Myfortic米芙

Myfortic

mycophenolic acid

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Mycophenolate Na
Indications/Uses
Prophylaxis of acute transplant rejection in patients receiving allogeneic renal transplants in combination w/ ciclosporin for microemulsion & corticosteroids.
Dosage/Direction for Use
720 mg bd. De novo patients Initial dose must be administered w/in 72 hr following transplantation.
Administration
May be taken with or without food: Swallow whole, do not crush.
Contraindications
Hypersensitivity to mycophenolate Na, mycophenolic acid or mycophenolate mofetil. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
Not to be used in patients w/ hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase eg, Lesch-Nyhan & Kelley-Seegmiller syndrome; & patients w/ galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Increased risk of developing lymphomas & other malignancies particularly of the skin. Over-suppression of the immune system w/ increased susceptibility to infections & sepsis. Viral reactivation in patients infected w/ HBV or HCV; monitor patients infected w/ hepatitis B or C for clinical & lab signs of active HBV or HCV infection. Risk of progressive multifocal leukoencephalopathy & pure red cell aplasia. Reports of hypogammaglobulinaemia & bronchiectasis when combined w/ other immunosuppressants. Patients w/ active serious digestive system disease. Report any sign of bone marrow depression. Perform complete blood counts on a regular basis. Concomitant use of drugs that interfere w/ enterohepatic circulation eg, cholestyramine or activated charcoal. Concomitant use w/ azathioprine; induction therapies eg, anti-T lymphocyte globulin or basiliximab. Avoid use of live attenuated vaccines. Abstinence or highly effective contraception is recommended during treatment. Men should not donate semen during therapy or at least 90 days after discontinuation. Patient should not donate blood during therapy or at least 6 wk after discontinuation. Childn.
Adverse Reactions
Viral, bacterial & fungal infections; leukopenia; hypocalcemia, hypokalemia, hyperuricemia; anxiety; HTN; diarrhoea; arthralgia. Upper resp tract infections, pneumonia; anaemia, thrombocytopenia; hyperkalemia, hypomagnesemia; dizziness, headache; hypotension; cough, dyspnoea; abdominal distension, abdominal pain, constipation, dyspepsia, flatulence, gastritis, nausea, vomiting; abnormal liver function test; acne, pruritus; myalgia; increased blood creatinine; asthenia, fatigue, peripheral oedema, pyrexia.
Drug Interactions
Expect increased levels of mycophenolic acid glucuronide & aciclovir/ganciclovir when Myfortic & aciclovir/ganciclovir are administered concomitantly. Decreased AUC & Cmax w/ Mg- & Al-containing antacids. Decreased efficacy w/ bile acid sequestrates or oral activated charcoal. Decreased exposure of mycophenolic acid w/ ciclosporin. Increased mycophenolic acid AUC & variability w/ tacrolimus. Do not give live vaccines to patients w/ impaired immune response.
MIMS Class
Immunosuppressants
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Myfortic gastro-resistant tab 180 mg
Packing/Price
120's
Form
Myfortic gastro-resistant tab 360 mg
Packing/Price
120's
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