Mycophenolate

pronounced as (mye koe fen' oh late)

Brand Name(s): CellCept®, Myfortic®, Myhibbin®, also available generically

Why is this medicine prescribed?

Mycophenolate is used to prevent transplant organ rejection (attack of the new organ by the immune system) in people who have received kidney, heart, or liver transplants. Mycophenolate is in a class of medications called immunosuppressive agents. It works by weakening the body's immune system so it will not attack and reject the transplanted organ.

Are there other uses for this medicine?

Mycophenolate is also used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever). Talk to your doctor about the possible 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?

Mycophenolate comes as a capsule, a tablet, a delayed-release (releases the medication in the intestine) tablet, and a suspension (liquid) to take by mouth. It is usually taken twice a day on an empty stomach (1 hour before or 2 hours after eating or drinking), unless your doctor tells you otherwise. Take mycophenolate at about the same times every day, and try to space your doses about 12 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mycophenolate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

The medication in the delayed-release tablet (Myfortic) is absorbed differently by the body than the medication in the suspension, tablet, and capsule (CellCept, Myhibbin). These products cannot be substituted for each other. Each time you have your prescription filled, make sure that you have received the right product. If you think you received the wrong medication, talk to your doctor and pharmacist right away.

Swallow the tablets, delayed-release tablets, and capsules whole; do not split, chew, or crush them. Do not open the capsules. If a capsule is accidentally opened, avoid contact with your skin or eyes and avoid breathing in the powder. If any contact occurs, wash the affected area well with soap and water; rinse eyes with water.

Do not mix mycophenolate suspension with any other medication.

Be careful not to spill the suspension or to splash it onto your skin. If you do get the suspension on your skin, wash the area well with soap and water. If you get the suspension in your eyes, rinse with plain water. Use wet paper towels to wipe up any spilled liquids.

Mycophenolate helps prevent organ transplant rejection only as long as you are taking the medication. Continue to take mycophenolate even if you feel well. Do not stop taking mycophenolate without talking to your doctor.

What special precautions should I follow?

Before taking mycophenolate,

  • tell your doctor and pharmacist if you are allergic to mycophenolate, mycophenolic acid, any other medications, or any of the ingredients in the mycophenolate or mycophenolic acid product you are taking. If you are taking mycophenolate suspension (Cellcept), tell your doctor and pharmacist if you are allergic to aspartame or sorbitol. If you are taking mycophenolate suspension (Myhibbin), tell your doctor if you are allergic to polysorbate 80 or sorbitol. 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. Also be sure tell your doctor if you stop taking any of your medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome (inherited diseases that cause high levels of a certain substance in the blood, joint pain, and problems with motion and behavior); anemia (a lower than normal number of red blood cells); neutropenia (less than normal number of white blood cells); ulcers or any disease that affects your stomach, intestines, or digestive system; or kidney or liver disease.
  • tell your doctor if you are breastfeeding.
  • you should know that mycophenolate may make you drowsy, confused, dizzy, lightheaded, or cause uncontrollable shaking of a part of the body. Do not drive a car or operate machinery until you know how this medication affects you.
  • do not have any vaccinations without talking to your doctor.
  • if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability), you should know that mycophenolate suspension (Cellcept) contains aspartame, a source of phenylalanine.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

If you are taking mycophenolate tablet, capsule, or suspension (Cellcept, Myhibbin) take the missed dose as soon as you remember it. However, if the next dose is less than 2 hours away, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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 the following:

  • stomach pain
  • nausea
  • vomiting
  • heartburn
  • diarrhea
  • fever, sore throat, chills, cough and other signs of infection

What side effects can this medicine cause?

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

  • constipation
  • nausea
  • vomiting
  • difficulty falling asleep or staying asleep
  • pain, especially in the back, muscles, or joints
  • headache
  • gas
  • prickling, tingling, or burning feeling on the skin
  • swelling of the hands, arms, feet, ankles, or lower legs
  • tremor

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • sudden severe stomach pain, stomach pain that doesn't go away, or diarrhea
  • difficulty breathing
  • chest pain
  • rash
  • itching
  • dizziness, fainting, pale skin, lack of energy, shortness of breath, or fast heartbeat
  • unusual bleeding or bruising; vomiting or spitting up blood or brown material that resembles coffee grounds; bloody or black, tarry stools; or blood in urine
  • fever, muscle or joint stiffness or pain

Mycophenolate 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 excess heat and moisture (not in the bathroom). Mycophenolate suspension may also be stored in a refrigerator. Do not freeze mycophenolate suspension. Dispose of any unused mycophenolate suspension after 60 days. Wear disposable gloves when handling the bottle and bottle cap of mycophenolate suspension.

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 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.

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