Mycophenolate Mofetil 500 mg Tab

Mycophenolate Mofetil 500 mg Tablets

Immunosuppressant – Antimetabolite / Lymphocyte Proliferation Inhibitor

ATC Code: L04AA06

WHO Essential Medicines List: ✔️ Yes

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Phonetic Pronunciation

/ˌmaɪ.koʊˈfɛn.ə.leɪt ˈmoʊ.fə.tɪl/ — MY-koe-FEN-oh-late MOH-feh-til

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Product Description

Mycophenolate mofetil is an immunosuppressive antimetabolite prodrug that is rapidly hydrolyzed to its active form, mycophenolic acid (MPA). It acts as a selective, non-competitive inhibitor of inosine monophosphate dehydrogenase (IMPDH), a critical enzyme in the de novo synthesis of guanosine nucleotides. This inhibition leads to suppressed proliferation of T and B lymphocytes, making it highly effective in preventing transplant rejection.

Mycophenolate is routinely used as part of a triple immunosuppressive regimen alongside calcineurin inhibitors (e.g., tacrolimus or cyclosporine) and corticosteroids. It is available in generic and branded presentations and is widely included in transplant protocols worldwide.

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Available Presentation

• Strength per tablet: 500 mg
• Formulation: Film-coated oral tablet
• Volume: Solid oral dose form
• Dilution Required: ❌ No
• Packaging: Box of 50 tablets or blister packs of 10 or 25 tablets
• Storage: Store below 25°C. Protect from moisture. Do not use if packaging is damaged.

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Indications

• Prophylaxis of organ rejection in:
  • Renal transplantation
  • Hepatic transplantation
  • Cardiac transplantation
• Used in combination with calcineurin inhibitors and corticosteroids

Uses

• Primary Use: Immunosuppression in solid organ transplantation
• Additional Uses: Treatment of acute or chronic rejection; prevention of antibody-mediated rejection; alternative to azathioprine

Off-label / Investigational Uses

• Systemic lupus erythematosus (SLE), especially lupus nephritis
• Myasthenia gravis
• Autoimmune hepatitis
• ANCA-associated vasculitis
• Psoriasis (resistant cases)
• Nephrotic syndrome

Pediatric Use

✔️ Approved for use in pediatric renal transplant patients aged ≥3 months (depending on jurisdiction). Doses are weight- or BSA-based. Requires close hematologic and gastrointestinal monitoring.

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Regulatory and Safety Profile

• ATC Code: L04AA06
• WHO Essential Medicines List: ✔️ Yes
• Pharmacologic Class: Antimetabolite / Immunosuppressant
• Black Box Warning (U.S. FDA): ✔️ Yes
  • Increased risk of serious infections
  • Malignancy risk: lymphoma and skin cancer
  • Teratogenic: contraindicated in pregnancy
• Monitoring: CBC, renal/liver function, pregnancy testing, infection screening

Contraindications

• Hypersensitivity to mycophenolate mofetil or mycophenolic acid
• Pregnancy (Category D)
• Women of childbearing potential not using effective contraception
• Active serious infections

Common Side Effects

• Gastrointestinal: nausea, vomiting, diarrhea
• Hematologic: leukopenia, anemia, thrombocytopenia
• Infections: CMV, BK virus
• Skin: acne, rash
• Increased malignancy risk with long-term use

Monitoring Parameters

• CBC with differential (weekly, then monthly)
• Liver function tests (ALT, AST, bilirubin)
• Serum creatinine and BUN
• Pregnancy testing for women of reproductive age
• CMV and EBV serology, tuberculosis risk evaluation

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For wholesale pricing, Certificate of Analysis (COA) requests, or immunosuppressive supply chain support, please contact us at: info@panamfarma.com