Myfortic Side Effects

Please note - some side effects for Myfortic 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 Myfortic - for the Consumer

Myfortic Delayed-Release Tablets

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 Myfortic Delayed-Release Tablets:

Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; mild tiredness or weakness; nausea; upset stomach; tremor; trouble sleeping; 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, 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.

Myfortic Side Effects - for the Professional

Myfortic

The incidence of adverse events for Myfortic® (mycophenolic acid) was determined in randomized, comparative, active-controlled, double-blind, double-dummy trials in prevention of acute rejection in de novo and maintenance kidney transplant patients.

      The principal adverse reactions associated with the administration of Myfortic include constipation, nausea, and urinary tract infection in de novo patients and nausea, diarrhea and nasopharyngitis in maintenance patients.

      Adverse events reported in ≥20% of patients receiving Myfortic or mycophenolate mofetil in the 12-month de novo renal study and maintenance renal study, when used in combination with cyclosporine, USP (MODIFIED) and corticosteroids, are listed in Table 4. Adverse event rates were similar between Myfortic and mycophenolate mofetil in both de novo and maintenance patients.

Table 4 Adverse Events (%) in Controlled de novo and Maintenance Renal Studies Reported in ≥20% of Patients

Table 5 summarizes the incidence of opportunistic infections in de novo and maintenance transplant patients, which were similar in both treatment groups.

Table 5 Viral and Fungal Infections (%) Reported Over 0-12 Months

      The following opportunistic infections occurred rarely in the above controlled trials: aspergillus and cryptococcus.

      The incidence of malignancies and lymphoma is consistent with that reported in the literature for this patient population. Lymphoma developed in 2 de novo patients (0.9%), (one diagnosed 9 days after treatment initiation) and in 2 maintenance patients (1.3%) (one was AIDS-related), receiving Myfortic with other immunosuppressive agents in the 12-month controlled clinical trials. Non-melanoma skin carcinoma occurred in 0.9% de novo and 1.8% maintenance patients. Other types of malignancy occurred in 0.5% de novo and 0.6% maintenance patients.

      The following adverse events were reported between 3% to <20% incidence in de novo and maintenance patients treated with Myfortic in combination with cyclosporine and corticosteroids are listed in Table 6.

Table 6 Adverse Events Reported in 3% to <20% of Patients Treated with Myfortic® in Combination with Cyclosporine* and Corticosteroids

* USP (MODIFIED)

      The following additional adverse reactions have been associated with the exposure to MPA when administered as a sodium salt or as mofetil ester:

Gastrointestinal: Colitis (sometimes caused by CMV), pancreatitis, esophagitis, intestinal perforation, gastrointestinal hemorrhage, gastric ulcers, duodenal ulcers, and ileus.

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.

Respiratory: Interstitial lung disorders, including fatal pulmonary fibrosis, have been reported rarely with MPA administration and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in post-transplant patients receiving MPA derivatives.

Postmarketing Experience

Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with mycophenolate mofetil (MMF). Mycophenolate mofetil (MMF) is metabolized to mycophenolic acid (MPA), the active ingredient in Myfortic and the active form of the drug.

Side Effects by Body System

Hematologic

Hematologic side effects including anemia (21.6% de novo) and leukopenia (19.2% de novo) have been reported. Lymphocele, thrombocytopenia, increased blood creatinine and decreased hemoglobin have been reported in de novo patients. Leukopenia, anemia, and increased blood creatinine have been reported in maintenance patients.

Gastrointestinal

Gastrointestinal side effects including constipation (38.0% de novo), nausea (29.1% de novo and 24.5% maintenance), diarrhea (23.5% de novo and 21.4% maintenance), vomiting (23.0% de novo), and dyspepsia (22.5%de novo) have been reported. Upper, lower, and general abdominal pain, flatulence, abdominal distension, sore throat, gingival hyperplasia, and loose stool have been reported in de novo patients. Vomiting, dyspepsia, general and upper abdominal pain, constipation, gastroesophageal reflux disease, and loose stool have been reported in maintenance patients.

