Cellcept

Cellcept Medication Information:

Cellcept medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.

Cellcept
Cellcept 250 mg
Cellcept 500 mg

About Cellcept

What Cellcept is used for

  • CellCept is used after kidney, heart and liver transplantation to help prevent organ rejection.

  • CellCept belongs to a family of drugs known as “immunosuppressants”. These drugs work to “suppress” or reduce the body's immune response.

  • CellCept must be given with other drugs such as cyclosporine (Sandimmune or Neoral) and corticosteroids (e.g., prednisone, prednisolone, methylprednisolone, prednisolone acetate, methylprednisolone acetate) which also suppress your immune system. Together these drugs help prevent the rejection of your transplanted organ.

What Cellcept does

  • Your body's immune system works to protect you from infections and other foreign material. When you receive a transplant, your immune system recognizes the new organ as foreign, and will try to reject it. CellCept, works to reduce this reaction, so that your body is more likely to accept the transplanted organ.

When Cellcept should not be used

  • CellCept should not be used in patients allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any component of the drug product.

  • CellCept i.v. should not be used in patients who are allergic to Polysorbate 80 (TWEEN).

What the medicinal ingredient is

Mycophenolate mofetil.

What the nonmedicinal ingredients for Cellcept are

CellCept 250 mg capsules contain the following nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, indigotine (FD&C blue #2) aluminum lake, gelatin, potassium hydroxide, red iron oxide, shellac, titanium dioxide, and yellow iron oxide; may also contain silicon dioxide and sodium lauryl sulfate.

CellCept 500 mg film-coated tablets contain the following nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, indigotine (FD&C blue #2) aluminum lake, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone (K-90), titanium dioxide; may also contain propylene glycol.

CellCept 200 mg/mL powder for oral suspension contains the following nonmedicinal ingredients: aspartame, citric acid, colloidal silicon dioxide, fruit flavour, methylparaben, sodium citrate, sorbitol, soybean lecithin, and xanthan gum.

CellCept i.v. 500 mg/vial contains the following nonmedicinal ingredients: citric acid, 5 mg, polysorbate 80, 25 mg, and sodium hydroxide and/or hydrochloric acid to adjust pH.

What dosage forms Cellcept comes in

CellCept 250 mg capsule is available as a blue/brown two-piece hard gelatin capsule printed in black ink with “CellCept 250” on the blue cap and “Roche” on the brown body. Ten capsules are contained in each blister pack.

CellCept 500 mg tablet is available as a lavender coloured, caplet shaped film-coated tablet engraved with “CellCept 500” on one side and “Roche” on the other. Ten tablets are contained in each blister pack.

CellCept 200 mg/mL powder for oral suspension is available as a white to off-white fruit flavour suspension. Each bottle of suspension is supplied with a bottle adapter and 2 oral dispensers{*Oral dosing dispenser manufactured by F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland.}.

CellCept i.v. is available for patients who are unable to take oral medications. CellCept i.v. is available as a 20 mL sterile vial containing 500 mg of mycophenolate mofetil as the hydrochloride salt.


Warnings and Precautions

Warning

Because CellCept suppresses your immune system, you are more likely to get infections and have a greater chance of developing cancer. The chances of developing either are similar to the chances seen in patients taking other immunosuppressants.

Special Note For Female Patients

  • Women must avoid pregnancy while taking CellCept as it may cause an increased risk of first trimester pregnancy loss or damage to the unborn baby. For this reason it is recommended that you discuss with your doctor if you are pregnant or become pregnant while taking CellCept. You will want to discuss the possible benefits and risks of continuing with this drug.

  • Women (who have the potential of becoming pregnant) should have a negative serum (blood) or urine pregnancy test within 1 week prior to beginning therapy.

  • Before, during your treatment and for 6 weeks after stopping your treatment with CellCept, you must use two reliable methods of birth control.

  • It is recommended that you do not breast-feed your baby if you are taking CellCept as it may pass into breast milk and may harm your baby.

