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Vinorelbine Tartrate Injection:

  • 10 mg/mL, 1 mL single-dose vial (SDV)
  • 10 mg/mL, 5 mL single-dose vial (SDV)

INDICATIONS AND USAGE
Vinorelbine is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced nonsmall cell lung cancer (NSCLC). In patients with Stage IV NSCLC, Vinorelbine is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, Vinorelbine is indicated in combination with cisplatin.

WARNING

Vinorelbine Tartrate Injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous (IV) use only. Intrathecal administration of other vinca alkaloids has resulted in death. Syringes containing this product should be labeled “WARNING - FOR IV USE ONLY. FATAL if given intrathecally.”

Severe granulocytopenia resulting in increased susceptibility to infection may occur. Granulocyte counts should be ≥1,000 cells/mm3 prior to the administration of Vinorelbine. The dosage should be adjusted according to complete blood counts with differentials obtained on the day of treatment.

Caution — It is extremely important that the intravenous needle or catheter be properly positioned before Vinorelbine is injected. Administration of Vinorelbine may result in extravasation causing local tissue necrosis and/or thrombophlebitis (see DOSAGE AND ADMINISTRATION: Administration Precautions).

Please refer to full prescribing information.

Important Safety Information

Common adverse events include granulocytopenia, leukopenia, anemia, fatigue, asthenia, injection site reactions, nausea, vomiting, diarrhea, constipation and peripheral neuropathy.