VINORELBINE injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

VINORELBINE TARTRATE (UNII: 253GQW851Q) (VINORELBINE - UNII:Q6C979R91Y)

Disponibil de la:

Actavis Pharma, Inc.

INN (nume internaţional):

VINORELBINE

Compoziție:

VINORELBINE 10 mg in 1 mL

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Vinorelbine injection is indicated: - In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) - As a single agent for the treatment of patients with metastatic NSCLC None Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], Vinorelbine can cause fetal harm when administered to a pregnant woman. Available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively (see Data). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 1

Rezumat produs:

Vinorelbine Injection, USP is a clear, colorless to pale yellow solution in water for injection, USP containing 10 mg vinorelbine per mL. Vinorelbine Injection, USP is available in single-dose, clear glass vials with elastomeric stoppers and white (10 mg/mL) and lime green (50 mg/5 mL) caps, individually packaged in a carton in the following vial sizes: Storage Conditions Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours. Protect from light. DO NOT FREEZE. The vial stopper is not made with natural rubber latex. Sterile, Nonpyrogenic, Preservative-free. Vinorelbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

VINORELBINE- VINORELBINE INJECTION, SOLUTION
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VINORELBINE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VINORELBINE INJECTION.
VINORELBINE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1994
WARNING: MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE MYELOSUPPRESSION RESULTING IN SERIOUS INFECTION, SEPTIC SHOCK,
AND DEATH CAN
OCCUR (5.1).
DECREASE THE DOSE OR WITHHOLD VINORELBINE IN ACCORD WITH RECOMMENDED
DOSE
MODIFICATIONS (2.2).
INDICATIONS AND USAGE
Vinorelbine injection is a vinca alkaloid indicated:
In combination with cisplatin for first-line treatment of patients
with locally advanced or metastatic non-
small cell lung cancer (NSCLC) (1)
As a single agent for first-line treatment of patients with metastatic
NSCLC (1)
DOSAGE AND ADMINISTRATION
In combination with cisplatin: 25 to 30 mg/m as an intravenous
injection or infusion once weekly (2.1)
Single agent: 30 mg/m as intravenously once a week (2.1)
Adjust dose in patients with decreased neutrophil counts or elevated
serum total bilirubin (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 10 mg/mL and 50 mg/5 mL in single-dose vial (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hepatic Toxicity: Monitor hepatic function prior to initiation and
during treatment (5.2)
Severe constipation and bowel obstruction, including necrosis and
perforation, occur. Institute a
prophylactic bowel regimen to mitigate potential constipation, bowel
obstruction and/or paralytic ileus.
(5.3)
Extravasation can result in severe tissue injury, local tissue
necrosis and/or thrombophlebitis.
Immediately stop vinorelbine and institute recommended management
procedures (5.4)
Neurologic Toxicity: Severe sensory and motor neuropathies occur.
Monitor patients for new or
worsening signs and symptoms of neuropathy. Discontinue for Grade 2 or
greater neuropathy (5.5)
Pulmonary toxicity a