Mycophenolic acid: Brands, Price & Uses in Bangladesh

Mycophenolic acid is an immunosuppressant approved, in combination with cyclosporine and corticosteroids, for the following use:

• Prophylaxis of organ rejection in kidney (renal) transplantation - established, FDA-approved indication in adult and pediatric patients (5 years of age and older, at least 6 months post-transplant). Mycophenolic acid must always be used as part of a combination immunosuppressive regimen; it is not used as monotherapy.

Off-label/guideline-supported uses (not FDA-approved, used based on transplant center protocols and specialist judgement): maintenance immunosuppression in liver, heart, lung, and pancreas transplantation, and in select autoimmune conditions (e.g., lupus nephritis) as a mycophenolate mofetil alternative in patients with intolerance to that formulation. These uses should only be undertaken under the supervision of a specialist experienced in transplantation or immunosuppressive therapy.

Renal impairment: In adult patients with severe chronic renal impairment (GFR less than 25 mL/min/1.73m²) outside the immediate post-transplant period, doses above 720 mg twice daily should be avoided and patients should be monitored closely. No dose adjustment is required for delayed graft function post-transplant.

Hepatic impairment: No dose adjustment has been established as necessary for hepatic parenchymal disease, but hepatically impaired patients should be monitored closely.

Administration: Mycophenolic acid tablets should be taken on an empty stomach (1 hour before or 2 hours after food) when possible, and swallowed whole - do not crush, chew, or split the tablets, as this destroys the enteric coating that protects the stomach.

The most common adverse reactions (occurring in ≥20% of patients) associated with Mycophenolic acid include:

• Gastrointestinal: diarrhea, constipation, nausea, vomiting, dyspepsia, abdominal pain
• Hematologic: anemia, leukopenia (low white blood cell count)
• Infections: urinary tract infection, cytomegalovirus (CMV) infection (reflecting immunosuppression)
• Other: insomnia, headache, tremor, peripheral edema, hypertension, postoperative pain, and elevated liver enzymes

Serious/less common effects: severe neutropenia or pancytopenia (requiring regular blood count monitoring), progressive multifocal leukoencephalopathy (PML) and other opportunistic infections, increased risk of lymphoma and skin malignancies (see Precautions and Warnings), and pure red cell aplasia (rare).