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Brand Name: Navelbine Trade Name: vinorelbine
FDA Approved For: NAVELBINE 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, NAVELBINE is indicated as a single-agent or in combination with cisplatin. In Stage III NSCLC, NAVELBINE is indicated in combination with cisplatin. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Carcinogen: The carcinogenic potential of NAVELBINE has not been studied. Mutagen: Vinorelbine has been shown to affect chromosome number and possibly structure in vivo (polyploidy in bone marrow cells from Chinese hamsters and a positive micronucleus test in mice). It was not mutagenic in the Ames test and gave inconclusive results in the mouse lymphoma TK Locus assay. The significance of these or other short-term test results for human risk is unknown. Vinorelbine did not affect fertility to a statistically significant extent when administered to rats on either a once-weekly (9 mg/m2, approximately one third the human dose) or alternate-day schedule (4.2 mg/m2, approximately one seventh the human dose) prior to and during mating. However, biweekly administration for 13 or 26 weeks in the rat at 2.1 and 7.2 mg/m2 (approximately one fifteenth and one fourth the human dose) resulted in decreased spermatogenesis and prostate/seminal vesicle secretion.
Manufacturer and/or Distributor: GlaxoSmithKline    

Adverse Reactions:
Granulocytopenia is the major dose-limiting toxicity with NAVELBINE. Dose adjustments are required for hematologic toxicity and hepatic insufficiency (see DOSAGE AND ADMINISTRATION ). Data in the following table are based on the experience of 365 patients (143 patients with NSCLC; 222 patients with advanced breast cancer) treated with IV NAVELBINE as a single-agent in three clinical studies. The dosing schedule in each study was 30 mg/m2 NAVELBINE on a weekly basis. (See Table) *None of the reported toxicities were influenced by age Grade based on modified criteria from the National Cancer Institute. Patients with NSCLC had not received prior chemotherapy. The majority of the remaining patients had received prior chemotherapy Incidence of paresthesia plus hypesthesia. Hematologic Granulocytopenia was the major dose-limiting toxicity with NAVELBINE, it was generally reversible and not cumulative over time. Granulocyte nadirs occurred 7 to 10 days after the dose with granulocyte recovery usually within the following 7 to 14 days. Granulocytopenia resulted in hospitalizations for fever and/or sepsis in 8% of patients. Septic deaths occurred in approximately 1% of patients. Prophylactic hematologic growth factors have not been routinely used with NAVELBINE. If medically necessary, growth factors may be administered at recommended doses no earlier than 24 hours after the administration of cytotoxic chemotherapy. Growth factors should not be administered in the period 24 hours before the administration of chemotherapy. Grade 3 or 4 anemia occurred in 1% of patients, although blood products were administered to 18% of patients who received NAVELBINE. Grade 3 or 4 thrombocytopenia was reported in 1% of patients. Neurologic Mild to moderate peripheral neuropathy manifested by paresthesia and hypesthesia were the most frequently reported neurologic toxicities. Loss of deep tendon reflexes occurred in less than 5% of patients. The development of severe peripheral neuropathy was infrequent (1%) and generally reversible. Skin Alopecia was reported in 12% of patients and was usually mild. Like other anticancer vinca alkaloids, NAVELBINE is a moderate vesicant. Injection site reactions, including erythema, pain at injection site, and vein discoloration occurred in approximately one third of patients; 5% were severe. Chemical phlebitis along the vein proximal to the site of injection was reported in 10% of patients. Gastrointestinal Mild or moderate nausea occurred in 34% of patients treated with NAVELBINE; severe nausea was infrequent (< 2%). Prophylactic administration of antiemetics was not routine in patients treated with single-agent NAVELBINE. Due to the low incidence of severe nausea and vomiting with single-agent NAVELBINE, the use of serotonin antagonists is generally not required. Constipation occurred in 29% of patients, with paralytic ileus occurring in 1%. Vomiting, diarrhea, anorexia, and stomatitis were usually mild or moderate and each occurred in less than 20% of patients. Hepatic Transient elevations of liver enzymes were reported without clinical symptoms. Cardiovascular Chest pain was reported in 5% of patients. Most reports of chest pain were in patients who had either a history of cardiovascular disease or tumor within the chest. There have been rare reports of myocardial infarction. Pulmonary Shortness of breath was reported in 3% of patients; it was severe in 2% (see PRECAUTIONS: General). Interstitial pulmonary changes were documented in a few patients. Other Fatigue occurred in 27% of patients. It was usually mild or moderate but tended to increase with cumulative dosing. Other toxicities that have been reported in less than 5% of patients include jaw pain, myalgia, arthralgia, and rash. Hemorrhagic cystitis and the syndrome of inappropriate ADH secretion were each reported in < 1% of patients. Combination Use In a randomized study, 206 patients received treatment with NAVELBINE plus cisplatin and 206 patients received single-agent NAVELBINE. The toxicity profile of cisplatin is known (see full prescribing information for cisplatin). The incidence of severe nausea and vomiting was 30% for NAVELBINE/cisplatin compared to < 2% for single-agent NAVELBINE. Cisplatin did not appear to increase the incidence of neurotoxicity observed with single-agent NAVELBINE. However, myelosuppression, specifically Grade 3 and 4 granulocytopenia, was greater with the combination of NAVELBINE/cisplatin (79%) than with single-agent NAVELBINE (53%). The incidence of fever and infection may be increased with the combination. Observed During Clinical Practice In addition to the adverse events reported from clinical trials the following events have been identified during post approval use of NAVELBINE. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness frequency of reporting or potential causal connection to NAVELBINE. Body As A Whole: Systemic allergic reactions reported as anaphylaxis, pruritus, urticaria, and angioedema; flushing; and radiation recall events such as dermatitis and esophagitis (see PRECAUTIONS) have been reported. Hematologic: Thromboembolic events including pulmonary embolus and deep venous thrombosis have been reported primarily in seriously ill and debilitated patients with known predisposing risk factors for these events. Neurologic: Peripheral neurotoxicities such as, but not limited to, muscle weakness and disturbance of gait, have been observed in patients with and without prior symptoms. There may be increased potential for neurotoxicity in patients with pre-existing neuropathy, regardless of etiology who receive NAVELBINE. Vestibular and auditory deficits have been observed with NAVELBINE, usually when used in combination with cisplatin. Skin: Injection site reactions, including localized rash, and urticaria, blister formation, and skin sloughing have been observed in clinical practice. Some of these reactions may be delayed in appearance. Gastrointestinal: Dysphagia and mucositis have been reported. Cardiovascular: Hypertension, hypotension, vasodilation, tachycardia, and pulmonary edema have been reported. Pulmonary: Pneumonia has been reported. Musculoskeletal: Headache has been reported, with and without other musculoskeletal aches and pains. Other: Pain in tumor-containing tissue, back pain, and abdominal pain have been reported. Electrolyte abnormalities, including hyponatremia with or without the syndrome of inappropriate ADH secretion, have been reported in seriously ill and debilitated patients. Combination Use: Patients with prior exposure to paclitaxel and who have demonstrated neuropathy should be monitored closely for new or worsening neuropathy. Patients who have experienced neuropathy with previous drug regimens should be monitored for symptoms of neuropathy while receiving NAVELBINE. NAVELBINE may result in radiosensitizing effects with prior or concomitant radiation therapy (see PRECAUTIONS).

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