Indications |
Oral Prophylaxis of acute renal graft rejection Adult: As mycophenolate mofetil: 1 g bid starting within 72 hr of transplantation. Max: 2 g/day. As mycophenolic acid: 720 mg bid. Child: As mycophenolate mofetil: 2-18 yr: 600 mg/m2 bid. Max: 1 g bid. BSA 1.25-1.5 m2: 750 mg bid; >1.5 m2: 1 g bid. As mycophenolic acid: 5-16 yr: 400 mg/m2 bid (max: 720 mg bid). BSA 1.19-1.58 m2: 540 mg bid (max: 1,080 mg); >1.58 m2: 720 mg bid (max: 1,440 mg). Elderly: As mycophenolic acid: Max: 720 mg bid. Renal impairment: Severe chronic renal impairment (GFR <25 ml/min/1.73 m2): Avoid >1 g bid of mycophenolate mofetil. Oral Prophylaxis of cardiac graft rejection Adult: As mycophenolate mofetil: 1.5 g bid starting within 5 days after transplantation. Intravenous Prophylaxis of acute renal graft rejection Adult: As mycophenolate mofetil: 1 g bid by IV infusion over 2 hr starting within 24 hr after transplantation for up to 14 days, convert to oral therapy as soon as possible. Renal impairment: Severe chronic renal impairment (GFR <25 ml/min/1.73 m2): Avoid >1 g bid of mycophenolate mofetil. Intravenous Prophylaxis of hepatic transplant rejection Adult: As mycophenolate mofetil: 1 g bid by IV infusion over 2 hr for the first 4 days (up to a max of 14 days) following transplantation. To be started within 24 hr of transplantation. Subsequently, convert to oral admin at 1.5 g bid as soon as possible. Intravenous Prophylaxis of cardiac graft rejection Adult: As mycophenolate mofetil: 1.5 g bid starting within 5 days after transplantation, convert to oral admin as soon as possible. Reconstitution: Reconstitute in glucose 5% to a final concentration of 6 mg/ml mycophenolate mofetil. |
Contraindications |
Pregnancy, lactation. Rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT), including Kelley-Seegmiller or Lesch-Nyhan syndrome. |
Warnings / Precautions |
Teratogenic in animals; avoid inhalation or direct skin contact. Monitor patients for lymphoproliferative disorders; advise patient to limit exposure to sunlight/UV light. Active peptic ulcer disease. Severe renal impairment. Mycophenolate mofetil and mycophenolate sodium are not interchangeable. Perform CBCs; monitor for neutropenia. |
Adverse Reactions |
Diarrhoea, vomiting, GI haemorrhage and perforation; leucopenia; asthenia, pain, headache, anaemia, thrombocytopenia, renal tubular necrosis, haematuria, BP changes, hyperglycaemia, disturbances of electrolytes and blood lipids, peripheral oedema, dyspnoea, cough, acne, rash, alopecia, dizziness, insomnia, paraesthesia, tremor, hypersensitivity reactions, pancreatitis, hepatitis. Potentially Fatal: Angioedema, anaphylaxis, fatal pulmonary fibrosis. |
Overdose Reactions |
No reported cases. At plasma levels >100 mcg/ml, small amounts of the inactive metabolite may be removed by haemodialysis. Excretion of MPA may be enhanced by bile acid sequestrants (e.g. colestyramine). |
Drug Interactions |
Increased plasma levels of both drugs when combined with aciclovir, valaciclovir, ganciclovir and valganciclovir. Reduced absorption with colestyramine, magnesium- and aluminium hydroxide-containing products, sevelamer and other calcium-free phosphate binders. Reduced plasma levels with ciclosporin, metronidazole, quinolones, rifamycins. May reduce plasma levels of progestins; may reduce efficacy of oral contraceptives. Increased plasma levels with probenecid. May reduce efficacy of live vaccines. See Below for More mycophenolic acid Drug Interactions |
Food Interactions |
Food reduces MPA peak serum levels by 40% and 33% following mycophenolate mofetil and mycophenolate sodium admin, respectively. Extent of absorption is not affected. Avoid cat's claw and echinacea as they have immunostimulant effects. |
Mechanism of Actions |
Mycophenolic acid acts by blocking purine synthesis of human lymphocytes through reversible inhibition of inosine monophosphate dehydrogenase. It also inhibits proliferation of both T- and B- lymphocytes. Absorption: Mycophenolate mofetil/mycophenolate sodium: Both extensively absorbed from the GI tract. Distribution: Mycophenolic acid (MPA): 97% bound to plasma proteins. Metabolism: Mycophenolate is converted to active MPA, which undergoes enterohepatic recirculation. MPA is metabolised by glucuronidation to the inactive glucuronide. Excretion: Via urine (as the glucuronide and negligible amounts of MPA); via faeces (about 6% of a dose). Mean half-life of MPA: 17.9 hr (as oral mycophenolate mofetil) and 16.6 hr (as IV mycophenolate mofetil); 12 hr (as mycophenolate sodium). |
Storage Conditions |
Intravenous: Store vials and reconstituted solution at 15-30°C (59-86°F). Begin infusion within 4 hr of reconstitution. Oral: Store at 15-30°C (59-86°F). Protect tablet from light. Do not freeze oral suspension. |
ATC Classification |
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression. |
Storage |
Intravenous: Store vials and reconstituted solution at 15-30°C (59-86°F). Begin infusion within 4 hr of reconstitution. Oral: Store at 15-30°C (59-86°F). Protect tablet from light. Do not freeze oral suspension. |
Available As |
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Mycophenolic Acid (Mycophenolate Mofetil)
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Drug - Drug Interactions of Mycophenolic Acid (Mycophenolate Mofetil)
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