Matulane

It is used to treat some kinds of cancer.

Procarbazine is thought to interfere with the growth of cancer cells which are eventually destroyed. It also blocks the action of a chemical substance in the central nervous system called monoamine oxidase (MAO), but this is probably not related to its effect against cancer. Since the growth of normal body cells may also be affected by procarbazine, other effects will also occur. Some of these may be serious and must be reported to your doctor . Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with procarbazine, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Procarbazine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Capsule

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information about the use of procarbazine in children, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Side effects may be more likely to occur in elderly patients, who are usually more sensitive to the effects of procarbazine.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amitriptyline


• Amphetamine


• Apraclonidine


• Atomoxetine


• Benzphetamine


• Brimonidine


• Bupropion


• Carbamazepine


• Citalopram


• Cyclobenzaprine


• Cyproheptadine


• Desvenlafaxine


• Dexfenfluramine


• Dexmethylphenidate


• Dextroamphetamine


• Dextromethorphan


• Diethylpropion


• Duloxetine


• Fenfluramine


• Fluoxetine


• Guanadrel


• Guanethidine


• Isocarboxazid


• Isometheptene


• Levodopa


• Levomethadyl


• Linezolid


• Lisdexamfetamine


• Maprotiline


• Mazindol


• Meperidine


• Methamphetamine


• Methyldopa


• Methylphenidate


• Milnacipran


• Morphine


• Morphine Sulfate Liposome


• Nefopam


• Opipramol


• Paroxetine


• Phendimetrazine


• Phenelzine


• Phenmetrazine


• Phentermine


• Phenylalanine


• Phenylephrine


• Phenylpropanolamine


• Procarbazine


• Pseudoephedrine


• Rasagiline


• Reserpine


• Rizatriptan


• Rotavirus Vaccine, Live


• Selegiline


• Sertraline


• Sibutramine


• Sumatriptan


• Tapentadol


• Tetrabenazine


• Tranylcypromine


• Venlafaxine


• Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetophenazine


• Albuterol


• Altretamine


• Amoxapine


• Arformoterol


• Avocado


• Bacillus of Calmette and Guerin Vaccine, Live


• Bambuterol


• Bitolterol


• Bitter Orange


• Broxaterol


• Buspirone


• Chlorpromazine


• Clenbuterol


• Clomipramine


• Clovoxamine


• Desipramine


• Difenoxin


• Diphenoxylate


• Dixyrazine


• Dothiepin


• Doxepin


• Droperidol


• Entacapone


• Ephedrine


• Ethchlorvynol


• Ethopropazine


• Femoxetine


• Fenoterol


• Fentanyl


• Fluphenazine


• Fluvoxamine


• Formoterol


• Guarana


• Hexoprenaline


• Imipramine


• Influenza Virus Vaccine, Live


• Isoetharine


• Kava


• Levalbuterol


• Licorice


• Lofepramine


• Ma Huang


• Mate


• Measles Virus Vaccine, Live


• Mesoridazine


• Methotrimeprazine


• Mirtazapine


• Mumps Virus Vaccine, Live


• Nefazodone


• Nortriptyline


• Oxycodone


• Perazine


• Periciazine


• Perphenazine


• Pipotiazine


• Pirbuterol


• Poliovirus Vaccine, Live


• Procaterol


• Prochlorperazine


• Promazine


• Promethazine


• Propiomazine


• Protriptyline


• Reboxetine


• Rimiterol


• Ritodrine


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Salmeterol


• Smallpox Vaccine


• St John`s Wort


• Sumatriptan


• Terbutaline


• Thiethylperazine


• Thioridazine


• Tolcapone


• Trifluoperazine


• Triflupromazine


• Trimipramine


• Tulobuterol


• Typhoid Vaccine


• Tyrosine


• Varicella Virus Vaccine


• Warfarin


• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose


• Acetohexamide


• Benfluorex


• Chlorpropamide


• Ginseng


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Guar Gum


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Metformin


• Methotrexate


• Miglitol


• Repaglinide


• Tolazamide


• Tolbutamide


• Troglitazone

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tyramine Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcoholism

