Procarbazine

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Procarbazine can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Capsules, ivory, containing the equivalent of 50 mg procarbazine as the hydrochloride; in bottles of 100 (NDC 54482-053-01). Imprint on capsules: MATULANE σ sigma-tau.

REFERENCES

1. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: U.S. Government Printing Office NIH Publication No. 83-2621.

2. AMA Council Report. Guidelines for handling parenteral antineoplastics. JAMA. Mar 15, 1985; 253:1590-1592.

3. 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.

4. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust. Apr 30,1983; 1:426-428.

5. 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.

6. ASHP technical assistance bulletin on handling cytotoxic drugs in hospitals. Am J Hosp Pharm. Jan 1985; 42:131-137.

Manufactured by: AAIPharma Inc., 1726 North 23rd st. Wilmington, NC 28405. for : sigm-tau Pharmaceuticals, Inc., Revised : Dec 2015

Do not use procarbazine if you are pregnant. It could harm the unborn baby.

You should not take procarbazine if you are allergic to it, or if you have bone marrow suppression.

Before you take procarbazine, tell your doctor if you have liver or kidney disease, low white or red blood cell counts, low platelet counts, fluid retention, or if you have received other cancer medications or radiation within the past 30 days.

Do not drink alcohol while taking procarbazine.

Avoid smoking during your treatment.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while taking procarbazine. The vaccine may not work as well during this time.

While you are taking procarbazine, you must not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while taking procarbazine?" section of this leaflet. Eating tyramine while you are taking procarbazine can raise your blood pressure to dangerous levels, causing life-threatening symptoms.

Do not drink alcohol. Procarbazine can cause unpleasant side effects when you drink alcohol.

Avoid smoking during your treatment. Smoking may increase your risk of lung cancer while taking procarbazine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using procarbazine. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

While you are taking procarbazine, you should avoid foods that are high in tyramine, including:

• avocados, bananas, figs, papaya, raisins, and sauerkraut;
• beef or chicken liver, meats prepared with tenderizer, bologna, pepperoni, summer sausage, game meat, meat extracts;
• pickled or smoked fish, anchovies, dried fish, herring, caviar, shrimp paste;
• beer (alcoholic and nonalcoholic), wine (especially red wine), champagne, sherry, vermouth, and other distilled spirits;
• caffeine (including coffee, tea, cola), ginseng;
• cheese -- especially aged or processed cheeses (American, blue, boursault, brie, camembert, cheddar, gruyere, mozzarella, parmesan, romano, roquefort, Swiss);
• chocolate;
• sour cream and yogurt;
• soy sauce, miso soup, bean curd, fava beans; or
• yeast extracts.

Eating tyramine while you are taking procarbazine can raise your blood pressure to dangerous levels, causing life-threatening side effects.

Procarbazine is a prescription medication used to treat certain types of Hodgkins disease. Procarbazine belongs to a group of drugs called alkylating agents. These work by slowing or stopping the growth of cancer cells in your body.

Procarbazine comes as a capsule to take by mouth. It is usually taken one or more times a day, with or without food.

Common side effects include nausea, vomiting, and low blood counts.

Procarbazine is a prescription medication used in combination with other medications to treat certain types of Hodgkins disease. Hodgkins disease consists of different types of cancer that begin in a type of white blood cells that normally fights infection.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
 

Procarbazine may be found in some form under the following brand names:

• Matulane

Somes serious side effects of procarbazine include:

• sores in the mouth and throat
• severe or ongoing diarrhea
• pain, burning, numbness, pricking, or tingling in the hands or feet or on the skin
• uncontrollable shaking of a part of your body
• confusion
• hallucinating (seeing things or hearing voices that do not exist)
• seizures
• vision changes
• fainting
• dizziness
• fast or irregular heartbeat
• fever, sore throat, chills, or other signs of infection
• unusual bruising or bleeding
• black, tarry stools
• red urine
• hives
• rash
• itching
• difficulty breathing or swallowing
• yellowing of the skin or eyes

Seek medical help if you experience any of these side effects.

Procarbazine may increase the risk that you will develop other cancers.

