{"id":"procarbazine","rwe":[{"pmid":"41890358","year":"2026","title":"Long-term outcome of nimustine-based chemotherapy for oligodendroglioma.","finding":"","journal":"Neuro-oncology advances","studyType":"Clinical Study"},{"pmid":"41707757","year":"2026","title":"Mapping the molecular landscape of glioblastoma: Pathogenesis, therapeutic targets and bioactive interventions.","finding":"","journal":"Critical reviews in oncology/hematology","studyType":"Clinical Study"},{"pmid":"41689681","year":"2026","title":"Consolidation reduced-dose whole-brain radiation therapy with response-adapted boost in older patients with newly diagnosed primary central nervous system lymphoma.","finding":"","journal":"Journal of neuro-oncology","studyType":"Clinical Study"},{"pmid":"41562675","year":"2026","title":"Paraneoplastic Neuro-Ophthalmologic Symptoms as Initial Manifestation of Hodgkin Lymphoma.","finding":"","journal":"Hematology reports","studyType":"Clinical Study"},{"pmid":"41557853","year":"2026","title":"Ibrutinib in combination with rituximab, methotrexate, vincristine, and procarbazine (R-MVP/i) for newly diagnosed primary CNS lymphoma (PCNSL).","finding":"","journal":"Neuro-oncology","studyType":"Clinical Study"}],"_fda":{"id":"caa705fa-c467-49b5-a7cb-ae2c8b872a86","set_id":"1aa75a3a-18c9-49e1-91a6-293d0b7da756","openfda":{"unii":["XH0NPH5ZX8"],"route":["ORAL"],"rxcui":["207588","314167"],"spl_id":["caa705fa-c467-49b5-a7cb-ae2c8b872a86"],"brand_name":["Matulane"],"spl_set_id":["1aa75a3a-18c9-49e1-91a6-293d0b7da756"],"package_ndc":["54482-054-01"],"product_ndc":["54482-054"],"generic_name":["PROCARBAZINE HYDROCHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["PROCARBAZINE HYDROCHLORIDE"],"manufacturer_name":["Leadiant Biosciences, Inc."],"application_number":["NDA016785"],"is_original_packager":[true]},"version":"9","warnings":["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. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenicity of procarbazine hydrochloride in mice, rats and monkeys has been reported in a considerable number of studies. Instances of a second nonlymphoid malignancy, including lung cancer and acute myelocytic leukemia, have been reported in patients with Hodgkin's disease treated with procarbazine in combination with other chemotherapy and/or radiation. The risks of secondary lung cancer from treatment appear to be multiplied by tobacco use. The International Agency for Research on Cancer (IARC) considers that there is \"sufficient evidence\" for the human carcinogenicity of procarbazine hydrochloride when it is given in intensive regimens which include other antineoplastic agents but that there is inadequate evidence of carcinogenicity in humans given procarbazine hydrochloride alone. Mutagenesis Procarbazine hydrochloride has been shown to be mutagenic in a variety of bacterial and mammalian test systems. Impairment of Fertility Azoospermia and antifertility effects associated with procarbazine hydrochloride administration in combination with other chemotherapeutic agents for treating Hodgkin's disease have been reported in human clinical studies. Since these patients received multicombination therapy, it is difficult to determine to what extent procarbazine hydrochloride alone was involved in the male germcell damage. The usual Segment I fertility/reproduction studies in laboratory animals have not been carried out with procarbazine hydrochloride. However, compounds which inhibit DNA, RNA and/or protein synthesis might be expected to have adverse effects on gametogenesis. Unscheduled DNA synthesis in the testis of rabbits and decreased fertility in male mice treated with procarbazine hydrochloride have been reported."],"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. 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.","Pregnancy See WARNINGS section."],"overdosage":["OVERDOSAGE 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."],"references":["REFERENCES Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: U.S. Government Printing Office NIH Publication No. 83-2621. AMA Council Report. Guidelines for handling parenteral antineoplastics. JAMA . Mar 15, 1985; 253:1590-1592. National Study Commission on Cytotoxic Exposure: Recommendations for handling cytotoxic agents. Available from Louis P. Jeffrey, ScD, Director of Pharmacy Services, Rhode Island Hospital, 593 Eddy Street, Providence, Rhode Island 02902. