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Cellcept

Last reviewed on RxList: 9/10/2020
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.

QUESTION

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

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 can affect your immune system, and may cause certain white blood cells to grow out of control. Call your doctor right away if you have:

  • fever, 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 or burning when you urinate;
  • tenderness around the transplanted kidney;
  • 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;
  • a blood infection (sepsis)--fever, flu symptoms, mouth and throat ulcers, rapid heart rate, shallow breathing; 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;
  • high blood sugar;
  • abnormal blood tests;
  • pain anywhere in your body;
  • low blood cell counts; or
  • increased blood pressure or 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)

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Cellcept Professional Information

SIDE EFFECTS

The principal adverse reactions associated with the administration of CellCept include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections eg, opportunistic infection (see WARNINGS: Serious Infections and WARNINGS: New Or Reactivated Viral Infections).

The adverse event profile associated with the administration of CellCept Intravenous has been shown to be similar to that observed after administration of oral dosage forms of CellCept.

CellCept Oral

The incidence of adverse events for CellCept was determined in randomized, comparative, double-blind trials in prevention of rejection in renal (2 active, 1 placebo-controlled trials), cardiac (1 active-controlled trial), and hepatic (1 active-controlled trial) transplant 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 PRECAUTIONS).

Safety data are summarized below for all active-controlled trials in renal (2 trials), cardiac (1 trial), and hepatic (1 trial) transplant patients. Approximately 53% of the renal patients, 65% of the cardiac patients, and 48% of the hepatic patients have been treated for more than 1 year. Adverse events reported in ≥20% of patients in the CellCept treatment groups are presented below.

Table 9 Adverse Events in Controlled Studies in Prevention of Renal, Cardiac or Hepatic Allograft Rejection (Reported in ≥20% of Patients in the CellCept

  Renal Studies Cardiac Study Hepatic Study
CellCept 2 g/day CellCept 3 g/day Azathioprine 1 to 2 mg/kg/day or 100 to 150 mg/day CellCept 3 g/day Azathioprine 1.5 to 3 mg/kg/day CellCept 3 g/day Azathioprine 1 to 2 mg/kg/day
(n=336) (n=330) (n=326) (n=289) (n=289) (n=277) (n=287)
% % % % % % %
Body as a Whole
Pain 33.0 31.2 32.2 75.8 74.7 74.0 77.7
Abdominal pain 24.7 27.6 23.0 33.9 33.2 62.5 51.2
Fever 21.4 23.3 23.3 47.4 46.4 52.3 56.1
Headache 21.1 16.1 21.2 54.3 51.9 53.8 49.1
Infection 18.2 20.9 19.9 25.6 19.4 27.1 25.1
Sepsis 27.4 26.5
Asthenia 43.3 36.3 35.4 33.8
Chest pain 26.3 26.0
Back pain 34.6 28.4 46.6 47.4
Ascites 24.2 22.6
Hematologic and Lymphatic
Anemia 25.6 25.8 23.6 42.9 43.9 43.0 53.0
Leukopenia 23.2 34.5 24.8 30.4 39.1 45.8 39.0
Thrombocytopenia 23.5 27.0 38.3 42.2
Hypochromic anemia 24.6 23.5
Leukocytosis 40.5 35.6 22.4 21.3
Urogenital
Urinary tract infection 37.2 37.0 33.7
Kidney function abnormal 21.8 26.3 25.6 28.9
Cardiovascular
Hypertension 32.4 28.2 32.2 77.5 72.3 62.1 59.6
Hypotension 32.5 36.0
Cardiovascular disorder 25.6 24.2
Tachycardia 20.1 18.0 22.0 15.7
Metabolic and Nutritional
Peripheral edema 28.6 27.0 28.2 64.0 53.3 48.4 47.7
Hypercholesteremia 41.2 38.4
Edema 26.6 25.6 28.2 28.2
Hypokalemia 31.8 25.6 37.2 41.1
Hyperkalemia 22.0 23.7
Hyperglycemia 46.7 52.6 43.7 48.8
Creatinine increased 39.4 36.0
BUN increased 34.6 32.5
Lactic dehydrogenase increased 23.2 17.0
Hypomagnesemia 39.0 37.6
Hypocalcemia 30.0 30.0
Digestive
Diarrhea 31.0 36.1 20.9 45.3 34.3 51.3 49.8
Constipation 22.9 18.5 22.4 41.2 37.7 37.9 38.3
Nausea 19.9 23.6 24.5 54.0 54.3 54.5 51.2
Dyspepsia 22.4 20.9
Vomiting 33.9 28.4 32.9 33.4
Anorexia 25.3 17.1
Liver function tests abnormal 24.9 19.2
Respiratory
Infection 22.0 23.9 19.6 37.0 35.3
Dyspnea 36.7 36.3 31.0 30.3
Cough increased 31.1 25.6
Lung disorder 30.1 29.1 22.0 18.8
Sinusitis 26.0 19.0
Pleural effusion 34.3 35.9
Skin and Appendages
Rash 22.1 18.0
Nervous System
Tremor 24.2 23.9 33.9 35.5
Insomnia 40.8 37.7 52.3 47.0
Dizziness 28.7 27.7
Anxiety 28.4 23.9
Paresthesia 20.8 18.0

