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MAR-MYCOPHENOLATE MOFETIL is a brand name for Mycophenolate Mofetil, supplied as a powder for suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MAR-MYCOPHENOLATE MOFETIL (mycophenolate mofetil) is indicated for: Adults The prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. MAR-MYCOPHENOLATE MOFETIL should be used concomitantly with cyclosporine and corticosteroids. 1.1 Pediatrics (2-18 years of age) …
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations MAR-MYCOPHENOLATE MOFETIL (mycophenolate mofetil) should be used concomitantly with standard cyclosporine andcorticosteroid therapy. MAR-MYCOPHENOLATE MOFETIL Po wd er fo r Oral Suspension The initial oral dose of MAR-MYCOPHENOLATE MOFETIL should be given as soon as possible following renal, cardiac or hepatic transplantation.
Food had no effect on MPA AUC, but has been shown to decrease MPACmax by 40%. It is recommended that MAR-MYCOPHENOLATE MOFETIL be administered on an empty stomach. Note: If required MAR-MYCOPHENOLATE MOFETIL Oral Suspension can be administered via a nasogastric tube with a minimum size of 8 French.
2 Recommended Dose and Dosage Adjustment Adults Renal Transplantation A dose of 1 g administered orally twice a day (daily dose of 2 g) is recommended for use in renal transplant patients. 5 g administered twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients.
Patients receiving 2 g per day of MAR-MYCOPHENOLATE MOFETIL in these trials demonstrated an overall better safety profile than did patients receiving 3 g per day of MAR-MYCOPHENOLATE MOFETIL. 5 g twice daily oral (daily dose of 3 g) is recommended for use in adult cardiac transplant patients.
5 g twice daily oral (daily dose of 3 g) is recommended for use in adult hepatic transplant patients. Pediatrics (2 to 18 years) The recommended dose of MAR-MYCOPHENOLATE MOFETIL oral suspension for renal transplant patients is 600 mg/m2 body surface area twice daily (up to a maximum of 2 g daily).
73m2) outside the immediate post-transplant period, doses of MAR-MYCOPHENOLATE MOFETIL greater than 1 g administered twice a day should be avoided.
These patients should also be carefully observed (see CLINICAL PHARMACOLOGY:
Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment. MAR- MYCOPHENOLATE MOFETIL should be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
3 x 103/μL), dosing with MAR-MYCOPHENOLATE MOFETIL should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed Page 6 of 63 appropriately. (See WARNINGS AND PRECAUTIONS: Immune, Monitoring and Laboratory Tests and ADVERSE REACTIONS) Delayed Renal Graft Function Post Transplant No dose adjustment is recommended for these patients, however, they should be carefully observed (see CLINICAL PHARMACOLOGY: Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency).
1 Adverse Reaction Overview The adverse event profile associated with the use of immunosuppressive drugs is often difficult to establish owing to the presence of underlying disease and the concurrent use of many other medications. The principal adverse reactions associated with the administration of MAR-MYCOPHENOLATE MOFETIL (mycophenolate mofetil) include diarrhea, leukopenia, sepsis and vomiting, and there is evidence of a higher frequency of certain types of infections.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Mycophenolate mofetil (oral) The incidence of adverse events for mycophenolate mofetil 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.
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 renal patients, 65% of the cardiac patients and 45% of the hepatic patients have been treated for more than one year.
Adverse events, whether or not deemed to be causally associated with the study medication, reportedin ≥ 10% of patients in treatment groups are presented below. 0 […]
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. g. g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in changes of MPA exposure (See DRUG INTERACTIONS). g. cholestyramine, sevelamer, antibiotics) should be used with caution due to their potential to reduce the plasma levels and efficacy of mycophenolate mofetil (see Drug-Drug Interactions).
g. g. risk of rejection, treatment with antibiotics, addition or removal of an interacting medication). It is recommended that MAR-MYCOPHENOLATE MOFETIL (mycophenolate mofetil) should not be administered concomitantlywith azathioprine because both have the potential to cause bone marrow suppression and such concomitant administration has not been studied clinically.
Blood Donation Patients should not donate blood during therapy and for at least 6 weeks following discontinuation of MAR-MYCOPHENOLATE MOFETIL. Carcinogenesis and Mutagenesis Neoplasms Patients receiving MAR-MYCOPHENOLATE MOFETIL, as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. As with all patients at an increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor (see ADVERSE REACTIONS).
