Indications |
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: 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%. 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. Hepatic impairment: 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%. Intravenous Cervical cancer Adult: 30 mg/m2/dose days 1 and 8 of a 21-day treatment cycle. Hepatic impairment: Dose adjustments may be needed. Intravenous Breast cancer Adult: 25 mg/m2/dose every 7 days. Hepatic impairment: Dose adjustments may be needed. Intravenous Ovarian cancer Adult: 25 mg/m2/dose every 7 days. Hepatic impairment: Dose adjustments may be needed. Special Populations: Dosage adjustment in hepatic impairment: Serum bilirubin ≤2 mg/dL: Administer 100% of starting dose. Serum bilirubin 2.3-3 mg/dL: Administer 50% of starting dose. Serum bilirubin >3 mg/dL: Administer 25% of starting dose. Dosage adjustment in haematological toxicity: Granulocyte counts should be 1000 cells/mm3 and over prior to the treatment. Adjust dosage based on granulocyte counts obtained on the day of treatment: Granulocytes ≥1500 cells/mm3: 100% of starting dose. Granulocytes 1000-1499 cells/mm3: 50% of starting dose. Granulocytes <1000 cells/mm3: Do not administer. Repeat granulocytes count in 1 week; if 3 consecutive wkly doses are held because granulocyte count is <1000 cells/mm3, discontinue vinorelbine. For patients who, during treatment, have experienced fever and/or sepsis while granulocytopaenic or had 2 consecutive wkly doses are held due to granulocytopaenia, subsequent doses be: 75% of starting dose for granulocytes 1500 cells/mm3, 37.5% of starting dose for granulocytes 1000-1499 cells/mm3. |
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. |
Warnings / 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. |
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. See Below for More vinorelbine tartrate Drug Interactions |
Mechanism of Actions |
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. |
Storage Conditions |
Intravenous: Store at 2-8°C. Protect from light. Oral: Store at 2-8°C. |
ATC Classification |
L01CA04 - vinorelbine ; Belongs to the class of plant alkaloids and other natural products, vinca alkaloids and analogues. Used in the treatment of cancer. |
Storage |
Intravenous: Store at 2-8°C. Protect from light. Oral: Store at 2-8°C. |
Available As |
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Vinorelbine
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Vinorelbine Containing Brands
Vinorelbine is used in following diseases
Drug - Drug Interactions of Vinorelbine
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