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procarbazine (Matulane)

 

Classes: Antineoplastics, Alkylating

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