Cellcept Information
Cellcept (Mycophenolate) Description
Cellcept (Mycophenolate) (mycophenolate mofetil) is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.
The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of CHNO, a molecular weight of 433.50, and the following structural formula:
Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group.
Mycophenolate mofetil hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1.
Cellcept (Mycophenolate) is available for oral administration as capsules containing 250 mg of mycophenolate mofetil, tablets containing 500 mg of mycophenolate mofetil, and as a powder for oral suspension, which when constituted contains 200 mg/mL mycophenolate mofetil.
Inactive ingredients in Cellcept (Mycophenolate) 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.
Inactive ingredients in Cellcept (Mycophenolate) 500 mg tablets include black iron oxide, croscarmellose sodium, FD&C blue #2 aluminum lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone (K-90), red iron oxide, talc, and titanium dioxide; may also contain ammonium hydroxide, ethyl alcohol, methyl alcohol, n-butyl alcohol, propylene glycol, and shellac.
Inactive ingredients in Cellcept (Mycophenolate) Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum.
Cellcept (Mycophenolate) Intravenous is the hydrochloride salt of mycophenolate mofetil. The chemical name for the hydrochloride salt of mycophenolate mofetil is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of CHNO HCl and a molecular weight of 469.96.
Cellcept (Mycophenolate) Intravenous is available as a sterile white to off-white lyophilized powder in vials containing mycophenolate mofetil hydrochloride for administration by intravenous infusion only. Each vial of Cellcept (Mycophenolate) Intravenous contains the equivalent of 500 mg mycophenolate mofetil as the hydrochloride salt. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide may have been used in the manufacture of Cellcept (Mycophenolate) Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of mycophenolate mofetil, 6 mg/mL. (For detailed method of preparation, see ).
Cellcept (Mycophenolate) Clinical Pharmacology
Mycophenolate mofetil has been demonstrated in experimental animal models to prolong the survival of allogeneic transplants (kidney, heart, liver, intestine, limb, small bowel, pancreatic islets, and bone marrow).
Mycophenolate mofetil has also been shown to reverse ongoing acute rejection in the canine renal and rat cardiac allograft models. Mycophenolate mofetil also inhibited proliferative arteriopathy in experimental models of aortic and cardiac allografts in rats, as well as in primate cardiac xenografts. Mycophenolate mofetil was used alone or in combination with other immunosuppressive agents in these studies. Mycophenolate mofetil has been demonstrated to inhibit immunologically mediated inflammatory responses in animal models and to inhibit tumor development and prolong survival in murine tumor transplant models.
Mycophenolate mofetil 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. 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, MPA has potent cytostatic effects on lymphocytes. MPA inhibits proliferative responses of T- and B-lymphocytes to both mitogenic and allospecific stimulation. Addition of guanosine or deoxyguanosine reverses the cytostatic effects of MPA on lymphocytes. MPA also suppresses antibody formation by B-lymphocytes. MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. Mycophenolate mofetil did not inhibit early events in the activation of human peripheral blood mononuclear cells, such as the production of interleukin-1 (IL-1) and interleukin-2 (IL-2), but did block the coupling of these events to DNA synthesis and proliferation.
Cellcept (Mycophenolate) Clinical Studies
A double-blind, randomized, comparative, parallel-group, multicenter study in primary cardiac transplant recipients was performed at 20 centers in the United States, 1 in Canada, 5 in Europe and 2 in Australia. The total number of patients enrolled was 650; 72 never received study drug and 578 received study drug. Patients received Cellcept (Mycophenolate) 1.5 g bid (n=289) or azathioprine 1.5 to 3 mg/kg/day (n=289), in combination with cyclosporine (Sandimmune or Neoral) and corticosteroids as maintenance immunosuppressive therapy. The two primary efficacy endpoints were: (1) the proportion of patients who, after transplantation, had at least one endomyocardial biopsy-proven rejection with hemodynamic compromise, or were retransplanted or died, within the first 6 months, and (2) the proportion of patients who died or were retransplanted during the first 12 months following transplantation. Patients who prematurely discontinued treatment were followed for the occurrence of allograft rejection for up to 6 months and for the occurrence of death for 1 year.
(1) Rejection:
Cellcept (Mycophenolate) Contraindications
Allergic reactions to Cellcept (Mycophenolate) have been observed; therefore, Cellcept (Mycophenolate) is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. Cellcept (Mycophenolate) Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
Cellcept (Mycophenolate) Warnings
(see )
Patients receiving immunosuppressive regimens involving combinations of drugs, including Cellcept (Mycophenolate) , as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see ). The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
As usual for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Lymphoproliferative disease or lymphoma developed in 0.4% to 1% of patients receiving Cellcept (Mycophenolate) (2 g or 3 g) with other immunosuppressive agents in controlled clinical trials of renal, cardiac, and hepatic transplant patients (see ).