The placebo-controlled renal transplant study generally showed fewer adverse events occurring in ≥20% of patients. In addition, those that occurred were not only qualitatively similar to the azathioprine-controlled renal transplant studies, but also occurred at lower rates, particularly for infection, leukopenia, hypertension, diarrhea and respiratory infection.

The above data demonstrate that in three controlled trials for prevention of renal rejection, patients receiving 2 g/day of CellCept had an overall better safety profile than did patients receiving 3 g/day of CellCept. The above data demonstrate that the types of adverse events observed in multicenter controlled trials in renal, cardiac, and hepatic transplant patients are qualitatively similar except for those that are unique to the specific organ involved.

Sepsis, which was generally CMV viremia, was slightly more common in renal transplant patients treated with CellCept compared to patients treated with azathioprine. The incidence of sepsis was comparable in CellCept and in azathioprine-treated patients in cardiac and hepatic studies.

In the digestive system, diarrhea was increased in renal and cardiac transplant patients receiving CellCept compared to patients receiving azathioprine, but was comparable in hepatic transplant patients treated with CellCept or azathioprine.

Patients receiving CellCept alone or as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see WARNINGS: Lymphoma And Malignancy). The incidence of malignancies among the 1483 patients treated in controlled trials for the prevention of renal allograft rejection who were followed for ≥1 year was similar to the incidence reported in the literature for renal allograft recipients.

Lymphoproliferative disease or lymphoma 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 renal, cardiac, and hepatic transplant patients followed for at least 1 year (see WARNINGS: Lymphoma And Malignancy). 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. Threeyear safety data in renal and cardiac transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data.

In pediatric patients, no other malignancies besides lymphoproliferative disorder (2/148 patients) have been observed.

Severe neutropenia (ANC <0.5 x 103/μL) developed in up to 2.0% of renal transplant patients, up to 2.8% of cardiac transplant patients and up to 3.6% of hepatic transplant patients receiving CellCept 3 g daily (see WARNINGS: Neutropenia, PRECAUTIONS: Laboratory Tests and DOSAGE AND ADMINISTRATION).

All transplant patients are at increased risk of opportunistic infections. The risk increases with total immunosuppressive load (see WARNINGS: Serious Infections and WARNINGS: New Or Reactivated Viral Infections). Table 10 shows the incidence of opportunistic infections that occurred in the renal, cardiac, and hepatic transplant populations in the azathioprine-controlled prevention trials:

Table 10 Viral and Fungal Infections in Controlled Studies in Prevention of Renal, Cardiac or Hepatic Transplant Rejection

