Cellcept

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 8/25/2021
Cellcept Side Effects Center

What Is CellCept?

CellCept (mycophenolate mofetil) is an immunosuppressive agent used to prevent your body from rejecting a kidney, liver, or heart transplant. CellCept is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication. CellCept is available in generic form.

What Are Side Effects of CellCept?

Common side effects of CellCept include:

  • constipation,
  • nausea,
  • headache,
  • diarrhea,
  • vomiting,
  • stomach pain or upset,
  • loss of appetite,
  • gas,
  • tremor,
  • trouble sleeping (insomnia),
  • weakness,
  • swelling in your hands or feet,
  • numbness or tingly feeling, or
  • anxiety.

Tell your doctor if you experience unlikely but serious side effects of CellCept including:

  • unusual tiredness,
  • fast or irregular heartbeat,
  • muscle weakness,
  • easy bleeding or bruising,
  • swelling of the feet or ankles,
  • mental/mood changes,
  • weakness on one side of the body, or
  • unusual change in the amount of urine.

Dosage for CellCept

The dose of CellCept depends on the type of transplant performed.

What Drugs, Substances, or Supplements Interact with CellCept?

CellCept may interact with cholestyramine, antibiotics, acyclovir, ganciclovir, valacyclovir, or other medicines that weaken the immune system. Tell your doctor all medications you use.

CellCept During Pregnancy and Breastfeeding

CellCept is not recommended for use during pregnancy because of possible harm to the fetus. Women of childbearing age should have a negative pregnancy test within 1 week of starting this medication. Use two forms of birth control starting 4 weeks before beginning therapy, and continue for at least 6 weeks after the drug is stopped. Consult your doctor. It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug and for 6 weeks after stopping it. Consult your doctor for details.

Additional Information

Our CellCept (mycophenolate mofetil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Kidney Stones: Symptoms, Causes, and Treatment See Slideshow
Cellcept Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mycophenolate mofetil may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Mycophenolate mofetil affects your immune system and may increase your risk of cancer or serious infection. Call your doctor right away if you have:

  • fever of 100.5 degrees F or higher, swollen glands, painful mouth sores, cold or flu symptoms, headache, ear pain;
  • stomach pain, vomiting, diarrhea, weight loss;
  • weakness on one side of your body, loss of muscle control;
  • confusion, thinking problems, loss of interest in things that normally interest you;
  • pain around the transplanted kidney;
  • pain or burning when you urinate;
  • dark urine, jaundice (yellowing of the skin or eyes);
  • tingly or painful blistering rash on one side of your body;
  • swelling, warmth, redness, or oozing around a skin wound; or
  • a new skin lesion, or a mole that has changed in size or color.

Also call your doctor at once if you have:

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

  • stomach pain, nausea, vomiting, diarrhea, constipation;
  • swelling in your ankles or feet;
  • rash;
  • headache, dizziness, tremors;
  • fever, sore throat, cold symptoms, or other signs of infections;
  • abnormal blood tests, high blood sugar;
  • pain anywhere in your body;
  • low blood cell counts; or
  • high or low blood pressure, fast heart rate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cellcept (Mycophenolate Mofetil)

QUESTION

The only purpose of the kidneys is to filter blood. See Answer
Cellcept Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Embryofetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Lymphomas and Other Malignancies [see WARNINGS AND PRECAUTIONS]
  • Serious Infections [see WARNINGS AND PRECAUTIONS]
  • Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Complications [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

An estimated total of 1557 patients received CELLCEPT during pivotal clinical trials in the prevention of acute organ rejection. Of these, 991 were included in the three renal studies, 277 were included in one hepatic study, and 289 were included in one cardiac study. Patients in all study arms also received cyclosporine and corticosteroids.

The data described below primarily derive from five randomized, active-controlled double-blind 12-month trials of CELLCEPT in de novo kidney (3) heart (1) and liver (1) transplant patients [see Clinical Studies].

CELLCEPT Oral

The incidence of adverse reactions for CELLCEPT was determined in five randomized, comparative, doubleblind trials in the prevention of rejection in kidney, heart and liver transplant patients (two active- and one placebo-controlled trials, one active-controlled trial, and one active-controlled trial, respectively) [see Clinical Studies].

