Vinorelbine tartrate


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Non-small cell lung cancer 60 mg/m2/wk for 3 wk, up to 80 mg/m2/wk depending on neutrophil count. IV Non-small cell lung cancer As single agent: 30 mg/m2/wk. Delay treatment if neutrophil count is <2000 cells/mm3 until recovery. As combination therapy w/ cisplatin: 25-30 mg/m2 every 7 days. Cervical cancer 30 mg/m2/dose on days 1 and 8 of a 21-day treatment cycle. Breast cancer; Ovarian cancer 25 mg/m2/dose every 7 days.
Dosage Details
Intravenous
Cervical cancer
Adult: 30 mg/m2/dose days 1 and 8 of a 21-day treatment cycle.

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

Intravenous
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.

Oral
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
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 2.1-3 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 2.1-3 mg/100 ml: Reduce IV dose by 50%. Bilirubin >3 mg/100 ml: Reduce IV dose by 75%.
Contraindications
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.
Special Precautions
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.
Adverse Reactions
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
Drug Interactions
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.
Action
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.
Pharmacokinetics:
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.
Storage
Intravenous:
Store at 2-8°C. Protect from light.
Oral:
Store at 2-8°C.
Disclaimer: This information is independently developed by MIMS based on Vinorelbine tartrate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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