  Renal Studies Cardiac Study Hepatic Study
CellCept 2 g/day CellCept 3 g/day Azathioprine 1 to 2 mg/kg/day or 100 to 150 mg/day CellCept 3 g/day Azathioprine 1.5 to 3 mg/kg/day CellCept 3 g/day Azathioprine 1 to 2 mg/kg/day
(n=336) (n=330) (n=326) (n=289) (n=289) (n=277) (n=287)
% % % % % % %
Herpes simplex 16.7 20.0 19.0 20.8 14.5 10.1 5.9
CMV              
–Viremia/syndrome 13.4 12.4 13.8 12.1 10.0 14.1 12.2
– Tissue invasive disease 8.3 11.5 6.1 11.4 8.7 5.8 8.0
Herpes zoster 6.0 7.6 5.8 10.7 5.9 4.3 4.9
Cutaneous disease 6.0 7.3 5.5 10.0 5.5 4.3 4.9
Candida 17.0 17.3 18.1 18.7 17.6 22.4 24.4
– Mucocutaneous 15.5 16.4 15.3 18.0 17.3 18.4 17.4

The following other opportunistic infections occurred with an incidence of less than 4% in CellCept patients in the above azathioprine-controlled studies: Herpes zoster, visceral disease; Candida, urinary tract infection, fungemia/disseminated disease, tissue invasive disease; Cryptococcosis; Aspergillus/Mucor; Pneumocystis carinii.

In the placebo-controlled renal transplant study, the same pattern of opportunistic infection was observed compared to the azathioprine-controlled renal studies, with a notably lower incidence of the following: Herpes simplex and CMV tissue-invasive disease.

In patients receiving CellCept (2 g or 3 g) in controlled studies for prevention of renal, cardiac or hepatic rejection, fatal infection/sepsis occurred in approximately 2% of renal and cardiac patients and in 5% of hepatic patients (see WARNINGS: Serious Infections). In cardiac transplant patients, the overall incidence of opportunistic infections was approximately 10% higher in patients treated with CellCept than in those receiving azathioprine, but this difference was not associated with excess mortality due to infection/sepsis among patients treated with CellCept.

The following adverse events were reported with 3% to <20% incidence in renal, cardiac, and hepatic transplant patients treated with CellCept, in combination with cyclosporine and corticosteroids.

Table 11 Adverse Events Reported in 3% to <20% of Patients Treated With CellCept in Combination With Cyclosporine and Corticosteroids

Body System
Body as a Whole abdomen enlarged, abscess, accidental injury, cellulitis, chills occurring with fever, cyst, face edema, flu syndrome, hemorrhage, hernia, lab test abnormal, malaise, neck pain, pelvic pain, peritonitis
Hematologic and Lymphatic coagulation disorder, ecchymosis, pancytopenia, petechia, polycythemia, prothrombin time increased, thromboplastin time increased
Urogenital acute kidney failure, albuminuria, dysuria, hydronephrosis, hematuria, impotence, kidney failure, kidney tubular necrosis, nocturia, oliguria, pain, prostatic disorder, pyelonephritis, scrotal edema, urine abnormality, urinary frequency, urinary incontinence, urinary retention, urinary tract disorder
Cardiovascular angina pectoris, arrhythmia, arterial thrombosis, atrial fibrillation, atrial flutter, bradycardia, cardiovascular disorder, congestive heart failure, extrasystole, heart arrest, heart failure, hypotension, pallor, palpitation, pericardial effusion, peripheral vascular disorder, postural hypotension, pulmonary hypertension, supraventricular tachycardia, supraventricular extrasystoles, syncope, tachycardia, thrombosis, vasodilatation, vasospasm, ventricular extrasystole, ventricular tachycardia, venous pressure increased
Metabolic and Nutritional abnormal healing, acidosis, alkaline phosphatase increased, alkalosis, bilirubinemia, creatinine increased, dehydration, gamma glutamyl transpeptidase increased, generalized edema, gout, hypercalcemia, hypercholesteremia, hyperlipemia, hyperphosphatemia, hyperuricemia, hypervolemia, hypocalcemia, hypochloremia, hypoglycemia, hyponatremia, hypophosphatemia, hypoproteinemia, hypovolemia, hypoxia, lactic dehydrogenase increased, respiratory acidosis, SGOT increased, SGPT increased, thirst, weight gain, weight loss
Digestive anorexia, cholangitis, cholestatic jaundice, dysphagia, esophagitis, flatulence, gastritis, gastroenteritis, gastrointestinal disorder, gastrointestinal hemorrhage, gastrointestinal moniliasis, gingivitis, gum hyperplasia, hepatitis, ileus, infection, jaundice, liver damage, liver function tests abnormal, melena, mouth ulceration, nausea and vomiting, oral moniliasis, rectal disorder, stomach ulcer, stomatitis
Respiratory apnea, asthma, atelectasis, bronchitis, epistaxis, hemoptysis, hiccup, hyperventilation, lung edema, lung disorder, neoplasm, pain, pharyngitis, pleural effusion, pneumonia, pneumothorax, respiratory disorder, respiratory moniliasis, rhinitis, sinusitis, sputum increased, voice alteration
Skin and Appendages acne, alopecia, fungal dermatitis, hemorrhage, hirsutism, pruritus, rash, skin benign neoplasm, skin carcinoma, skin disorder, skin hypertrophy, skin ulcer, sweating, vesiculobullous rash
Nervous agitation, anxiety, confusion, convulsion, delirium, depression, dry mouth, emotional lability, hallucinations, hypertonia, hypesthesia, nervousness, neuropathy, paresthesia, psychosis, somnolence, thinking abnormal, vertigo
Endocrine Cushing’s syndrome, diabetes mellitus, hypothyroidism, parathyroid disorder
Musculoskeletal arthralgia, joint disorder, leg cramps, myalgia, myasthenia, osteoporosis
Special Senses abnormal vision, amblyopia, cataract (not specified), conjunctivitis, deafness, ear disorder, ear pain, eye hemorrhage, tinnitus, lacrimation disorder

