Cellcept
Generic Name: Mycophenolate Mofetil
Brand Name: Cellcept
Indications
Cellcept is indicated to prevent graft-versus-host disease after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Cellcept is a type of immunosuppressive agent.
Dosage and Administration
Cellcept is available as 250mg capsules, 500mg tablets, oral suspension of 225ml and intravenous in a 20 mL, sterile vial containing the equivalent of 500 mg mycophenolate mofetil.
Normal dosage: A dose of 1 g administered orally or intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 2 g) is recommended for use in renal transplant patients. A dose of 1.5 g bid administered intravenously (over NO LESS THAN 2 HOURS) or 1.5 g bid oral (daily dose of 3 g) is recommended for use in adult cardiac transplant patients. A dose of 1 g bid administered intravenously (over NO LESS THAN 2 HOURS) or 1.5 g bid oral (daily dose of 3 g) is recommended for use in adult hepatic transplant patients.
The initial oral dose of CellCept should be given as soon as possible following renal, cardiac or hepatic transplantation. Food had no effect on MPA AUC, but has been shown to decrease MPA Cmax by 40%. Therefore, it is recommended that CellCept be administered on an empty stomach. However, in stable renal transplant patients, CellCept may be administered with food if necessary.
Overdose: Overdose symptoms may include nausea, vomiting, diarrhea, unusual bleeding or bruising, and signs of infection.
Drug Description
CellCept (mycophenolate mofetil) is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.
The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula:
 |
Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 μg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group.
Mycophenolate mofetil hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1.
Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty in breathing; swelling of your face, lips, tongue, or throat.
Stop using mycophenolate mofetil and call your doctor at once if you have any of these serious side effects:
- fever, chills, body aches, flu symptoms
- easy bruising or bleeding, unusual weakness
- coughing up blood or vomit that looks like coffee grounds
- bloody, black, or tarry stools
- painful or difficult urination
- chest pain; or
- feeling like you might pass out
Less serious side effects may include:
- nausea, vomiting, stomach pain, diarrhea, or constipation
- headache, mild weakness
- swelling in your hands or feet
- numbness or tingly feeling; or
- anxiety, sleep problems (insomnia)
This is not a complete list of the side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
Precautions
- Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
- Do not receive a "live" vaccine while you are being treated with CellCept. The live vaccine may not work as well during your treatment, and may not fully protect you from disease.
- Avoid using antacids without your doctor's advice while using CellCept. Antacids contain different medicines and some types can make it harder for your body to absorb CellCept.
- Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). CellCept can increase your risk of skin cancer. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
- You should not use this medication if you are allergic to mycophenolate mofetil, mycophenolic acid (Myfortic), or to an ingredient called Polysorbate 80.
- Before using mycophenolate mofetil, tell your doctor if you are allergic to any drugs, or if you have:
- a stomach ulcer or other disorders of your stomach or intestines
- kidney disease
- a viral, bacterial, or fungal infection; or
- a rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome
- FDA pregnancy category D. This medication can cause harm to an unborn baby, especially if used during the first trimester of pregnancy. Do not use mycophenolate mofetil without telling your doctor if you are pregnant or if you plan to become pregnant during treatment.
- If you are a woman of child-bearing potential, you will be required to receive contraceptive counseling and to start using two forms of birth control 4 weeks before the start of your treatment with mycophenolate mofetil. You will also need to have a negative pregnancy test within 1 week before your treatment begins.
- It is not known whether mycophenolate mofetil passes into breast milk or if it could harm a nursing baby. Do not use mycophenolate mofetil without telling your doctor if you are breast-feeding a baby.
- The oral liquid form of this medication may contain phenylalanine. Talk to your doctor before using this form of mycophenolate mofetil if you have phenylketonuria (PKU).
Drug Interactions
Before using CellCept, tell your doctor if you are using any of the following drugs:
- cholestyramine (Questran);
- any type of antibiotic;
- acyclovir (Zovirax), ganciclovir (Cytovene), or valacyclovir (Valtrex); or
- other medicines that weaken the immune system, such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), tacrolimus (Prograf), or daclizumab (Zenapax).
This list is not complete and there may be other drugs that can interact with CellCept. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