The three de novo kidney studies with 12-month duration compared two dose levels of oral CELLCEPT (1 g twice daily and 1.5 g twice daily) with azathioprine (2 studies) or placebo (1 study) when administered in combination with cyclosporine (Sandimmune®) and corticosteroids to prevent acute rejection episodes. One study also included anti-thymocyte globulin (ATGAM®) induction therapy.

In the de novo heart transplantation study with 12-month duration, patients received CELLCEPT 1.5 g twice daily (n=289) or azathioprine 1.5 to 3 mg/kg/day (n=289), in combination with cyclosporine (Sandimmune® or Neoral®) and corticosteroids as maintenance immunosuppressive therapy.

In the de novo liver transplantation study with 12-month duration, patients received CELLCEPT 1 g twice daily intravenously for up to 14 days followed by CELLCEPT 1.5 g twice daily orally or azathioprine 1 to 2 mg/kg/day intravenously followed by azathioprine 1 to 2 mg/kg/day orally, in combination with cyclosporine (Neoral®) and corticosteroids as maintenance immunosuppressive therapy. The total number of patients enrolled was 565.

Approximately 53% of the kidney transplant patients, 65% of the heart transplant patients, and 48% of the liver transplant patients were treated for more than 1 year. Adverse reactions reported in ≥ 20% of patients in the CELLCEPT treatment groups are presented below. The safety data of three kidney transplantation studies are pooled together.

Table 3 : Adverse Reactions in Controlled Studies of De Novo Kidney, Heart or Liver Transplantation Reported in ≥20% of Patients in the CELLCEPT Group

Adverse drug reaction (MedDRA) System Organ Class Kidney Studies Heart Study Liver Study
CellCept 2g/day (n=501) or 3g/day
(n=490)
AZA 1 to 2 mg/kg/day or 100 to 150 mg/day Placebo CellCept 3g/day AZA 1.5 to 3 mg/kg/day CellCept 3g/day AZA 1 to 2 mg/kg/day
(n=991)% (n=326)% (n=166)% (n=289)% (n=289)% (n=277)% (n=287)%
Infections and infestations
Bacterial infections 39.9 33.7 37.3 - - 27.4 26.5
Viral infections -* - - 31.1 24.9 - -
Blood and lymphatic system disorders
Anemia 20.0 23.6 2.4 45.0 47.1 43.0 53.0
Ecchymosis - - - 20.1 9.7 - -
Leukocytosis - - - 42.6 37.4 22.4 21.3
Leukopenia 28.6 24.8 4.2 34.3 43.3 45.8 39.0
Thromb ocy topeni a - - - 24.2 28.0 38.3 42.2
Metabolism and nutrition disorders
Hypercholesterolemia - - - 46.0 43.9 - -
Hyperglycemia - - - 48.4 53.3 43.7 48.8
Hyperkalemia - - - - - 22.0 23.7
Hypocalcemia - - - - - 30.0 30.0
Hypokalemia - - - 32.5 26.3 37.2 41.1
Hypomagnesemia - - - 20.1 14.2 39.0 37.6
Psychiatric disorders
Depression - - - 20.1 15.2 - -
Insomnia - - - 43.3 39.8 52.3 47.0
Nervous system disorders
Dizziness - - - 34.3 33.9 - -
Headache - - - 58.5 55.4 53.8 49.1
Tremor - - - 26.3 25.6 33.9 35.5
Cardiac disorders
Tachycardia - - - 22.8 21.8 22.0 15.7
Vascular disorders
Hypertension 27.5 32.2 19.3 78.9 74.0 62.1 59.6
Hypotension - - - 34.3 40.1 - -
Respiratory, thoracic and mediastinal disorders
Cough - - - 40.5 32.2 - -
Dyspnea - - - 44.3 44.3 31.0 30.3
Pleural effusion - - - - - 34.3 35.9
Gastrointestinal disorders
Abdominal pain 22.4 23.0 11.4 41.9 39.4 62.5 51.2
Constipation - - - 43.6 38.8 37.9 38.3
Decreased appetite - - - - - 25.3 17.1
Diarrhea 30.4 20.9 13.9 52.6 39.4 51.3 49.8
Dyspepsia - - - 22.1 22.1 22.4 20.9
Nausea - - - 56.1 60.2 54.5 51.2
Vomiting - - - 39.1 34.6 32.9 33.4
Hepatobiliary disorders
Blood lactate dehydrogenase increased - - - 23.5 18.3 - -
Hepatic enzyme increased - - - - - 24.9 19.2
Skin and subcutaneous tissues disorders
Rash - - - 26.0 20.8 - -
Renal and urinary disorders
Blood creatinine increased - - - 42.2 39.8 - -
Blood urea increased - - - 36.7 34.3 - -
General disorders and administration site conditions
Asthenia - - - 49.1 41.2 35.4 33.8
Edema† 21.0 28.2 8.4 67.5 55.7 48.4 47.7
Pain‡ 24.8 32.2 9.6 79.2 77.5 74.0 77.5
Pyrexia - - - 56.4 53.6 52.3 56.1
*“-” Indicates that the incidence was below the cutoff value of 20% for inclusion in the table.
†“Edema” includes peripheral edema, facial edema, scrotal edema.
‡“Pain” includes musculoskeletal pain (myalgia, neck pain, back pain).

