warnings

What is the most important information I should know about Cellcept (Mycophenolate Mofetil (Oral/Injection))?

You should not use this medicine if you are allergic to mycophenolate mofetil, mycophenolic acid, or polysorbate 80.

Talk with your doctor about the risks and benefits of mycophenolate mofetil. This medicine may increase your risk of cancer, serious or fatal infections, or a viral infection that can cause kidney transplant failure.

Tell your doctor if you have ever had:

a stomach ulcer or problems with digestion, diabetes;
hepatitis B or C or other viral infection (may become active or get worse while you are using mycophenolate mofetil);
phenylketonuria, or PKU (the liquid form of this medicine may contain phenylalanine); or
a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

This medicine can cause a miscarriage or birth defects, especially during the first 3 months of pregnancy. You will need to have a negative pregnancy test before and during treatment with this medicine. If you are able to get pregnant, you must use specific forms of birth control to prevent pregnancy while using mycophenolate mofetil, and for at least 6 weeks after your last dose. Sexually active men and their partners should use effective contraception during treatment and for at least 90 days after the last dose.

Mycophenolate mofetil can make birth control pills less effective. Ask your doctor about using an additional barrier form of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy.

You do not need to use additional birth control if you use an intrauterine device (IUD), if you have had a tubal ligation, or if your sexual partner has had a vasectomy.

This medicine comes with patient instructions about the most effective non-hormonal forms of birth control to use. Follow these directions carefully. Ask your doctor if you have any questions.

If a pregnancy occurs during treatment, do not stop taking mycophenolate mofetil. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191).

Mycophenolate mofetil is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are unable to use other needed transplant medications.

You should not breastfeed while using mycophenolate mofetil.

Side Effects

What are the side effects of Cellcept (Mycophenolate Mofetil (Oral/Injection))?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mycophenolate mofetil may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Mycophenolate mofetil affects your immune system and may increase your risk of cancer or serious infection. Call your doctor right away if you have:

fever of 100.5 degrees F or higher, swollen glands, painful mouth sores, cold or flu symptoms, headache, ear pain, loss of smell or taste, stomach pain, vomiting, diarrhea, weight loss;
weakness on one side of your body, loss of muscle control, confusion, thinking problems, loss of interest in things that normally interest you;
pain around the transplanted kidney, pain or burning when you urinate, dark urine, jaundice (yellowing of the skin or eyes);
tingly or painful blistering rash on one side of your body, swelling, warmth, redness, or oozing around a skin wound; or
a new skin lesion, or a mole that has changed in size or color.

Also call your doctor at once if you have:

bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds, fever, joint stiffness and pain, and muscle pain; or
low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

stomach pain, nausea, vomiting, diarrhea, constipation, swelling in your ankles or feet, rash, pain anywhere in your body;
headache, dizziness, tremors, fever, sore throat, cold symptoms, or other signs of infections; or
abnormal blood tests, high blood sugar, high or low blood pressure, fast heart rate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take Cellcept (Mycophenolate Mofetil (Oral/Injection)) if I’m pregnant or breastfeeding?

Positive evidence of risk

Based on FDA pregnancy categories

If a pregnancy occurs during treatment, do not stop taking mycophenolate mofetil. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191).

Mycophenolate mofetil is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are unable to use other needed transplant medications.

You should not breastfeed while using mycophenolate mofetil.

Interactions

What drugs and food should I avoid while taking Cellcept (Mycophenolate Mofetil (Oral/Injection))?

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Mycophenolate mofetil can make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not receive a "live" vaccine while using mycophenolate mofetil. The vaccine may not work as well and may not fully protect you from disease.

You must not donate blood or sperm while using this medicine, and for at least 6 weeks (for blood) or 90 days (for sperm) after your last dose.

Dosage Guidelines & Tips

How to take Cellcept (Mycophenolate Mofetil (Oral/Injection))?

Use Cellcept (Mycophenolate Mofetil (Oral/Injection)) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You must remain under the care of a doctor while you are using mycophenolate mofetil.

Mycophenolate mofetil injection is given as an infusion into a vein. A healthcare provider will give you this injection.

Take oral mycophenolate mofetil on an empty stomach, at least 1 hour before or 2 hours after a meal.

Swallow the capsule or tablet whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing a tablet or capsule.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Shake the oral suspension (liquid) before you measure a dose. Use only the dosing syringe provided with this medicine.

Mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic) are not absorbed equally in the body. Avoid medication errors by using only the brand, form, and strength of this medicine that your doctor has prescribed.

You will need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Throw away any unused liquid that is older than 60 days.

The liquid medicine may also be stored in the refrigerator. Do not freeze.

What should I do if I missed a dose of Cellcept (Mycophenolate Mofetil (Oral/Injection))?

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 2 hours. Do not use two doses at one time.