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust. Apr 30,1983; 1:426-428. Jones RB, Frank R, Mass T: Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA. Sept-Oct 1983; 33:258-263. ASHP technical assistance bulletin on handling cytotoxic drugs in hospitals. Am J Hosp Pharm. Jan 1985; 42:131-137. Manufactured by Alcami Corporation 1726 North 23rd St. Wilmington, NC 28405 for Leadiant Biosciences, Inc. Rockville, MD 20850 Revised: November 2023 MAT12 Printed in U.S.A. Leadiant Logo"],"description":["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. It is a white to pale yellow crystalline powder which is soluble but unstable in water or aqueous solutions. The molecular weight of procarbazine hydrochloride is 257.76 and the structural formula is: chemical structure"],"precautions":["PRECAUTIONS General Undue toxicity may occur if Matulane is used in patients with impairment of renal and/or hepatic function. When appropriate, hospitalization for the initial course of treatment should be considered. If radiation or a chemotherapeutic agent known to have marrow-depressant activity has been used, an interval of one month or longer without such therapy is recommended before starting treatment with Matulane. The length of this interval may also be determined by evidence of bone marrow recovery based on successive bone marrow studies. Prompt cessation of therapy is recommended if any one of the following occurs: Central nervous system signs or symptoms such as paresthesias, neuropathies or confusion. Leukopenia (white blood count under 4000). Thrombocytopenia (platelets under 100,000). Hypersensitivity reaction. Stomatitis - The first small ulceration or persistent spot soreness around the oral cavity is a signal for cessation of therapy. Diarrhea - Frequent bowel movements or watery stools. Hemorrhage or bleeding tendencies. Bone marrow depression often occurs 2 to 8 weeks after the start of treatment. If leukopenia occurs, hospitalization of the patient may be needed for appropriate treatment to prevent systemic infection. Information for Patients Patients should be warned not to drink alcoholic beverages while on Matulane therapy since there may be an Antabuse (disulfiram)‑like reaction. They should also be cautioned to avoid foods with known high tyramine content such as wine, yogurt, ripe cheese and bananas. Over-the-counter drug preparations which contain antihistamines or sympathomimetic drugs should also be avoided. Patients taking Matulane should also be warned against the use of prescription drugs without the knowledge and consent of their physician. Patients should be advised to discontinue tobacco use. Laboratory Tests Baseline laboratory data should be obtained prior to initiation of therapy. The hematologic status as indicated by hemoglobin, hematocrit, white blood count (WBC), differential, reticulocytes and platelets should be monitored closely - at least every 3 or 4 days. Hepatic and renal evaluation are indicated prior to beginning therapy. Urinalysis, transaminase, alkaline phosphatase and blood urea nitrogen tests should be repeated at least weekly. Drug Interactions See WARNINGS section. No cross-resistance with other chemotherapeutic agents, radiotherapy or steroids has been demonstrated. Carcinogenesis, Mutagenesis, Impairment of Fertility See WARNINGS section. Pregnancy See WARNINGS section. Nursing Mothers 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. Pediatric Use Undue toxicity, evidenced by tremors, coma and convulsions, has occurred in a few cases. Dosage, therefore, should be individualized (see DOSAGE AND ADMINISTRATION). Very close clinical monitoring is mandatory."],"how_supplied":["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."],"boxed_warning":["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."],"pediatric_use":["Pediatric Use Undue toxicity, evidenced by tremors, coma and convulsions, has occurred in a few cases. Dosage, therefore, should be individualized (see DOSAGE AND ADMINISTRATION). Very close clinical monitoring is mandatory."],"effective_time":"20240916","nursing_mothers":["Nursing Mothers 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."],"laboratory_tests":["Laboratory Tests Baseline laboratory data should be obtained prior to initiation of therapy. The hematologic status as indicated by hemoglobin, hematocrit, white blood count (WBC), differential, reticulocytes and platelets should be monitored closely - at least every 3 or 4 days. Hepatic and renal evaluation are indicated prior to beginning therapy. Urinalysis, transaminase, alkaline phosphatase and blood urea nitrogen tests should be repeated at least weekly."],"adverse_reactions":["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. 