Somatuline Depot
(Lanreotide Acetate)Dosage & Administration
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Somatuline Depot Prescribing Information
Warnings & Precautions, Steatorrhea and Malabsorption of Dietary Fats (New onset steatorrhea, stool discoloration and loose stools have been reported in patients receiving somatostatin analogs, including SOMATULINE DEPOT. Somatostatin analogs reversibly inhibit secretion of pancreatic enzymes and bile acids, which may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new occurrence or worsening of these symptoms are reported in patients receiving SOMATULINE DEPOT, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly. | 07/2024 |
SOMATULINE DEPOT is a somatostatin analog indicated for:
- the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ()
1.1 AcromegalySOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.
- the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ()
1.2 Gastroenteropancreatic Neuroendocrine TumorsSOMATULINE DEPOT is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
- the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. ()
1.3 Carcinoid SyndromeSOMATULINE DEPOT is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
- For deep subcutaneous injection only.
- SOMATULINE DEPOT is intended for administration by a healthcare provider.
- Refer to the Instructions For Use (IFU) for complete administration instructions with illustrations.
- Remove SOMATULINE DEPOT from the refrigerator 30 minutes prior to administration and allow to come to room temperature.
- Keep pouch sealed until just prior to injection.
- Product left in its sealed pouch at room temperature (not to exceed 104°F or 40°C) for up to 72 hours may be returned to the refrigerator for continued storage and use at a later time.
- Prior to administration, inspect the SOMATULINE DEPOT syringe visually for particulate matter and discoloration. Do not administer if particulate matter or discoloration is observed. The content of the prefilled syringe is a semi-solid phase having a gel-like appearance, with viscous characteristics and a color varying from white to pale yellow. The supersaturated solution can also contain micro bubbles that can clear up during injection. These differences are normal and do not interfere with the quality of the product.
- Slowly administer for 20 seconds as a deep subcutaneous injection in the superior external quadrant of the buttock.
- Alternate the injection site between the right and left sides from one injection to the next.
- For deep subcutaneous injection only.
- Intended for administration by a healthcare provider.
- Administer in the superior external quadrant of the buttock.
- Alternate injection sites.
- For deep subcutaneous injection only.
- SOMATULINE DEPOT is intended for administration by a healthcare provider.
- Refer to the Instructions For Use (IFU) for complete administration instructions with illustrations.
- Remove SOMATULINE DEPOT from the refrigerator 30 minutes prior to administration and allow to come to room temperature.
- Keep pouch sealed until just prior to injection.
- Product left in its sealed pouch at room temperature (not to exceed 104°F or 40°C) for up to 72 hours may be returned to the refrigerator for continued storage and use at a later time.
- Prior to administration, inspect the SOMATULINE DEPOT syringe visually for particulate matter and discoloration. Do not administer if particulate matter or discoloration is observed. The content of the prefilled syringe is a semi-solid phase having a gel-like appearance, with viscous characteristics and a color varying from white to pale yellow. The supersaturated solution can also contain micro bubbles that can clear up during injection. These differences are normal and do not interfere with the quality of the product.
- Slowly administer for 20 seconds as a deep subcutaneous injection in the superior external quadrant of the buttock.
- Alternate the injection site between the right and left sides from one injection to the next.
- Acromegaly: 90 mg every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1 levels. See full prescribing information for titration regimen.
- GEP-NETs: 120 mg every 4 weeks.
- Carcinoid Syndrome: 120 mg every 4 weeks. If patients are already being treated with SOMATULINE DEPOT for GEP-NET, do not administer an additional dose for carcinoid syndrome.
- See full prescribing information for dosage adjustment in patients with acromegaly and renal or hepatic impairment. (,
2.3 Dosage Adjustment in Renal ImpairmentAcromegalyThe recommended starting dosage of SOMATULINE DEPOT in acromegalic patients with moderate or severe renal impairment (creatinine clearance less than 60 mL/min) is 60 mg via the deep subcutaneous route at 4-week intervals for 3 months followed by dosage adjustment
[see Dosage and Administration (2.2), Use in Specific Populations (8.6)].)2.4 Dosage Adjustment in Hepatic ImpairmentAcromegalyThe recommended starting dosage of SOMATULINE DEPOT in acromegalic patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) is 60 mg via the deep subcutaneous route at 4-week intervals for 3 months followed by dosage adjustment
[see Dosage and Administration (2.2), Use in Specific Populations (8.7)].
Injection: 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL sterile, single-dose, prefilled syringes fitted with an automatic safety system (attached retractable needle and needle guard). The prefilled syringes contain a white to pale yellow, semi-solid formulation.
There is no information available on the presence of lanreotide in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Studies show that lanreotide acetate administered subcutaneously passes into the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk
SOMATULINE DEPOT is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide
The following adverse reactions have been identified during post-approval use of SOMATULINE DEPOT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.