Driving and Operating Machinery MAR-MYCOPHENOLATE MOFETIL may have a moderate influence on the ability to drive and use machines. Patients should be advised to use caution when driving or using machines if they experience adverse drug reactions such as somnolence, confusion, dizziness, tremor or hypotension during treatment with MAR- MYCOPHENOLATE MOFETIL.
Endocrine and Metabolism Mycophenolate mofetil is an inosine monophosphate dehydrogenase (IMPDH) inhibitor, therefore it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl- transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
MAR-MYCOPHENOLATE MOFETIL (mycophenolate mofetil) is contraindicated in patients with a known hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product (see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
MAR-MYCOPHENOLATE MOFETIL is contraindicated during pregnancy due to its mutagenic and teratogenic potential (see WARNINGS and PRECAUTIONS). MAR-MYCOPHENOLATE MOFETIL is contraindicated in women of childbearing potential not using highly effective contraceptive methods and without providing a pregnancy test result.
(see WARNINGS and PRECAUTIONS). MAR-MYCOPHENOLATE MOFETIL is contraindicated in women who are breastfeeding (see WARNINGS and PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 Reconstitution Oral Solutions: Preparation of Oral Suspension: 1. Tap the closed bottle several times to loosen the powder. 2. Measure 94 mL of purified water in a graduated cylinder. 3. Add approximately half of the total amount of the purified water for reconstitution to the bottle and shake the closed bottle well for about 1 minute.
4. Add the remainder of water and shake the closed bottle well for about 1 minute. 5. Remove the child-resistant cap and push bottle adapter into neck of bottle. 6. Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottleadapter in the bottle and child-resistant status of the cap.
Dispense with patient information leaflet and oral dispensers. Oral dispensers are for use with MAR- MYCOPHENOLATE MOFETIL oral suspension only. It is recommended to write the date of expiration of the reconstituted suspension on the bottle label in the space provided.
) Net contents after reconstitution of the oral suspension is 175 mL, containing 200 mg/mL mycophenolate mofetil. Store reconstituted suspension at 15-30oC. Do not freeze. Discard any unused portion 60 days after reconstitution. 4 Administration: It is recommended that MAR-MYCOPHENOLATE MOFETIL Powder for Oral Suspension be reconstituted by the pharmacist prior to dispensing to the patient (see DOSAGE AND ADMINISTRATION: Reconstitution, Preparation of Oral Suspension).
56 mg phenylalanine per mLsuspension). Gastrointestinal MAR-MYCOPHENOLATE MOFETIL should be administered with caution in patients with active serious digestive system disease. 4% of hepatic transplant patients treated with mycophenolate mofetil 3g daily.
Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, and rarely perforation (colon, gall bladder). Most patients receiving mycophenolate mofetil were also receiving other drugs that are known to be associated with these complications.
Patients with active peptic ulcer disease were excluded from enrollment in studies with mycophenolate mofetil. Page 9 of 63 Hematologic Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents.
The mechanism for mycophenolate mofetil induced PRCA is unknown. In some cases PRCA was found to be reversible with dose reduction or cessation of mycophenolate mofetil therapy. In transplant patients however reduced immunosuppression may placethe graft at risk.
Patients receiving MAR-MYCOPHENOLATE MOFETIL should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression. Patients receiving MAR-MYCOPHENOLATE MOFETIL should be monitored for neutropenia.
Complete blood counts should be performed weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year (see Monitoring and Laboratory Tests and DOSAGE AND ADMINISTRATION: Dosage Adjustment).
The development of neutropenia may be related to MAR- MYCOPHENOLATE MOFETIL itself, concomitant medications, viral infections, or some combination of these causes. 3 x 103/μL), dosing with MAR- MYCOPHENOLATE MOFETIL should be interrupted or the dose should be reduced, appropriate diagnostic tests performed, and the patient managed appropriately.
Neutropenia has been observed most frequently in the period from 31 to 180 days post- transplant for patients treated for prevention of renal, cardiac and hepatic rejection. 6% hepatic transplant patients receiving mycophenolate mofetil 3g daily (see ADVERSE REACTIONS).
Immune Mycophenolate mofetil has been administered in combination with the following agents in clinical trials: anti- thymocyte globulin [equine] (Atgam®) induction, muromonab-CD3 (Orthoclone OKT®3), cyclosporine (Sandimmune®, Neoral®), and corticosteroids.
The efficacy and safety of the use of mycophenolate mofetil in combination with other immunosuppressive agents has not been determined. Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections and sepsis.
Such infections include latent viral reactivation, such as hepatitis B or hepatitis C […]