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. Second nonlymphoid malignancies (including lung cancer, acute myelocytic leukemia and malignant myelosclerosis) and azoospermia have been reported in patients with Hodgkin's disease treated with procarbazine in combination with other chemotherapy and/or radiation. The risks of secondary lung cancer from treatment appear to be multiplied by tobacco use."],"contraindications":["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."],"drug_interactions":["Drug Interactions See WARNINGS section. No cross-resistance with other chemotherapeutic agents, radiotherapy or steroids has been demonstrated."],"general_precautions":["General Undue toxicity may occur if Matulane is used in patients with impairment of renal and/or hepatic function. When appropriate, hospitalization for the initial course of treatment should be considered. If radiation or a chemotherapeutic agent known to have marrow-depressant activity has been used, an interval of one month or longer without such therapy is recommended before starting treatment with Matulane. The length of this interval may also be determined by evidence of bone marrow recovery based on successive bone marrow studies. Prompt cessation of therapy is recommended if any one of the following occurs: Central nervous system signs or symptoms such as paresthesias, neuropathies or confusion. Leukopenia (white blood count under 4000). Thrombocytopenia (platelets under 100,000). Hypersensitivity reaction. Stomatitis - The first small ulceration or persistent spot soreness around the oral cavity is a signal for cessation of therapy. Diarrhea - Frequent bowel movements or watery stools. Hemorrhage or bleeding tendencies. Bone marrow depression often occurs 2 to 8 weeks after the start of treatment. If leukopenia occurs, hospitalization of the patient may be needed for appropriate treatment to prevent systemic infection."],"teratogenic_effects":["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."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The precise mode of cytotoxic action of procarbazine has not been clearly defined. There is evidence that the drug may act by inhibition of protein, RNA and DNA synthesis. Studies have suggested that procarbazine may inhibit transmethylation of methyl groups of methionine into t‑RNA. The absence of functional t‑RNA could cause the cessation of protein synthesis and consequently DNA and RNA synthesis. In addition, procarbazine may directly damage DNA. Hydrogen peroxide, formed during the auto‑oxidation of the drug, may attack protein sulfhydryl groups contained in residual protein which is tightly bound to DNA. Procarbazine is metabolized primarily in the liver and kidneys. The drug appears to be auto-oxidized to the azo derivative with the release of hydrogen peroxide. The azo derivative isomerizes to the hydrazone, and following hydrolysis splits into a benzylaldehyde derivative and methylhydrazine. The methylhydrazine is further degraded to CO 2 and CH 4 and possibly hydrazine, whereas the aldehyde is oxidized to N -isopropylterephthalamic acid, which is excreted in the urine. Procarbazine is rapidly and completely absorbed. Following oral administration of 30 mg of 14 C-labeled procarbazine, maximum peak plasma radioactive concentrations were reached within 60 minutes. After intravenous injection, the plasma half-life of procarbazine is approximately 10 minutes. Approximately 70% of the radioactivity is excreted in the urine as N -isopropylterephthalamic acid within 24 hours following both oral and intravenous administration of 14 C-labeled procarbazine. Procarbazine crosses the blood-brain barrier and rapidly equilibrates between plasma and cerebrospinal fluid after oral