Teratogenic in animals; avoid inhalation or direct skin contact. Monitor patients for lymphoproliferative disorders; advise patient to limit exposure to sunlight/UV light. Perform CBCs; monitor for neutropenia.
Mycophenolate mofetil and mycophenolate sodium are not interchangeable.
Lactation: Unknown whether drug is excreted in breast milk; avoid using, or do not nurse
Indication
Prophylaxis of acute renal graft rejection, Prophylaxis of cardiac graft rejection, Liver Transplant
Contra Indication
Pregnancy, lactation. Rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT), including Kelley-Seegmiller or Lesch-Nyhan syndrome.
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Mycophenolic acid acts by blocking purine synthesis of human lymphocytes through reversible inhibition of inosine monophosphate dehydrogenase. It also inhibits proliferation of both T- and B- lymphocytes.
Interaction
Increased plasma levels of both drugs when combined with aciclovir, valaciclovir, ganciclovir and valganciclovir. Reduced absorption with colestyramine, magnesium- and aluminium hydroxide-containing products, sevelamer and other calcium-free phosphate binders. Reduced plasma levels with ciclosporin, metronidazole, quinolones, rifamycins. May reduce plasma levels of progestins; may reduce efficacy of oral contraceptives. Increased plasma levels with probenecid. May reduce efficacy of live vaccines.
Pregnancy Category Note
Pregnancy
Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems
Consider alternative immunosuppressants with less potential for embryofetal toxicity; risks and benefits of therapy should be discussed with the pregnant woman; the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear
Animal data
Oral administration of mycophenolate to rats and rabbits during period of organogenesis produced congenital malformations and pregnancy loss at doses less than recommended clinical dose (0.02 to 0.1 times the recommended clinical doses in kidney and heart transplant patients)
Lactation
There are no data on presence of drug in human milk, or effects on milk production; there are limited data in the National Transplantation Pregnancy Registry on effects of mycophenolate on a breastfed child; studies in rats treated with MMF have shown mycophenolic acid (MPA) to be present in milk
Because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant; the developmental and health benefits of breastfeeding should be considered along with the mother?s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from the underlying maternal condition
Adult Dose
Oral
Adult
Prophylaxis of acute renal graft rejection
As Mycophenolate Mofetil (MMF): 1 g twice daily starting w/in 72 hr of transplantation. Max: 2 g/day.
Prophylaxis of cardiac graft rejection, Liver Transplant
Adult:
As Mycophenolate Mofetil (MMF):1.5 g bid starting within 5 days after transplantation.
Child Dose
<3 months
Safety and efficacy not established
>3 months
Prophylaxis of organ rejection in patients receiving allogeneic renal transplants
As Mycophenolate Mofetil (MMF):
MMF (suspension): 600 mg/m? PO q12hr; not to exceed 2 g/day
MMF: BSA 1.25-1.5 m?: 750 mg capsule PO q12hr
MMF: BSA >1.5 m?: 1 g capsule/tablet PO q12hr
Renal Dose
Renal impairment
MMF: In severe renal impairment (glomerular filtration rate [GFR] <25 mL/min/1.73 m?), not to exceed 1 g q12hr
No dosage adjustment needed in renal transplant patients experiencing delayed graft function post-operatively.
Administration
Drug is taken on empty stomach 1 hour before or 2 hours after meals
Once dosage is stabilized, MMF can be taken with food after kidney transplant
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The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.