Matulane

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

Matulane 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.

Matulane 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.
 

• Sigma-Tau Pharmaceuticals, Inc.

Common side effects include the following:

• 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

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

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

This is not a complete list of Matulane drug interactions. Ask your doctor or pharmacist for more information.

Somes serious side effects of Matulane 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.

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

Do not take Matulane if you

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

Tyramine is a naturally occurring compound found in some cheeses and other foods that may cause dangerously high blood pressure in people taking Matulane:

• You should avoid eating very large amounts of foods containing high amounts of tyramine such as:
  • cheese (particularly strong or aged varieties)
  • sour cream
  • Chianti wine
  • sherry
  • beer (including non-alcoholic beer)
  • liqueurs
  • pickled herring
  • anchovies
  • caviar
  • liver
  • canned figs
  • raisins
  • bananas
  • avocados (particularly if overripe)
  • chocolate
  • soy sauce
  • sauerkraut
  • the pods of broad beans (fava beans)
  • yeast extracts
  • yogurt
  • meat extracts
  • meat prepared with tenderizers
  • dry sausage

Some of the signs and symptoms of dangerously high blood pressure (hypertensive crisis) are:

• severe headache
• vision problems
• confusion
• stupor (mental numbness)
• coma
• seizures
• chest pain
• unexplained nausea or vomiting
• stroke-like symptoms (sudden numbness or weakness - especially on one side of the body)

Get emergency medical help if you experience these symptoms.

Before taking Matulane,

• tell your doctor and pharmacist if you are allergic to Matulane, any other medications, or any of the ingredients in Matulane capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• 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 Matulane. If you become pregnant while receiving Matulane, call your doctor. Matulane 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. You should avoid becoming pregnant while taking Matulane.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Matulane crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Matulane.

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

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

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store at 59° to 86°F (15° to 30°C).
• Keep this and all medications out of the reach of children.

It is recommended that Matulane be given 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 to patients for proper monitoring of treatment.