administration."],"indications_and_usage":["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."],"nonteratogenic_effects":["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."],"information_for_patients":["Information for Patients Patients should be warned not to drink alcoholic beverages while on Matulane therapy since there may be an Antabuse (disulfiram)‑like reaction. They should also be cautioned to avoid foods with known high tyramine content such as wine, yogurt, ripe cheese and bananas. Over-the-counter drug preparations which contain antihistamines or sympathomimetic drugs should also be avoided. Patients taking Matulane should also be warned against the use of prescription drugs without the knowledge and consent of their physician. Patients should be advised to discontinue tobacco use."],"dosage_and_administration":["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. 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. 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 (see PRECAUTIONS section), 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. 1-6 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate."],"spl_product_data_elements":["Matulane procarbazine hydrochloride STARCH, CORN MANNITOL TALC GELATIN, UNSPECIFIED TITANIUM DIOXIDE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 PROCARBAZINE HYDROCHLORIDE PROCARBAZINE Ivory MATULANE;LB213"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - BOTTLE LABEL NDC 54482-054-01 MATULANE ® (PROCARBAZINE HYDROCHLORIDE) 50 mg Each capsule contains 50 mg procarbazine in the form of the hydrochloride salt. Rx only 100 Capsules Usual Dosage: See package insert. Dispense in tight, light-resistant containers as defined in USP/NF. STORE AT 59° TO 86°F (15° to 30°C) Leadiant Biosciences Mfd. for Leadiant Biosciences, Inc. Rockville, MD 20850 Mfd. by: Alcami Corporation 2320 Scientific Park Drive Wilmington, NC 28405 M10 PC3986F image-03"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenicity of procarbazine hydrochloride in mice, rats and monkeys has been reported in a considerable number of studies. Instances of a second nonlymphoid malignancy, including lung cancer and acute myelocytic leukemia, have been reported in patients with Hodgkin's disease treated with procarbazine in combination with other chemotherapy and/or radiation. The risks of secondary lung cancer from treatment appear to be multiplied by tobacco use. The International Agency for Research on Cancer (IARC) considers that there is \"sufficient evidence\" for the human carcinogenicity of procarbazine hydrochloride when it is given in intensive regimens which include other antineoplastic agents but that there is inadequate evidence of carcinogenicity in humans given procarbazine hydrochloride alone. Mutagenesis Procarbazine hydrochloride has been shown to be mutagenic in a variety of bacterial and mammalian test systems. Impairment of Fertility Azoospermia and antifertility effects associated with procarbazine hydrochloride administration in combination with other chemotherapeutic agents for treating Hodgkin's disease have been reported in human clinical studies. Since these patients received multicombination therapy, it is difficult to determine to what extent procarbazine hydrochloride alone was involved in the male germcell damage. The usual Segment I fertility/reproduction studies in laboratory animals have not been carried out with procarbazine hydrochloride. However, compounds which inhibit DNA, RNA and/or protein synthesis might be expected to have adverse effects on gametogenesis. Unscheduled DNA synthesis in the testis of rabbits and decreased fertility in male mice treated with procarbazine hydrochloride have been reported.","Carcinogenesis The carcinogenicity of procarbazine hydrochloride in mice, rats and monkeys has been reported in a considerable number of studies. Instances of a second nonlymphoid malignancy, including lung cancer and acute myelocytic leukemia, have been reported in patients with Hodgkin's disease treated with procarbazine in combination with other chemotherapy and/or radiation. The risks of secondary lung cancer from treatment appear to be multiplied by tobacco use. The International Agency for Research on Cancer (IARC) considers that there is \"sufficient evidence\" for the human carcinogenicity of procarbazine