VINORELBINE injection solution concentrate
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
13-01-2018
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Active ingredient:
VINORELBINE TARTRATE (UNII: 253GQW851Q) (VINORELBINE - UNII:Q6C979R91Y)
Available from:
Teva Parenteral Medicines, Inc.
INN (International Name):
VINORELBINE TARTRATE
Composition:
VINORELBINE 10 mg in 1 mL
Prescription type:
PRESCRIPTION DRUG
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
VINORELBINE- VINORELBINE INJECTION, SOLUTION, CONCENTRATE
TEVA PARENTERAL MEDICINES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VINORELBINE INJECTION USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VINORELBINE
INJECTION USP.
VINORELBINE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1994
WARNING: MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 20%) are neutropenia,
anemia, liver enzyme elevation, nausea, vomiting,
asthenia, constipation, injection site reaction, and peripheral
neuropathy (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR DRUG.SAFETY@TEVAPHARM.COM; OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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SEVERE MYELOSUPPRESSION RESULTING IN SERIOUS INFECTION, SEPTIC SHOCK,
AND DEATH MAY OCCUR (5.1).
DECREASE THE DOSE OR WITHHOLD VINORELBINE IN ACCORD WITH RECOMMENDED
DOSE MODIFICATIONS (2.2).
Vinorelbine injection USP 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)
In combination with cisplatin: 25 to 30 mg/m as a single intravenous
injection weekly (2.1)
2
Single agent: 30 mg/m as a single intravenous injection weekly (2.1)
2
Adjust the dose in patients with decreased neutrophil counts or
elevated serum total bilirubin (2.2)
Injection: single use vials of 10 mg/1 mL and 50 mg/5 mL (3)
None
Hepatic toxicity: monitor liver function during treatment (5.2)
Severe constipation and bowel obstruction including necrosis and
perforation can occur. Institute a prophylactic
bow
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