Matulane (procarbazine hydrochloride)

WARNING

It is recommended that Matulane 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.

Common side effects of Matulane include:

• nausea and vomiting (may be severe),
• loss of appetite,
• stomach pain,
• constipation,
• dry mouth,
• diarrhea,
• difficulty swallowing,
• drowsiness,
• tiredness,
• dizziness,
• headache,
• trouble sleeping,
• muscle or joint pain,
• temporary hair loss,
• darkening of the skin,
• itching or rash,
• urinating more than usual, or
• changes in your menstrual periods

• The following doses are for administration of the drug as a single agent.
• When used in combination with other anticancer drugs, the Matulane dose should be appropriately reduced, eg, in the MOPP regimen, the Matulane dose is 100 mg/m² daily for 14 days.
• All dosages are based on the patient's actual weight.
• However, the estimated lean body mass (dry weight) is used if the patient is obese or if there has been a spurious weight gain due to edema, ascites or other forms of abnormal fluid retention.

Adults

• To minimize the nausea and vomiting experienced by a high percentage of patients beginning Matulane therapy, single or divided doses of 2 to 4 mg/kg/day for the first week are recommended.
• Daily dosage should then be maintained at 4 to 6 mg/kg/day until maximum response is obtained or until the white blood count falls below 4000/cmm or the platelets fall below 100,000/ cmm.
• When maximum response is obtained, the dose may be maintained at 1 to 2 mg/kg/day.
• Upon evidence of hematologic or other toxicity, the drug should be discontinued until there has been satisfactory recovery.
• After toxic side effects have subsided, therapy may then be resumed at the discretion of the physician, based on clinical evaluation and appropriate laboratory studies, at a dosage of 1 to 2 mg/kg/day.

Pediatric Patients

• Very close clinical monitoring is mandatory. Undue toxicity, evidenced by tremors, coma and convulsions, has occurred in a few cases. Dosage, therefore, should be individualized. The following dosage schedule is provided as a guideline only.
• Fifty (50) mg per square meter of body surface per day is recommended for the first week.
• Dosage should then be maintained at 100 mg per square meter of body surface per day until maximum response is obtained or until leukopenia or thrombocytopenia occurs.
• When maximum response is attained, the dose may be maintained at 50 mg per square meter of body surface per day.
• Upon evidence of hematologic or other toxicity, the drug should be discontinued until there has been satisfactory recovery, based on clinical evaluation and appropriate laboratory tests.
• After toxic side effects have subsided, therapy may then be resumed.
• Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

• It is not known whether Matulane is excreted in human milk.
• Because of the potential for tumorigenicity shown for procarbazine hydrochloride in animal studies, mothers should not nurse while receiving this drug.
• Procarbazine hydrochloride can cause fetal harm when administered to a pregnant woman.
• While there are no adequate and well-controlled studies with procarbazine hydrochloride in pregnant women, there are case reports of malformations in the offspring of women who were exposed to procarbazine hydrochloride in combination with other antineoplastic agents during pregnancy.
• Matulane should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
• Women of childbearing potential should be advised to avoid becoming pregnant.