VINORELBINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

vinorelbine tartrate (UNII: 253GQW851Q) (vinorelbine - UNII:Q6C979R91Y)

Available from:

Sagent Pharmaceuticals

INN (International Name):

vinorelbine tartrate

Composition:

vinorelbine 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Vinorelbine Injection, USP is supplied as follows: Vinorelbine Injection, USP is a clear, colorless to pale yellow aqueous solution. Storage Conditions Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Protect from light. Retain in carton until time of use. Discard unused portion. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours. Store diluted solutions of Vinorelbine Injection, USP at 5° to 30°C (41° to 86°F) [see Dosage and Administration (2.3)] . Vinorelbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VINORELBINE- VINORELBINE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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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
Vinorelbine Injection: 10 mg per 1 mL and 50 mg per 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