Vincristine Sulphate Pharmachemie

Vincristine Sulphate Pharmachemie

vincristine sulfate

Manufacturer:

Teva

Distributor:

Zuellig
Concise Prescribing Info
Contents
Vincristine sulphate
Indications/Uses
Monotherapy or in combination w/ other oncolytic drugs for the treatment of acute lymphocytic leukaemia; malignant lymphomas, including Hodgkin's disease & non-Hodgkin's lymphomas; multiple myeloma; solid tumours including (metastatic) breast carcinoma, small cell lung carcinoma; Ewing's sarcoma, embryonal rhabdomyosarcoma, primitive neuro-ectodermal tumours (eg, medulloblastoma & neuroblastoma), Wilms tumour & retinoblastoma; ITP.
Dosage/Direction for Use
IV When used as monotherapy, administer at 1 wk intervals. In combination w/ other antineoplastic agents, dosing frequency depends on the protocol. Adult Usual dose: 1.4 mg/m2 (max 2 mg) once a wk. Childn 1.5-2 mg/m2 once a wk. Childn weighing ≤10 kg Usual starting dose: 0.05 mg/kg once a wk. Patient w/ hepatic impairment or w/ direct serum biliribun >3 mg/100 mL Reduce dose by 50%.
Contraindications
Hypersensitivity. Patients w/ neuromuscular disorders (eg, demyelinating form of Charcot-Marie-Tooth syndrome); severe liver function disorder; constipation & impending ileus, especially in childn. Patients treated w/ RT in which the liver is involved.
Special Precautions
Patients w/ existing neurological disorders or liver function disorders; ischaemic heart disorders. Avoid extravasation. Intrathecal administration results in fatal neurotoxicity. Avoid contact w/ skin & eyes. Neurotoxic effect of vincristine sulphate may be additive w/ other neurotoxic agents or increased by spinal cord irradiation & neurological disease. Patients who received vincristine w/ anticancer drugs known to be carcinogenic have developed 2nd malignancies. Prophylactic measures to prevent constipation are recommended. Risk of leukopenia & thrombocytopenia; infection. Acute elevation of serum uric acid level can occur during remission-induction w/ acute leukaemia. May affect ability to drive & use machines. Contraceptive measures should be taken by both male & female patients during treatment & for 6 mth after treatment discontinuation. May cause irreversible fertility. Genotoxic. Should not be used during pregnancy, particularly during the 1st trimester. Discontinue breast-feeding during treatment. Elderly.
Adverse Reactions
Alopecia. Neurological toxicity; temporary thrombocytosis; acute shortness of breath & bronchospasms; nausea, vomiting, constipation, abdominal pain; colic-like abdominal pain; azoospermia; inj site irritation.
Drug Interactions
Potential interaction w/ oral anticoagulants. Increased plasma conc w/ CYP3A4 & P-gp inhibitors eg, ritonavir, nelfinavir, ketoconazole, itraconazole, erythromycin, cyclosporine, nifedipine, nefazodone. Concomitant administration w/ itraconazole has been associated w/ premature &/or increased severity of neuromuscular side effects. Reduced blood levels of phenytoin & increased proconvulsant effect. Potentiation of therapeutic & toxic effect w/ other cytostatics. Potentiated bone marrow suppression w/ other bone marrow depressive medicinal products eg, doxorubicin (especially in combination w/ prednisone). Possible severe & prolonged peripheral neuropathy w/ neurotoxic medicinal products (eg, INH, L-asparaginase, cyclosporin A). Because of immunosuppression w/ vincristine, formation of Ab by the body may be reduced as a reaction to the inactivated vaccine. Concomitant administration of a live virus vaccine may enhance the replication & the side effects of the virus vaccine, &/or the formation of Ab by the body as a reaction to the vaccine may be reduced. Reduced absorption &/or therapeutic effect of digoxin. Acute pulmonary reactions can occur w/ mitomycin C. RT can enlarge the peripheral neurotoxicity of vincristine. Excessive immunosuppression w/ risk of lymphoproliferation w/ ciclosporine or tacrolimus. Atypical neuropathies w/ stinging or burning sensation in distal extremities were reported more frequently w/ colony-stimulating factors. Reports of severe liver toxicity w/ dactinomycin in patients w/ Wilms tumour. Raynaud syndrome w/ bleomycin.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CA02 - vincristine ; Belongs to the class of plant alkaloids and other natural products, vinca alkaloids and analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Vincristine Sulphate Pharmachemie soln for inj 1 mg/mL
Packing/Price
1's
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