Procarbazine

What is Procarbazine?

• Procarbazine (Matulane) is an orally administered alkylating agent used in combination with other anti-neoplastic agents in the therapy of Hodgkin’s disease and malignant melanoma.

Procarbazine

Procarbazine ball-and-stick

What are the uses of this medicine?

Procarbazine (Matulane) is approved to be used with other drugs to treat:

• Hodgkin lymphoma that is advanced. It is used in adults and children.

How does this medicine work?

Procarbazine mechanism

• Procarbazine (proe kar' ba zeen) is a methylhydrazine derivative which is activated in the liver to highly reactive alkylating intermediates.
• These intermediates methylate DNA which causes inhibition of DNA, RNA and protein synthesis and cell death.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with known hypersensitivity to the drug
• no adequate marrow reserve as demonstrated by bone marrow aspiration

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following:

• barbiturate medications such as phenobarbital
• medications for high blood pressure
• medications for nausea or mental illness
• opioid (narcotic) medications for pain
• sedatives
• sleeping pills
• tranquilizers
• certain antidepressants including amitriptyline (Elavil) and imipramine (Tofranil)
• medications for asthma
• medications for allergies, hay fever
• medications containing alcohol (cough and cold products, such as Nyquil, and other liquid products); and nasal decongestants, including nose drops and sprays.

Is this medicine FDA approved?

• Procarbazine was approved for use in the United States in 1969 and it remains a commonly used agent in the treatment of Hodgkin’s and non-Hodgkin’s lymphomas and brain cancer.
• Procarbazine is rarely used alone, but is found in common cancer chemotherapeutic regimens such as MOPP (mechlorethamine, vincristine [oncovin], procarbazine and prednisone), COPP (cyclophosphamide, vincristine [oncovin], procarbazine and prednisone), and PCV (procarbazine, lomustine [CCNU], vincristine).

How should this medicine be used?

Recommended dosage: In 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.

In Pediatric Patients:

• 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.

Administration:

• Procarbazine comes as a capsule to take by mouth.
• It is usually taken one or more times a day.
• The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer you have.
• Take procarbazine at around the same time(s) every day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As capsules containing the equivalent of 50 mg procarbazine as the hydrochloride.

This medicine is available in fallowing brand namesː

• Matulane

What side effects can this medication cause?

The most common side effects of this medicine include:

• Leukopenia
• anemia
• thrombopenia
• Nausea
• vomiting

Other side effects may include:

• Hematologic
• Gastrointestinal
• Neurologic
• Cardiovascular
• Ophthalmic
• Respiratory
• Dermatologic
• Allergic
• Genitourinary
• Musculoskeletal
• Psychiatric
• Endocrine

What special precautions should I follow?

• 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.
• Preparations which contain antihistamines or sympathomimetic drugs should also be avoided.
• 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.
• It is not known whether Matulane is excreted in human milk. Mothers should not nurse while receiving this drug.
• It is recommended that MATULANE be given only by or under the supervision of a physician experienced in the use of potent antineoplastic drugs.
• Procarbazine therapy has been associated with serum enzyme elevations during therapy and with rare cases of idiosyncratic, clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• vomiting
• enteritis
• diarrhea
• hypotension
• tremors
• convulsions
• coma

Management of overdosage:

• Treatment should consist of either the administration of an emetic or gastric lavage.
• General supportive measures such as intravenous fluids are advised.
• Patients should have frequent complete blood counts and liver function tests throughout their period of recovery and for a minimum of two weeks thereafter.

Can this medicine be used in pregnancy?

• Procarbazine hydrochloride can cause fetal harm when administered to a pregnant woman.
• 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.

Can this medicine be used in children?

• Due toxicity, evidenced by tremors, coma and convulsions, has occurred in a few cases.
• Dosage, therefore, should be individualized.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PROCARBAZINE HYDROCHLORIDE

Inactive ingredients:

• STARCH, CORN
• MANNITOL
• TALC
• GELATIN, UNSPECIFIED
• TITANIUM DIOXIDE
• FD&C YELLOW NO. 6
• D&C YELLOW NO. 10

Who manufactures and distributes this medicine?

Mfd. for Leadiant Biosciences, Inc., Gaithersburg, MD

Mfd. by:

• Alcami Corporation, Scientific Park Drive,
• Wilmington, NC

What should I know about storage and disposal of this medication?

• STORE AT 59° TO 86°F (15° to 30°C).

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• Dailymed label info on Procarbazine
• FDA Procarbazine