MYCOPHENOLATE MOFETIL CAPS 250 MG 500CT
Generic: mycophenolate mofetil
MYCOPHENOLATE MOFETIL CAPS 250 MG 500CT
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Identification
mycophenolate mofetil
mycophenolate mofetil
Ascend Laboratories, LLC
HUMAN PRESCRIPTION DRUG
Administration
CAPSULE
ORAL
ANDA200197
Active Ingredients
| Ingredient | Strength |
|---|---|
| MYCOPHENOLATE MOFETIL | 250 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS & USAGE Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies ( 14.1 )], heart [see Clinical Studies ( 14.2 )] or liver transplants [see Clinical Studies ( 14.3 )] , in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)
Dosage & Administration
2 DOSAGE & ADMINISTRATION ADULTS DOSAGE Kidney Transplant 1g twice daily,orally or intravenously (IV) over no less than 2h (2.2) Heart Transplant 1.5 g twice daily orally or IV, over no less than 2 h (2.3) Liver Transplant 1.5 g twice daily orally or 1 g twice daily IV over no less than 2 h (2.4) PEDIATRICS Kidney Transplant 600mg/m 2 orally twice daily, up to maximum of 2 g daily (2.2) Heart Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g or 15 mL of oral suspension) (2.3) Liver Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g or 15 mL of oral suspension) (2.4) Mycophenolate mofetil intravenous is an alternative when patients cannot tolerate oral medication. Administer within 24 hours following transplantation, until patients can tolerate oral medication, up to 14 days. ( 2.1 ) Reduce or interrupt dosing in the event of neutropenia. ( 2.5 ) See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia ( 2.5 ), preparation of oral suspension and IV solution. (2.6 ) 2.1 Important Administration Instructions Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy. Mycophenolate Mofetil Capsules, Tablets and Oral Suspension Mycophenolate mofetil oral dosage forms (capsules, tablets or oral suspension) should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of mycophenolate mofetil oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent. Mycophenolate mofetil tablets should not be crushed and mycophenolate mofetil capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil capsules and oral suspension. If such contact occurs, they must wash the area of contact thoroughly with soap and water. In case of ocular contact, rinse eyes with plain water. The initial oral dose of mycophenolate mofetil should be given as soon as possible following kidney, heart or liver transplant. It is recommended that mycophenolate mofetil be administered on an empty stomach. In stable transplant patients, however, mycophenolate mofetil may be administered with food if necessary [see Clinical Pharmacology ( 12.3 )]. Once reconstituted, mycophenolate mofetil for oral suspension must not be mixed with any liquids prior to dose administration. If needed, mycophenolate mofetil for oral suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter). Patients should be instructed to take a missed dose as soon as they remember, except if it is closer than 2 hours to the next scheduled dose; in this case, they should continue to take mycophenolate mofetil at the usual times. 2.2 Dosage Recommendations for Kidney Transplant Patients Adults The recommended dosage for adult kidney transplant patients is 1 g orally or intravenously infused over no less than 2 hours, twice daily (total daily dose of 2 g). Pediatrics (3 months and older) Pediatric dosing is based on body surface area (BSA). The recommended dosage of mycophenolate mofetil for oral suspension for pediatric kidney transplant patients 3 months and older is 600 mg/m 2 , administered twice daily (maximum total daily dose of 2g or 10 mL of the oral suspension). Pediatric patients with BSA ≥ 1.25 m 2 may be dosed with capsules or tablets as follows: Table 1 Pediatric Kidney Transplant: Dosage Using Capsules or Tablets Body Surface Area Dosage 1.25 m 2 to less than 1.5 m 2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose) Greater than and equal to 1.5 m 2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total daily dose) 2.3 Dosage Recommendations for Heart Transplant Patients Adults The recommended dosage of mycophenolate mofetil for adult heart transplant patients is 1.5 g orally or intravenously infused over no less than 2 hours administered twice daily (total daily dose of 3 g). Pediatrics (3 months and older) The recommended starting dosage of mycophenolate mofetil oral suspension for pediatric heart transplant patients 3 months and older is 600 mg/m 2 , administered twice daily. If well tolerated, the dose can be increased to a maintenance dosage of 900 mg/m 2 twice daily (maximum total daily dose of 3 g or 15 mL of the oral suspension). The dose may be individualized based on clinical assessment. Pediatric patients with BSA ≥1.25 m 2 may be started on therapy with capsules or tablets as follows: Table 2 Pediatric Heart Transplant: Pediatric Starting Dosage Using Capsules or Tablets Body Surface Area Starting Dosage * 1.25 m 2 to less than 1.5 m 2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose) ≥ 1.5 m 2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total daily dose) * Maximum maintenance dose: 3 g total daily. 