CellCept Side Effects
Please note - some side effects for CellCept may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of CellCept - for the Consumer
CellCept
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using CellCept:
Seek medical attention right away if any of these SEVERE side effects occur when using CellCept:Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; nausea; upset stomach; tremor; trouble sleeping; vomiting; mild tiredness or weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; swollen glands; symptoms of infection (eg, fever, chills, cough, or sore throat); symptoms of urinary tract infection (eg, difficult, frequent, or painful urination; blood in urine; lower stomach or back pain); unusual bruising or bleeding; unusual or persistent tiredness or weakness; unusual skin lumps or growths; unusual weight loss; vomiting blood that looks like coffee grounds; white patches in mouth or throat; yellowing of the skin or eyes.
CellCept Capsules
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using CellCept Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using CellCept Capsules:Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; mild tiredness or weakness; nausea; tremor; trouble sleeping; upset stomach; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; swollen glands; symptoms of infection (eg, fever, chills, cough, sore throat); symptoms of urinary tract infection (eg, blood in urine; difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual or persistent tiredness or weakness; unusual skin lumps or growths; unusual weight loss; vomiting blood that looks like coffee grounds; white patches in the mouth or throat; yellowing of the skin or eyes.
CellCept Solution
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using CellCept Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using CellCept Solution:Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; nausea; pain, redness, or swelling at the injection site; upset stomach; tremor; trouble sleeping; vomiting; mild tiredness or weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; swollen glands; symptoms of infection (eg, fever, chills, cough, or sore throat); symptoms of urinary tract infection (eg, difficult, frequent, or painful urination; blood in urine; lower stomach or back pain); unusual bruising or bleeding; unusual or persistent tiredness or weakness; unusual skin lumps or growths; unusual weight loss; vomiting blood that looks like coffee grounds; white patches in the mouth or throat; yellowing of the skin or eyes.
CellCept Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using CellCept Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using CellCept Suspension:Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; nausea; upset stomach; tremor; trouble sleeping; vomiting; mild tiredness or weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; swollen glands; symptoms of infection (eg, fever, chills, cough, or sore throat); symptoms of urinary tract infection (eg, difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual skin lumps or growths; unusual tiredness or weakness; unusual weight loss; vomiting blood that looks like coffee grounds; white patches in the mouth or throat; yellowing of the skin or eyes.
CellCept Side Effects - for the Professional
CellCept
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). 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.
GeriatricsElderly 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.
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.
| 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 |
| Hyper-cholesteremia | – | – | – | 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. 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. 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 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 × 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.
All transplant patients are at increased risk of opportunistic infections. The risk increases with total immunosuppressive load). Table 9 shows the incidence of opportunistic infections that occurred in the renal, cardiac, and hepatic transplant populations in the azathioprine-controlled prevention trials:
| 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.
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.
| 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 |
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
Congenital malformations including ear malformations have been reported in offspring of patients exposed to mycophenolate mofetil during pregnancy.
Digestive
Colitis (sometimes caused by cytomegalovirus), pancreatitis, isolated cases of intestinal villous atrophy.
Hematologic and Lymphatic
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressive agents.
Resistance Mechanism Disorders
Serious life-threatening infections such as meningitis and infectious endocarditis have been reported occasionally and 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.
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.
TopSide Effects by Body System
Gastrointestinal
Gastrointestinal side effects appear to have been dose related.
A well designed, placebo-controlled study of mycophenolate (2 or 3 grams daily) combined with cyclosporine and corticosteroids versus cyclosporine and corticosteroids alone for prevention of acute renal allograft rejection reported a similar frequency of adverse events. There was a trend towards more diarrhea (16% vs. 12%), nausea (6% vs. 3%), gastroenteritis (4% vs. 1%), and vomiting (4% vs. 1%) in the mycophenolate group, especially with the higher dose. Gastrointestinal, rectal, and duodenal hemorrhage, hemorrhagic pancreatitis and large intestine perforation occurred rarely and only in the mycophenolate mofetil group. In general, adverse effects occurred with a higher frequency as the dose was increased above 2 grams per day. Mycophenolate mofetil should be used cautiously in patients with active gastrointestinal disease.
Gastrointestinal side effects including diarrhea (36%), nausea (20%), and vomiting (13%) have been the most common side effects. A case of mycophenolate mofetil-induced ischemic colitis also has been reported.
