Mycophenolate Mofetil

• Embryofetal Toxicity 

Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney and nervous system. Counsel for pregnancy prevention. You can avoid the usage of MMF if safer treatment options are available.

• Lymphoma and Other Malignancies 

Cellcept has the potential of developing lymphomas and other malignancies, especially of the skin. These patients are advised to wear protective clothing and use a broad-spectrum sunscreen with a high protection factor in order to reduce sunlight and UV light exposure. Post-transplant lymphoproliferative disorder (PTLD) may occur rarely who are EBV seronegative, especially in young children.

• Serious infections

Patients receiving Cellcept have a high risk of developing bacterial, fungal, protozoal and new or reactivated viral infections, including opportunistic infections. These infections may lead to serious outcomes, including hospitalizations and death.

Serious viral infections reported include: 

• • Polyomavirus-associated nephropathy (PVAN), especially due to BK virus infection 
  • JC virus-associated progressive multifocal leukoencephalopathy (PML)
  • Cytomegalovirus (CMV) infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor are at highest risk of CMV viremia and CMV disease. 
  • Viral reactivation in patients infected with Hepatitis B and C 
  • COVID-19 

It is advised to either reduce or discontinue the medication according to the condition.

• Blood Dyscrasias: Neutropenia and Pure Red Cell Aplasia (PRCA) 

Severe neutropenia has been observed in patients taking Cellcept. The dosage should be interrupted or reduced, appropriate diagnostic tests performed, and the patient managed appropriately. Consider monitoring with complete blood counts weekly for the first month, twice monthly for the second and third months, and monthly for the remainder of the first year. 

Patients are also developing pure red cell aplasia (PRCA) when treated in combination with other immunosuppressive agents. In some cases, PRCA was found to be reversible with dose reduction or cessation of CELLCEPT therapy. 

• Gastrointestinal complications

Symptoms like Gastrointestinal bleeding requiring hospitalization, ulceration and perforations were observed in clinical trials. 

• Patients with Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency (HGPRT) 

Cellcept should be avoided in patients with hereditary deficiencies of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndromes because it may cause an exacerbation of disease symptoms characterized by the overproduction and accumulation of uric acid leading to symptoms associated with gout such as acute arthritis, tophi, nephrolithiasis or urolithiasis and renal disease including renal failure. 

• Acute Inflammatory Syndrome (AIS) Associated with Mycophenolate Products 

The use of MMF and Mycophenolate Products may cause AIS which is paradoxical pro-inflammatory reaction characterized by fever, arthralgias, arthritis, muscle pain and elevated inflammatory markers including, C-reactive protein and erythrocyte sedimentation rate, without evidence of infection or underlying disease recurrence. Discontinue treatment and consider other treatment alternatives based on the risk and benefit for the patient. 

• Hypersensitivity Reactions 

Symptoms of hypersensitivity reactions such as angioedema and anaphylaxis, have been reported. Discontinue CELLCEPT; treat and monitor until symptoms resolve 

• Immunizations

The use of live attenuated vaccines should be avoided (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) and patients should be advised that vaccinations may be less effective. 

• Local Reactions with Rapid Intravenous Administration 

Avoid administration of Cellcept intravenously by rapid or bolus injection as it may cause phlebitis and thrombosis. 

• Risks in Patients with Phenylketonuria 

CELLCEPT Oral Suspension contains aspartame, a source of phenylalanine that is harmful to phenylketonuria. Consider the combined daily amount of phenylalanine from all sources, including Cellcept before prescribing it in oral Suspension form to a patient with PKU.

• Blood Donation 

Patients should not donate blood for at least 6 weeks following discontinuation of medication because their blood or blood products might be administered to a female of reproductive potential or a pregnant woman. 

• Semen Donation 

Men should not donate semen during therapy and for 90 days following discontinuation of medication.

• Effect of Concomitant Medications on Mycophenolic Acid Concentrations

Several medications can affect the levels of mycophenolic acid (MPA) in your body when taken with CellCept. Monitor and adjust MPA levels if other medicines are started, stopped, or changed.

• Potential Impairment of Ability to Drive or Operate Machinery 

Patients should avoid driving or using machines if they experience somnolence, confusion, dizziness, tremor, or hypotension during treatment