Mofetab Tablets / Film-coated
Mycophenolate Mofetil
500mg
Tabuk Pharmaceutical Manufacturing Co.
| Pack size | 150's (10's Blister x 15) |
|---|---|
| Dispensing mode | POM |
| Source | SAUDI ARABIA |
| Agent | ALPHAMED CO. (AUH) LTD. |
| Retail Price | 940.00 AED |
Indications
Mofetab Tablets / Film-coated is used for:
Prophylaxis of acute renal graft rejection, Prophylaxis of cardiac graft rejection, Liver Transplant
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/m² PO q12hr; not to exceed 2 g/day
MMF: BSA 1.25-1.5 m²: 750 mg capsule PO q12hr
MMF: BSA >1.5 m²: 1 g capsule/tablet PO q12hr
Renal Dose
Renal impairment
MMF: In severe renal impairment (glomerular filtration rate [GFR] <25 mL/min/1.73 m²), 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
Contra Indications
Pregnancy, lactation. Rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT), including Kelley-Seegmiller or Lesch-Nyhan syndrome.
Precautions
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
Pregnancy-Lactation
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
Interactions
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.
Adverse Effects
Side effects of Mycophenolate Mofetil :
>10%
Hyperglycemia (44%), Hypercholesterolemia (41%), Hypomagnesemia (39%), Dyspnea (37%), Back pain (35%), Increased blood urea nitrogen (BUN) (35%), Leukopenia (34%), Pleural effusion (34%), Urinary tract infection (34%), Increasing frequency of cough (31%), Hypocalcemia (30%), Hypertension (28%), Abdominal pain (27%), Peripheral edema (27%), Anemia (26%), Fever (23%), Nausea (23%), Hyperkalemia (22%), Diarrhea (21%), Infection (21%), Headache (16%)
1-10%
Melanoma (1.6-4.2%), Other malignancies (0.7-2.1%), Lymphoma (0.4-1%), Opportunistic infection (including herpes), Neutropenia, GI bleeding, Pulmonary fibrosis, Progressive multifocal leukoencephalopathy
Potentially Fatal: Angioedema, anaphylaxis, fatal pulmonary fibrosis.
Mechanism 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.
Note
Mofetab 500mg Tablets / Film-coated manufactured by Tabuk Pharmaceutical Manufacturing Co.. Its generic name is Mycophenolate Mofetil. Mofetab is availble in United Arab Emirates.
Farmaco UAE drug index information on Mofetab Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.