All Patients

  • If you have a restriction to dietary phenylalanine, talk to you doctor or pharmacist before you use CellCept Oral Suspension.

  • Tell all health professionals you see (doctor, dentist, nurses, pharmacists) that you are taking CellCept.

  • Be sure to keep all appointments at your transplant clinic. During these visits, complete blood counts will need to be measured weekly in the first month, twice monthly for the second and third months of treatment, and then monthly for the remainder of the first year. Your doctor may sometimes order additional blood tests.

BEFORE you use CellCept talk to your doctor or pharmacist

  • If you have had a bad, unusual or allergic reaction to CellCept, mycophenolic acid, or mycophenolate sodium;

  • If you are pregnant, plan to become pregnant, or are breast-feeding a baby;

  • About all other health conditions you have now, or have had in the past, especially problems with your stomach or bowel movements;

  • About all other medicines or treatments you have used or are using, including any products you buy at a pharmacy, supermarket or health food store.


Interactions with Cellcept

  • Do not take any other drugs without asking your doctor or pharmacist first.

  • Taking antacids at the same time as CellCept may affect the way CellCept works for you and therefore should not be taken simultaneously.

  • Taking Renagel (sevelamer), or other calcium free phosphate binders at the same time as CellCept may affect the way CellCept works for you and therefore should not be taken at the same time.

  • Taking combinations of antibiotics at the same time as CellCept may affect the way CellCept works for you. Do not take any other drugs without asking your doctor or pharmacist first.

  • During treatment with CellCept, vaccinations may be less effective and live vaccines should not be given. Do discuss this with your doctor before you get any vaccinations or immunizations.

  • Do not take cholestyramine, which is used to treat high blood cholesterol.


Proper Use of Cellcept

  • Your doctor has decided the dose you should take based on your medical condition and response to the drug.

  • The initial dose of CellCept should be taken as soon as possible following transplantation. If you are not sure of your dose, or when to take it, ask your doctor, pharmacist or nurse.

  • Space your two doses of CellCept as evenly as you can throughout the day leaving about 12 hours between each dose.

  • If you have trouble remembering doses, or if you are uncertain about how to take them talk to your doctor, nurse or pharmacist and be sure to discuss any concerns you have about taking the drug as prescribed.

  • CellCept must be taken with other immunosuppressive medicines (such as cyclosporine and corticosteroids). Discuss with your doctor if you are to stop, or to continue, the other immunosuppressant drugs you had been taking.

  • Try to take your doses at the same times each day. Taking your medicine at the same time each day will also help you remember each dose.

  • Vomiting or diarrhea may prevent CellCept from being taken up into your body. Always call your doctor if you have either of these episodes.

  • Do not change the dose on your own, no matter how you are feeling. Call your doctor.

  • Do not stop taking CellCept on your own even if you have been taking it for several years.

Usual dose

CellCept should be taken on an empty stomach.

Kidney Transplant Patients

Adults

  • A dose of 1 g taken twice a day (daily dose of 2 g) is recommended after kidney transplantation.

Pediatric Patients

  • In pediatrics (2 years and older), the recommended dose of CellCept oral suspension following kidney transplantation is 600 mg/m2 body surface area{†Body surface area is the total surface area of the body, and is represented as square meters (m2). It is calculated from your weight and height. Body surface area is used in many measurements in medicine, such as determining the amount of drug you need to take.} twice a day (up to a maximum daily dose of 2 g).

  • Pediatric patients with a body surface area† of 1.25 to 1.5 m2 may be dosed with CellCept capsules at a dose of 750 mg twice a day (1.5 g daily dose). Pediatric patients with a body surface area† greater than 1.5 m2 may be dosed with CellCept capsules or tablets at a dose of 1 g twice a day (2 g daily dose).

Heart Transplant Patients

Adults

  • A dose of 1.5 g twice a day (daily dose of 3 g) is recommended after heart transplantation in adults.

 

Technical Information