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VINORELBINE is a brand name for Vinorelbine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
VINORELBINE INJECTION, USP is contraindicated in patients with known hypersensitivity to vinorelbine tartrate. As with other vinca alkaloids, VINORELBINE INJECTION, USP is contraindicated in patients who have drug- induced severe granulocytopenia or severe thrombocytopenia.
WARNINGS VINORELBINE INJECTION, USP is a cytotoxic drug and should be used only by physicians experienced with cancer chemotherapeutic drugs. Blood counts should be taken prior to the next dose. Discontinue or reduce the dosage upon evidence of abnormal depression of the bone marrow.
VINORELBINE INJECTION, USP is for intravenous use only. Vinorelbine tartrate is a moderate vesicant and can produce phlebitis or extravasation injury. Inadequate flushing of the vein after peripheral administration may increase the risk of phlebitis.
It is extremely important that the needle be properly positioned in the vein before this product is injected. If leakage into surrounding tissue should occur during intravenous administration of VINORELBINE INJECTION, USP, it may cause severe irritation.
The injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. A low incidence of death (1%) due to neutropenic sepsis has been reported (see ADVERSE REACTIONS). Bone marrow toxicity, specifically granulocytopenia, is dose-limiting.
Complete blood counts with differentials should be performed and results reviewed prior to each dose of vinorelbine tartrate. VINORELBINE INJECTION, USP should not be administered to patients with granulocyte counts <1000 cells/mm3.
Patients developing severe granulocytopenia should be monitored carefully for evidence of infection and/or fever (see DOSAGE AND ADMINISTRATION). Pregnancy There are no studies in pregnant women. Vinorelbine tartrate has been shown to be embryotoxic Page 5 of 32 and/or fetotoxic in animals (see TOXICOLOGY).
VINORELBINE INJECTION, USP should not be used in pregnancy. Nursing Mothers It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of its potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued in women who are receiving therapy with VINORELBINE INJECTION, USP.
Use in Children Safety and effectiveness in children have not been established. PRECAUTIONS General In all instances where the use of VINORELBINE INJECTION, USP is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse events.
Most drug-related adverse reactions are reversible. If severe adverse events occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken based on the clinical judgment of the physician.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Vinorelbine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Re-institution of therapy with VINORELBINE INJECTION, USP should be carried out with caution and alertness as to possible recurrence of toxicity. VINORELBINE INJECTION, USP should be used with extreme caution in patients whose bone marrow reserve may have been compromised by prior irradiation or chemotherapy, or whose marrow function is recovering from previous chemotherapy.
Administration of VINORELBINE INJECTION, USP to patients with prior radiation therapy may result in radiation recall reactions (see ADVERSE REACTIONS and Drug Interactions). Patients with a prior history or pre-existing neuropathy, regardless of etiology, should be monitored for new or worsening signs and symptoms of neuropathy while receiving vinorelbine tartrate.
Acute shortness of breath and severe bronchospasm have been reported infrequently following Page 6 of 32 the administration of vinorelbine tartrate and of other vinca alkaloids. These events have been encountered most commonly when the vinca alkaloid was used in combination with mitomycin and may require aggressive treatment, particularly when there is pre-existing pulmonary dysfunction.
Bronchodilators, steroids and/or oxygen have produced symptomatic relief. Care must be exercised to avoid contamination of the eye with VINORELBINE INJECTION, USP. Accidental exposure should be treated immediately with a large volume of irrigation solution (water or sodium chloride).
Use in the Elderly Of the total number of patients in North American clinical studies of intravenous vinorelbine tartrate, approximately one-third were 65 years of age or greater. No overall differences in effectiveness or safety were observed between these patients and younger patients.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use in Pregnancy See WARNINGS. Patients with Special Diseases and Conditions Hematologic Since dose-limiting clinical toxicity is the result of depression of the white blood cell count, it is imperative that complete blood counts with differentials be obtained prior to each dose of vinorelbine tartrate (see ADVERSE REACTIONS, Hematologic).
Hepatic There is no evidence that the toxicity of vinorelbine tartrate is enhanced in patients with elevated liver enzymes: no data are available for patients with severe baseline cholestasis. However, pharmacologic evidence suggests that the liver plays an important role in the metabolism of vinorelbine tartrate.
Although there are no data available from patients with severe liver disease, caution should be exercised when administering VINORELBINE INJECTION, USP to patients with severe hepatic injury or impairment. Drug Interaction Acute pulmonary reactions have been reported with vinorelbine tartrate and other vinca alkaloids used in conjunction with mitomycin (see PRECAUTIONS, General).
Vinorelbine tartrate Page 7 of 32 should be administered with caution in combination with mitomycin. Although the pharmacokinetics of vinorelbine are not influenced by the concurrent administration of cisplatin, the incidence of […]