Somatuline Depot




Indications
Dosage
How Supplied

INDICATIONS

Acromegaly

SOMATULINE DEPOT (lanreotide) Injection 60 mg, 90 mg, and 120 mg 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.

Gastroenteropancreatic Neuroendocrine Tumors

SOMATULINE DEPOT Injection 120 mg is indicated for the treatment of patients with unresectable, well-or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Somatuline Depot should be administered by healthcare professionals. Please see enclosed Instructions for Use Leaflet for administration of Somatuline Depot.

Acromegaly

Patients should begin treatment with SOMATULINE DEPOT 90 mg given via the deep subcutaneous route, at 4-week intervals for 3 months.

After 3 months, dosage may be adjusted as follows:

  • GH greater than 1ng/mL to less than or equal to 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain SOMATULINE DEPOT dose at 90 mg every 4 weeks
  • GH greater than 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled: increase SOMATULINE DEPOT dose to 120 mg every 4 weeks.
  • GH less than or equal to 1 ng/mL, IGF-1 normal, and clinical symptoms controlled: reduce SOMATULINE DEPOT dose to 60 mg every 4 weeks.

Thereafter, the dose should be adjusted according to the response of the patient as judged by a reduction in serum GH and/or IGF-1 levels; and/or changes in symptoms of acromegaly.

Patients who are controlled on SOMATULINE DEPOT 60 mg or 90 mg may be considered for an extended dosing interval of SOMATULINE DEPOT 120 mg every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response.

Continued monitoring of patient response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.

The starting dose in patients with moderate or severe renal impairment or moderate or severe hepatic impairment should be 60 mg via the deep subcutaneous route at 4-week intervals for 3 months followed by dose adjustment as described above [see CLINICAL PHARMACOLOGY].

Gastroenteropancreatic Neuroendocrine Tumors

The recommended dose of SOMATULINE DEPOT is 120 mg administered every 4 weeks by deep subcutaneous injection. There is no recommended dose adjustment for mild or moderate renal impairment. There is insufficient information to recommend a dose for patients with severe renal impairment or with hepatic impairment of any severity [see CLINICAL PHARMACOLOGY].

Administration

SOMATULINE DEPOT is provided in a single-dose, prefilled syringe affixed with an automatic needle protection system. Inject SOMATULINE DEPOT via the deep subcutaneous route in the superior external quadrant of the buttock. Alternate the injection site between the right and left sides from one injection to the next. Remove SOMATULINE DEPOT from the refrigerator 30 minutes prior to administration. Keep pouch sealed until just prior to injection.

HOW SUPPLIED

Dosage Forms And Strengths

Injection: 60 mg/0.2 mL, 90 mg/0.3 mL and 120 mg/0.5 mL sterile, single-use, prefilled syringes fitted with an automatic needle guard. The prefilled syringes contain a white to pale yellow, semi-solid formulation.

SOMATULINE DEPOT is supplied in strengths of 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL in a single, sterile, prefilled, ready-to-use, polypropylene syringe (fitted with an automatic needle guard) fitted with a 20 mm needle covered by a low density polythylene sheath.

Each prefilled syringe is sealed in a laminated pouch and packed in a carton.

NDC 15054-1060-3 60 mg/0.2 mL, sterile, prefilled syringe
NDC
15054-1090-3 90 mg/0.3 mL, sterile, prefilled syringe
NDC 15054-1120-3 120 mg/0.5 mL, sterile, prefilled syringe

Storage And Handling

SOMATULINE DEPOT must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) and protected from light in its original package. Thirty (30) minutes prior to injection, remove sealed pouch of SOMATULINE DEPOT from refrigerator and allow it to come to room temperature. Keep pouch sealed until injection.

Each syringe is intended for single use. Do not use beyond the expiration date on the packaging.

SOMATULINE DEPOT is manufactured by Ipsen Pharma Biotech, Parc d'Activities du Plateau de Signes, 83870 Signes, France for Ipsen Biopharmaceuticals, Inc., 106 Allen Road, Basking Ridge, NJ 07920 USA. Revised: December 2014.

Last reviewed on RxList: 1/5/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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