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Myfortic

Myfortic

mycophenolic acid

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Mycophenolate Na
Indications/Uses
In combination w/ ciclosporin microemulsion & corticosteroids for prophylaxis of acute transplant rejection in adults receiving allogeneic renal transplants.
Dosage/Direction for Use
Administration
May be taken with or without food: Do not crush.
Contraindications
Hypersensitivity to mycophenolate Na, mycophenolic acid or mycophenolate mofetil. Women of childbearing potential not using highly effective contraception. Not to be used during pregnancy & lactation.
Special Precautions
Avoid use in patients w/ hypoxanthine-guanine phosphoribosyl-transferase deficiency eg, Lesch-Nyhan & Kelley-Seegmiller syndrome. Increased risk of developing lymphomas & other malignancies. Progressive multifocal leukoencephalopathy; pure red cell aplasia; active serious digestive system disease; immunosuppressed patients. Monitor patients infected w/ hepatitis B or C for clinical & lab signs of active HBV or HCV infection. Patients should not donate blood during therapy or for at least 6 wk after last dose. Monitor CBC wkly during 1st mth, twice mthly for 2nd & 3rd mth through 1st yr; neutropenia. Avoid use of live attenuated vaccines. Concomitant use w/ other immunosuppressants. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Severe chronic renal impairment (GFR <25 mL/min-1/1.73 m-2). Males should use effective contraception & not donate semen during treatment & for at least 90 days after last dose. Women of childbearing potential should use effective contraception prior to, during & for 6 wk after last dose. Not to be initiated until -ve pregnancy test has been obtained. Ped <18 yr.
Adverse Reactions
Viral, bacterial & fungal infections; leukopenia; hypocalcaemia, hypokalaemia, hyperuricaemia; HTN; diarrhoea. URTIs, pneumonia; anaemia, thrombocytopenia; hyperkalaemia, hypomagnesaemia; anxiety; dizziness, headache; aggravated HTN, hypotension; cough, dyspnoea, exertional dyspnoea; abdominal distension & pain, constipation, dyspepsia, flatulence, gastritis, loose stools, nausea, vomiting; abnormal hepatic function tests; arthralgia, asthenia, myalgia; increased blood creatinine; fatigue, peripheral oedema, pyrexia.
Drug Interactions
Diminished Ab response to other vaccines. Higher mycophenolic acid glucuronide & aciclovir plasma conc. Decreased absorption w/ Mg- & Al hydroxide-containing antacids. Decreased AUC & Cmax by PPIs. Higher mean AUC & lowered Cmax w/ tacrolimus. Decreased systemic exposure by cholestyramine & other drugs interfering w/ enterohepatic circulation. Not to be co-administered w/ azathioprine. Concomitant use w/ ganciclovir, OCs.
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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