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APO-MYCOPHENOLIC ACID is a brand name for Mycophenolic Acid, supplied as a tablet (enteric-coated). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-MYCOPHENOLIC ACID (mycophenolate sodium) is indicated for: • the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine, and corticosteroids. 1.1 Pediatrics Safety and efficacy in pediatric patients have not been established. Limited…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • APO-MYCOPHENOLIC ACID should be used in combination with cyclosporine and corticosteroid therapy. 5 Drug-Food Interactions). 440 g total daily dose). • Geriatric Use: No dose adjustments are required. The recommended dose is 720 mg administered twice daily.
• Pediatric Use: Safety and efficacy in pediatric patients have not been established. Limited pharmacokinetic data are available for pediatric renal transplant patients. 3 Pharmacokinetics Special Populations and Conditions, Pediatrics).
• Treatment during Rejection Episodes: Renal transplant rejection does not affect MPA pharmacokinetics; dosage reduction or interruption of APO-MYCOPHENOLIC ACID is not required. • Patients with Renal Impairment: No dose adjustments are needed in patients experiencing delayed post-operative renal graft function.
73 m2) should be carefully monitored. • Patients with Hepatic Impairment: No dose adjustments are needed for renal transplant patients with hepatic parenchymal disease. 3×103 /mcL), dosing with APO-MYCOPHENOLIC ACID should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed appropriately (see 7 WARNINGS AND PRECAUTIONS, Hematologic).
4 Administration • Patients are to be instructed that APO-MYCOPHENOLIC ACID tablets should not be crushed, chewed, or cut prior to ingesting but to be swallowed whole in order to maintain the integrity of the enteric coating. 5 Missed Dose Not applicable
1 Adverse Reaction Overview The most common (>25%) adverse events from clinical trial data from de novo kidney transplant patients treated with mycophenolate sodium include constipation, nausea, and urinary tract infection. Clinical trial data from maintenance patients treated with mycophenolate sodium show that nausea, diarrhea and nasopharyngitis were the most frequently observed adverse reactions (> 15%).
5%) in controlled clinical trials. 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. The incidence of adverse events for mycophenolate sodium 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.
Adverse events reported in > 10% of patients receiving mycophenolate sodium or MMF in the 12-months de novo renal study and maintenance renal study, when used in combination with cyclosporine are listed in Table 2. Adverse event rates were similar between mycophenolate sodium and MMF in both de novo and maintenance patients.
1 - - Table 3 summarizes the incidence of opportunistic infections in de novo and maintenance transplant patients, which were similar in both treatment groups. 8 0 Long term administration of mycophenolate sodium (up to 30 months of exposure) did not show any unexpected changes in the pattern of adverse events including infections and malignancies.
APO-MYCOPHENOLIC ACID (Mycophenolic acid delayed-release tablets) Page 15 of 44 Unclassified / Non classifié The following adverse events were reported between 3% to <10% incidence in de novo and maintenance patients treated with mycophenolate sodium in combination with cyclosporine and corticosteroids are listed in Table 4.
, Hematologic). 4 Administration • Patients are to be instructed that APO-MYCOPHENOLIC ACID tablets should not be crushed, chewed, or cut prior to ingesting but to be swallowed whole in order to maintain the integrity of the enteric coating.
5 Missed Dose Not applicable 5 OVERDOSAGE There have been anecdotal reports of deliberate or accidental overdoses with mycophenolate sodium, whereas not all patients experienced related adverse events. In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the class.
Accordingly an overdose of mycophenolate sodium could possibly result in over suppression of the immune system and may increase the susceptibility to infection including opportunistic infections, fatal infections and sepsis. g. 2 Clinical Trail Adverse Reactions).
Possible signs and symptoms of acute overdose could include the following: hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea and vomiting, and dyspepsia.
General supportive measures and symptomatic treatment should be followed in all cases of over dosage. Although dialysis may be used to remove the inactive metabolite MPAG, it would not be expected to remove clinically significant amounts of the active moiety MPA due to the 98% plasma protein binding of MPA.
By interfering with enterohepatic circulation of MPA, activated charcoal or bile acid sequestrants, such as cholestyramine, may reduce the systemic MPA exposure. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
APO-MYCOPHENOLIC ACID (Mycophenolic acid delayed-release tablets) Page 7 of 44 Unclassified / Non classifié 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral Enteric Coated Tablets equivalent to 180 mg and 360 mg mycophenolic acid (as mycophenolate sodium) Colloidal silicon dioxide, methylcellulose, sodium lauryl sulfate, and stearic acid.
