LANREOTIDE ACETATE injection

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

LANREOTIDE ACETATE (UNII: IEU56G3J9C) (LANREOTIDE - UNII:0G3DE8943Y)

Fáanlegur frá:

Cipla USA Inc.

Stjórnsýsluleið:

SUBCUTANEOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 post-marketing case reports with lanreotide use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmenta

Vörulýsing:

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-dose, sterile, prefilled, ready-to-use, polypropylene syringe and a safety needle device. The safety needle device is a sterile, single use needle system consisting of a needle (1.2 mm x 20 mm, stainless steel) held in protective plastic safety housing. The single-dose prefilled syringe is contained in a plastic tray and is packed in a triple-layered aluminium pouch. The sterile safety needle is co-packaged along with the sealed aluminium pouch in the kit carton box and is attached to the former at the point of use. NDC 69097-880-67      60 mg/0.2 mL, sterile, prefilled syringe NDC 69097-890-67      90 mg/0.3 mL, sterile, prefilled syringe NDC 69097-870-67  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. 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 usage at a later time.

Leyfisstaða:

New Drug Application

Vara einkenni

LANREOTIDE ACETATE- LANREOTIDE ACETATE INJECTION
CIPLA USA INC.
----------
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
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. (2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL of lanreotide
in single-dose prefilled syringes
(3)
CONTRAINDICATIONS
Hypersensitivity to lanreotide. (4)
WARNINGS AND PRECAUTIONS
Cholelithiasis and Complications of Cholelithiasis: Monitor
periodically. Discontinue if complications of
cholthiasis 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 Abnormalities: Decrease in heart rate may occur. Use
with caution in at-risk patients.
(5.3)
Thyroid Function Abn