Cellcept Capsule
Mycophenolate Mofetil
250mg
F. Hoffmann-La Roche Ltd
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Available as:
Indications
Cellcept Capsule is used for:
Prophylaxis of acute renal graft rejection, Prophylaxis of cardiac graft rejection, Liver Transplant
Adult Dose
Oral
Prophylaxis of acute renal graft rejection
Adult: 1 g bid starting within 72 hr of transplantation. Max: 2 g/day.
Prophylaxis of cardiac graft rejection, Liver Transplant
Adult: 1.5 g bid starting within 5 days after transplantation.
Child Dose
Kidney Transplant
<3 months
Safety and efficacy not established
>3 months
Prophylaxis of organ rejection in patients receiving allogeneic renal transplants
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 postoperatively
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. Active peptic ulcer disease. Severe renal impairment. Mycophenolate mofetil and mycophenolate sodium are not interchangeable. Perform CBCs; monitor for neutropenia.
Lactation: Unknown whether drug is excreted in breast milk; avoid using, or do not nurse
Pregnancy-Lactation
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
Cellcept 250mg Capsule manufactured by F. Hoffmann-La Roche Ltd. Its generic name is Mycophenolate Mofetil. Cellcept is availble in Nepal.
Farmaco Nepal drug index information on Cellcept Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.