Generic Cellcept

MYCOPHENOLATE MOFETIL
Tablets: 500 mg (Rx) CellCept (Roche)
Capsules: 250 mg (Rx) CellCept (Roche)
Powder for Oral Suspension: 200 mg/mL (constituted) CellCept (Roche)
Powder for Injection, lyophilized: 500 mg (as HCI) CellCept (Roche)

Warning:
Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal, hepatic, or cardiac transplant patients should use mycophenolate. Manage patients receiving the drug in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Indications
Allogeneic transplants: For the prophylaxis of organ rejection in patients receiving allogeneic renal, hepatic, or cardiac transplants. Use mycophenolate concomitantly with cyclosporine and corticosteroids.
Unlabeled uses: Refractory uveitis (2 g/day alone or incombination with previous corticosteroid, cyclosporine, or tacrolimus therapy).

Administration and Dosage
Renal transplantation: 1 g administered orally of IV (over > 2 hours) twice a day (daily dose of 2 g). Although a dose of 1.5 g twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients. Patients receiving 2 g/day demonstrate an overall better safety profile than patients receiving 3 g/day.
Cardiac transplantation: 1.5 g administered orally or IV (over > 2 hours) twice daily (daily dose of 3 g) is recommended.
Hepatic transplantation: 1 g twice daily administered IV (over > 2 hours) or 1.5 g twice daily orally (daily dose of 3 g) is recommended.
Capsules, oral suspension, and tablets: Give the initial oral dose as soon as possible following transplantation. It is recommended that mycophenolate be administered on an empty stomach. However, in stable renal transplant patients, it may be administered with food if necessary.
If required, the oral suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
IV administration: Do not administer IV solution by rapid or bolus IV injection. Mycophenolate IV is recommended for patients unable to take capsules or tablets. Administer 2 hours by peripheral or central vein.
Preparation of oral suspension: Tap the closed bottle several times to loosen the powder. Measure 94 mL of water in a graduated cylinder Add at 1/2 the total amount of water for constitution to the bottle and shake the closed bottle well for about 1 minute. Add the remainder of water and shake the closed bottle well for about 1 minute. Remove the child-resistant cap and push bottle adapter into neck of bottle. Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap. Preparation of infusion solution (6 mg/mL). Mycophenolate IV must be reconstituted and diluted to a concentration of 6 mg/mL using 5% Dextrose Injection. Mycophenolate IV is incompatible with other IV infusion solutions.
Mycophenolate IV does not contain an antibacterial preservative; use within 4 hours of reconstitution and dilution.
Reconstitute the contents of each vial with 14 mL of 5% Dextrose Injection. Gently shake the vial to dissolve the drug. The resulting solution is slightly yellow. Discard the vial if particulate matter of discoloration is observed.
Further dilute the contents of 2 reconstituted vials (for a 1 g dose) into 140 mL of 5% Dextrose Injection or 3 reconstituted vials (for a 1.5 g dose) into 210 mL of 5% Dextrose Injection. The final concentration of both solutions is 6 mg/mL. Discard the infusion solution if particulate matter or discoloration is observed.
Dosage adjustments. In patients with severe chronic renal impairment (GFR 1 g administered twice a day; carefully observe these patients. No dose adjustments are needed in patients experiencing delayed graft function postoperatively. If neutropenia develops, interrupt dosing or reduce the dose, pet-form appropriate diagnostic tests, and appropriately manage the patient.
Handling/Disposal: Because mycophenolate has demonstrated teratogenic effects in tats and rabbits, do not crush tablets, and do not open or crush the capsules. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in mycophenolate capsules, oral suspension, and injection (before or after constitution). If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water. Should a spill occur, wipe up using paper towels wetted with water to remove spilled powder or suspension.
Admixture incompatibility: Do not mix or administer mycophenolate IV concurrently via the same infusion catheter with other IV drugs or infusion admixtures.

Actions
Pharmacology: Mycophenolate is rapidly absorbed following oral administration and hydrolyzed to form MPA, which is the active metabolite. 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 without incorporation into DNA.
Pharmacokinetics:
Absorption/Distribution - Following oral and IV administration, mycophenolate undergoes rapid and extensive absorption and complete pre-systemic metabolism to MPA, the active metabolite.
In 12 healthy volunteers, the mean absolute bioavailability of oral mycophenolate relative to IV mycophenolate (based on MPA AUG) was 94%. The AUC for MPA appeals to increase in a dose-proportional fashion in renal transplant patients receiving multiple doses of mycophenolate up to a daily dose of 3 g.
Immediately post-transplant ( Metabolism - In addition to MPA, other metabolites of the 2-hydtoxyethyl-mor-pholino moiety are also recovered in the urine.
Excretion - Negligible amount of drug is excreted as MPA (

Contraindications
Hypersensitivity to the drag, mycophenolic acid, or any component of the drug product; people with a sensitivity to polysorbate 80 (Tween) (IV only).

