Mycophenolate Mofetil (Oral Route, Intravenous Route)

Drug Information provided by: Micromedex

ARTICLE SECTIONS

US Brand Names

Cellcept

Description

Mycophenolate belongs to a group of medicines known as immunosuppressive agents. It is used to lower the body's natural immunity in patients who receive organ transplants.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Mycophenolate works by preventing the white blood cells from getting rid of the transplanted organ.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, mycophenolate is used in certain patients with the following medical condition:

Lupus nephritis

This product is available in the following dosage forms:

Capsule
Powder for Suspension
Tablet

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

For kidney transplants—This medicine has been tested in children 3 months and older and, in effective doses, has not been shown to cause different side effects or problems than it does in adults .

For heart or liver transplants—Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of mycophenolate in children with use in other age groups .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of mycophenolate in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving mycophenolate .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 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.

Activated Charcoal
Aluminum Carbonate, Basic
Aluminum Hydroxide
Aluminum Phosphate
Azathioprine
Bacillus of Calmette and Guerin Vaccine, Live
Cholestyramine
Colesevelam
Colestipol
Dihydroxyaluminum Aminoacetate
Dihydroxyaluminum Sodium Carbonate
Magaldrate
Magnesium Carbonate
Magnesium Hydroxide
Magnesium Oxide
Magnesium Trisilicate
Measles Virus Vaccine, Live
Metronidazole
Mumps Virus Vaccine, Live
Norfloxacin
Poliovirus Vaccine, Live
Rifampin
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Smallpox Vaccine
Typhoid Vaccine, Live
Varicella Virus Vaccine
Yellow Fever Vaccine

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.

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:

Delayed kidney function following kidney transplantation or
Kidney problems, severe—Reduced elimination of mycophenolate and increased chance of developing fever and chills, cough or hoarseness, lower back or side pain, painful or difficult urination.

Digestive system disease, active—Risk of bleeding from the stomach.

Kelley-Seegmiller syndrome or
Lesch-Nyhan syndrome—This medicine should be avoided in patients with these conditions .

Phenylketonuria (PKU)—The oral suspension may contain aspartame, which can make your condition worse .

Proper Use

This medicine should be taken on an empty stomach.

Take this medicine only as directed by your doctor. Do not take more or less of it and do not take it more often than your doctor ordered. Taking too much may increase the chance of side effects, while taking too little may lead to rejection of your transplanted organ.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

Do not stop taking this medicine without first checking with your doctor. Your physician will use the results of tests and your physical examination to decide how long you should take this medicine.

The capsules or tablets of mycophenolate should be swallowed whole. The tablets should not be crushed and the capsules should not be opened. It is important that other people not be exposed to the mycophenolate powder. You should not inhale the powder or allow the powder or oral suspension liquid to touch your skin .

You should use the dispenser that was given to you by your pharmacist to measure out the correct amount of oral suspension. If you have any questions about this, ask your doctor or pharmacist .

The oral suspension expires and should be discarded after 60 days .

A nurse or other trained health professional will give you the injection form of this medicine. The injection form is given through a needle placed in one of your veins .

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.

For oral dosage form (capsules or tablets):
- For prevention of rejection of transplanted heart:
  - Adults—1.5 grams (six capsules or three tablets) two times a day.
- For prevention of rejection of transplanted kidney:
  - Adults—1 gram (four capsules or two tablets) two times a day.
  - Children 3 months and older—Dose is based on child's size as instructed by the doctor .
- For prevention of rejection of transplanted liver:
  - Adults—1.5 grams (six capsules or three tablets) two times a day.

For oral dosage form (suspension):
- For prevention of rejection of transplanted heart:
  - Adults—1.5 grams two times a day.
- For prevention of rejection of transplanted kidney:
  - Adults—1 gram two times a day.
  - Children 3 months and older—Dose is based on child's size as instructed by the doctor .
- For prevention of rejection of transplanted liver:
  - Adults—1.5 grams two times a day .

For injection dosage form:
- For prevention of rejection of transplanted heart:
  - Adults—1.5 grams two times a day.
- For prevention of rejection of transplanted kidney:
  - Adults—1 gram two times a day.
- For prevention of rejection of transplanted liver:
  - Adults—1 gram two times a day.

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.

Call your doctor or pharmacist for instructions.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits. Your doctor will want to do laboratory tests to make sure that mycophenolate is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. To keep from getting pregnant, use two forms of birth control such as condoms, a diaphragm, or contraceptive foam or jelly while you are using this medicine and for 6 weeks after your treatment ends. Birth control pills may not work while you are using this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away .

While you are taking mycophenolate, it is important to maintain good dental hygiene and see a dentist regularly for teeth cleaning.

Treatment with mycophenolate may increase the chance of getting other infections. If you can, avoid contact with people with colds or other infections. The effects of mycophenolate may cause increased infections and delayed healing. Dental work, whenever possible, should be completed prior to beginning this medicine. If you think you are getting a cold or other infection, check with your doctor.

This medicine may increase your risk of developing a serious brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs .

While you are being treated with mycophenolate, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Mycophenolate 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 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 within the last several months. 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 .

Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system. Talk to your doctor if you have concerns about this risk .

Use a strong sunscreen on your skin when you are outdoors. You may also wear a hat and cover your skin with clothing. Avoid sunlamps and tanning beds .

It is important that you handle mycophenolate with care. If the medicine gets on your skin, wash thoroughly with soap and water, and if it gets in your eyes, rinse with water. Should a spill occur, wipe it up using paper towels wetted with water to remove the powder or liquid .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blood in the urine
Chest pain or discomfort
Cough or hoarseness
Fever or chills
Increased cough
Lower back or side pain
Painful or difficult urination
Shortness of breath
Swelling of feet or lower legs

Less common

Abdominal pain
Black, tarry stools
Bloody vomit
Enlarged gums
Irregular heartbeat
Joint pain
Muscle aches or pain
Pinpoint red spots on the skin
Red, inflamed, bleeding gums
Sores inside mouth
Trembling or shaking of hands or feet
Unusual bleeding or bruising
White patches on the mouth, tongue, or throat

Incidence not known

Abdominal distention
Back pain
Blue lips, fingernails, or skin
Blurred vision
Chronic or occasional diarrhea
Clumsiness
Confusion
Convulsions
Coughing or spitting up blood
Difficult or troubled breathing
Difficulty speaking or understanding what others say
Dizziness
Drowsiness
General feeling of illness or nausea
Headache
Heart murmur
Irregular, fast or slow, or shallow breathing
Loss of coordination
Memory loss
Night sweats
Severe headache
Sore throat
Stiff neck and/or back
Stools that float, are foul smelling, or "fatty"
Sudden high fever or low-grade fever for months
Unusual tiredness or weakness
Vision changes
Weakness in the legs

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