In the three de novo kidney studies, patients receiving 2 g/day of CELLCEPT had an overall better safety profile than did patients receiving 3 g/day of CELLCEPT.

Post-transplant lymphoproliferative disease (PTLD, pseudolymphoma) developed in 0.4% to 1% of patients receiving CELLCEPT (2 g or 3 g daily) with other immunosuppressive agents in controlled clinical trials of kidney, heart and liver transplant patients followed for at least 1 year [see WARNINGS AND PRECAUTIONS]. Non-melanoma skin carcinomas occurred in 1.6% to 4.2% of patients, other types of malignancy in 0.7% to 2.1% of patients. Three-year safety data in kidney and heart transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data. In pediatric patients, PTLD was observed in 1.35% (2/148) by 12 months post-transplant.

Cytopenias, including leukopenia, anemia, thrombocytopenia and pancytopenia are a known risk associated with mycophenolate and may lead or contribute to the occurrence of infections and hemorrhages [see WARNINGS AND PRECAUTIONS]. Severe neutropenia (ANC <0.5 x 103/μL) developed in up to 2% of kidney transplant patients, up to 2.8% of heart transplant patients and up to 3.6% of liver transplant patients receiving CELLCEPT 3 g daily [see WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION].

The most common opportunistic infections in patients receiving CELLCEPT with other immunosuppressants were mucocutaneous candida, CMV viremia/syndrome, and herpes simplex. The proportion of patients with CMV viremia/syndrome was 13.5%. In patients receiving CELLCEPT (2 g or 3 g) in controlled studies for prevention of kidney, heart or liver rejection, fatal infection/sepsis occurred in approximately 2% of kidney and heart patients and in 5% of liver patients [see WARNINGS AND PRECAUTIONS].

The most serious gastrointestinal disorders reported were ulceration and hemorrhage, which are known risks associated with CELLCEPT. Mouth, esophageal, gastric, duodenal, and intestinal ulcers often complicated by hemorrhage, as well as hematemesis, melena, and hemorrhagic forms of gastritis and colitis were commonly reported during the pivotal clinical trials, while the most common gastrointestinal disorders were diarrhea, nausea and vomiting. Endoscopic investigation of patients with CELLCEPT-related diarrhea revealed isolated cases of intestinal villous atrophy [see WARNINGS AND PRECAUTIONS].

The following adverse reactions were reported with 3% to <20% incidence in kidney, heart, and liver transplant patients treated with CELLCEPT, in combination with cyclosporine and corticosteroids.

