International reference: 1 US FDA recall for this ingredient

Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled as the following drug: METHAZOLAMIDE, Tablet, 50 mg, NDC 00781107101, Pedigree: AD37072_11, EXP: 5/13/2014. (mycophenolic)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in South Africa.

Canceled South Africa · SAHPRA

MICASSYL EC 360

Mycophenolic Acid

47/32.2/1208

What it does

Mycophenolic is a medicine that helps prevent the body from rejecting transplanted organs.

Commonly used for: organ transplant rejection prevention, kidney transplant, heart transplant, liver transplant

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Sourcing - Kenya only

Registration & product details

Registration no.
47/32.2/1208
Registration date
2022/05/18
Expiry date
-
Status
Canceled
Active ingredient
Mycophenolic Acid
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
Accord Healthcare (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:11:38 · updated 2026-09-16 04:00:04

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Mycophenolic is a medicine that helps prevent the body from rejecting transplanted organs.

What it treats

  • organ transplant rejection prevention
  • kidney transplant
  • heart transplant
  • liver transplant

How it works

Mycophenolic works by suppressing the immune system to stop it from attacking the new organ.

Who it's for

This medicine is for patients who have received a transplant and need help keeping their body from rejecting the new organ.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: mycophenolic

Mycophenolic acid is an immunosuppressive agent derived from the mold Penicillium brevicompactum, primarily used to prevent organ rejection in transplant patients. It inhibits lymphocyte proliferation and reduces antibody formation, making it beneficial in various autoimmune diseases as well.

Indications

  • Prophylaxis of organ rejection in kidney transplantation
  • Prophylaxis of organ rejection in heart transplantation
  • Prophylaxis of organ rejection in liver transplantation
  • Treatment of systemic lupus erythematosus
  • Treatment of rheumatoid arthritis

Dosage

Children: Refer to BNF for Children for specific dosing guidelines.

Adults: Refer to BNF for specific dosing guidelines.

Mechanism of action

Mycophenolic acid exerts its effects primarily by inhibiting inosine monophosphate dehydrogenase (IMPDH), which is crucial in the de novo pathway of purine synthesis. This leads to decreased lymphocyte proliferation, particularly affecting T and B lymphocytes, which rely heavily on this pathway for their proliferation and function.

Pharmacodynamics

The inhibition of IMPDH results in reduced synthesis of purines, which are essential for the proliferation of lymphocytes. This immunosuppressive action helps to prevent graft rejection in transplant patients and controls autoimmune conditions. Mycophenolate mofetil (MMF), a prodrug of mycophenolic acid, is often used due to its enhanced bioavailability and safety profile.

Pharmacokinetics

Mycophenolic acid is rapidly absorbed after oral administration, with peak plasma concentrations occurring approximately 1 to 2 hours post-dose. It is extensively metabolized in the liver, primarily to its active form, mycophenolic acid. The drug has a half-life of approximately 16 to 18 hours, and its elimination is predominantly via the renal route. Dosing adjustments may be necessary in patients with renal impairment.

Contra-indications

  • Hypersensitivity to mycophenolate mofetil or any component of the formulation
  • Pregnant women, due to the risk of teratogenicity
  • Active infections, particularly viral infections such as cytomegalovirus (CMV)

Adverse effects

  • Gastrointestinal disturbances such as nausea, vomiting, and diarrhea
  • Increased risk of infections due to immunosuppression
  • Bone marrow suppression leading to leukopenia and thrombocytopenia
  • Elevated liver enzymes
  • Renal impairment

Interactions

  • Antacids and cholestyramine may reduce absorption of mycophenolate
  • Concomitant use with other immunosuppressants increases the risk of infections and malignancies
  • Certain antibiotics, such as rifampicin, may affect mycophenolate metabolism

Precautions

  • Monitor white blood cell counts regularly due to the risk of leukopenia
  • Assess for signs of infection, especially in patients on long-term therapy
  • Use caution in patients with a history of gastrointestinal disorders
  • Avoid pregnancy during treatment and provide effective contraception

Pregnancy

Mycophenolate is contraindicated in pregnancy due to significant risks of fetal malformations and pregnancy loss. Women of childbearing potential must use effective contraception during treatment.

Breast-feeding

Mycophenolate is excreted in breast milk; caution is recommended when administering to breastfeeding mothers as potential adverse effects on the infant are possible.

Storage

Store at room temperature, away from moisture and light. Keep out of reach of children.

Formulations

  • Mycophenolate mofetil capsules
  • Mycophenolate mofetil tablets
  • Mycophenolate mofetil oral suspension

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.