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VINORELBINE TARTRATE FOR is a brand name for Vinorelbine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ......................................................................................... 3 CONTRAINDICATIONS .............................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Data in the following tables are based on the experience of 365 patients (143 patients with NSCLC; 222 patients with advanced breast cancer) for whom a complete safety database was available and who were treated with vinorelbine tartrate as a single agent in three North American trials (one NSCLC trial and two advanced breast cancer trials).
Patients treated for breast cancer were allowed to have received adjuvant chemotherapy in both trials, and in one, up to two prior regimens for advanced disease. The dosing schedule was 30 mg/m2 intravenous vinorelbine tartrate on a weekly basis.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Page 8 of 32 Table 1 Summary of Adverse Events Occurring in ≥5% of 365 Patients Receiving Single-Agent Vinorelbine Tartrate that are Possibly Attributable to the Study Medicationa,b Adverse Event % Incidence All Grades % Incidence Grade 3 % Incidence Grade 4 ABC n=222 NSCLC n=143 ABC n=222 NSCLC n=143 ABC n=222 NSCLC n=143 General Injection site reaction Asthenia Pain Pain injection site Fever Pain Abdomen Pain Chest Phlebitis 21 41 16 18 19 12 8 5 38 25 15 13 10 6 5 10 1 8 3 3 1 1 1 0 5 5 2 1 0 1 2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Digestive System Nausea Constipation Anorexia Stomatitis Vomiting Diarrhea 50 38 19 16 23 20 33 28 16 15 14 13 3 3 <1 0 2 <1 1 2 2 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 Musculoskeletal System Myasthenia 9 5 2 1 <1 0 Nervous System Paresthesia Hypesthesia 20 11 11 10 0 <1 1 0 0 <1 0 0 Respiratory System Dyspnea 9 3 1 2 1 0 Skin and Appendages Alopecia Rash 12 5 12 5 0 0 1 0 0 0 0 0 ABC=Advanced Breast Cancer NSCLC=Non-Small Cell Lung Cancer a Grade based on modified criteria of the National Cancer Institute b Patients with NSCLC had not received prior chemotherapy.
The majority of patients with advanced breast cancer had received prior chemotherapy Cardiovascular Chest pain was reported in 5% of NSCLC and 8% of breast cancer patients. Most reports of chest pain were in patients who had either a history of cardiovascular disease or tumor within the chest.
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There have been rare reports of myocardial infarction; however, these have not been shown definitely attributable to vinorelbine tartrate. Dermatologic Alopecia was reported in only 12% of patients and was usually mild. Vinorelbine tartrate injection is a moderate vesicant.
Injection site reactions, including erythema, pain at injection site, and vein discoloration occurred in approximately one-third of all patients; 2% were severe. Chemical phlebitis along the vein proximal to the site of injection was reported.
Page 9 of 32 Gastrointestinal Mild or moderate nausea occurred in 32% of NSCLC and 47% of breast cancer patients treated with vinorelbine tartrate. Severe nausea was infrequent (1% and 3% in NSCLC and breast cancer patients respectively).
Prophylactic administration of antiemetics was not routine in patients treated with single-agent vinorelbine tartrate. Constipation occurred in approximately 28% of NSCLC and 38% of breast cancer patients, with paralytic ileus occurring in less than 2% of patients.
Vomiting, diarrhea, anorexia, and stomatitis were usually mild or moderate and occurred in less than 20% of patients. Hepatic Transient elevations of liver enzymes were reported without clinical symptoms. Neurologic Mild to moderate peripheral neuropathy manifested by paresthesia and hypesthesia were the most frequently reported neurologic toxicities (10% to 20%, see Table 2).
Loss of deep tendon reflexes occurred in less than 5% of patients. The development of severe peripheral neuropathy was unusual. Pulmonary Shortness of breath was reported in 3% of NSCLC and 9% of breast cancer patients; and was severe in 2% of each patient population.
Interstitial pulmonary changes have been documented in a few patients. Other Asthenia occurred in approximately 25% of patients with NSCLC and 41% of patients with breast cancer. It was usually mild or moderate but tended to increase with cumulative dosing.
Other toxicities that have been reported in ≤ 5% of patients include jaw pain, myalgia, arthralgia, headache, dysphagia, and rash. Hemorrhagic cystitis and the syndrome of inappropriate ADH secretion were each reported in 4% of patients.
The treatment of these entities are mainly symptomatic. v. fluids for forced diuresis and/or irrigation of bladder. For the treatment of SIADH, please refer to the major textbooks of medicine. Abnormal Hematologic and Clinical Chemistry Findings Hematologic Granulocytopenia was the major dose-limiting toxicity with vinorelbine tartrate; it was generally reversible and not cumulative over time.
Granulocyte nadirs occurred 7 to 10 days after the dose and usually recovered within the following 7 to 14 days. Granulocytopenia resulted in hospitalizations for fever and/or sepsis in 8% of NSCLC and 9% of breast cancer patients. Septic deaths occurred in approximately 1% of patients.
Grade 3 or 4 anemia occurred in 1% of lung cancer and 14% of breast cancer patients. Blood products were administered to 18% of patients who received vinorelbine tartrate. The incidence of Grade 3 and 4 thrombocytopenia was less than 1%.
Page 10 of 32 Table 2 Hematologic Adverse Events and Clinical Chemistry Elevations in 365 Patients Receiving Single-Agent Vinorelbine Tartrate that are Possibly Attributable to the Study Medicationa,b Hematology ABC (%) NSCLC (%) Granulocytopenia <2,000 cells/mm3 <500 cells/mm3 96 41 80 28 Leukopenia <4,000 cells/mm3 <1,000 cells/mm3 99 16 81 12 Thrombocytopenia <100,000cells/mm3 <50,000 cells/mm3 6 <1 4 1 […]