In pediatric patients, no other malignancies besides lymphoproliferative disorder (2/148 patients) have been observed (see ).
Immunosuppressed patients are at increased risk for opportunistic infections, including activation of latent viral infections. These include cases of progressive multifocal leukoencephalopathy (PML) and BK virus-associated nephropathy (BKVAN) which have been observed in patients receiving immunosuppressants, including Cellcept (Mycophenolate) .
Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with Cellcept (Mycophenolate) . Hemiparesis, apathy, confusion, cognitive deficiencies and ataxia were the most frequent clinical features observed. The reported cases generally had risk factors for PML, including treatment with immunosuppressant therapies and impairment of immune function. In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms and consultation with a neurologist should be considered as clinically indicated. Consideration should be given to reducing the amount of immunosuppression in patients who develop PML. In transplant patients, physicians should also consider the risk that reduced immunosuppression represents to the graft.
BKVAN is associated with serious outcomes, including deteriorating renal function and renal graft loss (see ). Patient monitoring may help detect patients at risk for BK virus-associated nephropathy. Reduction in immunosuppression should be considered for patients who develop evidence of BK virus-associated nephropathy.
Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 1 week prior to beginning therapy. Cellcept (Mycophenolate) therapy should not be initiated until a negative pregnancy test report is obtained.
Women of childbearing potential (including pubertal girls and peri-menopausal women) taking Cellcept (Mycophenolate) must receive contraceptive counseling and use effective contraception. The patient should begin using her two chosen methods of contraception 4 weeks prior to starting Cellcept (Mycophenolate) therapy, unless abstinence is the chosen method. She should continue contraceptive use during therapy and for 6 weeks after stopping Cellcept (Mycophenolate) . Patients should be aware that Cellcept (Mycophenolate) reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness (see and ).
Severe neutropenia [absolute neutrophil count (ANC)
Patients receiving Cellcept (Mycophenolate) should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with Cellcept (Mycophenolate) in combination with other immunosuppressive agents. The mechanism for mycophenolate mofetil induced PRCA is unknown; the relative contribution of other immunosuppressants and their combinations in an immunosuppression regimen are also unknown. In some cases, PRCA was found to be reversible with dose reduction or cessation of Cellcept (Mycophenolate) therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.
CAUTION: Cellcept (Mycophenolate) INTRAVENOUS SOLUTION SHOULD NEVER BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.
Cellcept (Mycophenolate) Precautions
Gastrointestinal bleeding (requiring hospitalization) has been observed in approximately 3% of renal, in 1.7% of cardiac, and in 5.4% of hepatic transplant patients treated with Cellcept (Mycophenolate) 3 g daily. In pediatric renal transplant patients, 5/148 cases of gastrointestinal bleeding (requiring hospitalization) were observed.
Gastrointestinal perforations have rarely been observed. Most patients receiving Cellcept (Mycophenolate) were also receiving other drugs known to be associated with these complications. Patients with active peptic ulcer disease were excluded from enrollment in studies with mycophenolate mofetil. Because Cellcept (Mycophenolate) has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, hemorrhage, and perforation, Cellcept (Mycophenolate) should be administered with caution in patients with active serious digestive system disease.
Subjects with severe chronic renal impairment (GFR
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment. Cellcept (Mycophenolate) may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
In patients with delayed renal graft function posttransplant, mean MPA AUC(0-12h) was comparable, but MPAG AUC(0-12h) was 2-fold to 3-fold higher, compared to that seen in posttransplant patients without delayed renal graft function. In the three controlled studies of prevention of renal rejection, there were 298 of 1483 patients (20%) with delayed graft function. Although patients with delayed graft function have a higher incidence of certain adverse events (anemia, thrombocytopenia, hyperkalemia) than patients without delayed graft function, these events were not more frequent in patients receiving Cellcept (Mycophenolate) than azathioprine or placebo. No dose adjustment is recommended for these patients; however, they should be carefully observed (see and).
In cardiac transplant patients, the overall incidence of opportunistic infections was approximately 10% higher in patients treated with Cellcept (Mycophenolate) than in those receiving azathioprine therapy, but this difference was not associated with excess mortality due to infection/sepsis among patients treated with Cellcept (Mycophenolate) (see ).
There were more herpes virus (H. simplex, H. zoster, and cytomegalovirus) infections in cardiac transplant patients treated with Cellcept (Mycophenolate) compared to those treated with azathioprine (see ).
It is recommended that Cellcept (Mycophenolate) not be administered concomitantly with azathioprine because both have the potential to cause bone marrow suppression and such concomitant administration has not been studied clinically.
In view of the significant reduction in the AUC of MPA by cholestyramine, caution should be used in the concomitant administration of Cellcept (Mycophenolate) with drugs that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Cellcept (Mycophenolate) (see ).
