Medically reviewed by Drugs.com. Last updated on July 6, 2020.
(lan REE oh tide)
- Lanreotide (Long-Acting Aqueous)
- Lanreotide Acetate
- Lanreotide Autogel
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous [preservative free]:
Somatuline Depot: 120 mg/0.5 mL (0.5 mL); 60 mg/0.2 mL (0.2 mL); 90 mg/0.3 mL (0.3 mL)
Brand Names: U.S.
- Somatuline Depot
- Somatostatin Analog
Lanreotide is a synthetic octapeptide analogue of natural somatostatin which is a peptide inhibitor of multiple endocrine, neuroendocrine, and exocrine mechanisms. Lanreotide displays a greater affinity for somatostatin type 2 (SSTR2) and type 5 (SSTR5) receptors found in pituitary gland, pancreas, and growth hormone (GH) secreting neoplasms of pituitary gland and a lesser affinity for somatostatin receptors 1, 3, and 4. Lanreotide reduces GH secretion and also reduces the levels of insulin-like growth factor 1.
15.14 L (Trocóniz 2009)
Urine (<5% as unchanged drug); feces (<0.5% as unchanged drug)
Time to Peak
7 to 12 hours (Trocóniz 2009)
23 to 30 days
Special Populations: Renal Function Impairment
In patients with ESRD, there is approximately a 2-fold decrease in total serum clearance, with a consequent 2-fold increase in half-life and AUC.
Special Populations: Hepatic Function Impairment
A 30% reduction in clearance was observed in patients with moderate to severe hepatic impairment.
Special Populations: Elderly
Compared with healthy younger subjects, elderly subjects showed an 85% increase in half-life and a 65% increase in mean residence time.
Use: Labeled Indications
Acromegaly: Long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
The Endocrine Society and the Acromegaly Consensus Group suggest use of a first-generation long-acting somatostatin analog (eg, lanreotide, octreotide) as first-line therapy in patients with persistent disease despite surgical resection or in whom surgery is not appropriate. Alternative agents are suggested for patients with mild disease postoperatively. Preoperative use of somatostatin analogs is also suggested in select patients to reduce surgical risk from severe comorbidities, although there is conflicting evidence of the long-term benefit of this strategy (ACG [Melmed 2018], ES [Katznelson 2014]).
Carcinoid syndrome: Treatment of carcinoid syndrome in adults (to reduce the frequency of short acting somatostatin analog rescue therapy).
Gastroenteropancreatic neuroendocrine tumors: Treatment (to improve progression-free survival) of unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
Hypersensitivity to lanreotide or any component of the formulation
Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to somatostatin or related peptides; complicated, untreated bile duct lithiasis
Acromegaly: SubQ: Initial: 90 mg once every 4 weeks for 3 months; after initial 3 months, continue monitoring and adjust dose as necessary based on clinical response of patient, growth hormone (GH) levels, and/or insulin-like growth factor 1 (IGF-1) levels as follows:
GH ≤1 ng/mL, IGF-1 normal, symptoms stable: Decrease dose to 60 mg once every 4 weeks; once stabilized on 60 mg once every 4 weeks, may consider regimen of 120 mg once every 6 or 8 weeks (extended-interval dosing).
GH >1 to 2.5 ng/mL, IGF-1 normal, symptoms stable: Continue 90 mg once every 4 weeks; once stabilized on 90 mg once every 4 weeks, may consider regimen of 120 mg once every 6 or 8 weeks (extended-interval dosing).
GH >2.5 ng/mL, IGF-1 elevated and/or uncontrolled symptoms: Increase dose to 120 mg once every 4 weeks. In some cases, individualized doses of 180 mg once every 4 weeks or 120 mg once every 3 weeks have been used successfully in partial responders (Giustina 2017).
Note: If clinical and/or biochemical response is inadequate at maximum dosage, consider alternative agents (eg, pasireotide, pegvisomant) or starting combination therapy (eg, with pegvisomant or cabergoline) (ACG [Melmed 2018], ES [Katznelson 2014]).
Carcinoid syndrome: SubQ: 120 mg once every 4 weeks (if already receiving lanreotide for treatment of gastroenteropancreatic neuroendocrine tumors [GEP-NETs], do not administer an additional dose for carcinoid syndrome).
GEP-NETs: SubQ: 120 mg once every 4 weeks until disease progression or unacceptable toxicity.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
Allow to reach room temperature by removing sealed pouch from refrigerator 30 minutes prior to administration; keep in sealed pouch until just prior to administration. Product left in its sealed pouch at room temperature (<40°C [104°F]) for <24 hours may be returned to the refrigerator for storage and use at a later time. Lanreotide depot has a semi-solid phase with a gel-like viscous white to pale yellow appearance.
