministered with moderate CYP3A4 inhibitors. Concurrent use may increase risk of lurasidone-related adverse reactions.
- lutetium Lu 177-dota-tate
lanreotide decreases effects of lutetium Lu 177-dota-tate by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as lutetium Lu 177-dota-tate and may affect its efficacy. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hr prior to each lutetium Lu 177-dota-tate dose. Administer short- and long-acting octreotide during treatment as recommended.
- metformin
lanreotide decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor.
- nateglinide
nateglinide, lanreotide. Other (see comment). Use Caution/Monitor. Comment: Somatostatin analogues may potentiate or attenuate nateglinide's hypoglycemic action.
Minor (0)
Adverse Effects
>10%
Abdominal pain (19%)
Cholelithiasis (20%)
Diarrhea (57%)
Nausea (11%)
Bradyarrhythmia (5% to 18% )
Injection site reaction (subcutaneous depot, 6% to 22% ; intramuscular, up to 50% )
Flatulence (up to 14% )
Anemia (3% to 14% )
1-10%
Arthralgia (7%)
Constipation (8%)
Headache (7%)
Loose stools (6%)
Vomiting (7%)
Hyper-/hypoglycemia/diabetes (7%)
Sinus bradycardia (3%)
<1%
Injection site pruritus
Steatorrhea
Aortic valve regurgitation
Allergic skin reaction
Mitral valve regurgitation
Pancreatitis
Postmarketing Reports
Angioedema
Anaphylaxis
Gastrointestinal disorders: Abdominal pain, diarrhea, and steatorrhea
Hepatobiliary disorders: Cholecystitis, pancreatitis
General disorders and administration site conditions: Injection site reactions
Cardiac: Hypertension
Injection site reacsions: Injection site abscess
Warnings
Contraindications
Hypersensitivity to lanreotide
Cautions
Risk of reducing gallbladder motility, which could lead to gallstone formation; monitor periodically
Inhibition of insulin and glucagon secretion; may affect glucose regulation, which can lead to hyper-hypoglycemia; glucose monitoring is recommended; adjust antidiabetic treatment accordingly
Decreases in thyroid function reported; thyroid function tests are recommended where clinically indicated
Bradycardia, hypertension, and sinus bradycardia reported; use with caution in at-risk patients; initiate appropriate medical management in patients who develop symptomatic bradycardia
Pharmacological gastrointestinal effects of lanreotide may reduce the intestinal absorption of concomitant drugs; lanreotide may decrease the relative bioavailability of cyclosporine; concomitant administration of lanreotide and cyclosporine may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels
Cholelithiasis (gallstones) resulting in complications, including cholecystitis, cholangitis, and pancreatitis, and requiring cholecystectomy reported; if complications of cholelithiasis are suspected, discontinue therapy and treat appropriately
Use caution in renal/hepatic impairment, diabetes
Pregnancy & Lactation
Pregnancy
Limited available data based on postmarketing case reports, use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes
A reproductive study in pregnant rats given 30 mg/kg of lanreotide by subcutaneous injection every 2 weeks (5 times the human dose, based on body surface area comparisons) resulted in decreased embryo/fetal survival
Lactation
There is no information available on presence of lanreotide in human milk, effects of drug on breastfed infant, or on milk production; studies show that lanreotide acetate administered subcutaneously passes into the milk of lactating rats; due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk
Because of potential for serious adverse reactions in breastfed infants, including effects on glucose metabolism and bradycardia, advise women not to breastfeed during treatment and for 6 months (6 half-lives) following the last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Analog of somatostatin, which is a peptide inhibitor of multiple endocrine, neuroendocrine, and exocrine mechanisms
Absorption
Peak plasma concentration (single dose): 3.8 ng/mL (60 mg-dose); 5.7 ng/mL (90 mg-dose); 7.7 ng/mL (120 mg-dose)
Peak plasma time: 7-12 hr
Distribution
Protein binding: 79-83%
Vd: 0.2 L/kg
Bioavailability: ~69-83%
Metabolism
Half-Life: 23-36 days
Excretion: Urine (<5%); feces (<0.5%)
Administration
SC Preparation
Remove lanreotide from refrigerator 30 minutes prior to administration; allow to come to room temperature
Visually inspect injection for particulate matter and discoloration
Do not administer if particulate matter or discoloration is observed
SC Administration
Administer as a deep SC injection only in the superior external quadrant of the buttock
Alternate the injection site between the right and left sides from one injection to another
Storage
Store in refrigerator at 2-8°C (36- 46°F)
Protect from light
Store in the original package
Images
Patient Handout
lanreotide subcutaneous
LANREOTIDE DEPOT - INJECTION
(lan-REE-oh-tide)
COMMON BRAND NAME(S): Somatuline
USES: This medication is a long-acting form of lanreotide. Lanreotide is used to treat a condition called acromegaly that occurs when the body makes too much of a certain natural substance called growth hormone. It is used when surgery or radiation treatment have not been fully successful or cannot be used. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Lanreotide works by decreasing the amount of growth hormone to normal levels.This drug is not a cure for acromegaly. It is used for the long-term treatment of this condition.This medication is also used to treat certain cancer or tumors of the stomach, intestines, or pancreas. It may help to slow down the growth of these tumors. Lanreotide is also used to treat carcinoid syndrome. It may help reduce the need to use another medication to treat diarrhea or flushing caused by carcinoid syndrome.
HOW TO USE: Read the Patient Information Leaflet provided by your doctor or pharmacist before you start using lanreotide and before each monthly injection since there may be new information. If you have any questions, consult your doctor or pharmacist.This medication is given by injection deep under the skin of your buttock by a health care professional as directed by your doctor, usually once every 4 weeks. To reduce irritation from the injection, your doctor will alternate between the left and right buttock with each dose. The dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder (such as every 4 weeks).Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Headache, muscle/joint pain, dizziness, nausea, vomiting, loose stools, diarrhea, constipation, stomach upset, gas, or weight loss may occur. Pain and irritation at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of gallbladder problems/gallstones (such as fever, stomach/abdominal pain, severe nausea/vomiting, yellowing eyes/skin, unexplained pain in the back/right shoulder), signs of an underactive thyroid (such as unexplained weight gain, cold intolerance, severe constipation, unusual/extreme tiredness, growth/lump/swelling on the front of the neck), slow heartbeat, mental/mood changes (such as depression).This medication may rarely cause changes in blood sugar, especially if you have diabetes. Symptoms of high blood sugar include increased thirst and urination. Symptoms of low blood sugar include nervousness, shakiness, sweating, fast heartbeat, and hunger. Tell your doctor right away if you experience symptoms of high or low blood sugar while using this medication. Monitor your blood sugar levels as directed by your doctor. Your doctor may need to adjust your diabetes medications.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using lanreotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex found in the packaging), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, diabetes, heart problems (such as slow heartbeat, high blood pressure, heart valve problems), thyroid problems, gallbladder problems (such as gallstones).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: beta blockers (such as metoprolol, propranolol), pegvisomant.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as growth hormone levels, blood glucose tests, thyroid function, blood pressure, heart rate) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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