Myfortic

Myfortic

mycophenolic acid

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Concise Prescribing Info
Contents
Mycophenolic acid (as 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 bid (1,440 mg daily dose). Patient w/ severe chronic renal impairment (GFR <25 mL/min/1.73 m2) Should be carefully followed-up.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to mycophenolate Na, mycophenolic acid or mycophenolate mofetil.
Special Precautions
Not to be used in patients w/ hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase. Increased risk of developing lymphomas & other malignancies particularly of the skin. Over-suppression of the immune system w/ increased susceptibility to infection. 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. Patients w/ active serious digestive system disease. Report any sign of bone marrow depression. Perform complete blood counts on a regular basis. Avoid live-attenuated vaccines. Male patient should use condoms &/or partner should use highly effective contraception. Not to be used during pregnancy & lactation. Childn.
Adverse Reactions
Viral, bacterial & fungal infections, leukopenia, hypocalcemia, hypokalemia, hyperuricemia, HTN, hypotension, diarrhea. Upper resp tract infection, pneumonia, anemia, thrombocytopenia, hyperkalemia, hypomagnesemia, anxiety, dizziness, headache, aggravated HTN, cough, dyspnea, exertional dyspnea, abnormal hepatic function test, abdominal distension/pain, constipation, dyspepsia, flatulence, gastritis, loose stools, nausea, vomiting, arthralgia, asthenia, myalgia, increased blood creatinine, fatigue, peripheral edema, pyrexia.
Drug Interactions
Live vaccines. Concomitant use w/ cholestyramine & drugs that interfere w/ enterohepatic circulation; aciclovir, ganciclovir & OCs; antacids containing Mg & Al hydroxides; azathioprine. Systemic conc may change when switching from ciclosporin to tacrolimus & vice versa.
MIMS Class
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Myfortic gastro-resistant tab 360 mg
Packing/Price
120's
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