Cellcept

Generic name: Mycophenolate Mofetil (oral/injection)
Drug class: Selective immunosuppressants

Usage of Cellcept

CellCept weakens your body's immune system, to help keep it from "rejecting" a transplanted organ. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

CellCept is used to prevent organ rejection in patients who are at least three months of age who have received a liver transplant, a heart transplant, or a kidney transplant.

CellCept is used with other immunosuppressant medicines containing cyclosporine and corticosteroids.

Cellcept side effects

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

CellCept 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 CellCept 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.

Before taking Cellcept

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

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

Stop using CellCept and call your doctor at once 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 CellCept);

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.

Mycophenolate mofetil 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 CellCept, 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.

CellCept 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 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 unable to use other needed transplant medications.

You should not breastfeed while using CellCept.

Relate drugs

How to use Cellcept

Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis:

-RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day); [in clinical trials, 1.5 g orally or IV 2 times a day (3 gm per day) was used effectively, however, the safety profile for 3 gm a day was lower] -CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day) -HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV) Comments: -This drug should be used concomitantly with cyclosporine and corticosteroids. -The IV formulation should be administered over no less than 2 hours. -IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Usual Geriatric Dose for Organ Transplant -- Rejection Prophylaxis:

-RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day) -CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day) -HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV) Comments: -This drug should be used concomitantly with cyclosporine and corticosteroids. -The IV formulation should be administered over no less than 2 hours. -IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis:

-RENAL TRANSPLANTATION: 3 months to 18 years of age: Oral Suspension: 600 mg/m2 orally 2 times a day up to a maximum of 2 grams per day -Pediatric patients with a body surface area of 1.25 to 1.5 m2 may be dosed with the oral capsules at 750 mg orally 2 times a day (1.5 g per day) -Pediatric patients with a body surface area greater than 1.5 m2 may be dosed with the oral capsules at 1 g orally 2 times a day (2 g per day) Comments: -This drug should be used concomitantly with cyclosporine and corticosteroids. -The IV formulation should be administered over no less than 2 hours.-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Warnings

Cellcept can cause a miscarriage or birth defects when used during pregnancy. Both men and women should use effective birth control to prevent pregnancy during and shortly after treatment with CellCept.

Using CellCept may increase your risk of cancer, serious infections, or kidney transplant failure.

Call your doctor right away if you have symptoms such as: fever, swollen glands, weight loss, vomiting or diarrhea, painful urination, a new skin lesion, any change in your mental state, weakness on one side of your body, or pain near your transplanted kidney.

What other drugs will affect Cellcept

If you take sevelamer or an antacid, take your oral CellCept dose 2 hours before you take these other medicines.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect CellCept, especially:

azathioprine, cholestyramine;

antiviral medicine - acyclovir, ganciclovir, valacyclovir, valganciclovir;

an antibiotic - amoxicillin, ciprofloxacin, metronidazole, norfloxacin, rifampin, sulfa drugs; or

a stomach acid reducer - esomeprazole, lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

This list is not complete and many other drugs may interact with mycophenolate mofetil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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