SubQ: Administer by deep subcutaneous injection (only) into superior outer quadrant of buttocks. Alternate injection sites between the right and left sides from one injection to the next. Remove sealed pouch from refrigerator 30 minutes prior to administration in order to reach room temperature. Keep pouch sealed until just prior to injection.
Store at 2°C to 8°C (36°F to 46°F). Protect from light; store in the original package.
Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy
Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy
Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Monitor therapy
Bromocriptine: Somatostatin Analogs may increase the serum concentration of Bromocriptine. Somatostatin Analogs may also delay bromocriptine absorption and time to maximum plasma concentrations. Monitor therapy
Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Consider therapy modification
Codeine: Somatostatin Analogs may decrease the metabolism of Codeine. The formation of two major codeine metabolites (morphine and norcodeine) may be impaired by somatostatin analogs. Monitor therapy
Copper Cu 64 Dotatate: Somatostatin Analogs may diminish the diagnostic effect of Copper Cu 64 Dotatate. Management: Imaging with copper Cu 64 dotatate positron emission tomography (PET) should be performed just prior to dosing with somatostatin analogs. If on somatostatin analogs, stop long-acting agents 28 days before, and short-acting agents 2 days before, imaging. Consider therapy modification
CycloSPORINE (Systemic): Somatostatin Analogs may decrease the serum concentration of CycloSPORINE (Systemic). Monitor therapy
Fexinidazole [INT]: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole [INT]. Avoid combination
Gallium Ga 68 Dotatate: Somatostatin Analogs may diminish the diagnostic effect of Gallium Ga 68 Dotatate. Specifically, a false negative PET scan may occur if Gallium GA 68 Dotatate is used during treatment with somatostatin analogs. Management: Imaging with gallium Ga 68 dotatate positron emission tomography (PET) should be performed just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hours before imaging with gallium Ga 68 dotatate. Consider therapy modification
Gallium Ga 68 Dotatoc: Somatostatin Analogs may diminish the diagnostic effect of Gallium Ga 68 Dotatoc. Management: Imaging with gallium Ga 68 dotatoc positron emission tomography (PET) should be performed just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hours before imaging with gallium Ga 68 dotatoc. Consider therapy modification
Herbs (Hypoglycemic Properties): May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy
Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Monitor therapy
Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Monitor therapy
Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Monitor therapy
Lutetium Lu 177 Dotatate: Somatostatin Analogs may diminish the therapeutic effect of Lutetium Lu 177 Dotatate. Specifically, the therapeutic effect of Lutetium Lu 177 Dotatate may be diminished if the timing of Somatostatin Analog administration is not carried out as recommended. Management: Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to lutetium Lu 177 dotatate dose. Administer short and long-acting octreotide during treatment as recommended. See full interaction monograph Consider therapy modification
Macimorelin: Somatostatin Analogs may diminish the diagnostic effect of Macimorelin. Avoid combination
Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy
Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy
Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy
Pegvisomant: Somatostatin Analogs may enhance the adverse/toxic effect of Pegvisomant. Specifically, this combination may increase the risk for significant elevations of liver enzymes. Monitor therapy
Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy
Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy
Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy
Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Monitor therapy
Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy
Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Consider therapy modification
Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Consider therapy modification
Terlipressin: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy
Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Cardiovascular: Bradycardia (3% to 18%), hypertension (5% to 14%)
Central nervous system: Headache (5% to 16%)
Dermatologic: Injection site pruritus (≤17%), rash at injection site (≤15%)
Endocrine & metabolic: Diabetes mellitus (≤14%), hyperglycemia (≤14%), hypoglycemia (≤14%), weight loss (5% to 11%)
Gastrointestinal: Diarrhea (26% to 65%), abdominal pain (7% to 34%), cholelithiasis (2% to 27%), vomiting (5% to 19%), flatulence (6% to 15%), nausea (9% to 11%)
Hematologic & oncologic: Anemia (3% to 14%)
Hepatic: Gallbladder sludge (≤20%)
Immunologic: Antibody development (≤11%)
Local: Inflammation at injection site (≤22%), injection site reaction (≤22%), pain at injection site (≤22%), residual mass at injection site (≤22%), induration at injection site (≤17%), injection site nodule (≤17%), bleeding at injection site (≤15%), discomfort at injection site (≤15%), hematoma at injection site (≤15%), injection site extravasation (≤15%), injection site granuloma (≤15%), swelling at injection site (≤15%)
Neuromuscular & skeletal: Musculoskeletal pain (19%)
1% to 10%:
Cardiovascular: Sinus bradycardia (3% to 7%)
Central nervous system: Dizziness (7% to 9%), depression (7%)
Gastrointestinal: Loose stools (6% to 9%), constipation (5% to 8%)
Neuromuscular & skeletal: Arthralgia (7% to 10%), muscle spasm (5%)
Respiratory: Dyspnea (6%)
<1%, postmarketing, and/or case reports: Abscess at injection site, anaphylaxis, angioedema, aortic insufficiency, cholecystitis, hypothyroidism, mitral valve insufficiency, pancreatitis, steatorrhea
Concerns related to adverse effects:
• Cholelithiasis: May reduce gall bladder motility, leading to gall stone formation (may be dose- or duration-related); may require periodic monitoring. Cholelithiasis and complications of cholelithiasis (eg, cholecystitis, cholangitis, pancreatitis) requiring cholecystectomy have been reported; discontinue and treat appropriately if suspected.
