Procarbazine Hydrochloride
Generic Name: procarbazine hydrochloride
Brand Names:
Matulane
DESCRIPTION Matulane (procarbazine hydrochloride), a hydrazine derivative antineoplastic agent, is available as capsules containing the equivalent of 50 mg procarbazine as the hydrochloride. Each capsule also contains cornstarch, mannitol and talc. Gelatin capsule shells contain titanium dioxide, FD&C Yellow No. 6 and D&C Yellow No. 10. Chemically, procarbazine hydrochloride is N ‑isopropyl-∝-(2‑methylhydrazino)‑ p ‑toluamide monohydrochloride.
Overview
DESCRIPTION Matulane (procarbazine hydrochloride), a hydrazine derivative antineoplastic agent, is available as capsules containing the equivalent of 50 mg procarbazine as the hydrochloride. Each capsule also contains cornstarch, mannitol and talc. Gelatin capsule shells contain titanium dioxide, FD&C Yellow No. 6 and D&C Yellow No. 10. Chemically, procarbazine hydrochloride is N ‑isopropyl-∝-(2‑methylhydrazino)‑ p ‑toluamide monohydrochloride.
Uses
INDICATIONS AND USAGE Matulane is indicated for use in combination with other anticancer drugs for the treatment of Stage III and IV Hodgkin's disease. Matulane is used as part of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) regimen.
Dosage
DOSAGE AND ADMINISTRATION 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.
Side Effects
ADVERSE REACTIONS Leukopenia, anemia and thrombopenia occur frequently. Nausea and vomiting are the most commonly reported side effects. Other adverse reactions are: Hematologic Pancytopenia; eosinophilia; hemolytic anemia; bleeding tendencies such as petechiae, purpura, epistaxis and hemoptysis. Gastrointestinal Hepatic dysfunction, jaundice, stomatitis, hematemesis, melena, diarrhea, dysphagia, anorexia, abdominal pain, constipation, dry mouth. Neurologic Coma, convulsions, neuropathy, ataxia, paresthesia, nystagmus, diminished reflexes, falling, foot drop, headache, dizziness, unsteadiness. Cardiovascular Hypotension, tachycardia, syncope. Ophthalmic Retinal hemorrhage, papilledema, photophobia, diplopia, inability to focus. Respiratory Pneumonitis, pleural effusion, cough.
Interactions
Drug Interactions See WARNINGS section. No cross-resistance with other chemotherapeutic agents, radiotherapy or steroids has been demonstrated.
Warnings
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. WARNINGS To minimize CNS depression and possible potentiation, barbiturates, antihistamines, narcotics, hypotensive agents or phenothiazines should be used with caution. Ethyl alcohol should not be used since there may be an Antabuse (disulfiram)-like reaction. Because Matulane exhibits some monoamine oxidase inhibitory activity, sympathomimetic drugs, tricyclic antidepressant drugs (eg, amitriptyline HCI, imipramine HCI) and other drugs and foods with known high tyramine content, such as wine, yogurt, ripe cheese and bananas, should be avoided. A further phenomenon of toxicity common to many hydrazine derivatives is hemolysis and the appearance of Heinz‑Ehrlich inclusion bodies in erythrocytes. CONTRAINDICATIONS Matulane is contraindicated in patients with known hypersensitivity to the drug or inadequate marrow reserve as demonstrated by bone marrow aspiration. Due consideration of this possible state should be given to each patient who has leukopenia, thrombocytopenia or anemia.
Pregnancy
Pregnancy Teratogenic Effects 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.
Storage
HOW SUPPLIED Capsules, ivory, containing the equivalent of 50 mg procarbazine as the hydrochloride; in bottles of 100 (NDC 54482-054-01). Imprint on capsules: MATULANE LB213.
Frequently Asked Questions
What is Procarbazine Hydrochloride used for?▼
INDICATIONS AND USAGE Matulane is indicated for use in combination with other anticancer drugs for the treatment of Stage III and IV Hodgkin's disease. Matulane is used as part of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) regimen.
What are the side effects of Procarbazine Hydrochloride?▼
ADVERSE REACTIONS Leukopenia, anemia and thrombopenia occur frequently. Nausea and vomiting are the most commonly reported side effects. Other adverse reactions are: Hematologic Pancytopenia; eosinophilia; hemolytic anemia; bleeding tendencies such as petechiae, purpura, epistaxis and hemoptysis. Gastrointestinal Hepatic dysfunction, jaundice, stomatitis, hematemesis, melena, diarrhea, dysphagia, anorexia, abdominal pain, constipation, dry mouth. Neurologic Coma, convulsions, neuropathy, ataxia, paresthesia, nystagmus, diminished reflexes, falling, foot drop, headache, dizziness, unsteadiness. Cardiovascular Hypotension, tachycardia, syncope. Ophthalmic Retinal hemorrhage, papilledema, photophobia, diplopia, inability to focus. Respiratory Pneumonitis, pleural effusion, cough.
Can I take Procarbazine Hydrochloride during pregnancy?▼
Pregnancy Teratogenic Effects 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.
What are the important warnings for 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. WARNINGS To minimize CNS depression and possible potentiation, barbiturates, antihistamines, narcotics, hypotensive agents or phenothiazines should be used with caution. Ethyl alcohol should not be used since there may be an Antabuse (disulfiram)-like reaction. Because Matulane exhibits some monoamine oxidase inhibitory activity, sympathomimetic drugs, tricyclic antidepressant drugs (eg, amitriptyline HCI, imipramine HCI) and other drugs and foods with known high tyramine content, such as wine, yogurt, ripe cheese and bananas, should be avoided. A further phenomenon of toxicity common to many hydrazine derivatives is hemolysis and the appearance of Heinz‑Ehrlich inclusion bodies in erythrocytes. CONTRAINDICATIONS Matulane is contraindicated in patients with known hypersensitivity to the drug or inadequate marrow reserve as demonstrated by bone marrow aspiration. Due consideration of this possible state should be given to each patient who has leukopenia, thrombocytopenia or anemia.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.