2.4 Dosage Recommendations for Liver Transplant Patients Adults The recommended dosage of mycophenolate mofetil for adult liver transplant patients is 1.5 g administered orally twice daily (total daily dose of 3 g) or 1 g infused intravenously over no less than 2 hours, twice daily (total daily dose of 2 g). Pediatrics (3 months and older) The recommended starting dosage of mycophenolate mofetil oral suspension for pediatric liver transplant patients 3 months of age and older is 600 mg/m 2 , administered twice daily. If well tolerated, the dose can be increased to a maintenance dosage of 900 mg/m 2 twice daily (maximum total daily dose of 3 g or 15 mL of the oral suspension). The dose may be individualized based on clinical assessment. Pediatric patients with BSA ≥1.25 m 2 may be started on therapy with capsules or tablets as follows: Table 3 Pediatric Liver Transplant: Pediatric Starting Dosage Using Capsules or Tablets Body Surface Area Starting Dosage * 1.25 m 2 to less than 1.5 m 2 mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose) ≥ 1.5 m 2 mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total daily dose) * Maximum maintenance dose: 3 g total daily. 2.5 Dosage Modifications: Patients with Renal Impairment, Neutropenia Renal Impairment No dosage modifications are needed in kidney transplant patients with delayed graft function postoperatively [see Clinical Pharmacology ( 12.3 )] . In kidney transplant patients with severe chronic impairment of the graft (GFR less than 25 mL/min/1.73 m 2 ), do not administer doses of mycophenolate mofetil greater than 1 g twice a day. These patients should be carefully monitored [see Clinical Pharmacology ( 12.3 )]. Neutropenia If neutropenia develops (ANC less than 1.3 x 10 3 /mcL), dosing with mycophenolate mofetil should be interrupted or reduced, appropriate diagnostic tests performed, and the patient managed appropriately [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6.1 )]. 2.6 Preparation Instructions of Oral Suspension and Intravenous for Pharmacists General Preparation Instructions Before Handling the Formulations Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans. Follow applicable special handling and disposal procedures 1 [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.2 ), Use in Specific Populations ( 8.1 , 8.3 ), How Supplied/Storage and Handling ( 16.1 )]. Care should be taken to avoid inhalation or direct contact with skin or mucous membranes of the dry powder or the constituted suspension because MMF has demonstrated teratogenic effects in humans . Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table surface after reconstitution. If such contact occurs, wash hands thoroughly with soap and water; rinse eyes with water. Alert patients that they and others should also avoid inhalation or contact of the skin or mucous membranes with the oral suspension. Advise them to wash the area thoroughly with soap and water if such contact occurs; if ocular contact occurs, rinse eyes with plain water. Mycophenolate Mofetil For Oral Suspension Mycophenolate mofetil for oral suspension must be reconstituted by the pharmacist prior to dispensing to the patient. Mycophenolate mofetil oral suspension should not be mixed with any other medication. After reconstitution, the oral suspension contains 200 mg/mL MMF. Before proceeding with the reconstitution steps read the general preparation instructions above [see General Preparation Instructions Before Handling the Formulations]. The following are the steps for reconstitution: Tap the closed bottle several times to loosen the powder. Measure 94 mL of water in a graduated cylinder. Add approximately half the total amount of water for reconstitution to the bottle and shake the closed bottle well for about 1 minute. Add the remainder of water and shake the closed bottle well for about 1 minute. Remove the child-resistant cap and push bottle adapter into neck of bottle. Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap. Write the date of expiration of the constituted suspension on the bottle label. (The shelf-life of the constituted suspension is 60 days.) Dispense with the “Instruction for Use” and oral dispensers. Alert patients to read the important handling information described in the instructions for use. Store reconstituted suspension at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Storage in a refrigerator at 2°C to 8°C (36°F to 46°F) is acceptable. Do not freeze. Discard any unused portion 60 days after constitution.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Embryofetal Toxicity [see Warnings and Precautions ( 5.1 )] Lymphomas and Other Malignancies [see Warnings and Precautions ( 5.2 )] Serious Infections [see Warnings and Precautions ( 5.3 )] Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions ( 5.4 )] Gastrointestinal Complications [see Warnings and Precautions ( 5.5 )] Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch . com 6.1 Clinical Trials 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 1,557 adult patients received mycophenolate mofetil 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 mycophenolate mofetil in de novo kidney (3) heart (1) and liver (1) transplant patients [see Clinical Studies ( 14.1 , 14.2 , and 14.3 )] . Mycophenolate Mofetil Oral The incidence of adverse reactions for mycophenolate mofetil was determined in five randomized, comparative, double-blind 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 ( 14.1 , 14.2 and 14.3 )] . The three de novo kidney studies with 12-month duration compared two dose levels of oral mycophenolate mofetil (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 