hydrochloride when it is given in intensive regimens which include other antineoplastic agents but that there is inadequate evidence of carcinogenicity in humans given procarbazine hydrochloride alone.","Mutagenesis Procarbazine hydrochloride has been shown to be mutagenic in a variety of bacterial and mammalian test systems.","Impairment of Fertility Azoospermia and antifertility effects associated with procarbazine hydrochloride administration in combination with other chemotherapeutic agents for treating Hodgkin's disease have been reported in human clinical studies. Since these patients received multicombination therapy, it is difficult to determine to what extent procarbazine hydrochloride alone was involved in the male germcell damage. The usual Segment I fertility/reproduction studies in laboratory animals have not been carried out with procarbazine hydrochloride. However, compounds which inhibit DNA, RNA and/or protein synthesis might be expected to have adverse effects on gametogenesis. Unscheduled DNA synthesis in the testis of rabbits and decreased fertility in male mice treated with procarbazine hydrochloride have been reported.","Carcinogenesis, Mutagenesis, Impairment of Fertility See WARNINGS section."]},"tags":[{"label":"Alkylating Drug","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"L01XB01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Hodgkin's disease","category":"indication"},{"label":"Leadiant Biosci Inc","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["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."],"safetySignals":[{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"973 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"829 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"304 reports"},{"date":"","signal":"CONSTIPATION","source":"FDA FAERS","actionTaken":"265 reports"},{"date":"","signal":"PLATELET COUNT DECREASED","source":"FDA FAERS","actionTaken":"239 reports"},{"date":"","signal":"WHITE BLOOD CELL COUNT DECREASED","source":"FDA FAERS","actionTaken":"229 reports"},{"date":"","signal":"DECREASED APPETITE","source":"FDA FAERS","actionTaken":"177 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"172 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"148 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"135 reports"}],"drugInteractions":[{"url":"/drug/almotriptan","drug":"almotriptan","action":"Avoid combination","effect":"May interact with Almotriptan","source":"DrugCentral","drugSlug":"almotriptan"},{"url":"/drug/bupivacaine","drug":"bupivacaine","action":"Avoid combination","effect":"May interact with Bupivacaine","source":"DrugCentral","drugSlug":"bupivacaine"},{"url":"/drug/eletriptan","drug":"eletriptan","action":"Avoid combination","effect":"May interact with Eletriptan","source":"DrugCentral","drugSlug":"eletriptan"},{"url":"/drug/entacapone","drug":"entacapone","action":"Avoid combination","effect":"May interact with Entacapone","source":"DrugCentral","drugSlug":"entacapone"},{"url":"/drug/frovatriptan","drug":"frovatriptan","action":"Avoid combination","effect":"May interact with Frovatriptan","source":"DrugCentral","drugSlug":"frovatriptan"},{"url":"/drug/furazolidone","drug":"furazolidone","action":"Avoid combination","effect":"May interact with Furazolidone","source":"DrugCentral","drugSlug":"furazolidone"},{"url":"/drug/isocarboxazid","drug":"isocarboxazid","action":"Avoid combination","effect":"May interact with Isocarboxazid","source":"DrugCentral","drugSlug":"isocarboxazid"},{"url":"/drug/mepivacaine","drug":"mepivacaine","action":"Avoid combination","effect":"May interact with Mepivacaine","source":"DrugCentral","drugSlug":"mepivacaine"},{"url":"/drug/naratriptan","drug":"naratriptan","action":"Avoid combination","effect":"May interact with Naratriptan Hydrochloride","source":"DrugCentral","drugSlug":"naratriptan"},{"url":"/drug/pargyline","drug":"pargyline","action":"Avoid combination","effect":"May interact with Pargyline","source":"DrugCentral","drugSlug":"pargyline"},{"url":"/drug/phenelzine","drug":"phenelzine","action":"Avoid combination","effect":"May interact with Phenelzine","source":"DrugCentral","drugSlug":"phenelzine"},{"url":"/drug/procaine","drug":"procaine","action":"Avoid combination","effect":"May interact with