Cellcept 500 mg

Cellcept 500 mg | INDICATIONS AND USES

Mycophenolate Mofetil in combination with corticosteroids and either ciclosporin or tacrolimus is indicated for-

Prophylaxis of acute organ rejection and treatment of first or refractory organ rejection in patients receiving allogeneic renal transplants.
Prophylaxis of acute organ rejection in patients receiving allogeneic cardiac transplants. ... Read moreMycophenolate Mofetil in combination with corticosteroids and either ciclosporin or tacrolimus is indicated for-

Prophylaxis of acute organ rejection and treatment of first or refractory organ rejection in patients receiving allogeneic renal transplants.
Prophylaxis of acute organ rejection in patients receiving allogeneic cardiac transplants.
Prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplants.
Mycophenolate Mofetil is indicated for induction and maintenance therapy of patients with Class III-V lupus nephritis (diagnosed according to International Society of Nephrology/Renal Pathology Society classification.

Cellcept 500 mg | PHARMACOLOGY

Mechanism of Action: Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis. The mechanism by which MPA inhibits the enzymatic activity of IMPDH appears to be related to the ability of MPA to structurally mimic both nicotinamide adenine dinucleotide cofactor and a catalytic water molecule. This prevents the oxidation of IMP to xanthose-5’-monophosphate which is the committed step in de novo guanosine nucleotide biosynthesis. MPA has more potent cytostatic effects on lymphocytes than on other cells because T- and B lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilize salvage pathways.Pharmacodynamics: Mycophenolic acid, the active metabolite of mycophenolate mofetil, is a non-competitive, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). Inhibition of IMPDH blocks the de novo synthesis of guanosine nucleotides which are necessary substrates for DNA and RNA synthesis. Unlike other cell types which can use the salvage pathway, B and T lymphocytes are dependent upon the de novo pathway for the generation of guanosine. Data from in vitro studies indicate that mycophenolic acid and/or mycophenolate mofetil inhibit mixed lymphocyte responses and human peripheral blood lymphocyte proliferation induced by a variety of mitogens and antigens. Mycophenolic acid decreases intracellular pools of guanosine triphosphate (GTP) and deoxyguanosine triphosphate (dGTP) in mitogen-stimulated human peripheral blood monocytes or T lymphocytic cell lines but has no effect on GTP concentrations in human neutrophils.

Cellcept 500 mg | DOSAGE & ADMINISTRATION

Transplant patients:Standard dosage for prophylaxis of renal rejection

Adults: A dose of 1 g administered orally twice a day (daily dose of 2 g) is recommended for use in renal transplant patients.
Children (aged 3 months to 18 years): Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed Mycophenolate Mofetil Tablets at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area >1.5 m2 may be prescribed Mycophenolate Mofetil tablets at a dose of 1 gm twice daily (2 g daily dose).

Standard dosage for prophylaxis of cardiac rejection-

Adults: A dose of 1.5 g administered orally (over not less than 2 hour) twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
Children: no data are available for pediatric cardiac transplant patients.

Standard dosage for prophylaxis of hepatic rejection-

Adults: A dose of 1.5 g orally twice a day (daily dose of 3 g) is recommended for use in hepatic transplant patients
Children: no data are available for pediatric hepatic transplant patients.

Standard dosage for treatment of first or refractory renal rejection-

Adults: A dose of 1.5 g administered orally twice a day (daily dose of 3 g) is recommended for management of first or refractory rejection.
Children: no data are available for the treatment of first or refractory renal rejection in pediatric renal transplant patients.

Lupus nephritis patients:Standard Dosage for Induction Therapy-

Adults: A dose of 750 mg-1.5 g administered orally twice a day (daily dose of up to 3 g) is recommended
Children: A dose of 600 mg/m2 administered orally twice a day (up to a maximum of 2 g daily) is recommended

Standard Dosage for Maintenance Therapy-

Adults: A dose of 500 mg-1 g administered orally twice a day is recommended
Children: A dose of 300 mg/m2 administered orally twice a day is recommended

Mycophenolate Mofetil should be used in combination with corticosteroids. Doses should be introduced gradually and adjusted according to clinical response. Therapeutic drug monitoring could help prevent sub-therapeutic exposure (Cmin≥3.0 mg/L or inter-dose AUC ≥35 h*mg/L).

Cellcept 500 mg | DRUG INTERACTIONS

Caution should be exercised with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration.

Cellcept 500 mg | SIDE EFFECTS

The principal adverse reactions associated with the administration of Mycophenolate Mofetil includes diarrhea, leukopenia, sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, vomiting and there is evidence of a higher frequency of certain types of infections eg. opportunistic infections.

Cellcept 500 mg | USE DURING PREGNANCY AND LACTATION

Mycophenolate Mofetil is contraindicated in pregnancy and during breastfeeding. The safe use of Mycophenolate Mofetil during labor and delivery has not been established.

Cellcept 500 mg | PRECAUTIONS & WARNINGS

Mycophenolic acid tablets are used with caution because it-

Can increase new or reactive viral infections. Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation, or infections caused by polyomaviruses.
Can cause blood dyscrasias including pure red cell aplasia (PRCA).
Can cause serious GI tract complications (gastrointestinal bleeding, perforations and ulcers).
May increase the risk of developing lymphomas and other malignancies, particularly of the skin.
Use of live vaccines should be avoided during treatment with Mycophenolic acid.
Patients should not donate blood during therapy.

Cellcept 500 mg | USE IN SPECIAL POPULATIONS

Geriatric population: Geriatric patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal hemorrhage and pulmonary edema, compared with younger individuals.

Cellcept 500 mg | THERAPEUTIC CLASS

Immunological Chemotherapy, Immunosuppressant

Cellcept 500 mg | STORAGE CONDITIONS

Store in a cool (below 30°C), dry place and away from light. Keep out of the reach of children.