Vinotec 10mg Injection

Vinorelbine Injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for the treatment of patients with metastatic NSCLC Vinorelbine Injection is a vinca alkaloid indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for first-line treatment of patients with metastatic NSCLC

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. MYELOSUPPRESSION Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur. Decrease the dose or withhold Vinorelbine in accord with recommended dose modifications. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Severe myelosuppression resulting in serious infection, septic shock, and death can occur. Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment Severe constipation and bowel obstruction, including necrosis and perforation, occur. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus Extravasation can result in severe tissue injury, local tissue necrosis and/or thrombophlebitis. Immediately stop Vinorelbine and institute recommended management procedures Neurologic Toxicity: Severe sensory and motor neuropathies occur. Monitor patients for new or worsening signs and symptoms of neuropathy. Discontinue for Grade 2 or greater neuropathy Pulmonary toxicity and respiratory failure occur. Interrupt Vinorelbine in patients who develop unexplained dyspnea or have any evidence of pulmonary toxicity. Permanently discontinue for confirmed interstitial pneumonitis or ARDS Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception Myelosuppression, manifested by neutropenia, anemia and thrombocytopenia, occur in patients receiving Vinorelbine as a single agent and in combination with cisplatin. Neutropenia is the major dose-limiting toxicity with Vinorelbine. Grade 3-4 neutropenia occurred in 53% of patients treated with Vinorelbine at 30 mg/m 2 per week. Dose adjustment due to myelosuppression occurred in 51% of patients (Study 2). In clinical trials with Vinorelbine administered at 30 mg/m 2 per week, neutropenia resulted in hospitalizations for pyrexia and/or sepsis in 8% of patients. Death due to sepsis occurred in 1% of patients. Neutropenia nadirs occur between 7 and 10 days after dosing with neutropenia count recovery usually occurring within the following 7 to 14 days. Monitor complete blood counts prior to each dose of Vinorelbine. Do not administer Vinorelbine to patients with neutrophil counts <1,000 cells/mm 3. Adjustments in the dosage of Vinorelbine should be based on neutrophil counts obtained on the day of treatment. Hepatic Toxicity Drug-induced liver injury manifest by elevated aspartate aminotransferase (AST) and bilirubin occur in patients receiving Vinorelbine as a single agent and in combination with cytotoxic agents. Assess hepatic function prior to initiation of Vinorelbine and periodically during treatment. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression Hepatic Toxicity Severe Constipation and Bowel Obstruction Extravasation and Tissue Injury Neurologic Toxicity Pulmonary Toxicity and Respiratory Failure Most common adverse reactions (incidence ≥ 20%) are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy. Clinical Trials Experience Because clinical trials are conducted under varying designs and in different patient populations, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial and may not reflect the rates actually observed in clinical practice. Single Agent The data below reflect exposure to Vinorelbine as a single agent administered at a dose of 30 mg/m 2 on a weekly basis to 365 patients enrolled in 3 controlled studies for metastatic NSCLC and advanced breast cancer. The population included 143 patients with previously untreated metastatic NSCLC (Study 3) who received a median of 8 doses of Vinorelbine. The patients were aged 32 to 79 (median 61 years), 71% were male, 91% White, 48% had adenocarcinoma histology. The data also reflect exposure to Vinorelbine in 222 patients with previously treated advanced breast cancer who received a median of 10 doses of Vinorelbine. Vinorelbine is not indicated for the treatment of breast cancer. Selected adverse reactions reported in these studies are provided in Tables 1 and 2. The most common adverse reactions (≥ 20%) of single agent Vinorelbine were leukopenia, neutropenia, anemia, increased aspartate aminotransferase (AST), nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy. The most common (≥ 5%) Grade 3 or 4 adverse reactions were neutropenia, leukopenia, anemia, increased total bilirubin, increased AST, injection site reaction and asthenia. Approximately 49% of patients with NSCLC who were treated with Vinorelbine experienced at least one dose reduction due to an adverse reaction. Thirteen percent of patients discontinued Vinorelbine due to adverse reactions. The most frequent adverse reactions leading to Vinorelbine discontinuation were asthenia, dyspnea, nausea, constipation, anorexia, myasthenia and fever. Table 1: Hematologic Adverse Reactions Experienced in > 5% of Patients Receiving Vinorelbine *†: * Grade based on modified criteria from the National Cancer Institute version 1. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.