What is mycophenolate mofetil? What is mycophenolate mofetil used for?
Mycophenolic acid is an immunosuppressive drug. It is indicated for the prophylaxis of organ rejection in patients receiving kidney, heart, or liver transplants. mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids.
Mycophenolate mofetil is a prodrug (inactive form) of mycophenolic acid (MPA). Following oral administration, mycophenolate mofetil is rapidly absorbed and hydrolyzed (converted) to MPA. MPA is the active metabolite which has pharmacological activity.
MPA is a strong, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). IMPDH plays a critical role in the production of DNA. T and B lymphocytes (immune cells) are heavily dependent on the activity of IMPDH to make DNA to proliferate, whereas other cells can use alternative pathways. In patients who have received transplanted organs, the recipient's immune system attacks the transplanted organ because the body perceives it as foreign or harmful. MPA decreases the activity of the immune system by inhibiting the proliferation of immune cells that attack the transplanted organ. Mycophenolate is used with other medications that also inhibit the rejection of transplanted organs such as cyclosporine (Sandimmune, Gengraf, Neoral) and corticosteroids.
Mycophenolate mofetil was approved by the U.S. FDA on May 3, 1995.
What brand names are available for mycophenolate mofetil?
CellCept
Is mycophenolate mofetil available as a generic drug?
Yes
Do I need a prescription for mycophenolate mofetil?
Yes
What are the side effects of mycophenolate mofetil?
Common side effects include:
- diarrhea,
- vomiting,
- pain,
- pain in the stomach area,
- high blood pressure, and
- swelling of the lower legs, ankles, or feet.
It may also cause:
- infection,
- blood infection,
- sore throat,
- low white
and red blood cell count, and - low blood platelets (thrombocytopenia).
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What is the dosage for mycophenolate mofetil?
Mycophenolate mofetil should be given to patients as soon as possible
following organ transplantation. Mycophenolate mofetil is recommended to be
administered on an empty stomach, except in stable renal transplant patients in
whom it can be administered with food if necessary.
Kidney transplantation
- Adults: The recommended dose is 1 g administered orally or intravenously
(over no less than 2 hours) twice a day. - Pediatrics (3 months to 18 years of age): The recommended dose of the oral
suspension is 600 mg/m2 administered twice daily (maximum daily dose of 2 g/10
ml). Patients with a body surface area of 1.25 m2 to 1.5 m2 may be administered
capsules at a dose of 750 mg twice daily. Patients with a body surface area >1.5
m2 may be dosed with capsules or tablets at a dose of 1 g twice daily.
Heart transplantation
- Adults: The recommended dose is 1.5 g twice daily administered intravenously
over no less than 2 hours or 1.5 g orally twice daily.
Liver Transplantation
- Adults: The recommended dose is 1 g twice daily administered intravenously
over no less than 2 hours or 1.5 g orally twice daily. - Geriatrics (elderly patients): The recommended oral dose is 1 g twice daily
for kidney transplant patients, 1.5 g twice daily for
heart transplant patients,
and 1 g twice daily administered intravenously or 1.5 g twice daily administered
orally in
liver transplant patients.
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Which drugs or supplements interact with mycophenolate mofetil?
Co-administration of acyclovir (Zovirax) or ganciclovir (Cytovene, Vitrasert,
Zirgan) and mycophenolate mofetil may cause an increase in blood levels of
mycophenolate mofetil and the interacting drug since these drugs compete with
each other for elimination via the kidneys.
Antacids containing magnesium or aluminum hydroxide may decrease MPA blood
levels. If combination use is necessary, administration of the two medications
must be separated by several hours.
Proton pump inhibitors (PPIs) such as lansoprazole (Prevacid), pantoprazole
(Protonix), and omeprazole (Prilosec) have been shown to reduce MPA blood
levels. This effect may be due to a decrease in mycophenolate mofetil solubility
caused by reduced acid secretion in the stomach caused by PPIs.
Cholestyramine
(Questran, Questran Light) may cause a decrease in MPA blood levels by binding to it in
the intestine and preventing its absorption.
Cyclosporine (Sandimmune) may decrease MPA blood levels. Cyclosporine
inhibits multidrug-resistant-associated protein 2 (MRP-2) transporter in the
biliary tract, and this prevents the excretion of MPA into bile and elimination
from the body.
Mycophenolate mofetil may decrease the effectiveness of some oral
contraceptives (birth control pills). Combining mycophenolate mofetil with birth
control pills should be done cautiously, and additional contraceptive barriers
(such as condoms) should be used.
Sevelamer (Renvela) may decrease MPA blood levels. Sevelamer and other
calcium free phosphate binders that are used for treating patients with kidney
disease should not be administered with mycophenolate mofetil. If combination
treatment is necessary, sevelamer and other calcium free phosphate binders must
be given two hours after mycophenolic acid administration.
Norfloxacin (Noroxin) and metronidazole (Flagyl), two antibiotics, may
decrease MPA blood levels. Use of these antibiotics with mycophenolate mofetil
is not recommended. Other antibiotics that may also decrease MPA levels in the
blood are ciprofloxacin (Cipro), amoxicillin plus clavulanic acid (Augmentin),
and rifampin (Rifadin, Rimactane).
Probenecid may cause an increase in MPA blood levels by inhibiting its
excretion via renal tubular secretion.
Is mycophenolate mofetil safe to take if I’m pregnant or breastfeeding?
Mycophenolate mofetil is excreted in milk of rats. It is not
known if it also is excreted in human milk. Due to the lack of conclusive safety
data, mycophenolate mofetil should be used cautiously in nursing mothers.
What else should I know about mycophenolate mofetil?
What preparations of mycophenolate mofetil are available?
- Powder for injection: 500 mg
- Capsules: 250 mg
- Immediate-release tablets: 500 mg
- Delayed-release tablets: 180 and 360 mg
- Oral suspension: 200 mg/ml
How should I keep mycophenolate mofetil stored?
- Capsules and tablets should be stored at room temperature, between
15 C and 30 C (59 F and 86 F). - Oral suspension may be stored at room temperate
between 15 C and 30 C (59 F and 86 F) for up to 60 days. - Oral suspension also
may be stored in the refrigerator between 2 C and 8 C (36 F and 46 F), but it
should not be frozen.