Table 4 : Adverse Reactions in Controlled Studies of De Novo Kidney, Heart or Liver Transplantation Reported in 3% to <20% of Patients Treated with CELLCEPT in Combination with Cyclosporine and Corticosteroids

System Organ Class Adverse Reactions
Body as a Whole cellulitis, chills, hernia, malaise
Infections and Infestations fungal infections
Hematologic and Lymphatic coagulation disorder, ecchymosis, pancytopenia
Urogenital hematuria
Cardiovascular hypotension
Metabolic and Nutritional acidosis, alkaline phosphatase increased, hyperlipemia, hypophosphatemia, weight loss
Digestive esophagitis, flatulence, gastritis, gastrointestinal hemorrhage, hepatitis, ileus, nausea and vomiting, stomach ulcer, stomatitis
Neoplasm benign, malignant and unspecified neoplasm
Skin and Appendages skin benign neoplasm, skin carcinoma
Psychiatric confusional state
Nervous hypertonia, paresthesia, somnolence
Musculoskeletal arthralgia, myasthenia

Pediatric Study

The type and frequency of adverse events in a clinical study for prevention of kidney allograft rejection in 100 pediatric patients 3 months to 18 years of age dosed with CELLCEPT oral suspension 600 mg/m² twice daily (up to 1 g twice daily) were generally similar to those observed in adult patients dosed with CELLCEPT capsules at a dose of 1 g twice daily with the exception of abdominal pain, fever, infection, pain, sepsis, diarrhea, vomiting, pharyngitis, respiratory tract infection, hypertension, leukopenia, and anemia, which were observed in a higher proportion in pediatric patients.

Geriatrics

Elderly patients (≥65 years), particularly those who are receiving CELLCEPT as part of a combination immunosuppressive regimen, may be at increased risk of certain infections (including cytomegalovirus [CMV] tissue invasive disease) and possibly gastrointestinal hemorrhage and pulmonary edema, compared to younger individuals [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

CELLCEPT Intravenous

The safety profile of CELLCEPT Intravenous was determined from a single, double-blind, controlled comparative study of the safety of 2 g/day of intravenous and oral CELLCEPT in kidney transplant patients in the immediate post-transplant period (administered for the first 5 days). The potential venous irritation of CELLCEPT Intravenous was evaluated by comparing the adverse reactions attributable to peripheral venous infusion of CELLCEPT Intravenous with those observed in the intravenous placebo group; patients in the placebo group received active medication by the oral route.

Adverse reactions attributable to peripheral venous infusion were phlebitis and thrombosis, both observed at 4% in patients treated with CELLCEPT Intravenous.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CELLCEPT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

  • Embryo-Fetal Toxicity: Congenital malformations and spontaneous abortions, mainly in the first trimester, have been reported following exposure to mycophenolate mofetil (MMF) in combination with other immunosuppressants during pregnancy [see WARNINGS AND PRECAUTIONS, and Use In Specific Populations]. Congenital malformations include:
    • Facial malformations: cleft lip, cleft palate, micrognathia, hypertelorism of the orbits
    • Abnormalities of the ear and eye: abnormally formed or absent external/middle ear, coloboma, microphthalmos
    • Malformations of the fingers: polydactyly, syndactyly, brachydactyly
    • Cardiac abnormalities: atrial and ventricular septal defects
    • Esophageal malformations: esophageal atresia
    • Nervous system malformations: such as spina bifida.
  • Cardiovascular: Venous thrombosis has been reported in patients treated with CELLCEPT administered intravenously.
  • Digestive: Colitis, pancreatitis
  • General Disorders and Administration Site Conditions: De novo purine synthesis inhibitors-associated acute inflammatory syndrome is a newly described paradoxical pro-inflammatory reaction associated with mycophenolate and other purine synthesis inhibitors, characterized by fever, arthralgias, arthritis, muscle pain and elevated inflammatory markers. Anecdotal literature reports showed rapid improvements following discontinuation of the drug.
  • Hematologic and Lymphatic: Bone marrow failure, cases of pure red cell aplasia (PRCA) and hypogammaglobulinemia have been reported in patients treated with CELLCEPT in combination with other immunosuppressive agents [see WARNINGS AND PRECAUTIONS].
  • Immune: Hypersensitivity, hypogammaglobinemia.
  • Infections: Meningitis, infectious endocarditis, tuberculosis, atypical mycobacterial infection, progressive multifocal leukoencephalopathy, BK virus infection, viral reactivation of hepatitis B and hepatitis C, protozoal infections [see WARNINGS AND PRECAUTIONS].
  • Respiratory: Bronchiectasis, interstitial lung disease, fatal pulmonary fibrosis, have been reported rarely and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in post-transplant patients receiving CELLCEPT.
  • Vascular: Lymphocele