Immunologic

Immunologic side effects manifesting as infection have been reported. Infections have included urinary tract infection (29.1% de novo) and CMV infection (20.2% de novo). Viral and fungal infections reported have included any cytomegalovirus (21.6% de novo and 1.9% maintenance), cytomegalovirus disease (4.7% de novo), herpes simplex (8.0% de novo and 1.3% maintenance), herpes zoster (4.7% de novo and 1.9% maintenance), any fungal infection (10.8% de novo and 2.5% maintenance), Candida NOS (5.6% de novo), and Candida albicans (2.3% de novo and 0.6% maintenance). Aspergillus and Cryptococcus have been reported rarely. Nasopharyngitis, upper respiratory tract infection, oral candidiasis, sinusitis, wound infection, implant infection, and pneumonia have been reported in de novo patients. Nasopharyngitis, upper respiratory tract infection, urinary tract infection, influenza, and sinusitis have been reported in maintenance patients.

Nervous system

Nervous system side effects including insomnia (23.5%), tremor, headache, and dizziness (excluding vertigo) have been reported in de novo patients. Headache, dizziness, and insomnia have also been reported in maintenance patients.

General

General side effects including postoperative pain (23.9%), edema, lower limb edema, peripheral edema, pyrexia, pain, fatigue, and chest pain have been reported in de novo patients, Fatigue, pyrexia, edema, increased weight, peripheral edema, and chest pain have been reported in maintenance patients

Oncologic

Oncologic side effects including lymphoma (0.9% de novo and 1.3% maintenance). Non-melanoma skin carcinoma (0.9% de novo and 1.8% maintenance) has also been reported. Other (0.5% de novo and 0.6% maintenance) malignancies have also been reported.

Endocrine

Endocrine side effects including cushingoid and hirsutism have been reported in de novo patients.

Other

Other side effects including drug toxicity, complications of transplant surgery, postoperative complications, and postoperative wound complications have been reported in de novo patients. Post procedural pain has been reported in maintenance patients.

Metabolic

Metabolic side effects including hypocalcemia, hyperuricemia, hyperlipidemia, hypokalemia, hypophosphatemia, hypercholesterolemia, hyperkalemia, hypomagnesemia, diabetes mellitus, hyperphosphatemia, dehydration, fluid overload, hyperglycemia, and hypercalcemia have been reported in de novo patients. Dehydration, hypokalemia, and hypercholesterolemia have been reported in maintenance patients.

Musculoskeletal

Musculoskeletal side effects including back pain, arthralgia, limb pain, muscle cramps, and myalgia have been reported in de novo patients. Arthralgia, limb pain, back pain, muscle cramps, peripheral swelling, and myalgia have been reported in maintenance patients.

Psychiatric

Psychiatric side effects including anxiety have been reported in de novo patients. Depression has been reported in maintenance patients.

Genitourinary

Genitourinary side effects including renal tubular necrosis, renal impairment, dysuria, hematuria, hydronephrosis, bladder spasm, and urinary retention have been reported in de novo patients.

Cardiovascular

Cardiovascular side effects including tachycardia, hypertension, aggravated hypertension, and hypotension have been reported in de novo patients. Hypertension has also been reported in maintenance patients.

Respiratory

Respiratory side effects including cough, dyspnea, and exertional dyspnea have been reported in de novo patients. Cough dyspnea, pharyngolarygeal pain, and sinus congestion have been reported in maintenance patients.

Ocular

Ocular side effects including blurred vision have been reported in de novo patients.

Hepatic

Hepatic side effects including abnormal liver function tests have been reported. A case of mycophenolate sodium-induced hepatotoxicity has been reported.

Dermatologic

Dermatologic side effects including acne and pruritus have been reported in de novo patients. Rash and contusion have been reported in maintenance patients.

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