Mycophenolic acid


Full Prescribing Info
Dosage/Direction for Use

Oral
Prophylaxis of acute renal graft rejection
Adult: As mycophenolate mofetil: In combination with other immunosuppressants: 1 g bid started within 72 hours of transplantation. As mycophenolic acid: 720 mg bid started within 72 hours of transplantation.
Child: As mycophenolate mofetil: ≥3 months
: 600 mg/m2 bid. Max: 2 g daily. BSA 1.25-1.5 m2: 750 mg bid; ≥1.5 m2: 1 g bid. As mycophenolic acid: ≥5 years: 400 mg/m2/dose bid. (Max: 1,400 mg daily). BSA 1.19-1.58 m2: 540 mg bid; >1.58 m2: 720 mg bid.
Renal impairment: Severe chronic renal impairment (GFR <25 mL/min/1.73 m2): Avoid >1 g bid of mycophenolate mofetil.
Reconstitution:
Powder for oral suspension: Add a total of 94 mL of water to a bottle in order to provide a suspension containing 200 mg/mL. Shake the bottle after addition for approx 1 minute.

Oral
Prophylaxis of cardiac graft rejection
Adult: As mycophenolate mofetil: In combination with other immunosuppressants: 1.5 g bid started within 5 days of transplantation.
Reconstitution:
Powder for oral suspension: Add a total of 94 mL of water to a bottle in order to provide a suspension containing 200 mg/mL. Shake the bottle after addition for approx 1 minute.

Intravenous
Prophylaxis of acute renal graft rejection
Adult: As mycophenolate mofetil: In combination with other immunosuppressants: 1 g bid via IV infusion over 2 hours started within 24 hours of transplantation. Duration of therapy: Max 14 days. Convert to oral therapy as soon as tolerated.
Renal impairment: Severe chronic renal impairment (GFR <25 mL/min/1.73 m2): Avoid >1 g bid of mycophenolate mofetil.
Reconstitution:
IV: Reconstitute vial labelled as containing 500 mg with 14 mL of 5% dextrose injection; further dilute with 70 mL of 5% dextrose inj for IV infusion.

Intravenous
Prophylaxis of cardiac graft rejection
Adult: As mycophenolate mofetil: 1.5 g bid via IV infusion over 2 hours starting within 5 days after transplantation, convert to oral administration as soon as tolerated.
Reconstitution:
IV: Reconstitute vial labelled as containing 500 mg with 14 mL of 5% dextrose injection; further dilute with 70 mL of 5% dextrose inj for IV infusion.

Intravenous
Prophylaxis of hepatic transplant rejection
Adult: As mycophenolate mofetil: Initially, 1 g bid via IV infusion over 2 hours started within 24 hours of transplantation. Duration of treatment: 4 days up to Max 14 days. Then, convert to oral administration at 1.5 g bid as soon as tolerated.
Reconstitution:
IV: Reconstitute vial labelled as containing 500 mg with 14 mL of 5% dextrose injection; further dilute with 70 mL of 5% dextrose inj for IV infusion.
Contraindications
Pregnancy, lactation. Rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT) (e.g. Kelley-Seegmiller or Lesch-Nyhan syndrome).
Special Precautions
Patient with active serious gastrointestinal disease, active peptic ulcers. Renal impairment. Children. Avoid abrupt cessation of treatment. Mycophenolate mofetil and mycophenolate sodium are not interchangeable. Patient Counselling This drug may impair physical and mental ability, if affected, do not drive or operate machinery. Do not donate blood or blood products during treatment and for at least 6 months after the last dose. Monitoring Parameters Monitor CBC, LFT, renal function. Perform pregnancy test prior to initiation of therapy; then after 8-10 days in women of child-bearing potential, followed by repeat test during therapy. Monitor for signs and symptoms of infection, neurological symptoms, lymphoma, pure red cell aplasia, and autoimmune haemolytic anaemia.
Adverse Reactions
Significant: CNS depression, new or reactivation of viral infection, neutropenia, pure red cell aplasia, gastric or duodenal ulcers, gastrointestinal bleeding and/or perforation, myasthenia gravis (abrupt discontinuation of treatment). Blood and lymphatic system disorders: Leucopenia, thrombocytopenia, anaemia, pancytopenia, leukocytosis. Cardiac disorders: Tachycardia. Gastrointestinal disorders: Vomiting, abdominal pain, diarrhoea, nausea, dysgeusia. General disorders and administration site conditions: Oedema, pyrexia, chills, pain, malaise, asthenia. Infections and infestations: Sepsis, gastrointestinal candidiasis, UTI, herpes simplex, herpes zoster. Investigations: Increased hepatic enzymes. Metabolism and nutrition disorders: Acidosis, gout, anorexia. Musculoskeletal and connective tissue disorders: Arthralgia. Neoplasms benign, malignant and unspecified: Skin cancer, benign skin neoplasm. Nervous system disorders: Convulsion, hypertonia, tremor, somnolence, dizziness, headache, paraesthesia. Psychiatric disorders: Agitation, confusional state, depression, anxiety, abnormal thinking, insomnia. Respiratory, thoracic and mediastinal disorders: Pleural effusion, dyspnoea, cough. Skin and subcutaneous tissue disorders: Skin hypertrophy, rash, acne, alopecia. Vascular disorders: Hypertension, hypotension, vasodilation.
Potentially Fatal: Infections (e.g. progressive multifocal leukoencephalopathy, meningitis, infectious endocarditis), pulmonary fibrosis.
Drug Interactions
Mycophenolate mofetil may increase plasma concentration of aciclovir. Reduced absorption with antacids, polycarbophil calcium, sevelamer, colestyramine. Reduced MPA exposure with ciclosporin, antibiotics (e.g. aminoglycosides, cephalosporin, fluroquinolone, penicillins). Increased MPA exposure with isavuconazole, telmisartan. May reduce the efficacy of live attenuated vaccines.
Food Interaction
Food reduces MPA peak serum levels by 40% and 33% following mycophenolate mofetil and mycophenolate sodium administration, respectively.
Action
Mycophenolic acid suppresses the proliferation of both T and B lymphocytes and antibody formation by inhibiting inosine monophosphate dehydrogenase, resulting in depletion of guanosine nucleotide which is necessary for de novo purine synthesis in lymphocytes.
Absorption: Mycophenolate mofetil/mycophenolate Na: Rapidly and extensively absorbed from the gastrointestinal tract.
Distribution: Plasma protein binding: MPA: 97%.
Metabolism: Mycophenolate is metabolised pre-systemically into active mycophenolic acid (MPA), which undergoes enterohepatic recirculation. MPA is further metabolised via glucuronidation to inactive mycophenolic acid glucuronide.
Excretion: Mycophenolate: Via urine (as glucuronide and negligible amount of MPA); faeces (6%). Half-life of MPA: 17.9 hours (as oral mycophenolate mofetil); 16.6 hours (as IV mycophenolate mofetil); 12 hours (as mycophenolate Na).
Storage
Intravenous: Inj: Store at 25°C. Oral: Cap/Tab/Susp: Store at 25°C. Protect from light and moisture. Reconstituted oral suspension: Store between 2-8°C. Do not freeze.
CIMS Class
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Disclaimer: This information is independently developed by CIMS based on mycophenolic acid from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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