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Regulate Immune Function Preparations

Mycophenolate Mofetil capsules 250mg

Category:

Regulate Immune Function Preparations

CAS NO:

115007-34-6

Standard:

ChP,USP,

Price Range:

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Main Sales Markets:

North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

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YES

Product Description

Mycophenolate Mofetil capsules 250mg
Currently approved by the US FDA ANDA No.: 214079
Passed the FDA on-site inspection in September 2023. On May 21, 2024, the company received the PAI EIR report sent by the FDA in an encrypted format, which stated that the company has the conditions to apply for commercial production of the product. This is the third time the company has passed the FDA on-site inspection. The entire ANDA project was approved for marketing in early November 2024.

AI Product Description

*The following content is generated by AI and is for reference only.

Mycophenolate Mofetil capsules, 250 mg, are a potent immunosuppressive medication primarily prescribed to prevent organ rejection in patients who have received kidney transplants. Often used in combination with other drugs such as cyclosporine and corticosteroids, this agent works by inhibiting the proliferation of T and B lymphocytes, which are critical components of the immune system responsible for attacking foreign tissues. By blocking the enzyme inosine monophosphate dehydrogenase, Mycophenolate Mofetil effectively reduces the production of guanosine nucleotides, thereby halting DNA synthesis in rapidly dividing immune cells. Beyond kidney transplantation, this medication is increasingly utilized off-label or as part of approved protocols for treating various autoimmune disorders, including lupus nephritis and certain forms of vasculitis, where an overactive immune response causes tissue damage. It is crucial that patients adhere strictly to their prescribed dosage regimen, as inconsistent intake can compromise transplant success or disease management. Significant safety precautions must be observed during therapy. The most common adverse effects include gastrointestinal disturbances such as diarrhea, nausea, vomiting, and abdominal pain. More seriously, the drug suppresses bone marrow function, potentially leading to leukopenia, anemia, or thrombocytopenia; therefore, regular blood counts are mandatory. Patients face an elevated risk of infections due to reduced immunity and should promptly report any signs of fever or unusual fatigue. Furthermore, Mycophenolate Mofetil is teratogenic and carries a high risk of severe birth defects or pregnancy loss. Consequently, it is contraindicated in pregnant women, and females of childbearing potential must use highly effective contraception before, during, and after treatment. Patients should avoid live vaccines while on this therapy and inform all healthcare providers about their medication history. Regular monitoring of renal function and complete blood counts is essential to ensure therapeutic efficacy while minimizing toxicity. Any missed doses should be taken as soon as remembered unless it is nearly time for the next dose, but doubling up is never recommended. Always consult a specialist for personalized medical advice regarding this powerful immunosuppressant.