On theoretical grounds, because Cellcept (Mycophenolate) is an IMPDH (inosine monophosphate dehydrogenase) inhibitor, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
During treatment with Cellcept (Mycophenolate) , the use of live attenuated vaccines should be avoided and patients should be advised that vaccinations may be less effective (see).
In a 104-week oral carcinogenicity study in mice, mycophenolate mofetil in daily doses up to 180 mg/kg was not tumorigenic. The highest dose tested was 0.5 times the recommended clinical dose (2 g/day) in renal transplant patients and 0.3 times the recommended clinical dose (3 g/day) in cardiac transplant patients when corrected for differences in body surface area (BSA). In a 104-week oral carcinogenicity study in rats, mycophenolate mofetil in daily doses up to 15 mg/kg was not tumorigenic. The highest dose was 0.08 times the recommended clinical dose in renal transplant patients and 0.05 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. While these animal doses were lower than those given to patients, they were maximal in those species and were considered adequate to evaluate the potential for human risk (see ).
The genotoxic potential of mycophenolate mofetil was determined in five assays. Mycophenolate mofetil was genotoxic in the mouse lymphoma/thymidine kinase assay and the in vivo mouse micronucleus assay. Mycophenolate mofetil was not genotoxic in the bacterial mutation assay, the yeast mitotic gene conversion assay or the Chinese hamster ovary cell chromosomal aberration assay.
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. This dose represents 0.1 times the recommended clinical dose in renal transplant patients and 0.07 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (principally of the head and eyes) in the first generation offspring in the absence of maternal toxicity. This dose was 0.02 times the recommended clinical dose in renal transplant patients and 0.01 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.
Based on pharmacokinetic and safety data in pediatric patients after renal transplantation, the recommended dose of Cellcept (Mycophenolate) oral suspension is 600 mg/m bid (up to a maximum of 1 g bid). Also see and.
Safety and effectiveness in pediatric patients receiving allogeneic cardiac or hepatic transplants have not been established.
Cellcept (Mycophenolate) Adverse Reactions
The principal adverse reactions associated with the administration of Cellcept (Mycophenolate) include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections eg, opportunistic infection (see and ). The adverse event profile associated with the administration of Cellcept (Mycophenolate) Intravenous has been shown to be similar to that observed after administration of oral dosage forms of Cellcept (Mycophenolate) .
The adverse event profile of Cellcept (Mycophenolate) Intravenous was determined from a single, double-blind, controlled comparative study of the safety of 2 g/day of intravenous and oral Cellcept (Mycophenolate) in renal transplant patients in the immediate posttransplant period (administered for the first 5 days). The potential venous irritation of Cellcept (Mycophenolate) Intravenous was evaluated by comparing the adverse events attributable to peripheral venous infusion of Cellcept (Mycophenolate) Intravenous with those observed in the intravenous placebo group; patients in this group received active medication by the oral route.
Adverse events attributable to peripheral venous infusion were phlebitis and thrombosis, both observed at 4% in patients treated with Cellcept (Mycophenolate) Intravenous.
In the active controlled study in hepatic transplant patients, 2 g/day of Cellcept (Mycophenolate) Intravenous were administered in the immediate posttransplant period (up to 14 days). The safety profile of intravenous Cellcept (Mycophenolate) was similar to that of intravenous azathioprine.
Cellcept (Mycophenolate) Overdosage
The experience with overdose of Cellcept (Mycophenolate) in humans is very limited. The events received from reports of overdose fall within the known safety profile of the drug. The highest dose administered to renal transplant patients in clinical trials has been 4 g/day. In limited experience with cardiac and hepatic transplant patients in clinical trials, the highest doses used were 4 g/day or 5 g/day. At doses of 4 g/day or 5 g/day, there appears to be a higher rate, compared to the use of 3 g/day or less, of gastrointestinal intolerance (nausea, vomiting, and/or diarrhea), and occasional hematologic abnormalities, principally neutropenia, leading to a need to reduce or discontinue dosing.
In acute oral toxicity studies, no deaths occurred in adult mice at doses up to 4000 mg/kg or in adult monkeys at doses up to 1000 mg/kg; these were the highest doses of mycophenolate mofetil tested in these species. These doses represent 11 times the recommended clinical dose in renal transplant patients and approximately 7 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In adult rats, deaths occurred after single-oral doses of 500 mg/kg of mycophenolate mofetil. The dose represents approximately 3 times the recommended clinical dose in cardiac transplant patients when corrected for BSA.
MPA and MPAG are usually not removed by hemodialysis. However, at high MPAG plasma concentrations (>100 µg/mL), small amounts of MPAG are removed. By increasing excretion of the drug, MPA can be removed by bile acid sequestrants, such as cholestyramine (see ).
