cellcept

CellCept (mycophenolate mofetil) is an immunosuppressant, a medicine that lowers your body"s immune system. The immune system helps your body fight infections. Your body may "reject" an organ transplant when the immune system treats the new organ as an invader. An immunosuppressant helps to prevent this rejection.

CellCept is used to prevent your body from rejecting a kidney, liver, or heart transplant. CellCept is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication.

Important information

This medicine can cause a miscarriage or birth defects, especially if used during the first 3 months of pregnancy. If you are a woman of child-bearing potential, you must use specific types of birth control to prevent pregnancy before, during, and shortly after treatment with CellCept.

CellCept is sometimes given to pregnant women. Although this medicine can affect pregnancy or fertility, it is sometimes given to women who are unable to use other needed transplant medications.

Using CellCept may increase your risk of developing serious infections or other types of cancer, such as lymphoma or skin cancer. You must remain under the care of a doctor while you are using CellCept.

Do not open the CellCept capsule or crush or chew a tablet. Do not use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin.

Before taking this medicine

You should not use CellCept if you are allergic to mycophenolate mofetil, mycophenolic acid (Myfortic), or to an ingredient called Polysorbate 80.

Using CellCept may increase your risk of developing serious infections or other types of cancer, such as lymphoma or skin cancer. Ask your doctor about your specific risk.

To make sure CellCept is safe for you, tell your doctor if you have:

• a stomach ulcer or other disorder of your stomach or intestines;

• a viral, bacterial, or fungal infection; or

• a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

FDA pregnancy category D. 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 CellCept. You must prevent pregnancy before and during your treatment with CellCept, and for at least 6 weeks after your treatment ends.

See also: Pregnancy and breastfeeding warnings (in more detail)

If you are a woman of child-bearing potential, you will be required to use birth control. You have child-bearing potential (even if you are not sexually active) from the age of puberty until you have been in menopause for at least 12 months in a row.

CellCept can make hormonal birth control (pills, injections, implants, skin patches, or vaginal rings) less effective. If you use hormonal birth control, you must also use a back-up barrier method (such as a cervical sponge, a male or female condom, or a diaphragm or cervical cap used together with spermicide).

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 using CellCept. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191).

CellCept is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are pregnant or planning to become pregnant. Although this medicine can affect pregnancy or fertility, it is sometimes given to women who are unable to use other needed transplant medications.

It is not known whether mycophenolate mofetil passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

The liquid form may contain phenylalanine. Talk to your doctor before using this form of CellCept if you have phenylketonuria (PKU).

How should I use CellCept?

Use CellCept exactly as prescribed by your doctor. You must remain under the care of a doctor while you are using CellCept. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

The injection form of CellCept is injected into a vein through an IV. A healthcare provider will give you this injection.

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

Do not crush, chew, break, or open a CellCept capsule or tablet. Swallow it whole.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic) are not absorbed equally in the body. If you are switched from one brand to the other, take only the pills your doctor has prescribed. Always check your refills to make sure you have received the correct brand and type of medicine.

You will need regular medical tests to be sure this medicine is not causing harmful effects.

If you have ever had hepatitis B or C, CellCept can cause this condition to come back or get worse. You may need blood tests to check your liver function.

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.

CellCept dosing information

Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis:

Renal Transplantation: 1 g orally or intravenously twice a day. Orally: 1 hour before or 2 hours after a meal.
Intravenously: administered over 2 hours.

Cardiac Transplantation: 1.5 g intravenously twice a day administered over no less than 2 hours or 1.5 g orally twice a day

Hepatic Transplantation: 1 g intravenously twice a day administered over no less than 2 hours or 1.5 g orally twice a day

Usual Geriatric Dose for Organ Transplant -- Rejection Prophylaxis:

Renal Transplantation: 1 g orally or intravenously twice a day. Orally: 1 hour before or 2 hours after a meal.
Intravenously: administered over 2 hours.

Cardiac Transplantation: 1.5 g intravenously twice a day administered over no less than 2 hours or 1.5 g orally twice a day

Hepatic Transplantation: 1 g intravenously twice a day administered over no less than 2 hours or 1.5 g orally twice a day

Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis:

Renal transplantation:
3 months or younger: Data not available

3 months or older:
Initial dose: 600 mg/m2/dose twice daily up to a maximum of 2 grams/day.

Usual Pediatric Dose for Nephrotic Syndrome:

Frequently relapsing:
Initial dose: 12.5 to 18 mg/kg orally twice daily for 1 to 2 years with a tapering dose of prednisone.
Maximum dose: 2 grams per day.

Steroid-dependent:
Initial dose: 12 to 18 mg/kg or 600 mg/m2 orally twice daily.
Maximum dose: 2 grams per day.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using CellCept?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using CellCept. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid taking an antacid together with CellCept. If you also take sevelamer, take it at least 2 hours after you take oral CellCept.

Avoid exposure to sunlight or tanning beds. CellCept can increase your risk of developing skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

CellCept side effects

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

CellCept can lower blood cells that help your body fight infection. This can lead to serious conditions including herpes, shingles, hepatitis, blood or tissue infections, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure. Call your doctor right away if you have:

• diarrhea, stomach pain, nausea, vomiting, 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;

• fever, night sweats, tiredness, painful mouth sores, flu symptoms;

• runny or stuffy nose, cough, sore throat, ear pain, headache;

• pale skin, feeling light-headed or short of breath, easy bruising or bleeding (nosebleeds, bleeding gums);

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• pain or burning when you urinate;

• swelling, warmth, redness, or oozing around a skin wound; or

• a new bump or lesion on your skin, or a mole that has changed in size or color.

Common CellCept side effects may include:

• nausea, vomiting, diarrhea;

• swelling in your ankles or feet; or

• high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, shortness of breath).

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.

See also: Side effects (in more detail)

What other drugs will affect CellCept?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with CellCept, especially:

• azathioprine;

• cholestyramine;

• an antiviral medicine--acyclovir, ganciclovir, valacyclovir;

• an antibiotic--ciprofloxacin, metronidazole, norfloxacin, rifampin;

• stomach acid reducers--lansoprazole (Prevacid), pantoprazole (Protonix), and others; or

• a sulfa drug (Bactrim, Cotrim, Septra, and others).

This list is not complete. Other drugs may interact with mycophenolate mofetil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.