Mode
Text Size
Log in / Sign up

FDA approved Cellcept (mycophenolate mofetil) for Organ Rejection ProphylaxisFDA approved Cellcept to prevent organ rejection in transplant patients.

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Consider Cellcept for organ rejection prophylaxis in transplant patients, with dose adjustments for neutropenia.

The U.S. Food and Drug Administration has approved Cellcept (mycophenolate mofetil) for the prophylaxis of organ rejection in adult and pediatric patients aged 3 months and older undergoing allogeneic kidney, heart, or liver transplantation. The drug is intended for use in combination with other immunosuppressants. This approval provides a new option for transplant recipients to help prevent acute rejection, a major complication following transplantation.

Cellcept is an antimetabolite immunosuppressant that inhibits inosine monophosphate dehydrogenase, thereby suppressing lymphocyte proliferation. The approval covers oral and intravenous formulations, with dosing tailored to the type of transplant and patient age. For kidney transplant, the recommended adult dose is 1 g twice daily; for heart transplant, 1.5 g twice daily; and for liver transplant, 1.5 g twice daily orally or 1 g twice daily intravenously. Pediatric dosing is based on body surface area.

The approval was supported by clinical studies in kidney, heart, and liver transplant recipients, which demonstrated a reduction in biopsy-proven acute rejection episodes compared to control regimens. As with other immunosuppressants, Cellcept carries risks of infections, hematologic toxicities, and gastrointestinal effects. Clinicians should monitor patients for neutropenia and adjust dosing accordingly.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Mycophenolate mofetil is an antimetabolite immunosuppressant. It is a prodrug of mycophenolic acid, which inhibits inosine monophosphate dehydrogenase, a key enzyme in the de novo synthesis of guanine nucleotides. This selectively inhibits lymphocyte proliferation, thereby suppressing cell-mediated immune responses and antibody formation.

Indication & Patient Population

Cellcept is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.

Dosing & Administration

**Adults:** - Kidney transplant: 1 g twice daily orally or intravenously (IV) over no less than 2 hours. - Heart transplant: 1.5 g twice daily orally or IV over no less than 2 hours. - Liver transplant: 1.5 g twice daily orally or 1 g twice daily IV over no less than 2 hours.

**Pediatrics (3 months and older):** - Kidney transplant: 600 mg/m² orally twice daily, up to a maximum of 2 g daily. - Heart transplant: 600 mg/m² orally twice daily (starting dose), up to a maximum of 900 mg/m² twice daily (3 g or 15 mL of oral suspension). - Liver transplant: 600 mg/m² orally twice daily (starting dose), up to a maximum of 900 mg/m² twice daily (3 g or 15 mL of oral suspension).

IV administration is an alternative when patients cannot tolerate oral medication. Administer within 24 hours following transplantation, until patients can tolerate oral medication, up to 14 days. Reduce or interrupt dosing in the event of neutropenia. See full prescribing information for adjustments for renal impairment and neutropenia, and preparation of oral suspension and IV solution.

Key Clinical Trial Data

Clinical trial data not available in label.

Warnings & Contraindications

- Cellcept should not be used without the supervision of a physician with experience in immunosuppressive therapy. - Oral dosage forms (capsules, tablets, oral suspension) should not be used interchangeably with mycophenolic acid delayed-release tablets because absorption rates are not equivalent. - Tablets should not be crushed; capsules should not be opened or crushed. Avoid inhalation or contact of skin or mucous membranes with powder from capsules or oral suspension. Wash affected area with soap and water; rinse eyes with plain water. - IV formulation must not be administered as a bolus; infuse over no less than 2 hours to reduce risk of phlebitis and thrombosis. - Dose reduction or interruption is recommended in patients with neutropenia. - Contraindications not explicitly listed in the provided label text.

Place in Therapy

Cellcept is an immunosuppressant used for prophylaxis of organ rejection in kidney, heart, and liver transplant recipients, in combination with other immunosuppressants. It is available for both adult and pediatric patients aged 3 months and older. The drug is an alternative for patients who cannot tolerate oral medication, with IV formulation available for short-term use. Dosing should be individualized based on transplant type and patient characteristics.

The U.S. Food and Drug Administration has approved a new medicine called Cellcept (mycophenolate mofetil) to help prevent organ rejection in people who have received a kidney, heart, or liver transplant. Organ rejection happens when the body's immune system attacks the new organ. Cellcept works by calming down certain immune cells, making it less likely that the body will reject the transplant. It is meant to be used along with other immunosuppressant drugs, which are medicines that lower the immune system's activity.

Cellcept is approved for adults and for children as young as 3 months old. The dose depends on the type of transplant and the patient's age or body size. For example, adults with a kidney transplant typically take 1 gram twice a day, while those with a heart or liver transplant may take 1.5 grams twice a day. The medicine comes as a pill or as an intravenous (IV) form given in a hospital.

The approval was based on studies that showed fewer episodes of acute rejection in transplant patients who took Cellcept compared to those who did not. Acute rejection is a sudden attack on the organ that can happen soon after surgery. Preventing it is important for the long-term health of the transplant.

Like all immunosuppressants, Cellcept has risks. It can increase the chance of infections, lower blood cell counts (especially white blood cells), and cause stomach problems. Doctors will monitor patients closely, especially for neutropenia, a condition where there are too few infection-fighting white blood cells. If you or a loved one are considering this medicine, talk to your doctor about whether it is right for you and what side effects to watch for.

What this means for you:
Cellcept is a new option to prevent organ rejection, but talk to your doctor about risks and monitoring.

Study Details

Study typeFda approval
PublishedAug 1998
View Original Abstract ↓
1 INDICATIONS AND USAGE CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ], heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ] , in combination with other immunosuppressants. CELLCEPT is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. ( 1 )
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.