Adult Dosing

Hodgkin's disease

• Recommended dose: 2-4 mg/kg/day PO in single or divided doses for the first week, followed by 4-6 mg/kg/day until response or toxicity (WBC falls below 4,000/cmm or platelets below 100,000/cmm)
• Maintenance dose: 1-2 mg/kg/day
• With MOPP Regimen: 100 mg/m²/day on days 1-14 of a 28 day cycle

Pediatric Dosing

Hodgkin's disease

• Dosage should be individualized with close clinical monitoring. Below doses are guidelines only
• Recommended dose: 50 mg/m²/day PO x 1st wk, then 100 mg/m²/day until response or toxicity
• Maintenance dose: 50 mg/m²/day

[Outline]

• Adult Dosing
• Pediatric Dosing

• Stage III and IV Hodgkin's disease as a part of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisolone) regimen

• Hypersensitivity to procarbazine or any other component of the product
• Inadequate marrow reserve as demonstrated by bone marrow aspiration

• Administered 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 for proper monitoring of treatment

Renal Dose Adjustment

• Renal impairment: Caution advised; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised; dose adjustments not defined

See Supplemental Patient Information

• To minimize risk of CNS depression, barbiturates, antihistamines, narcotics, hypotensive agents, or phenothiazines should be used with caution
• Undue toxicity may occur if used in renal/hepatic impairment; consider hospitalization for initial course
• If radiation or a chemotherapeutic agent known to have marrow-depressant activity has been used, wait at least 1 month before starting procarbazine. Bone marrow suppression may occur 2-8 wks after starting therapy; hospitalization may be required if leukopenia occurs
• Avoid use in hypersensitivity, pregnancy or lactation, alcoholism, severe renal or liver impairment, pheochromocytoma and CHF
• Use of alcohol during therapy increases risk of disulfiram-like reaction
• Use of tobacco during procarbazine therapy increases risk of developing secondary lung cancer
• Discontinue if any of the following occurs: CNS signs or symptoms such as paresthesias/neuropathy/confusion; leukopenia (WBC <4,000/mm³); thrombocytopenia (platelets <100,000/mm³); hypersensitivity reaction; stomatitis; diarrhea; hemorrhage or bleeding tendencies
• Perform urinalysis, creatinine, transaminases, alkaline phosphatase and blood urea nitrogen tests before starting and every wk during treatment
• Measure reticulocyte count and CBC with differential and platelet count before starting and q3-4 days during treatment

Cautions: Use cautiously in

• Hepatic impairment
• Renal impairment
• Cardiovascular disease
• Psychiatric illness
• Patients with childbearing potential
• Infections
• Decreased bone marrow reserve
• Other chronic debilitating illnesses
• Headache
• Pediatric patients

Supplemental Patient Information

• Patients should be warned not to drink alcoholic beverages. 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 should be advised to discontinue tobacco use
• Use of additional prescription drugs with the knowledge and consent of their physician is advised

Pregnancy Category:D

Breastfeeding: Safety undetermined. Due to the potential for tumorigenicity shown for procarbazine in animal studies; manufacturer recommends discontinuation of breastfeeding.

• HEMA: Bone marrow suppression, leukopenia, anemia, thrombopenia; eosinophilia, hemolytic anemia, petechiae, purpura, epistaxis, hemoptysis, hemorrhage
• CV: Hypotension, tachycardia, syncope
• CNS: Seizures, neuropathy, ataxia, paresthesia, nystagmus, headache, dizziness, drowsiness, incoordination
• PSYCHIATRIC: Hallucinations, depression, nervousness, apprehension, nightmares
• DERM: Dermatitis, pruritus, urticaria, alopecia, flushing, herpes, hyperpigmentation, rash, flushing
• GI: Hepatic dysfunction, jaundice, melena, stomatitis, hematemesis, nausea, vomiting, anorexia, dry mouth, dysphagia, abdominal pain, diarrhea, constipation
• GU: Amenorrhea, azoospermia, hematuria, urinary frequency, nocturia
• ENDO: Gynecomastia
• EENT: Retinal hemorrhage, photophobia, diplopia, papilledema, inability to focus, hearing loss
• RESP: Pneumonitis, pleural effusion, cough
• MUSC: Myalgias/arthralgia
• MISC: Intercurrent infections, secondary malignancies, generalized allergic reactions, pyrexia, diaphoresis, fever, lethargy, weakness, fatigue, edema, chills, slurred speech, hoarseness, bleeding

• Antineoplastic; exact mechanism of action unknown; may inhibit protein, RNA, and DNA synthesis, resulting in cytotoxicity
• Primarily metabolized by liver and kidney; CYP450: Unknown
• Renally excreted: 70%
• Half-life: 10 mins

US Trade Name(s)

• Matulane

US Availability

Matulane

• CAPS: 50 mg

Canadian Trade Name(s)

• Matulane

Canadian Availability

Matulane

• CAPS: 50 mg

UK Trade Name(s)

• Only generic available

UK Availability

procarbazine (generic)

• CAPS: 50 mg

Australian Trade Name(s)

• Natulan

Australian Availability

Natulan

• CAPS: 50 mg

[Outline]

Hematology/Oncology

Antineoplastics

Alkylating Agents

Drug Name: Matulane (PROCARBAZINE HYDROCHLORIDE 50 mg)

Ingredient(s): N/A

Imprint: MATULANE;sigma;tau

Color(s): White

Shape: Capsule

Size (mm): 12.00

Score: 1

Inactive Ingredient(s): starch, corn / mannitol / talc / gelatin / methylparaben / propylparaben / potassium sorbate / titanium dioxide / fd&c yellow no. 6 / d&c yellow no. 10

Drug Label Author:
Sigma-Tau Pharmaceuticals, Inc.

DEA Schedule:
Non-Scheduled