Sanofetil

Sanofetil

mycophenolic acid

Manufacturer:

Sanbe
Concise Prescribing Info
Contents
Mycophenolate mofetil
Indications/Uses
Prophylaxis of acute organ rejection & increased graft & patient survival in patients receiving allogeneic cardiac transplants in combination w/ cyclosporin & corticosteroids.
Dosage/Direction for Use
Prophylaxis of renal rejection Initially 1.5 g twice daily orally w/in 72 hr following transplantation. Prophylaxis of cardiac rejection Initially 1.5 g twice daily orally w/in 5 days following transplantation. Elderly ≥65 yr 1 g twice daily for renal transplant & 1.5 g twice daily for cardiac transplant. Patient w/ severe renal impairment (GFR <25 mL/min/1.73 m2) Max: 1 g twice daily.
Contraindications
Hypersensitivity to mycophenolate mofetil or mycophenolic acid.
Special Precautions
Reduced immunosuppression may place the graft at risk. Increased risk of developing lymphomas & other malignancies, particularly of the skin. Vaccinations may be less effective; avoid use of live attenuated vaccines. Avoid use in patients w/ rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) eg, Lesch-Nyhan & Kelley-Seegmiller syndrome. Not to be administered concomitantly w/ azathioprine due to bone marrow suppression. Avoid administration of doses >1 g twice daily in renal patients w/ severe chronic renal impairment. Avoid use in pregnant woman.
Adverse Reactions
Asthenia, fever, headache, infection, pain (includes abdominal, back & chest), edema, sepsis. Cysts (including lymphocele & hydrocele), enlarged abdomen, facial edema, flu syndrome, hemorrhage, hernia, malaise, pelvic pain. Cardiac transplant patients: Chills. Cellulitis, neck pain, pallor. Serious life threatening infections eg, meningitis & infectious endocarditis.
Drug Interactions
Increase in conc of both drugs when administered w/ acyclovir. Decreased absorption w/ antacids containing Mg & Al hydroxides. Co-adminsitration w/ drugs that interfere w/ enterohepatic circulation eg, cholestyramine; tacrolimus. Ab response to other vaccines may be diminished.
MIMS Class
Immunosuppressants
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Sanofetil FC caplet 500 mg
Packing/Price
5 × 10's (Rp1,000,000/boks)
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