Procarbazine

IMPORTANT WARNING:

Procarbazine should be taken only under the supervision of a doctor with experience in the use of chemotherapy medications.

Keep all appointments with your doctor and the laboratory. Your doctor will order laboratory tests before, during and after your treatment to check your body's response to procarbazine.

WHY is this medicine prescribed?

Procarbazine is used in combination with other medications to treat certain types of Hodgkins disease (types of cancer that begin in a type of white blood cells that normally fights infection). Procarbazine is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

Procarbazine is also sometimes used in combination with other medications to treat certain types of brain tumors. Talk to your doctor about the risks of using this medication for your condition.

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

HOW should this medicine be used?

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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take procarbazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor may adjust your dose of procarbazine or stop your treatment for a period of time depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

What SPECIAL PRECAUTIONS should I follow?

Before taking procarbazine,

• tell your doctor and pharmacist if you are allergic to procarbazine, any other medications, or any of the ingredients in procarbazine capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking or you plan to take any of the following prescription or non-prescription medications: 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. Your doctor may tell you not to take these medications with procarbazine and may suggest other treatment(s).

• 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; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with procarbazine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have received radiation therapy or other chemotherapy within the last 4 weeks.

• tell your doctor if you have or have ever had kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant or breast-feed while you are taking procarbazine. If you become pregnant while receiving procarbazine, call your doctor. Procarbazine may harm the fetus.

• know that you should not drink alcoholic beverages (including beer and wine) while taking this drug. Alcohol may cause an upset stomach, vomiting, stomach cramps, headaches, sweating, and flushing (redness of the face).

• tell your doctor if you use tobacco products. Smoking may increase the risk that you will develop other cancers. You should stop smoking.

What SPECIAL DIETARY instructions should I follow?

You will need to avoid eating foods that contain very high amounts of tyramine, such as certain cheeses, yogurt, and bananas during your treatment with procarbazine. Talk to your doctor or dietitian about which foods you should avoid during your treatment or if you do not feel well after eating or drinking certain foods while taking procarbazine.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Procarbazine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• loss of appetite
• constipation
• stomach pain
• dryness of mouth
• changes in skin color
• hair loss
• difficulty falling asleep or staying asleep
• headache
• bone, joint, or muscle pain
• increased urination

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• 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

Procarbazine may increase the risk that you will develop other cancers. Talk to your doctor about this risk.

Procarbazine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• vomiting
• diarrhea
• dizziness or fainting
• uncontrollable shaking of a part of your body
• seizures

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.