Procaine","source":"DrugCentral","drugSlug":"procaine"},{"url":"/drug/protriptyline","drug":"protriptyline","action":"Avoid combination","effect":"May interact with Protriptyline","source":"DrugCentral","drugSlug":"protriptyline"},{"url":"/drug/rasagiline","drug":"rasagiline","action":"Avoid combination","effect":"May interact with Rasagiline","source":"DrugCentral","drugSlug":"rasagiline"},{"url":"/drug/selegiline","drug":"selegiline","action":"Avoid combination","effect":"May interact with Selegiline","source":"DrugCentral","drugSlug":"selegiline"},{"url":"/drug/tapentadol","drug":"tapentadol","action":"Avoid combination","effect":"May interact with Tapentadol","source":"DrugCentral","drugSlug":"tapentadol"},{"url":"/drug/tetracaine","drug":"tetracaine","action":"Avoid combination","effect":"May interact with Tetracaine","source":"DrugCentral","drugSlug":"tetracaine"},{"url":"/drug/tolcapone","drug":"tolcapone","action":"Avoid combination","effect":"May interact with Tolcapone","source":"DrugCentral","drugSlug":"tolcapone"},{"url":"/drug/tranylcypromine","drug":"tranylcypromine","action":"Avoid combination","effect":"May interact with Tranylcypromine","source":"DrugCentral","drugSlug":"tranylcypromine"},{"url":"/drug/trimipramine","drug":"trimipramine","action":"Avoid combination","effect":"May interact with Trimipramine","source":"DrugCentral","drugSlug":"trimipramine"}],"commonSideEffects":[{"effect":"Pancytopenia","drugRate":"reported","severity":"unknown"},{"effect":"Hepatic dysfunction","drugRate":"reported","severity":"unknown"},{"effect":"Hemolytic anemia","drugRate":"reported","severity":"unknown"},{"effect":"Bleeding tendencies","drugRate":"reported","severity":"unknown"},{"effect":"Hepatitis","drugRate":"reported","severity":"unknown"},{"effect":"Jaundice","drugRate":"reported","severity":"unknown"},{"effect":"Stomatitis","drugRate":"reported","severity":"unknown"},{"effect":"Hematemesis","drugRate":"reported","severity":"unknown"},{"effect":"Melena","drugRate":"reported","severity":"unknown"},{"effect":"Diarrhea","drugRate":"reported","severity":"unknown"},{"effect":"Dysphagia","drugRate":"reported","severity":"unknown"},{"effect":"Anorexia","drugRate":"reported","severity":"unknown"},{"effect":"Abdominal pain","drugRate":"reported","severity":"unknown"},{"effect":"Constipation","drugRate":"reported","severity":"unknown"},{"effect":"Dry mouth","drugRate":"reported","severity":"unknown"},{"effect":"Coma","drugRate":"reported","severity":"unknown"},{"effect":"Convulsions","drugRate":"reported","severity":"unknown"},{"effect":"Neuropathy","drugRate":"reported","severity":"unknown"},{"effect":"Ataxia","drugRate":"reported","severity":"unknown"},{"effect":"Paresthesia","drugRate":"reported","severity":"unknown"},{"effect":"Nystagmus","drugRate":"reported","severity":"unknown"},{"effect":"Diminished reflexes","drugRate":"reported","severity":"unknown"},{"effect":"Falling","drugRate":"reported","severity":"unknown"},{"effect":"Foot drop","drugRate":"reported","severity":"unknown"},{"effect":"Headache","drugRate":"reported","severity":"unknown"},{"effect":"Dizziness","drugRate":"reported","severity":"unknown"},{"effect":"Unsteadiness","drugRate":"reported","severity":"unknown"},{"effect":"Hypotension","drugRate":"reported","severity":"unknown"},{"effect":"Tachycardia","drugRate":"reported","severity":"unknown"},{"effect":"Syncope","drugRate":"reported","severity":"unknown"}],"contraindications":["Acute nephropathy","Alcoholism","Anemia","Bacterial infectious disease","Blood coagulation disorder","Bone marrow depression","Breastfeeding (mother)","Disease of liver","Hepatic failure","Kidney disease","Leukopenia","Mycosis","Peripheral nerve disease","Pregnancy, function","Protozoal Infection","Smokes tobacco daily","Thrombocytopenic disorder","Viral disease"],"specialPopulations":{"Pregnancy":"Procarbazine hydrochloride can cause fetal harm when administered to 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.","Paediatric use":"Undue toxicity, evidenced by tremors, coma and convulsions, has occurred in few cases. Dosage, therefore, should be individualized (see DOSAGE AND ADMINISTRATION). Very close clinical monitoring is mandatory."