Cellcept (Mycophenolate) Dosage And Administration
The initial oral dose of Cellcept (Mycophenolate) should be given as soon as possible following renal, cardiac or hepatic transplantation. Food had no effect on MPA AUC, but has been shown to decrease MPA Cby 40%. Therefore, it is recommended that Cellcept (Mycophenolate) be administered on an empty stomach. However, in stable renal transplant patients, Cellcept (Mycophenolate) may be administered with food if necessary.
Note:
It is recommended that Cellcept (Mycophenolate) Oral Suspension be constituted by the pharmacist prior to dispensing to the patient.
Cellcept (Mycophenolate) Oral Suspension should not be mixed with any other medication.
Mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits. There are no adequate and well-controlled studies in pregnant women (see and). Care should be taken to avoid inhalation or direct contact with skin or mucous membranes of the dry powder or the constituted suspension. If such contact occurs, wash thoroughly with soap and water; rinse eyes with water.
Dispense with patient instruction sheet and oral dispensers. It is recommended to write the date of expiration of the constituted suspension on the bottle label. (The shelf-life of the constituted suspension is 60 days.)
After constitution the oral suspension contains 200 mg/mL mycophenolate mofetil. Store constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Storage in a refrigerator at 2° to 8°C (36° to 46°F) is acceptable. Do not freeze. Discard any unused portion 60 days after constitution.
Caution should be exercised in the handling and preparation of solutions of Cellcept (Mycophenolate) Intravenous. Avoid direct contact of the prepared solution of Cellcept (Mycophenolate) Intravenous with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water (see and).
Cellcept (Mycophenolate) Intravenous does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions. Additionally, this product is sealed under vacuum and should retain a vacuum throughout its shelf life. If a lack of vacuum in the vial is noted while adding diluent, the vial should not be used.
Cellcept (Mycophenolate) Intravenous infusion solution must be prepared in two steps: the first step is a reconstitution step with 5% Dextrose Injection USP, and the second step is a dilution step with 5% Dextrose Injection USP. A detailed description of the preparation is given below:
Step 1
Step 2
If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 4 hours from reconstitution and dilution of the drug product. Keep solutions at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Cellcept (Mycophenolate) Intravenous should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.
In renal transplant patients with severe chronic renal impairment (GFR
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment. Cellcept (Mycophenolate) may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
If neutropenia develops (ANC
Cellcept (Mycophenolate) Handling And Disposal
Mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits (see ). Cellcept (Mycophenolate) tablets should not be crushed and Cellcept (Mycophenolate) capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Cellcept (Mycophenolate) capsules and Cellcept (Mycophenolate) Oral Suspension (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. Caution should be exercised in the handling and preparation of solutions of Cellcept (Mycophenolate) Intravenous. Avoid direct contact of the prepared solution of Cellcept (Mycophenolate) Intravenous with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Cellcept (Mycophenolate) Medication Guide
Read the Medication Guide that comes with Cellcept (Mycophenolate) before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.
Cellcept (Mycophenolate) is a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant. Rejection is when the body's immune system perceives the new organ as a "foreign" threat and attacks it.
Cellcept (Mycophenolate) is used with other medicines called cyclosporine (Sandimmune, Gengraf, Neoral) and corticosteroids. These medicines work together to prevent rejection to your transplanted organ.
Cellcept (Mycophenolate) has been used safely and works in children who received a kidney transplant as it does in adults. It is not known if Cellcept (Mycophenolate) is safe and works in children who receive a heart or liver transplant.
Tell your healthcare provider about all of your medical conditions, if you:
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. Do not take any new medicine without talking with your healthcare provider.
Side effects that happen more often in children than in adults taking Cellcept (Mycophenolate) include:
These are not all of the possible side effects of Cellcept (Mycophenolate) . Tell your healthcare provider about any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or to Genentech at 1-888-835-2555.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Cellcept (Mycophenolate) for a condition for which it was not prescribed. Do not give Cellcept (Mycophenolate) to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Cellcept (Mycophenolate) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Cellcept (Mycophenolate) that is written for healthcare professionals. For more information, call 1-888-835-2555 or visit www.gene.com/gene/products/information/Cellcept (Mycophenolate) .
This Medication Guide has been approved by the US Food and Drug Administration.
Cellcept (Mycophenolate) , CYTOVENE-IV, and VALCYTE are registered trademarks of Hoffmann-La Roche Inc.BACTRIM and BACTRIM DS are trademarks of Hoffmann-La Roche Inc.
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Repackaged by:
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MG Revised: February 2010
For additional copies of this Medication Guide, please call 1-800-617-8191 or visit www.gene.com/gene/products/information/Cellcept (Mycophenolate) .
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Representative sample of labeling (see the section for complete listing):
Cellcept (Mycophenolate) Principal Display Panel - Mg Capsule Carton
NDC 21695-171-00
Each capsule contains250 mg mycophenolate mofetil.
100 capsules
