Somatuline Depot

INDICATIONS

Somatuline Depot (lanreotide) Injection 60 mg, 90 mg and 120 mg is indicated for the longterm 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.

DOSAGE AND ADMINISTRATION

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 > 1 to ≤ 2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: maintain Somatuline Depot dose at 90 mg every 4 weeks.
  • GH > 2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled, increase Somatuline Depot dose to 120 mg every 4 weeks.
  • GH ≤ 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 patients response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.

Somatuline Depot should be injected via the deep subcutaneous route in the superior external quadrant of the buttock. The skin should not be folded and the needle should be inserted perpendicular to the skin, rapidly and to its full length. The injection site should alternate between the right and left side.

The starting dose in patients with moderate and severe renal or moderate and 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].

HOW SUPPLIED

Dosage Forms And Strengths

60, 90, and 120 mg sterile, single-use, pre-filled syringes. The pre-filled syringes contain a white to pale yellow, semi-solid formulation.

Somatuline Depot is supplied in strengths of 60 mg, 90 mg and 120 mg in a single, sterile, pre-filled, ready-to-use, polypropylene syringe fitted with a 20 mm needle covered by a dry natural rubber sheath. Each pre-filled syringe is sealed in a laminated pouch and packed in a carton.

NDC 15054-0060-1 60-mg, sterile, pre-filled syringe
NDC
15054-0090-1 90-mg, sterile, pre-filled syringe
NDC 15054-0120-1 120-mg, sterile, pre-filled 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 SAS BP, 707 Signes, 83030, Toulon Cedex 9, France for Ipsen Pharma SAS, 65 quai Georges Gorse, 92650, Boulogne, Billancourt Cedex, France. Revised February 2012.

Last reviewed on RxList: 12/12/2013
This monograph has been modified to include the generic and brand name in many instances.

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