Mycophenolic Acid (Mycophenolate Mofetil)

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
  • Mycophenolic Acid (Mycophenolate Mofetil) 180 mg
  • Mycophenolic Acid (Mycophenolate Mofetil) 250 mg
  • Mycophenolate Mofetil 250 mg
  • Mycophenolate Mofetil 360 mg
  • Mycophenolic Acid (Mycophenolate Mofetil) 360 mg
  • Mycophenolic Acid (Mycophenolate Mofetil) 500 mg
  • Mycophenolate Mofetil 500 mg
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    Mycophenolic Acid (Mycophenolate Mofetil) Containing Brands

    Click on Prescription information to see Indications ( Uses ), Contraindications, Prescription information of respective Constituents.

    Brand Name Manufacturer Unit/Price Package unit/Price Constituents/Unit
    Tablet Baxmune (250 mg) Super Speciality (Ranbaxy Laboratories Ltd) 1 Tablet
    ₹ 40.00
    10 Tablet
    ₹ 400.00
  • More Information Mycophenolic Acid (Mycophenolate Mofetil) 250 mg
  • See Brands having above combination
    Tablet Baxmune (500 mg) Super Speciality (Ranbaxy Laboratories Ltd) 1 Tablet
    ₹ 74.45
    10 Tablet
    ₹ 744.50
  • More Information Mycophenolic Acid (Mycophenolate Mofetil) 500 mg
  • See Brands having above combination
    Tablet Mofetyl (250 mg) RPG Life Sciences Ltd 1 Tablet
    ₹ 39.13
    10 Tablet
    ₹ 391.25
  • More Information Mycophenolic Acid (Mycophenolate Mofetil) 250 mg
  • See Brands having above combination
    Tablet Mofetyl (500 mg) RPG Life Sciences Ltd 1 Tablet
    ₹ 73.38
    10 Tablet
    ₹ 733.75
  • More Information Mycophenolic Acid (Mycophenolate Mofetil) 500 mg
  • See Brands having above combination
    Tablet Mofilet (250 mg) Emcure Pharmaceuticals Ltd. 1 Tablet
    ₹ 52.00
    10 Tablet
    ₹ 520.00
  • More Information Mycophenolic Acid (Mycophenolate Mofetil) 250 mg
  • See Brands having above combination
    Tablet Mofilet (500 mg) Emcure Pharmaceuticals Ltd. 1 Tablet
    ₹ 72.00
    10 Tablet
    ₹ 720.00
  • More Information Mycophenolic Acid (Mycophenolate Mofetil) 500 mg
  • See Brands having above combination
    Tablet Mycept (250 mg) Panacea Biotec Ltd 1 Tablet
    ₹ 47.25
    10 Tablet
    ₹ 472.50
  • More Information Mycophenolic Acid (Mycophenolate Mofetil) 250 mg
  • See Brands having above combination
    Tablet Renodapt S (180 mg) Biocon (India) Ltd 1 Tablet
    ₹ 40.00
    10 Tablet
    ₹ 400.00
  • More Information Mycophenolic Acid (Mycophenolate Mofetil) 180 mg
  • See Brands having above combination
    Tablet Immutil (500 mg) La Renon Healthcare Pvt. Ltd. 1 Tablet
    ₹ 62.00
    10 Tablets
    ₹ 620.00
  • More Information Mycophenolic Acid (Mycophenolate Mofetil) 500 mg
  • See Brands having above combination
    Tablet Immutil-S 360 La Renon Healthcare Pvt. Ltd. 1 Tablet
    ₹ 62.00
    10 Tablets
    ₹ 620.00
  • More Information Mycophenolic Acid (Mycophenolate Mofetil) 360 mg
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    Mycophenolic Acid (Mycophenolate Mofetil) is used in following diseases

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    Moderate, Consider therapy modification Aluminum hydroxide, magnesium hydroxide, and simethicone vs Mycophenolate
    Moderate, Consider therapy modification Aluminum hydroxide, magnesium hydroxide, and simethicone vs Mycophenolate
    Moderate, Consider therapy modification Citric acid bladder mixture vs Mycophenolate
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