Dosing and uses of Matulane (procarbazine)
Adult dosage forms and strengths
capsule
- 50mg
Hodgkin's Disease
Part of COPP, BEACOPP & MOPP regimens
2-4 mg/kg/day in single or divided doses for 7 days; increase dose by 4-6 mg/kg/day until maximum response obtained or WBC<4,000 cells/mm³ or plateletes<100,000 cells/mm³; reduce dosage to 1-2 mg/kg/day after maximum effect obtained
Alternatively, 100 mg/m² PO qDay for 7-14 days of each 28 day cycle in combo with other antineoplastics
Monitor: CBC
Glioma (Orphan)
Treatment of malignant glioma
Orphan indication sponsor
- Sigma-Tau Pharmaceuticals, Inc; 9841 Washingtonian Blvd, Suite 500; Gaithersburg, MD 20878
Renal Impairment
Use caution; may result in increased toxicity if BUN above 40 mg/dL
Hepatic Impairment
Use caution; may result in increased toxicity if AST or ALT >1.6 ULn
Pediatric dosage forms and strengths
capsule
- 50mg
Hodgkin's Disease
50 mg/m² PO qDay for 7 days; increase to 100 mg/m²/day until maximum response obtained or leukopenia or thrombocytopenia observed
Monitor: CBC
Geriatric dosage forms and strengths
Hodgkin's Disease
Adjust for renal impairment if necessary
Part of COPP, BEACOPP & MOPP regimens
2-4 mg/kg/day in single or divided doses for 7 days; increase dose by 4-6 mg/kg/day until maximum response obtained or WBC<4,000 cells/mm³ or plateletes<100,000 cells/mm³; reduce dosage to 1-2 mg/kg/day after maximum effect obtained
Alternatively, 100 mg/m² PO qDay for 7-14 days of each 28 day cycle in combo with other antineoplasticsMonitor: CBC
Matulane (procarbazine) adverse (side) effects
Frequency not defined
Neuropathy
Neurotoxicity
Nausea
Vomiting
Pleural effusion
Myelosuppression
Heinz bodies
Hepatic dysfunction
Impairment of fertility
Warnings
Black box warnings
The therapy should be given only by or under the supervision of a physician experienced in the use of potent antineoplastic drugs.
Adequate clinical and laboratory facilities should be available to patients for proper monitoring of treatment.
Contraindications
Hypersensitivity
Severe anemia, leukopenia, thrombocytopenia, bone marrow depression
Cautions
Discontnue if CNS S/S, hypersensitivity reaction, stomatitis, diarrhea, hemorrhage, hemolysis
Discontinue if WBC <4000/mm³ &/or Plateletes <100,000/mm³
Caution in hepatic/renal impairment
Avoid alcohol, food high in tyramine
Avoid pregnancy
May cause infertility
Has MAO inhibitor activity (potential for food and drug interactions)
Pregnancy and lactation
Pregnancy category: d
Lactation: Excreted in breast milk, do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Matulane (procarbazine)
Mechanism of action
Methylhydrazine derivative; inhibits protein, DNA, RNA synthesis; may suppress mitosis and damage DNA directly
Some MAOI activity
Pharmacokinetics
Half-life elimination: 1 hr
Peak Plasma Time: 1 hr
Metabolism: liver, kidney
Excretion: Urine