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Vinorelbine 25 mg/m 2 IV Dilute in normal saline (NS) to a final concentration between 0.5 and 2 mg/mL and administer over 6 to 10 minutes into the side port of a free-flowing IV infusion. Days 1, 8, 15, and 22

Vesicant/irritant properties: Vinorelbine is a vesicant and can cause significant tissue damage; avoid extravasation. Refer to UpToDate topic on "Extravasation injury from chemotherapy and other non-neoplastic vesicants". •

Infection prophylaxis: Primary prophylaxis with hematopoietic growth factors is not recommended (incidence of febrile neutropenia is approximately 7 percent [1] ). Refer to UpToDate topic on "Use of granulocyte colony stimulating factors in patients with chemotherapy-induced neutropenia". • Dose adjustment for preexisting baseline liver or renal dysfunction: A lower starting dose of vinorelbine may be needed for patients with hepatic impairment. The optimal approach to cisplatin therapy in patients with preexisting renal impairment is unknown. Such patients were excluded from the original trial [1] . Refer to UpToDate topics on "Chemotherapy hepatotoxicity and dose modification in patients with liver disease" and "Chemotherapy-related nephrotoxicity and dose modification in patients with renal insufficiency". Monitoring parameters: • CBC with differential and platelet count weekly during treatment. • Basic metabolic panel (creatinine and electrolytes) prior to each treatment cycle. • Liver function tests prior to each treatment cycle. • Monitor for hearing loss prior to each dose of cisplatin; audiometry as clinically indicated. Suggested dose alterations for toxicity: •

Myelotoxicity: Treatment with vinorelbine should be delayed until ANC is greater than 1500 cells/mm 3 based on the manufacturer's guidelines. A dose reduction of 50 percent is recommended for patients with ANC 1000/mm 3 to 1500/mm 3 . If a patient's ANC is <1000/mm 3 , the weekly dose of vinorelbine should be held and blood counts should be rechecked in one week. For patients who develop febrile neutropenia or who have had two consecutive weekly doses held, the following dose adjustments will apply for subsequent doses of vinorelbine. For ANC ≥1500/mm 3 , use a 25 percent dose reduction. For ANC 1000/mm 3 to 1400/mm 3 , use a 62.5 percent dose reduction. If ANC remains <1000/mm 3 , hold vinorelbine doses until count recovery and then follow above dosing guidelines [2] . •

Neurotoxicity: Neuropathy usually is seen with cumulative doses of cisplatin >400 mg/m 2 , although there is marked interindividual variation. Patients with mild neuropathy can continue to receive full cisplatin doses. However, if the neuropathy interferes with function, the risk of potentially disabling neurotoxicity must be weighed against the benefit of continued treatment. Refer to UpToDate topic on "Neurologic complications of platinum-based chemotherapy". •

Hepatotoxicity: The FDA-approved package insert recommends dose reduction for patients who develop hyperbilirubinemia during treatment with vinorelbine: - Serum bilirubin ≤2.0 mg/dL, give 100 percent of dose - Serum bilirubin 2.1 to 3.0 mg/dL, give 50 percent of dose - Serum bilirubin >3.0 mg/dL, give 20 percent of dose If there is a change in body weight of at least 10 percent, dose should be recalculated for all drugs. This table is provided as an example of how to administer this regimen; there may be other acceptable methods. This regimen must be administered by a clinician trained in the use of chemotherapy. The clinician is expected to use his or her independent medical judgment in the context of individual circumstances to make adjustments, as necessary. IV: intravenous; CBC: complete blood count; ANC: absolute neutrophil count. References: Winton T, et al. N Engl J Med 2005; 352:2589. Navelbine (vinorelbine) injection. US FDA-approved manufacturer's package insert. US National Library of Medicine. (Available online at dailymed.nlm.nih.gov, accessed on December 14, 2011).