Vinorelbine tartrate

Thông tin thuốc gốc
Chỉ định và Liều dùng
Cervical cancer
Adult: 30 mg/m2/dose days 1 and 8 of a 21-day treatment cycle.

Breast cancer, Ovarian cancer
Adult: 25 mg/m2/dose every 7 days.

Non-small cell lung cancer
Adult: As single agent: 30 mg/m2 wkly as infusion over 20-30 minutes (after diluting in 125 ml normal saline or glucose 5%) or as slow bolus over 5-10 minutes (after diluting in 20-50 ml normal saline or glucose 5%). Delay subsequent doses if neutrophil count is <2000 cells/mm3 until recovery. As combination therapy with cisplatin: 25-30 mg/m2 every 7 days.

Non-small cell lung cancer
Adult: 60 mg/m2once wkly for 3 wk, may increase subsequently to 80 mg/m2 once wkly. If neutrophil count is < 500 cells/mm3 or between 500-1000 cells/mm3 on 2 separate occasions, keep dose at 60 mg/m2 for next 3 doses.
Hepatic Impairment
Non-small cell lung cancer: Massive liver metastases(>75% of liver volume replaced by the tumour): Decrease dose by 1/3. Bilirubin 2.1-3 mg/100 ml: Reduce IV dose by 50%. Bilirubin >3 mg/100 ml: Reduce IV dose by 75%.
Cervical cancer: Dose adjustments may be needed.
Breast cancer,Ovarian cancer: Dose adjustments may be needed.
Massive liver metastases(>75% of liver volume replaced by the tumour): Decrease dose by 1/3. Bilirubin 2.1-3 mg/100 ml: Reduce IV dose by 50%. Bilirubin >3 mg/100 ml: Reduce IV dose by 75%.
Chống chỉ định
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.
Thận trọng
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.
Phản ứng phụ
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.
IV/Parenteral/PO: D
Tương tác
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.
Tác dụng
Description: Vinorelbine, a semisynthetic vinblastine derivative, binds to tubulin and inhibits microtubule formation. This disrupts the formation of the mitotic spindle thereby arresting the cell at metaphase.
Absorption: Rapidly absorbed. Oral bioavailability: 40%. Peak plasma concentration: 1.5-3 hr (oral).
Distribution: Widely distributed. Binding: 13.5% (plasma protein), 78% (platelets), 4.8% (lymphocytes).
Metabolism: Metabolised in liver by cytochrome P450 3A4 to active metabolite.
Excretion: Excreted mainly in faeces via bile and urine as metabolites and unchanged drug.
Bảo quản
Store at 2-8°C. Protect from light.
Store at 2-8°C.
Phân loại MIMS
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