}},"trials":[],"aliases":[],"company":"Leadiant Biosci Inc","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PROCARBAZINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:40:08.575032+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:40:14.327033+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:40:07.696487+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PROCARBAZINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:40:14.767844+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:40:05.340524+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"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.","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:40:05.340554+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:40:16.355832+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1321/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:40:15.545962+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA016785","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:40:05.340558+00:00"}},"allNames":"matulane","offLabel":[],"synonyms":["procarbazine","ibenzmethyzine","procarbazine hydrochloride","procarbazine HCl"],"timeline":[{"date":"1969-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SIGMA TAU to Leadiant Biosci Inc"},{"date":"1969-07-22","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sigma Tau)"}],"aiSummary":"Matulane (Procarbazine) is a small molecule alkylating drug originally developed by SIGMA TAU and currently owned by Leadiant Biosci Inc. It was FDA approved in 1969 for the treatment of Hodgkin's disease. As an off-patent medication, it is not commercially available as a generic. Matulane works by interfering with the DNA replication process in cancer cells, ultimately leading to cell death. Key safety considerations include potential hepatotoxicity and myelosuppression.","approvals":[{"date":"1969-07-22","orphan":false,"company":"SIGMA TAU","regulator":"FDA"}],"brandName":"Matulane","ecosystem":[{"indication":"Hodgkin's disease","otherDrugs":[{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"bleomycin","slug":"bleomycin","company":"Bristol Myers Squibb"},{"name":"brentuximab vedotin","slug":"brentuximab-vedotin","company":"Seattle Genetics"}],"globalPrevalence":null}],"mechanism":{"moaClass":"Alkylating Activity","modality":"Small Molecule","drugClass":"Alkylating Drug","explanation":"","oneSentence":"","technicalDetail":"Matulane exerts its cytotoxic effects through the alkylation of DNA, specifically at the O6 position of guanine, leading to DNA cross-linking and inhibition of DNA replication and transcription."},"commercial":{"launchDate":"1969","_launchSource":"DrugCentral (FDA 1969-07-22, SIGMA TAU)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2272","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=PROCARBAZINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PROCARBAZINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:26:00.296078","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:40:18.879982+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"procarbazine","indications":{"approved":[{"name":"Hodgkin's disease","source":"DrugCentral","snomedId":118599009,"regulator":"FDA","eligibility":"Stage III and IV Hodgkin's disease"}],"offLabel":[{"name":"Astrocytoma, anaplastic","source":"DrugCentral","drugName":"PROCARBAZINE","evidenceCount":298,"evidenceLevel":"strong"},{"name":"Diffuse non-Hodgkin's lymphoma, large cell","source":"DrugCentral","drugName":"PROCARBAZINE"},{"name":"Glioblastoma multiforme of brain","source":"DrugCentral","drugName":"PROCARBAZINE"},{"name":"Malignant neoplasm of brain","source":"DrugCentral","drugName":"PROCARBAZINE","evidenceCount":702,"evidenceLevel":"strong"},{"name":"Mycosis fungoides","source":"DrugCentral","drugName":"PROCARBAZINE","evidenceCount":12,"evidenceLevel":"moderate"},{"name":"Polycythemia vera","source":"DrugCentral","drugName":"PROCARBAZINE","evidenceCount":6,"evidenceLevel":"emerging"}],"pipeline":[]},"currentOwner":"Leadiant Biosci Inc","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT05675410","phase":"PHASE3","title":"A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-05-11","conditions":["Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8"],"enrollment":1875,"completionDate":"2031-04-28"},{"nctId":"NCT04947319","phase":"PHASE2","title":"Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ono Pharmaceutical Co. 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