• Angina (chest pain) or


• Heart or blood vessel disease or


• Heart attack or stroke (recent)a€”Lowered blood pressure caused by procarbazine may make problems associated with some of these conditions worse

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)a€”Risk of severe disease affecting other parts of the body

• Type 2 diabetes mellitusa€”Procarbazine may change the amount of diabetes medicine needed

• Epilepsya€”Procarbazine may change the seizures

• Headaches (severe or frequent)a€”You may not realize when a severe headache is caused by a dangerous reaction to procarbazine

• Infectiona€”Procarbazine can reduce immunity to infection

• Kidney diseasea€”Effects may be increased because of slower removal of procarbazine from the body

• Liver diseasea€”Procarbazine can cause severe liver disease to become much worse

• Mental illness (or history of)a€”Some cases of mental illness may be worsened

• Overactive thyroida€”Increased risk of dangerous reaction to procarbazine

• Parkinson`s diseasea€”May be worsened

• Pheochromocytomaa€”Blood pressure may be affected

Proper Use

Use this medicine only as directed by your doctor . Do not use more or less of it and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects while taking too little may not improve your condition.

Procarbazine is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the right time and do not mix them. Ask your health care professional to help you plan a way to take your medicines at the right times.

Procarbazine commonly causes nausea and vomiting . Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor . Ask your health care professional for ways to lessen these effects.

If you vomit shortly after taking a dose of procarbazine, check with your doctor . You will be told whether to take the dose again or to wait until the next scheduled dose .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Check with your doctor or hospital emergency room immediately if severe headache, stiff neck, chest pains, fast heartbeat, or nausea and vomiting occur while you are taking this medicine. These may be symptoms of a serious high blood pressure reaction that should have a doctor`s attention .

When taken with certain foods, drinks, or other medicines, procarbazine can cause very dangerous reactions such as sudden high blood pressure . To avoid such reactions, obey the following rules of caution :

• Do not eat foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses, yeast or meat extracts, fava or broad bean pods, smoked or pickled meat, poultry, or fish, fermented sausage (bologna, pepperoni, salami, and summer sausage) or other unfresh meat, or any overripe fruit. If a list of these foods and beverages is not given to you, ask your health care professional to provide one.


• Do not drink alcoholic beverages or alcohol-free or reduced-alcohol beer or wine.


• Do not eat or drink large amounts of caffeine-containing food or beverages, such as chocolate, coffee, tea, or cola.


• Do not take any other medicine unless approved or prescribed by your doctor . This especially includes over-the-counter (OTC) or nonprescription medicine such as that for colds (including nose drops or sprays), cough, asthma, hay fever, appetite control; a€śkeep awakea€ť products; or products that make you sleepy.

After you stop using this medicine you must continue to obey the rules of caution concerning food, drink, and other medication for at least 2 weeks since procarbazine may continue to react with certain foods or other medicines for up to 14 days after you stop taking it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

While you are being treated with procarbazine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor`s approval. Procarbazine may lower your body`s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take or should not have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine . Do not get close to them and do not stay in the same room with them for very long . If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth .

Procarbazine can lower the number of white blood cells in your blood temporarily, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination .


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin .


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

For diabetic patients:

• Procarbazine may affect blood sugar levels. While you are using this medicine, be especially careful in testing for sugar in your blood or urine .

If you are going to have surgery (including dental surgery) or emergency treatment tell the medical doctor or dentist in charge that you are using this medicine or have used it within the past 2 weeks.

Your doctor may want you to carry an identification card stating that you are using this medicine.

Side Effects

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 this medicine and get emergency help immediately if any of the following effects occur:

Rare

• 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:

Less common

• 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:

More common

• 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)

Less common

• Diarrhea


• Sores in mouth and on lips


• Tingling or numbness of fingers or toes


• Unsteadiness or awkwardness


• Yellow eyes or skin

Rare

• Fainting


• Skin rash, hives, or itching


• Wheezing

Some side effects 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:

More common

• Drowsiness


• Muscle or joint pain


• Muscle twitching


• Nausea and vomiting


• Nervousness


• Nightmares


• Trouble in sleeping


• Unusual tiredness or weakness

Less common

• 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.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.