Pediatrics

The type and frequency of adverse events in a clinical study in 100 pediatric patients 3 months to 18 years of age dosed with CellCept oral suspension 600 mg/m2 bid (up to 1 g bid) were generally similar to those observed in adult patients dosed with CellCept capsules at a dose of 1 g bid 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.

CellCept Intravenous

The adverse event 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 renal transplant patients in the immediate posttransplant period (administered for the first 5 days). The potential venous irritation of CellCept Intravenous was evaluated by comparing the adverse events attributable to peripheral venous infusion of CellCept Intravenous with those observed in the intravenous placebo group; patients in this group received active medication by the oral route.

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

In the active controlled study in hepatic transplant patients, 2 g/day of CellCept Intravenous were administered in the immediate posttransplant period (up to 14 days). The safety profile of intravenous CellCept was similar to that of intravenous azathioprine.

Postmarketing Experience

Congenital Disorders: Embryofetal Toxicity: Congenital malformations, including ear, facial, cardiac and nervous system malformations and an increased incidence of first trimester pregnancy loss have been reported following exposure to mycophenolate mofetil during pregnancy (see PRECAUTIONS: Pregnancy).

Digestive: Colitis (sometimes caused by cytomegalovirus), pancreatitis, isolated cases of intestinal villous atrophy.

Hematologic and Lymphatic: Cases of pure red cell aplasia (PRCA) and hypogammaglobulinemia have been reported in patients treated with CellCept in combination with other immunosuppressive agents.

Infections (see WARNINGS: Serious Infections, New Or Reactivated Viral Infections):

  • Serious life-threatening infections such as meningitis and infectious endocarditis have been reported occasionally.
  • There is evidence of a higher frequency of certain types of serious infections such as tuberculosis and atypical mycobacterial infection.
  • Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with CellCept. The reported cases generally had risk factors for PML, including treatment with immunosuppressant therapies and impairment of immune function.
  • Polyomavirus associated neuropathy (PVAN), especially due to BK virus infection, has been observed in patients receiving immunosuppressants, including CellCept. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.
  • Viral reactivation has been reported in patients infected with HBV or HCV.

Respiratory: Interstitial lung disorders, including 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 posttransplant patients receiving CellCept.

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

Related Resources for Cellcept

Read the Cellcept User Reviews »

© 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.

QUESTION

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

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