Indications
Vinorelbine soft capsule is used for:
Breast cancer, Ovarian cancer, Cervical cancer, Non-small cell lung cancer
Adult Dose
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%.
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.
Hepatic impairment: Dose adjustments may be needed.
Child Dose
Renal Dose
Administration
IV Preparation
May be diluted in syringe or bag
Syringe: dilute to 1.5-3 mg/mL in NS or D5W
IV Bag: dilute to 0.5-2 mg/mL in NS, 1/2NS, D5W, D5/½NS, LR or Ringer's
IV Administration
Administer IV over 6-10 min through sidearm of free-flowing IV closest to IV bag
Then flush with 75-125 mL of one of the IV fluids
Contra Indications
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.
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.
Lactation: not known if excreted in breast milk; do not nurse
Pregnancy-Lactation
Pregnancy
Based on animal findings, can cause fetal harm when administered to pregnant women
Verify pregnancy status in females of reproductive potential before initiating
Animal studies
In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with vinorelbine doses ~0.33 and 0.18 times the human therapeutic dose, respectively
Contraception
Females: Use effective contraception during treatment and for 6 months after final dose
Males: May damage spermatozoa; advise males with female sexual partners of reproductive potential to use effective contraception during treatment and for 3 months after final dose
Infertility
Males: Based on animal findings, may impair fertility
Lactation
Data are not available regarding drug in human milk or effects on breastfed infant or milk production
Because of potential harm; advise women not to breastfeed during treatment and for 9 days after final dose
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.
Side Effects
Side effects of Vinorelbine :
>10%
Leukopenia (92%), Granulocytopenia (90%), Anemia (83%), Elev AST (67%), Nausea (44%), Asthenia (36%), Constipation (35%), Fatigue (27%), Peripheral neuropathy (25%), Vomiting (20%), Anorexia (20%), Stomatitis (20%), Alopecia (12%)
1-10%
Dyspnea (7%), Chest pain (5%), Rash (5%), SOB (3%), Hemorrhagic cystitis (1%), SIADH (1%)
Mode of Action
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.
Note
Vinorelbine 30 mg soft capsule generic name is Vinorelbine. Vinorelbine 30 mg soft capsule is manufactured by ZAS CorporationVinorelbine is availble in all over Bangladesh.
Mes BD drug index information on Vinorelbine soft capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.