The following is a Drug Safety statement from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research:
On January 24, 2020, FDA approved labeling changes for the brand name Navelbine (vinorelbine tartrate injection) that removed instructions for preparing it in a syringe, and drug companies are required to update generic vinorelbine product labeling to match the brand name labeling. Vinorelbine tartrate injection is indicated to treat patients with metastatic non-small cell lung cancer (NSCLC) and, in combination with cisplatin, for patients with locally advanced or metastatic NSCLC.
On January 14, 2021, the agency removed instructions for preparing vincristine sulfate injection in a syringe. Vincristine sulfate injection is indicated to treat acute lymphocytic leukemia in children and adults, and as part of combination chemotherapy for patients with Hodgkin’s disease, non-Hodgkin’s malignant lymphomas (including Burkitt’s lymphoma), rhabdomyosarcoma, neuroblastoma, and Wilms’ tumor.
FDA also requested more extensive labeling changes for the preparation of vinblastine sulfate (for) injection products. These labeling changes will remove instructions for preparation in a syringe and add instructions for preparation in an intravenous infusion bag. The changes should be completed during 2021.
Vinblastine sulfate injection is indicated to treat numerous malignancies including: generalized Hodgkin’s disease (Stages III and IV), lymphocytic lymphoma, histiocytic lymphoma, mycosis fungoides (advanced stages), and advanced testicular carcinoma.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of vinca alkaloid products to FDA’s MedWatch Adverse Event Reporting program: