Description

Matulane (procarbazine hydrochloride), a hydrazine derivative antineoplastic agent, is available as capsules containing the equivalent of 50 mg procarbazine as the hydrochloride. Each capsule also contains cornstarch, mannitol and talc. Gelatin capsule shells contain titanium dioxide, FD&C Yellow No. 6 and D&C Yellow No. 10.

Chemically, procarbazine hydrochloride is N‑isopropyl-∝-(2‑methylhydrazino)‑ p‑toluamide monohydrochloride. It is a white to pale yellow crystalline powder which is soluble but unstable in water or aqueous solutions. The molecular weight of procarbazine hydrochloride is 257.76 and the structural formula is:

Before taking Matulane, tell your doctor:

• If you are allergic to Matulane; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Low white blood cell count, low platelet count, or low red blood cell count.
• If you have recently had radiation or other chemo.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Matulane, like certain drugs that are used for coughs and colds, low mood (depression), or weight loss. There are many drugs that must not be taken with Matulane.
• If you are breast-feeding. Do not breast-feed while you take Matulane.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Matulane with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Matulane?

• Tell all of your health care providers that you take Matulane. This includes your doctors, nurses, pharmacists, and dentists.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Other cancers have happened when Matulane was used with cancer drugs. Talk with the doctor.
• If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before getting any vaccines. Use of some vaccines with Matulane may either raise the chance of an infection or make the vaccine not work as well.
• Avoid drinking alcohol while taking Matulane.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Do not smoke, chew tobacco, or use other products that have nicotine while you are using Matulane.
• Some foods and drinks, like cheese and red wine, may cause sudden, severe high blood pressure when you are taking Matulane. This effect can be deadly. Talk with your doctor about your risk for this effect. Get a list of foods and drinks to avoid. Avoid these foods and drinks for as long as your doctor has told you after Matulane is stopped.
• If Matulane is stopped, follow diet for at least 2 more weeks.
• Use with care in children. Talk with the doctor.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking Matulane.
• If you are pregnant or you get pregnant while taking Matulane, call your doctor right away.

How is Matulane best taken?

Use Matulane as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with a full glass of water.
• Take with or without food.
• How Matulane is taken may change based on blood work results, side effects, and how well the drug is working.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Matulane that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all patients taking Matulane:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Shortness of breath.
• Very bad dizziness or passing out.
• A fast heartbeat.
• Swelling.
• Diarrhea.
• A burning, numbness, or tingling feeling that is not normal.
• Feeling confused.
• Change in eyesight, eye pain, or very bad eye irritation.
• If bright lights bother your eyes.
• Hearing loss.
• Shakiness.
• Seizures.
• Change in balance.
• Feeling very tired or weak.
• Mouth irritation or mouth sores.
• Trouble swallowing.
• Not able to control eye movements.
• Mood changes.
• Hallucinations (seeing or hearing things that are not there).
• Bad dreams.
• Passing urine more often.
• Sweating a lot.
• Slurred speech.

Children:

• For males, enlarged breasts.

What are some other side effects of Matulane?

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:

• Hair loss.
• Upset stomach or throwing up.
• Feeling sleepy.
• Dizziness.
• Not hungry.
• Dry mouth.
• Stomach pain.
• Constipation.
• Headache.
• Muscle or joint pain.
• Feeling tired or weak.
• Trouble sleeping.
• Change in color of skin.
• Flushing.
• Feeling nervous and excitable.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Matulane?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – BOTTLE LABEL

• NDC 54482-054-01
• MATULANE ®
  (PROCARBAZINE HYDROCHLORIDE)
• 50 mg
• Each capsule contains 50 mg procarbazine
  in the form of the hydrochloride salt.
• Rx only
• 100 Capsules
• Usual Dosage: See package insert.
• Dispense in tight, light-resistant containers as
  defined in USP/NF.
• STORE AT 59° TO 86°F (15° to 30°C)
• Leadiant
  Biosciences
• Mfd. for Leadiant Biosciences, Inc.,
  Gaithersburg, MD 20878 Mfd. by: Alcami
  Corporation, 2320 Scientific Park Drive,
  Wilmington, NC 28405          M9-0118   PC3986E

 

SRC: NLM .