• APO-MYCOPHENOLIC ACID (mycophenolate sodium) is contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or to any of its excipients (see 6 DOSAGE FORMS, STRENGTH, COMPOSITION AND PACKAGING).
• APO-MYCOPHENOLIC ACID is contraindicated during pregnancy due to its mutagenic and teratogenic potential. 1 Pregnant Women). • APO-MYCOPHENOLIC ACID should not be initiated in women of childbearing potential without providing a pregnancy test result to rule out unintended use in pregnancy.
• APO-MYCOPHENOLIC ACID is contraindicated in women who are breastfeeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mycophenolic Acid in Canada.
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Table 4:
Adverse Events Reported in 3% to <10% of Patients Treated with Mycophenolate Sodium in Combination with Cyclosporine and Corticosteroids de novo Renal Study Maintenance Renal Study Blood and lymphatic disorders Lymphocele, thrombocytopenia Leukopenia, anemia Cardiac disorder Tachycardia - Eye disorder Vision blurred - Endocrine disorders Cushingoid, hirsutism - Gastrointestinal disorder Flatulence, abdominal distension, sore throat, abdominal pain lower, abdominal pain, gingival hyperplasia, loose stool Abdominal pain, constipation, gastroesophageal reflux disease, loose stool, flatulence, abdominal pain upper General disorders and administration site conditions Fatigue, edema peripheral, chest pain Fatigue, pyrexia, edema, chest pain Infections and infestations Nasopharyngitis, herpes simplex, upper respiratory tract infection, oral candidiasis, herpes zoster, sinusitis, wound infection, implant infection, pneumonia Influenza, sinusitis Injury, poisoning, and procedural complications Drug toxicity Post procedural pain Investigations Hemoglobin decrease, blood pressure increased, liver function tests abnormal Blood creatinine increase, weight increase Metabolism and nutrition disorders Hypercholesterolemia, hyperkalemia, hypomagnesemia, diabetes mellitus, hyperphosphatemia, dehydration, fluid overload, hyperglycemia, hypercalcemia Dehydration, hypokalemia, hypercholesterolemia […]
The enteric coating of the tablet consists of hydroxypropyl methylcellulose, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, triethyl citrate, yellow iron oxide, FD&C Blue No. 2 (180 mg) and red iron oxide (360 mg).
APO-MYCOPHENOLIC ACID 180 mg tablets contain 180 mg of mycophenolic acid as mycophenolate sodium: Light green, round, slightly biconvex beveled edge enteric coated tablet. Engraved with “MYC” over “180” on one side, “APO” on the other side.
Available in bottles of 100 enteric coated tablets, and unit dose of 10 tablets per blister pack; 12 blister packs/carton. APO-MYCOPHENOLIC ACID 360 mg tablets contain 360 mg of mycophenolic acid as mycophenolate sodium: Light pink, oval, biconvex enteric coated tablet.
Engraved with “APO” on one side, “MYC 360” on the other side. Available in bottles of 100 enteric coated tablets, and unit dose of 10 tablets per blister pack; 12 blister packs/carton. 7 WARNINGS AND PRECAUTIONS General Patients receiving APO-MYCOPHENOLIC ACID should be instructed to immediately report any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow suppression.
Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate. Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate. Carcinogenesis and Mutagenesis Patients receiving immunosuppressive regimens involving combinations of drugs, including APO-MYCOPHENOLIC ACID, as part of an immunosuppressive regimen are at an increased risk APO-MYCOPHENOLIC ACID (Mycophenolic acid delayed-release tablets) Page 8 of 44 Unclassified / Non classifié 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 general advice to minimize the 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.
Endocrine and Metabolism On theoretical grounds, because APO-MYCOPHENOLIC ACID is an IMPDH Inhibitor, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl- transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Gastrointestinal Because mycophenolic acid derivatives have been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, hemorrhage, and perforation, APO-MYCOPHENOLIC ACID should be administered with caution in patients with active serious digestive system disease.
Gastrointestinal adverse events are common in patients receiving MPA treatment. Gastrointestinal bleeding (requiring hospitalization), gastrointestinal tract ulceration, and perforation have rarely been reported in de novo renal transplant patients or maintenance patients treated with mycophenolic acid enteric coated tablets during clinical trials.
Most patients receiving mycophenolic acid enteric coated tablets were also receiving other drugs known to be associated with these complications. Patients with active peptic ulcer disease were excluded from enrollment in studies with mycophenolate sodium.
Hematologic Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate sodium or mycophenolate mofetil (MMF) in combination […]