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:

Exelan Pharmaceuticals, Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lanreotide Injection 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. Lanreotide Injection 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. Lanreotide injection 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 data based on postmarketing case reports with Lanreotide injection use in pregnant women are not sufficient to determine a drug-associated risk of adverse dev

Product summary:

Lanreotide injection 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 needle guard) fitted with a 20 mm needle covered by a sheath. Each prefilled syringe is sealed in a laminated pouch and packed in a carton. NDC 76282-709-67           60 mg/0.2 mL, sterile, prefilled syringe NDC 76282-710-67           90 mg/0.3 mL, sterile, prefilled syringe NDC 76282-711-67           120 mg/0.5 mL, sterile, prefilled syringe Storage and Handling Store Lanreotide injection 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

LANREOTIDE ACETATE- LANREOTIDE ACETATE INJECTION
EXELAN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANREOTIDE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LANREOTIDE INJECTION.
LANREOTIDE INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2007
RECENT MAJOR CHANGES
Warnings and Precautions, Cholelithiasis and Complications of
Cholelithiasis (5.1)
4/2019
INDICATIONS AND USAGE
LANREOTIDE INJECTION 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)
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.
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
periodically. Discontinue if complications of
cholelithiasis are suspected. Gallstones may occur; consider periodic
monitoring. (5.1)
Hyperglycemia and Hypoglycemia: Glucose monitoring is recommended and
antidiabetic treatment
adjusted accordingly. (5.2, 7.1)
Cardiovascular Ab