Do not take procabazine if you

• are allergic to this medication or its inactive ingredients
• have poor bone marrow health

Adults

• Single or divided doses of 2 to 4 mg/kg/day for the first week are recommended.
• Daily dosage should then be at 4 to 6 mg/kg/day until maximum response is obtained or until toxicity occurs.
• When maximum response is obtained, the dose may be kept at 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:
  • 50 mg/m² of body surface area (BSA) per day is recommended for the first week.
  • Dosage should then be kept at 100 mg/m² of body surface area (BSA) per day until maximum response is obtained or until toxicity occurs.
  • When maximum response is reached, the dose may be kept at 50 mg/m² of body surface area (BSA) per day

Procarbazine is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Procarbazine is given with other cancer medicines to treat Hodgkin's Disease (a type of blood cancer).

Procarbazine may also be used for purposes not listed in this medication guide.

You should not take procarbazine if you are allergic to it, or if you have bone marrow suppression.

To make sure procarbazine is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease;

• anemia (low red blood cells);

• low levels of platelets in the blood;

• low white blood cell counts;

• fluid retention; or

• if you have received other cancer medications or radiation within the past 30 days.

Do not use procarbazine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Procarbazine can lower sperm count in men, which may affect fertility (your ability to have children).

It is not known whether procarbazine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking procarbazine.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Not hungry.
• Upset stomach or throwing up.
• Dry mouth.
• Hair loss.
• Belly pain.
• Hard stools (constipation).
• Headache.
• Muscle or joint pain.
• Feeling tired or weak.
• Not able to sleep.
• Change in color of skin.
• Flushing.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Protect from light.

Applies to procarbazine: oral capsule

Along with their needed effects, medicines like procarbazine can sometimes cause unwanted effects such as blood problems, loss of hair, high blood pressure reactions, and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking procarbazine and get emergency help immediately if any of the following effects occur:

• Chest pain (severe)
• enlarged pupils of eyes
• fast or slow heartbeat
• headache (severe)
• increased sensitivity of eyes to light
• increased sweating (possibly with fever or cold, clammy skin)
• stiff or sore neck

Check with your doctor immediately if any of the following side effects occur while taking procarbazine:

• Black, tarry stools
• blood in urine or stools
• bloody vomit
• cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on skin
• unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur while taking procarbazine:

• Confusion
• convulsions (seizures)
• cough
• hallucinations (seeing, hearing, or feeling things that are not there)
• missing menstrual periods
• shortness of breath
• thickening of bronchial secretions
• tiredness or weakness (continuing)

• Diarrhea
• sores in mouth and on lips
• tingling or numbness of fingers or toes
• unsteadiness or awkwardness
• yellow eyes or skin

• Fainting
• skin rash, hives, or itching
• wheezing

Some side effects of procarbazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Drowsiness
• muscle or joint pain
• muscle twitching
• nausea and vomiting
• nervousness
• nightmares
• trouble in sleeping
• unusual tiredness or weakness

• Constipation
• darkening of skin
• difficulty in swallowing
• dizziness or lightheadedness when getting up from a lying or sitting position
• dry mouth
• feeling of warmth and redness in face
• headache
• loss of appetite
• mental depression

This medicine may cause a temporary loss of hair in some people. After treatment with procarbazine has ended, normal hair growth should return.

When used as single agent therapy, the initial dosage recommended above is used in order to minimize the nausea and vomiting experienced by a high percentage of patients beginning therapy. The daily dosage may then be maintained at 4 to 6 mg/kg/day administered in single or divided doses, until a maximum response is obtained or until the event(s) listed in the paragraph below occur(s).

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 (WBC under 4,000)
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 or watery stools)
hemorrhage or bleeding tendencies

Bone marrow depression often occurs from 2 to 8 weeks after the start of treatment. If leukopenia occurs, hospitalization of the patient may be needed to prevent systemic infection.

After toxic side effects have subsided (based on clinical evaluation and appropriate laboratory studies), and at the discretion of the physician, therapy may be resumed at a dosage of approximately 1 to 2 mg/kg/day.