Warnings
Lymphomas/Malignancies: Patients receiving immunosuppressive regimens involving combinations of drugs, including mycophenolate, as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies particularly of the skin. Lymphoproliferative disease or lymphoma developed in 0.4% to 1% of patients in the controlled studies of prevention of rejection.
Instruct patients to limit exposure to sunlight and UV light by wearing protective clothing and using a strong sunscreen. Neutropenia; Up to 2% of renal transplant patients, up to 3.6% of hepatic transplant patients, and up to 2.8% of cardiac transplant patients receiving mycophenolate developed severe neutropenia. Neutropenia has been observed most frequently in the period from 31 to 180 days post-transplant in patients treated for prevention of rejection.
Renal function impairment: Avoid mycophenolate doses > 1 g administered twice a day and carefully observe patients.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment. Mycophenolate may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
Elderly: Elderly patients, particularly those who are receiving mycophenolate as part of a combination immunosuppressive regimen, may be at increased risk of certain infections (including CMV tissue invasive disease) and possibly GI hemorrhage and pulmonary edema, compared with younger individuals.
Pregnancy: Category C.
Lactation: It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from mycophenolate, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
Children. Safety and efficacy have not been established.

Precautions
Monitoring. Perform CBCs weekly during the first month of treatment, twice monthly for the second and third months, then monthly through the first year.
GI hemorrhage: GI tract hemorrhage has been observed in 3% of renal transplants, 5.4% of hepatic transplants, and 1.7% of cardiac transplants treated with mycophenolate 3 g/day. GI tract perforations rarely have been observed.
Delayed graft function: In patients with delayed graft function post-transplant, mean MPA AUC was comparable, but MPAG AUC was 2- to 3-fold higher compared to that seen in post-transplant patients without delayed graft function. No dose adjustment is recommended for these patients; however, they should be carefully observed.
Rare hereditary deficiency: On theoretical grounds, because mycophenolate is an inosine monophosphate dehydrogenase (IMPDH) inhibitor, avoid in patients with rate hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT), such as Lesch-Nyhan and Kelley-Seegmiller syndromes.
Phenylketonuria. Mycophenolate oral suspension contains aspartame, a source of phenylalanine (0.56 mg phenylalanine/mL suspension). Therefore, take care if the oral suspension is administered to patients with phenylketonuria.

Drug Interactions
Drugs that alter the GI flora: Drugs that alter the GI flora may interact with mycophenolate by disrupting enterohepatic recirculation. Interference of MPAG hydrolysis may lead to less MPA available for absorption.
Drugs that may be affected by mycophenolate include acyclovir, ganciclovir, live attenuated vaccines, oral contraceptives, phenytoin, and theophylline.
Drugs that may affect mycophenolate include acyclovir, antacids, azathioprine, cholestyramine, ganciclovir, iron, probenecid, and salicylates.
Drug/Food interactions: Food (27 g fat, 650 calories) had no effect on the extent of absorption (MPA AUC) of mycophenolate when administered at doses of 1.5 g twice-daily to renal transplant patients. However, MPA Cmax was decreased by 40% in the presence of food.

Adverse Reactions
The principal adverse reactions associated with mycophenolate include diarrhea, leukopenia, sepsis, and vomiting, and there is evidence of a higher frequency of certain types of infections.
Adverse reactions occurring in > 10% of patients include pain; abdominal pain; fever; headache; infection; pain; accidental injury; chills; ascites; hernia; amblyopia; peritonitis; sepsis; asthenia; chest pain; back pain; hypertension; hypotension; cardiovascular disorder; tachycardia; arrhythmia; bradycardia; pericardial effusion; heart failure; anemia; leukopenia; ecchymosis; thrombocytopenia; hypochromic anemia; leukocytosis; urinary tract infection; oliguria; kidney tubular necrosis; hematuria; kidney tubular necrosis; peripheral edema; hypercholesterolemia; hypophosphatemia; edema; hyperglycemia; liver function tests, abnormal; creatinine increased; BUN increased; LDH increased; bilirubinemia; hypervolemia; hyperuricemia; AST increased; hypomagnesemia; acidosis; weight gain; ALT increased; hyponatremia; hyperlipemia; hypocalcemia; hypoproteinemia; hypoglycemia; healing abnormal; hypokalemia; hyperkalemia; diarrhea; constipation; nausea; dyspepsia; vomiting; flatulence; abdomen enlarged; anorexia; cholangitis; hepatitis; cholestatic jaundice; oral moniliasis; dyspnea; cough increased; lung disorder; sinusitis; rhinitis; pleural effusion; asthma; atelectasis; pharyngitis; pneumonia; acne; rash; skin disorder; pruritus; sweating; tremor; insomnia; anxiety; paresthesia; hypertonia; depression; agitation; somnolence; confusion; nervousness; dizziness; leg cramps; myasthenia; myalgia.
Patients receiving mycophenolate 2 g/day had an overall better safety profile than did patients receiving 3 g/day. Sepsis, which was generally CMV viremia, was slightly more common in renal transplant patients treated with mycophenolate, compared with patients receiving azathioprine. The incidence of sepsis was comparable to mycophenolate and in azathioprine-treated patients in cardiac and hepatic studies. In the digestive system, diarrhea was increased in renal and cardiac transplant patients receiving mycophenolate compared with patients receiving azathioprine, but was comparable in hepatic transplant patients treated with mycophenolate or azathioprine. Severe neutropenia developed in GENERAL HEALTH

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