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Cellcept (MYCOPHENOLATE MOFETIL)

Cellcept works by inhibiting the enzyme inosine-5'-monophosphate dehydrogenase 2, which is necessary for the production of guanosine nucleotides.

Cellcept (Mycophenolate Mofetil) is a small molecule antimetabolite immunosuppressant developed by Roche Palo, targeting inosine-5'-monophosphate dehydrogenase 2. It is used to prevent organ transplant rejection and graft-versus-host disease. Cellcept is off-patent with 24 generic manufacturers, and its commercial status is generic. Key safety considerations include gastrointestinal and hematologic side effects. It was FDA approved in 1995 for various transplant indications.

At a glance

Mechanism of action

Mechanism of Action:. Mycophenolate mofetil has been demonstrated in experimental animal models to prolong the survival of allogeneic transplants (kidney, heart, liver, intestine, limb, small bowel, pancreatic islets, and bone marrow).Mycophenolate mofetil has also been shown to reverse ongoing acute rejection in the canine renal and rat cardiac allograft models. Mycophenolate mofetil also inhibited proliferative arteriopathy in experimental models of aortic and cardiac allografts in rats, as well as in primate cardiac xenografts. Mycophenolate mofetil was used alone or in combination with other immunosuppressive agents in these studies. Mycophenolate mofetil has been demonstrated to inhibit immunologically mediated inflammatory responses in animal models and to inhibit tumor development and prolong survival in murine tumor transplant models.Mycophenolate mofetil is rapidly absorbed following oral administration and hydrolyzed to form MPA, which is the active metabolite. MPA is potent,

Approved indications

• Prevention of Cardiac Transplant Rejection
• Prevention of Kidney Transplant Rejection
• Prevention of Liver Transplant Rejection
• The suppression of graft-versus-host disease in hematopoietic stem cell transplantation

Boxed warnings

• WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3) ] . Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3) ] . WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS See full prescribing information for complete boxed warning Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) ]. Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes [see Warnings and Precautions (5.3) ].

Common side effects

• Leukopenia
• Hypertension
• Abdominal pain
• Headache
• Fever
• Infection
• Kidney function abnormal
• Hyper-cholesteremia
• Hyperglycemia
• Diarrhea
• Peripheral edema
• Constipation

Key clinical trials

• Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies (PHASE2)
• Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis (PHASE2)
• Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita (PHASE2)
• Tocilizumab in Lung Transplantation (PHASE2)
• A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation (PHASE2,PHASE3)
• MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases (PHASE2)
• Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis (NA)
• Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis (PHASE4)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Cellcept CI brief — competitive landscape report
• Cellcept updates RSS · CI watch RSS
• Roche Palo portfolio CI