mycophenolate mofetil 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 mycophenolate mofetil 1 g twice daily intravenously for up to 14 days followed by mycophenolate mofetil 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 mycophenolate mofetil treatment groups are presented below. The safety data of three kidney transplantation studies are pooled together. Table 5 Adverse Reactions in Controlled Studies of De Novo Kidney, Heart or Liver Transplantation Reported in ≥20% of Patients in the Mycophenolate Mofetil Group Adverse drug reaction Kidney Studies Heart Study Liver Study Mycophenolate mofetil 2g/day (n=501) or 3g/day (n=490) AZA 1 to 2 mg/kg/day or 100 to 150 mg/day Placebo Mycophenolate mofetil 3g/day AZA 1.5 to 3 mg/kg/day Mycophenolate mofetil 3g/day AZA 1 to 2 mg/kg/day (n=991) (n=326) (n=166) (n=289) (n=289) (n=277) (n=287) System Organ Class % % % % % % % Infections and infestations Bacterial infections 39.9 33.7 37.3 - - 27.4 26.5 Viral infections - a - - 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 Thrombocytopenia - - - 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 b 21.0 28.2 8.4 67.5 55.7 48.4 47.7 Pain c 24.8 32.2 9.6 79.2 77.5 74.0 77.5 Pyrexia - - - 56.4 53.6 52.3 56.1 a : “-” Indicates that the incidence was below the cutoff value of 20% for inclusion in the table. b : “Edema” includes peripheral edema, facial edema, scrotal edema. c : “Pain” includes musculoskeletal pain (myalgia, neck pain, back pain). In the three de novo kidney studies, patients receiving 2 g/day of mycophenolate mofetil had an overall better safety profile than did patients receiving 3 g/day of mycophenolate mofetil. Post-transplant lymphoproliferative disease (PTLD, pseudolymphoma) developed in 0.4% to 1% of patients receiving mycophenolate mofetil (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 ( 5.2 )]. 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 ( 5.3 )] . Severe neutropenia (ANC<0.5x10 3 /mcL) 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 mycophenolate mofetil 3 g daily [see Warnings and Precautions ( 5.4 ) and Dosage and Administration ( 2.5 )]. The most common opportunistic infections in patients receiving mycophenolate mofetil 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 mycophenolate mofetil (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 ( 5.3 )]. The most serious gastrointestinal disorders reported were ulceration and hemorrhage, which are known risks associated with mycophenolate mofetil. 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 mycophenolate mofetil-related diarrhea revealed isolated cases of intestinal villous atrophy [see Warnings and Precautions ( 5.5 )] . The following adverse reactions were reported with 3% to <20% incidence in kidney, heart, and liver transplant patients treated with mycophenolate mofetil, in combination with cyclosporine and corticosteroids. Table 6 Adverse Reactions in Controlled Studies of De Novo Kidney, Heart or Liver Transplantation Reported in 3% to <20% of Patients Treated with Mycophenolate Mofetil 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 Pediatrics 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 mycophenolate mofetil for oral suspension 600 mg/m 2 twice daily (up to 1 g twice daily) were generally similar to those observed in adult patients dosed with mycophenolate mofetil 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. Safety information in pediatric heart transplant or pediatric liver transplant patients treated with mycophenolate mofetil is supported by an open-label study in pediatric liver transplant patients and publications; the type and frequency of the reported adverse reactions are consistent with those observed in pediatric patients following renal transplant and in adults. Geriatrics Geriatric patients (≥65 years), particularly those who are receiving mycophenolate mofetil 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 ( 5.3 ) and Adverse Reactions ( 6.1 )]. Mycophenolate Mofetil Intravenous The safety profile of mycophenolate mofetil intravenous was determined from a single, double-blind, controlled comparative study of the safety of 2 g/day of intravenous and oral mycophenolate mofetil in kidney transplant patients in the immediate post-transplant period (administered for the first 5 days). The potential venous irritation of mycophenolate mofetil intravenous was evaluated by comparing the adverse reactions attributable to peripheral venous infusion of mycophenolate mofetil 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 mycophenolate mofetil intravenous. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of mycophenolate mofetil. 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 ( 5.1 ), and Use in Specific Populations ( 8.1 ), ( 8.3 )] . 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 mycophenolate mofetil administered intravenously. Digestive : Colitis, pancreatitis Hematologic and Lymphatic : Bone marrow failure, cases of pure red cell aplasia (PRCA) and hypogammaglobulinemia have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents [see Warnings and Precautions ( 5.4 )] . Immune :Hypersensitivity reactions, including anaphylaxis and angioedema [see Warnings and Precautions (5.8)], 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 ( 5.3 )] . 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 mycophenolate mofetil. Vascular : Lymphocele