• Gastrointestinal effects: Diarrhea and loose stools may occur (may affect intestinal absorption of concurrently-administered medication); abdominal pain may also occur.
• Hyper-/hypoglycemia: Inhibition of insulin and glucagon secretion may affect glucose regulation, leading to hyper-/hypoglycemia. Carefully monitor blood glucose levels with the initiation of therapy and with dosage alterations. Use with caution in patients with diabetes; may require dosage adjustments in antidiabetic therapy.
• Hypersensitivity: Allergic reactions, including angioedema and anaphylaxis, have been reported.
• Thyroid disorders: Decreases (slight) in thyroid function have been observed during treatment for acromegaly; monitor thyroid function tests if clinically indicated. The incidence of clinical hypothyroidism is rare.
• Cardiac disorders: Bradycardia, sinus bradycardia, and hypertension have been observed with therapy. Use with caution in patients with preexisting cardiac disease; monitor heart rate. Patients without preexisting cardiac disease may experience a decrease in heart rate though not to the level of bradycardia. Appropriate medical therapy should be initiated if patients develop symptomatic bradycardia.
• Hepatic impairment: Use with caution in patients with acromegaly with moderate to severe hepatic impairment (systemic exposure may be increased); lower doses are recommended at therapy initiation. Lanreotide has not been studied in patients with neuroendocrine tumors with hepatic impairment.
• Renal impairment: Use with caution in patients with acromegaly with moderate to severe renal impairment; lower initial doses are recommended.
Serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) at 3 months and as clinically indicated in acromegaly patients (obtain levels 6 weeks after dose adjustment when switching to extended-interval dosing); blood glucose, glycemic control and antidiabetic regimen (patients with diabetes mellitus) should be assessed following initiation, then periodically or following dosage adjustments; thyroid function (where clinically indicated); heart rate, gallbladder monitoring if clinically indicated; routine gallbladder ultrasound is not considered necessary (ES [Katznelson 2014]).
Because normalization of insulin-like growth factor 1 and growth hormone may restore fertility in women with acromegaly, women of childbearing potential should use adequate contraception during treatment. The Endocrine Society suggests discontinuing long-acting formulations of somatostatin analogs approximately 2 months before attempts to conceive; short-acting octreotide may be used until conception if needed (Endocrine Society [Katznelson 2014]).
Information related to the use of lanreotide in pregnancy is limited (de Menis 1999; Teltayev 2017) and it is recommended to discontinue therapy during pregnancy (Endocrine Society [Katznelson 2014]). If treatment for acromegaly is required during pregnancy for worsening symptoms (eg, headaches or evidence of tumor growth), alternative agents are recommended. Monitoring of insulin-like growth factor 1 (IGF-1) and/or growth hormone (GH) is not recommended during pregnancy, as an active placental GH variant present in maternal blood limits the usefulness of the results (Endocrine Society [Katznelson 2014]).
What is this drug used for?
• It is used to treat acromegaly.
• It is used to treat a certain type of cancer called neuroendocrine tumor from the gastrointestinal tract or the pancreas (GEP-NETs).
• It is used to treat carcinoid syndrome.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Abdominal pain
• Passing gas
• Joint pain
• Muscle pain
• Muscle spasm
• Injection site irritation
• Weight loss
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit.
• Low blood sugar like dizziness, headache, fatigue, feeling weak, shaking, fast heartbeat, confusion, increased hunger, or sweating.
• Gallstones like pain in the upper right abdominal area, right shoulder area, or between the shoulder blades; yellow skin; or fever with chills.
• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting.
• Severe dizziness
• Passing out
• Severe headache
• Vision changes
• Thyroid problems like change in weight without trying, anxiety, agitation, feeling very weak, hair thinning, depression, neck swelling, trouble focusing, inability handling heat or cold, menstrual changes, tremors, or sweating.
• Chest pain
• Trouble with memory
• Slow heartbeat
• Shortness of breath
• Severe loss of strength and energy
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about lanreotide
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- 1 Review
- Drug class: somatostatin and somatostatin analogs
Other brands: Somatuline Depot