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Vinorelbine Actavis Injection contains Vinorelbine Tartrate
Vinorelbine Actavis Injection side effects
Neurotoxicity, peripheral paraesthesia, loss of deep tendon reflexes, abdominal pain, severe constipation, diarrhoea, alopecia, severe local irritation. Dose limiting granulocytopenia, leukopenia and anaemia. Intestinal obstruction, paralytic ileus, nausea, vomitinh, increased in LFT, chest pain, fatigue. Local pain and thrombophlebitis with repeated Inj.
Hepatic impairment. Compromised bone marrow reserve due to prior irradiation or chemotherapy; recovering marrow function from the effects of previous chemotherapy. Prior radiation therapy; past history or pre-existing neuropathy. CBC with differentials to be monitored prior to admin of subsequent doses. Delay subsequent doses, if neutrophil count < 2000 cells/mm3. Each admin to be followed by at least 250 ml of normal saline to flush the vein. Avoid extravasation. If extravasation occurs, stop infusion immediately, and flush the vein with normal saline solution; admin the remaining solution in another vein. Do not father a child during and up to six mth after treatment and females of childbearing potential to use effective method of contraception during treatment and three mth thereafter. When admin orally, capsules must be swallowed whole with water and not chewed or sucked.
Increased risk of granulocytopenia with cisplatin. Increased risk of neurotoxicity with paclitaxel, itraconazole, ketoconazole. Increased radiosensitising effects with prior or concomitant radiation therapy. Increased pulmonary toxicity with mitomycin. Increased myelotoxicity with zidovudine. Earlier onset and/or an increased severity of side effects with CYP3A inhibitors. Possible increase in vincristine levels with aprepitant. Possible infection with live vaccines.
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Hypersensitivity to vinorelbine or other vinca alkaloids; severe current or recent infection (within last 2 wk); neutropenia; thrombocytopenia; severe hepatic impairment. Intrathecal admin. Do not give concomitantly with radiotherapy if liver is in treatment field. Pregnancy, lactation.
Hepatic Impairment:Intravenous:
- Cervical cancer: Dose adjustments may be needed.
- Breast cancer, Ovarian cancer: Dose adjustments may be needed.
- Non-small cell lung cancer: Massive liver metastases(>75% of liver volume replaced by the tumour): Decrease dose by 1/3. Bilirubin 2.1 mg/100 ml: Reduce IV dose by 50%. Bilirubin >3 mg/100 ml: Reduce IV dose by 75%.
Oral:
- Massive liver metastases(>75% of liver volume replaced by the tumour): Decrease dose by 1/3. Bilirubin 2.1 mg/100 ml: Reduce IV dose by 50%. Bilirubin >3 mg/100 ml: Reduce IV dose by 75%.
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