Vinorelbine

Severe granulocytopenia may occur with treatment (may lead to infection); granulocyte counts should be ≥1000 cells/mm3 prior to treatment initiation; dosage adjustment may be required based on blood counts (monitor blood counts prior to each dose). Granulocytopenia is a dose-limiting toxicity; nadir is generally 7 to 10 days after administration and recovery occurs within the following 7 to 14 days. Monitor closely for infections and/or fever in patients with severe granulocytopenia. Use with extreme caution in patients with compromised marrow reserve due to prior chemotherapy or radiation therapy.

Vesicant; ensure proper catheter or needle position prior to (and during) infusion. Avoid extravasation. Extravasation may cause local tissue necrosis and/or thrombophlebitis.

May cause severe constipation (grade 3-4), paralytic ileus, intestinal obstruction, necrosis, and/or perforation; some events were fatal. Oral vinorelbine (not available in the US) is associated with a moderate antiemetic potential; antiemetics are recommended to prevent nausea/vomiting (Dupuis 2011; Hesketh 2017; Roila 2016); IV vinorelbine has a minimal emetic potential (Dupuis 2011; Hesketh 2017; Roila 2016).

May cause new-onset or worsening of pre-existing neuropathy; use with caution in patients with neuropathy. Monitor for new or worsening sign/symptoms of neuropathy. Dosage adjustment required.

Fatal cases of interstitial pulmonary changes and ARDS have been reported with single-agent therapy (mean onset of symptoms: 1 week). Promptly evaluate changes in baseline pulmonary symptoms or any new-onset pulmonary symptoms (eg, dyspnea, cough, hypoxia). Acute shortness of breath and severe bronchospasm have been reported with vinca alkaloids, usually when used in combination with mitomycin. Disease-related concerns:

Vinorelbine elimination is predominantly hepatic. While there is no evidence that toxicity is enhanced in patients with elevated transaminases, use with caution in patients with severe hepatic injury or impairment; dosage modification required for elevated total bilirubin.

May have radiosensitizing effects with prior or concurrent radiation therapy; radiation recall reactions may occur in patients who have received prior radiation therapy. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special handling:

Avoid eye contamination (exposure may cause severe irritation). Other warnings/precautions:

Should be administered under the supervision of an experienced cancer chemotherapy physician.

For IV use only; intrathecal administration of other vinca alkaloids has resulted in death. If dispensed in a syringe, should be labeled “for intravenous use only - fatal if given intrathecally". Vinorelbine should NOT be prepared during the preparation of any intrathecal medications. After preparation, keep vinorelbine in a location away from the separate storage location recommended for intrathecal medications.