Hematologic
A well designed, placebo-controlled study noted that hematologic adverse events resolved within one week. Hematologic side effects tend to occur early in the course of treatment and be dose-related. Careful monitoring of hematologic parameters may be warranted early in the course of therapy.
A well designed, placebo-controlled study of mycophenolate mofetil (2 or 3 grams daily) combined with cyclosporine and corticosteroids versus cyclosporine and corticosteroids alone for prevention of acute renal allograft rejection reported a similar frequency of adverse events. A trend towards higher frequencies of leukopenia (11%-14%) and anemia (4%-7%) were reported in the active groups. Pancytopenia and agranulocytosis occurred rarely. The proportion of patients with leukopenia between 31 and 180 days after transplantation was 3 times higher in the mycophenolate mofetil group. All observed hematologic effects resolved within one week. Adverse effects occur with a higher frequency as the dose exceeds 2 grams/day.
Hematologic side effects have included dose-related leukopenia (11% to 35%), anemia (25%), and thrombocytopenia (9%). Severe neutropenia has occurred in up to 2% of patients. Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents. A case in of mycophenolate mofetil causing deep venous thrombosis has also been reported.
Immunologic
Immunologic side effects have included immunosuppression. Immunosuppression associated with therapy has resulted in sepsis (primarily cytomegalovirus viremia) in approximately 20% of patients. Other opportunistic infections have included herpes simplex virus (18%), herpes zoster (7%), and invasive candidal infections (1%).
On a positive note, mycophenolate has been found to delay the recurrence of hepatitis C in liver transplant recipients.
Immunosuppression appeared to be dose-related.
In three controlled studies for the prevention of rejection, similar rates of fatal infections/sepsis (<2%) occurred in patients receiving mycophenolate mofetil or the control drug (usually azathioprine) in addition to other immunosuppressives. A well designed, placebo-controlled study of mycophenolate mofetil (2 or 3 grams daily) combined with cyclosporine and corticosteroids versus cyclosporine and corticosteroids alone for the prevention of acute renal allograft rejection reported a similar frequency of adverse events. Cytomegalovirus tissue-invasive disease (7%), herpes zoster (7%), and herpes simplex (15%) showed a trend towards a higher frequency in the mycophenolate mofetil group. In general, adverse effects occur with a higher frequency as the dose is increased above 2 grams per day.
Oncologic
Oncologic side effects including lymphoma and lymphoproliferative disease (1%) and non-melanoma skin carcinoma (2% to 4%) have been associated with therapy.
The incidence of new malignancies in patients receiving mycophenolate mofetil followed for greater than 1 year was similar to that reported in the literature for renal allograft recipients.
Renal
Epinette, et al reported a long-term follow up (to 13 years) of patients treated with mycophenolate mofetil on a compassionate-use basis for psoriasis. Dosages averaged between 3 and 4 grams daily (range 2 to 7 grams), higher than the currently recommended dose for renal transplant patients. Dysuria, urgency, and frequency occurred in 28% of patients during the first year and decreased to less than 5% thereafter. Subsequent dose reductions after the first year lessened renal adverse effects considerably.
Renal side effects have included urinary tract infections (37% to 45%), hematuria (13%), and kidney tubular necrosis (6% to 10%).
Metabolic
Metabolic side effects have included edema (12% to 28%), hyperphosphatemia (13%), hypokalemia (10%), hyperglycemia (10%), and hyperkalemia (9%).
Respiratory
Respiratory system side effects have included respiratory infection (23%), dyspnea (16%), and increased cough (16%). A case of primary tuberculosis one year after conversion from azathioprine to mycophenolate mofetil has also been reported.
Dermatologic
Dermatologic side effects including acne (10%) and rash (8%) have been reported in clinical trials. A case of dyshidrotic eczema has been reported. A case of papulosquamous psoriatic-like skin eruption has also been reported.
Musculoskeletal
Musculoskeletal side effects including a case of mycophenolate mofetil induced myopathy have been reported.
Other
Abdominal pain has been reported to be a critical complication of mycophenolate mofetil in renal transplant recipients.
Other side effects have included abdominal pain.
Hepatic
Hepatic side effects including a case of mycophenolate sodium-induced hepatotoxicity have been reported.
Top
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