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). 17.1 Embryofetal Toxicity Pregnancy loss and malformations Inform females of reproductive potential and pregnant women that use of mycophenolate mofetil during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Advise that they must use an acceptable form of contraception [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )]. Encourage pregnant women to enroll in the Pregnancy Exposure Registry. This registry monitors pregnancy outcomes in women exposed to mycophenolate [see Use in Specific Populations ( 8.1 )]. Contraception Discuss pregnancy testing, pregnancy prevention and planning with females of reproductive potential [see Use in Specific Populations ( 8.3 )]. Females of reproductive potential must use an acceptable form of birth control during the entire mycophenolate mofetil therapy and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence . Mycophenolate mofetil may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended [see Use in Specific Populations ( 8.3 )]. For patients who are considering pregnancy, discuss appropriate alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of mycophenolate mofetil should be discussed with the patient. Advise sexually active male patients and/or their partners to use effective contraception during the treatment of the male patient and for at least 90 days after cessation of treatment. This recommendation is based on findings of animal studies [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )]. 17.2 Development of Lymphoma and Other Malignancies Inform patients that they are at increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions ( 5.2 )] . Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use of broad-spectrum sunscreen with high protection factor. 17.3 Increased Risk of Serious Infections Inform patients that they are at increased risk of developing a variety of infections due to immunosuppression. Instruct them to contact their physician if they develop any of the signs and symptoms of infection explained in the Medication Guide [see Warnings and Precautions ( 5.3 )]. 17.4 Blood Dyscrasias Inform patients that they are at increased risk for developing blood adverse effects such as anemia or low white blood cells. Advise patients to immediately contact their healthcare provider if they experience any evidence of infection, unexpected bruising, or bleeding, or any other manifestation of bone marrow suppression [see Warnings and Precautions ( 5.4 )] . 17.5 Gastrointestinal Tract Complications Inform patients that mycophenolate mofetil can cause gastrointestinal tract complications including bleeding, intestinal perforations, and gastric or duodenal ulcers. Advise the patient to contact their healthcare provider if they have symptoms of gastrointestinal bleeding, or sudden onset or persistent abdominal pain [see Warnings and Precautions ( 5.5 )] . 17.6 Acute Inflammatory Syndrome Inform patients that acute inflammatory reactions have been reported in some patients who received mycophenolate mofetil. Some reactions were severe, requiring hospitalization. Advise patients to contact their physician if they develop fever, joint stiffness, joint pain or muscle pains [see Warnings and Precautions ( 5.7 )]. 17.7 Hypersensitivity Reactions Inform patients of the potential risk of hypersensitivity reactions. Advise patients to stop taking mycophenolate mofetil and seek immediate medical attention if signs or symptoms of hypersensitivity reaction occur (such as swelling of face, lips, tongue, or throat; difficulty breathing or swallowing) [see Warnings and Precautions ( 5.8 )]. 17.8 Immunizations Inform patients that mycophenolate mofetil can interfere with the usual response to immunizations. Before seeking vaccines on their own, advise patients to discuss first with their physician [see Warnings and Precautions ( 5.9) ]. 17.9 Administration Instructions Advise patients not to crush mycophenolate mofetil tablets and not to open mycophenolate mofetil capsules. Advise patients to avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil capsules and with the oral suspension. If such contact occurs, they must wash the area of contact thoroughly with soap and water. In case of ocular contact, rinse eyes with plain water. Advise patients to take a missed dose as soon as they remember, except if it is closer than 2 hours to the next scheduled dose; in this case they should continue to take mycophenolate mofetil at the usual times. 17.10 Blood Donation Advise patients not to donate blood during therapy and for at least 6 weeks following discontinuation of mycophenolate mofetil [see Warnings and Precautions ( 5.12 )]. 17.11 Semen Donation Advise males of childbearing potential not to donate semen during therapy and for 90 days following discontinuation of mycophenolate mofetil [see Warnings and Precautions ( 5.13 )]. 17.12 Potential to Impair Driving and Use of Machinery Advise patients that mycophenolate mofetil can affect the ability to drive or operate machines. Patients should avoid driving or operating machines if they experience somnolence, confusion, dizziness, tremor or hypotension during treatment with mycophenolate mofetil [see Warnings and Precautions ( 5.15 )]. For Medication Guide, please visit: http://www.ascendlaboratories.com/mg/mycomofetil.pdf Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA. Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.