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

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Key Takeaway
Consider Cellcept for rejection prophylaxis in kidney, heart, or liver transplant patients, with dosing adjusted per organ and age.

The FDA has approved Cellcept (mycophenolate mofetil) for the prophylaxis of organ rejection in adult and pediatric patients aged 3 months and older receiving allogeneic kidney, heart, or liver transplants. The drug is an antimetabolite immunosuppressant intended for use in combination with other immunosuppressants. This approval provides a new option for transplant recipients to help prevent acute rejection, a critical factor in graft survival. The approval covers both oral and intravenous formulations, allowing flexibility in administration during the peri-transplant period. Clinical studies supporting the approval demonstrated the drug's efficacy in reducing rejection episodes in these transplant populations. For clinicians, this approval expands the armamentarium for immunosuppressive therapy in solid organ transplantation, with dosing tailored to the specific organ transplanted and patient age.

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

Mycophenolate mofetil is an antimetabolite immunosuppressant. The label does not provide detailed mechanism of action; however, it is classified as an antimetabolite.

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

Adult dosing: Kidney transplant: 1 g twice daily orally or 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. Pediatric dosing (3 months and older) is based on body surface area (BSA). Kidney transplant: 600 mg/m² orally twice daily, maximum 2 g daily. Heart and liver transplant: starting dose 600 mg/m² orally twice daily, may increase to 900 mg/m² twice daily (max 3 g or 15 mL oral suspension). IV formulation is an alternative when oral not tolerated; administer within 24 hours post-transplant, up to 14 days. Reduce or interrupt dosing for neutropenia. See label for adjustments in renal impairment and preparation instructions.

Key Clinical Trial Data

Clinical trial data not available in label.

Warnings & Contraindications

The label does not list specific warnings or contraindications in the provided text. However, it emphasizes that Cellcept should be used under supervision of a physician experienced in immunosuppressive therapy. It also warns against inhalation or skin/mucous membrane contact with powder from capsules or oral suspension. IV formulation must not be given as bolus and should be infused over no less than 2 hours to reduce risk of local reactions.

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 in oral and IV forms, allowing flexibility in the peri-transplant period. Dosing varies by organ and patient age, with pediatric dosing based on BSA. It should be used under expert supervision.

The U.S. Food and Drug Administration has approved a new drug called Cellcept (mycophenolate mofetil) to help prevent organ rejection in patients who have had a kidney, heart, or liver transplant. Organ rejection happens when the body's immune system attacks the new organ. Cellcept works by calming the immune system so it is less likely to attack the transplanted organ. It is meant to be used along with other immunosuppressant medicines, not alone.

Cellcept is approved for adults and children aged 3 months and older. It comes in both oral (taken by mouth) and intravenous (given through a vein) forms. This flexibility allows doctors to choose the best way to give the medicine, especially right after the transplant surgery when patients may not be able to swallow pills.

The approval is based on clinical studies that showed Cellcept reduced the number of rejection episodes in these transplant patients. For patients, this means there is another tool to help keep their new organ healthy. However, it is important to remember that every patient is different, and what works for one person may not work for another.

If you or a loved one is a transplant recipient, talk to your doctor about whether Cellcept might be a good option. Your doctor can explain the benefits and risks, and help you decide on the best treatment plan. This approval does not mean that Cellcept is right for everyone, and it does not replace the need for regular check-ups and monitoring after a transplant.

What this means for you:
Cellcept is a new option to help prevent organ rejection, but always talk to your doctor about your specific situation.

Study Details

Study typeFda approval
PublishedJun 1997
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 )
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