pharmacopeia
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Boxed 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.

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Alkylating Activity; Nucleic Acid Synthesis Inhibitors.

Nucleic Acid Synthesis

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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 (see PRECAUTIONS section), 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.

Warnings & precautions

Sourced from openFDA

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. 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. 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.

Adverse reactions

Sourced from openFDA

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. Dermatologic Herpes, dermatitis, pruritus, alopecia, hyperpigmentation, rash, urticaria, flushing. Allergic Generalized allergic reactions. Genitourinary Hematuria, urinary frequency, nocturia. Musculoskeletal Pain, including myalgia and arthralgia; tremors. Psychiatric Hallucinations, depression, apprehension, nervousness, confusion, nightmares. Endocrine Gynecomastia in prepubertal and early pubertal boys. Miscellaneous Intercurrent infections, hearing loss, pyrexia, diaphoresis, lethargy, weakness, fatigue, edema, chills, insomnia, slurred speech, hoarseness, drowsiness.

Use in specific populations

Sourced from openFDA

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. 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. Procarbazine hydrochloride is teratogenic in the rat when given at doses approximately 4 to 13 times the maximum recommended human therapeutic dose of 6 mg/kg/day. Nonteratogenic Effects Procarbazine hydrochloride has not been adequately studied in animals for its effects on peri- and postnatal development. However, neurogenic tumors were noted in the offspring of rats given intravenous injections of 125 mg/kg of procarbazine hydrochloride on day 22 of gestation. Compounds which inhibit DNA, RNA and protein synthesis might be expected to have adverse effects on peri- and postnatal development.

Overdosage

Sourced from openFDA

The major manifestations of overdosage with Matulane would be anticipated to be nausea, vomiting, enteritis, diarrhea, hypotension, tremors, convulsions and coma. Treatment should consist of either the administration of an emetic or gastric lavage. General supportive measures such as intravenous fluids are advised. Since the major toxicity of procarbazine hydrochloride is hematologic and hepatic, patients should have frequent complete blood counts and liver function tests throughout their period of recovery and for a minimum of two weeks thereafter. Should abnormalities appear in any of these determinations, appropriate measures for correction and stabilization should be immediately undertaken. The estimated mean lethal dose of procarbazine hydrochloride in laboratory animals varied from approximately 150 mg/kg in rabbits to 1300 mg/kg in mice.

Approval history

Sourced from openFDA
  • Jul 22, 1969NDANDA016785Leadiant Biosci Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,484 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea97322%
  2. 2Fatigue82918%
  3. 3Vomiting3046.8%
  4. 4Constipation2655.9%
  5. 5Platelet Count Decreased2395.3%
  6. 6White Blood Cell Count Decreased2295.1%
  7. 7Decreased Appetite1773.9%
  8. 8Headache1723.8%
  9. 9Rash1483.3%
  10. 10Diarrhoea1353.0%
  11. 11Blood Count Abnormal1322.9%
  12. 12Neutropenia1322.9%
  13. 13Dizziness1042.3%
  14. 14Urticaria1022.3%
  15. 15Thrombocytopenia1002.2%

Literature

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Recent PubMed references pinned to Procarbazine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 88 ClinicalTrials.gov registrations naming Procarbazine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Procarbazine work?
Mechanism-of-action classes: Alkylating Activity; Nucleic Acid Synthesis Inhibitors.
What is Procarbazine used for?
According to FDA labeling, Procarbazine carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Procarbazine?
Procarbazine is classified as Methylhydrazines, Alkylating Drug, Alkylating Activity, Nucleic Acid Synthesis Inhibitors, Decreased DNA Replication, Decreased Mitosis, Decreased Protein Synthesis, Decreased RNA Replication.
What are the brand names for Procarbazine?
Procarbazine is marketed under brand names including Matulane.
What are the contraindications for Procarbazine?
Procarbazine labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for procarbazine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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