Myfortic

Myfortic

mycophenolic acid

Manufacturer:

Novartis Indonesia
Concise Prescribing Info
Contents
Mycophenolate Na
Indications/Uses
In combination w/ ciclosporin for microemulsion & corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogenic renal transplants. Induction & maintenance treatment of adult patients w/ WHO Class III, IV or V lupus nephritis.
Dosage/Direction for Use
720 mg twice daily (1,440 mg daily dose). Patient receiving mycophenolate mofetil 2 g Treatment can be replaced w/ Myfortic 720 mg twice daily. De novo patient Treatment must be initiated w/in 48 hr following transplantation. Lupus nephritis 720 mg twice daily (1,440 mg daily dose) in combination w/ a corticosteroid. Induction therapy: >1,440 mg/day, max: 2,160 mg/day. Dose may be tapered for maintenance purposes following a complete or partial response.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/cut.
Contraindications
Hypersensitivity to mycophenolate Na, mycophenolic acid or mycophenolate mofetil. Pregnant women.
Special Precautions
Patients w/ rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase eg, Lesch-Nyhan & Kelley-Segmiller syndrome. Not to be initiated until -ve pregnancy test has been obtained. Increased risk of developing lymphomas & other malignancies particularly of the skin. Avoid excessive exposure to sunlight & UV light. Patients should be advised to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression. 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. Monitor patients for blood dyscrasias (eg, neutropenia or anaemia). Perform complete blood cell counts wkly during the 1st mth, twice mthly for the 2nd & 3rd mth of treatment, then mthly through the 1st yr. Interrupt or discontinue treatment if blood dyscrasias occur. Shifting to Myfortic therapy should be under appropriate supervision to minimize the risk of graft rejection. Avoid use of live attenuated vaccines. Active serious digestive system disease; immunosuppressed patients, severe chronic renal impairment. Not recommended in combination w/ other immunosuppressive agents (eg, azathioprine). Women of childbearing potential must use highly effective contraception before, during, &/or 6 wk after the last dose of therapy. Male patient should use condoms &/or partner should use highly effective contraception during treatment & for a total of 13 wk after the last dose. Pregnancy. Not to be used during breast-feeding. Not recommended in childn.
Adverse Reactions
Viral, bacterial & fungal infections; leukopenia; diarrhea; hypocalcemia, hypokalemia, hyperuricemia; HTN, hypotension. UTI, herpes zoster infection, oral candidiasis, sinusitis, URTI, gastroenteritis, herpes simplex, nasopharyngitis, pneumonia; anaemia, thrombocytopenia; dizziness, headache; cough, dyspnea, exertional dyspnea; abdominal distension, pain, constipation, dyspepsia, flatulence, gastritis, loose stools, nausea, vomiting; fatigue, peripheral edema, pyrexia/fever; hyperkalemia, hypomagnesemia; abnormal hepatic function test; aggravated HTN; arthralgia, asthenia, myalgia; anxiety; increased blood creatinine.
Drug Interactions
May diminish Ab response of live vaccines. Increased conc of both aciclovir & mycophenolic acid glucuronide. Decreased absorption w/ Mg- & Al hydroxide-containing antacids. Decreased systemic exposure w/ cholestyramine & other drugs affecting the enterohepatic circulation.
MIMS Class
Immunosuppressants
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Myfortic EC tab 180 mg
Packing/Price
12 × 10's (Rp1,418,825/boks);5 × 10's (Rp591,175/boks)
Form
Myfortic EC tab 360 mg
Packing/Price
12 × 10's (Rp2,782,925/boks);5 × 10's (Rp1,159,570/boks)
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