SOMATULINE DEPOT- lanreotide acetate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

lanreotide acetate (UNII: IEU56G3J9C) (lanreotide - UNII:0G3DE8943Y)

Available from:

Ipsen Biopharmaceuticals, Inc.

INN (International Name):

lanreotide acetate

Composition:

lanreotide 60 mg in 0.2 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SOMATULINE 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. SOMATULINE 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. SOMATULINE DEPOT is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. 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 [ see Adverse Reactions (6.3)] . Risk Summary Limited available

Product summary:

SOMATULINE DEPOT is supplied in strengths of 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL as a white to pale yellow, semi-solid formulation in a single, sterile, prefilled, ready-to-use, polypropylene syringe fitted with an automatic safety system, a bromobutyl rubber plunger stopper and a 20 mm attached needle covered by a plastic cap. Each prefilled syringe is placed in a plastic tray, sealed in a laminated pouch and packed in a carton. Storage and Handling Store SOMATULINE DEPOT in the refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in the original package.

Authorization status:

New Drug Application

Summary of Product characteristics

SOMATULINE DEPOT- LANREOTIDE ACETATE INJECTION
IPSEN BIOPHARMACEUTICALS, INC.
REFERENCE LABEL SET ID: F11B1D88-74CA-4A6D-89FB-40D0F51BCA95
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOMATULINE DEPOT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SOMATULINE DEPOT.
SOMATULINE DEPOT (LANREOTIDE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
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)
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)
the treatment of adults with carcinoid syndrome; when used, it reduces
the frequency of short-acting
somatostatin analog rescue therapy. (1.3)
DOSAGE AND ADMINISTRATION
Administration (2.1):
For deep subcutaneous injection only.
Intended for administration by a healthcare provider.
Administer in the superior external quadrant of the buttock.
Alternate injection sites.
Recommended Dosage (2.1)
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.
Dosage Adjustment:
See full prescribing information for dosage adjustment in patients
with acromegaly and renal or hepatic
impairment. (2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL single-dose
prefilled syringes (3)
CONTRAINDICATIONS
Hypersensitivity to lanreotide. (4)
WARNINGS AND PRECAUTIONS
Cholelithiasis and Complications of Cholelithiasis: Monitor
pe