Generic
Mycophenolic Acid (Mycophenolate sodium)
6 brands available in the market
At a glance
Mycophenolic Acid is an immunosuppressant used to prevent organ rejection after kidney transplantation. It suppresses the immune system by inhibiting lymphocyte proliferation.
Description
Mycophenolic Acid is an immunosuppressive agent. It is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). It inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. Mycophenolic acid has cytostatic effects on lymphocytes. The delayed-release tablet is an enteric coated formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid.
Indications
- Prophylaxis of organ rejection in adult kidney transplant patients
- Prophylaxis of organ rejection in pediatric patients 5 years and older (at least 6 months post kidney transplant)
Therapeutic class
Immunosuppressant
Pharmacological class
IMPDH Inhibitor
Pharmacology
Mycophenolic acid is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis. MPA has more potent cytostatic effects on lymphocytes than on other cells because T- and B lymphocytes are critically dependent for their proliferation on de novo synthesis of purines.
Mechanism of action
Suppresses immune system by inhibiting lymphocyte proliferation and prevents organ rejection.
Dosage
Adult Kidney Transplant: 720 mg twice daily (1440 mg daily dose)
Pediatric Kidney Transplant (5 years+, at least 6 months post-transplant): 400 mg/m² twice daily (max 720 mg twice daily)
BSA 1.19-1.58 m²: 1080 mg/day (3x180 mg or 1x180+1x360 mg tablet twice daily)
BSA >1.58 m²: 1440 mg/day (4x180 mg or 2x360 mg tablet twice daily)
Administration
- Take on an empty stomach (1 hour before or 2 hours after meals)
- Swallow tablet whole; do not crush, chew or cut (to maintain enteric coating)
- Take at the same time each day
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose; do not double the dose.
Side effects
Common Side Effects (≥20%):
- Anemia
- Leukopenia
- Constipation
- Diarrhea
- Vomiting
- Dyspepsia
- Urinary tract infection
- CMV infection
- Insomnia
- Postoperative pain
Precautions & warnings
- Can cause embryofetal toxicity
- May increase new or reactive viral infections
- May cause blood dyscrasias (including pure red cell aplasia)
- May cause serious GI tract complications (bleeding, perforations, ulcers)
- May increase risk of lymphomas and other malignancies
- Avoid live vaccines
Contraindications
- Hypersensitivity
- Pregnancy (Category D - can cause fetal harm)
- Lactation
Drug interactions
- Caution with antacids, azathioprine, cyclosporin, rifampin, sevelamer, cholestyramine, acyclovir, metronidazole, hormonal contraceptives (may decrease mycophenolic acid concentration)
Food interactions
Food may affect absorption; take on empty stomach.
Use in pregnancy
Use in Pregnancy: Mycophenolic Acid is highly unsafe during pregnancy (Category D); definite evidence of severe fetal harm. Completely contraindicated. Discontinue treatment or discontinue nursing.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Mycophenolic Acid is unsafe during breastfeeding; may cause toxicity to the baby. Do not use.
Pediatric use
Dose established for children 5 years and older (at least 6 months post-transplant).
Geriatric use
Elderly patients require caution.
Renal / hepatic impairment
Renal Impairment: No dosage adjustment needed in patients experiencing delayed graft function post-operatively.
Hepatic Impairment: Caution in liver disease; dose adjustment may be needed.
Overdose effects
Overdose may cause over suppression of immune system and increased risk of infections; symptomatic treatment.
Storage conditions
Store below 30°C; protect from light and moisture; keep out of reach of children.
Chemical structure
Mycophenolic Acid