DRUG INTERACTIONS

Effect Of Other Drugs On CELLCEPT

Table 5 : Drug Interactions with CELLCEPT that Affect Mycophenolic Acid (MPA) Exposure

Antacids with Magnesium or Aluminum Hydroxide
Clinical Impact Concomitant use with an antacid containing magnesium or aluminum hydroxide decreases MPA systemic exposure [see CLINICAL PHARMACOLOGY], which may reduce CELLCEPT efficacy.
Prevention or Management Administer magnesium or aluminum hydroxide containing antacids at least 2h after CELLCEPT administration.
Proton Pump Inhibitors (PPIs)
Clinical Impact Concomitant use with PPIs decreases MPA systemic exposure [see CLINICAL PHARMACOLOGY], which may reduce CELLCEPT efficacy.
Prevention or Management Monitor patients for alterations in efficacy when PPIs are co-administered with CELLCEPT.
Examples Lansoprazole, pantoprazole
Drugs that Interfere with Enterohepatic Recirculation
Clinical Impact Concomitant use with drugs that directly interfere with enterohepatic recirculation, or indirectly interfere with enterohepatic recirculation by altering the gastrointestinal flora, can decrease MPA systemic exposure [see CLINICAL PHARMACOLOGY], which may reduce CELLCEPT efficacy.
Prevention or Management Monitor patients for alterations in efficacy or CELLCEPT related adverse reactions when these drugs are co-administered with CELLCEPT.
Examples Trimethoprim/sulfamethoxazole, bile acid sequestrants (cholestyramine), rifampin as well as aminoglycoside, cephalosporin, fluoroquinolone and penicillin classes of antimicrobials
Drugs Modulating Glucuronidation
Clinical Impact Concomitant use with drugs inducing glucuronidation decreases MPA systemic exposure, potentially reducing CELLCEPT efficacy, while use with drugs inhibiting glucuronidation increases MPA systemic exposure ]see CLINICAL PHARMACOLOGY], which may increase the risk of CELLCEPT related adverse reactions.
Prevention or Management Monitor patients for alterations in efficacy or CELLCEPT related adverse reactions when these drugs are co-administered with CELLCEPT.
Examples Telmisartan (induces glucuronidation); isavuconazole (inhibits glucuronidation).
Calcium Free Phosphate Binders
Clinical Impact Concomitant use with calcium free phosphate binders decrease MPA systemic exposure [see CLINICAL PHARMACOLOGY], which may reduce CELLCEPT efficacy.
Prevention or Management Administer calcium free phosphate binders at least 2 hours after CELLCEPT.
Examples Sevelamer

Effect Of CELLCEPT On Other Drugs

Table 6 : Drug Interactions with CELLCEPT that Affect Other Drugs

Drugs that Undergo Renal Tubular Secretion
Clinical Impact When concomitantly used with CELLCEPT, its metabolite MPAG, may compete with drugs eliminated by renal tubular secretion which may increase plasma concentrations and/or adverse reactions associated with these drugs.
Prevention or Management Monitor for drug-related adverse reactions in patients with renal impairment.
Examples Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir
Combination Oral Contraceptives
Clinical Impact Concomitant use with CELLCEPT decreased the systemic exposure to levonorgestrel, but did not affect the systemic exposure to ethinylestradiol [see CLINICAL PHARMACOLOGY], which may result in reduced combination oral contraceptive effectiveness.

Read the entire FDA prescribing information for Cellcept (Mycophenolate Mofetil)

© Cellcept Patient Information is supplied by Cerner Multum, Inc. and Cellcept Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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