May 01, 2019 this medication guide summarizes the most important information about mycophenolate mofetil capsules. Cellcept is the brand name of the prescription drug mycophenolate mofetil, used to prevent organ rejection in people whove had a kidney, heart, or liver transplant. Contraindications hypersensitivity to mycophenolate mofetil, mycophenolic acid, mycophenolate sodium, or any component of the formulation. Some clinicians have greater experience prescribing mycophenolate mofetil. See full prescribing information for cellcept cellcept mycophenolate mofetilcapsules, for oral use cellcept mycophenolate mofetiltablets, for oral use. On november 8, 2007, roche, the maker of cellcept, submitted an evaluation of its pml cases in patients who have received cellcept in addition to other immunosuppressive medicines. Our cellcept mycophenolate mofetil side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Percentages of adverse reactions were similar in studies comparing cellcept to myfortic in patients following renal transplant. These highlights do not include all the information needed to use uloric safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use procrit safely and effectively. Prescribing to be initiated by a hospital specialist or if appropriate by a gp with specialist interest but with the potential to transfer to primary care. Please refer to the full prescribing information for additional adverse reactions. For example, cellcept and some reflux drugs shouldnt be taken at the same time.
Mycophenolate mofetil oral dosage forms oral suspension should not be used interchangeably with mycophenolic acid delayedrelease tablets. You can ask your doctor or pharmacist for information about cellcept that is written for healthcare professionals. Neoral soft gelatin capsules cyclosporine capsules, usp. Phlebitis and thrombosis have been reported with intravenous administration. Not all patients who take cellcept experience side effects. I took my nexium an hour or two before taking the cellcept.
Some of these opinions may contain information about treatments or uses of drug products that have not been approved by the u. Cellcept should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year. Important changes in the cellcept mycophenolate mofetil prescribing information. Procrit epoetin alfa injection, for intravenous or subcutaneous use initial u. Neoral soft gelatin capsules cyclosporine capsules, usp modified neoral oral solution cyclosporine oral solution, usp modified rx only prescribing information warning only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe neoral. Cellcept mycophenolate mofetil side effects, dosage. Highlights of prescribing information these highlights do not include all the information needed to use remodulin safely and effectively. The fda has asked novartis, the maker of myfortic, for data on pml cases and to revise the myfortic prescribing information to include the same information about pml included in the cellcept prescribing. Myfortic delayed release tablets and mycophenolate mofetil tablets and capsules. Autoimmune hepatitis aih is a chronic disease of unknown cause with persistent inflammation of the liver and the potential for necrosis and progression to cirrhosis associated with it. Side effects of cellcept mycophenolate mofetil, warnings. Highlights of prescribing information these highlights do not include all the information needed to use myfortic safely and effectively. If you would like more information, talk with your doctor.
Mycophenolate mofetil cellcept mycophenolate mofetil mmf is fda approved for prophylaxis of organ rejection concomitantly with cyclosporine and corticosteroids in patients receiving allogenic renal cellcept, myfortic, cardiac cellcept, or hepatic cellcept. Tell your healthcare provider about all of the medicines you take, including prescription and. Please see the enclosed cellcept complete prescribing information, which includes additional information for warnings, precautions, and dosage and administration. Before prescribing cellcept oral suspension to a patient with pku, consider the combined daily amount of phenylalanine from all sources, including cellcept. What is the most important information i should know about cellcept.
Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. Myfortic mycophenolic acid delayedrelease tablets, for oral use initial u. Cellcept potentially can cause a number of side effects. Mycophenolate suspension fda prescribing information, side. New cellcept mycophenolate mofetil medication guide. The expectation is that these guidelines should provide sufficient information to enable gps to be confident to take clinical and legal responsibility for. Do prescribers have to be trained in the mycophenolate rems in order to prescribe mycophenolatecontaining products. Risk of thyroid ccell tumors see full prescribing information for complete boxed warning. Cellcept, myfortic linked to progressive multifocal. Learn about the cellcept copay card and how cellcept mycophenolate mofetil is used for people who have had a kidney, heart, or liver transplant. Before prescribing cellcept oral suspension to a patient with pku, consider the combined daily amount of phenylalanine from all. Read the medication guide that comes with cellcept before you start taking it and each time you refill your prescription. Cellcept, innmycophenolate mofetil european medicines agency. Table 8 of the adverse reactionssection of the cellcept prescribing information.
Dailymed cellcept mycophenolate mofetil tablet, film. You can ask your doctor or pharmacist for information about mycophenolate mofetil capsules that is written for health professionals. Highlights of prescribing information procrit epoetin alfa. Highlights of prescribing information these highlights do not include all the information needed to use cimzia safely and effectively. Reporting adverse events health care providers and patients are encouraged to report adverse events in patients taking cellcept to genentech at 18888352555. See full prescribing information for complete boxed warning. Cimzia certolizumab pegol for injection, for subcutaneous use cimzia certolizumab pegol injection, for subcutaneous use initial u.
If you are woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription as mycophenolate causes birth defects. The chemical name for mycophenolate mofetil mmf is 2morpholinoethyl e61,3. These highlights do not include all the information needed to use cellcept. Dec 19, 2019 these highlights do not include all the information needed to use cellcept safely and effectively. Advise the patient to read the fdaapproved patient labeling patient information. Antihemophilic factorvon willebrand factor complex human, humatep is approved to treat and prevent bleeding in adult patients with hemophilia a classical hemophilia. It is not intended to be and should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease.
Cellcept fda prescribing information, side effects and uses. Healthcare professionals are not required to complete the mycophenolate rems prescriber training confirmation form in order to prescribe mycophenolatecontaining medicines. Use of cellcept is associated with increased pregnancy loss and congenital malformationschange from pregnancy category c to pregnancy category d. Mycophenolate mofetil cellcept us fda approved prescribing. It was mandated by the food and drug administration fda. The content on the uptodate website is not intended nor recommended as a substitute for medical advice, diagnosis, or treatment. Mar 19, 2014 there is a lot of information on taking cellcept that i didnt know and wasnt informed of by my doc or the med sheet that came with the cellcept. Tanzeum albiglutide for injection, for subcutaneous use initial u. However, healthcare professionals who prescribe mycophenolatecontaining medicines will be. See full prescribing information for instructions on reconstitution of vfend lyophilized powder for intravenous use and reconstitution of vfend oral suspension and important administration instructions 2. Full prescribing information 1 indications and usage dupixent is indicated for the following diseases. Vfend voriconazole tablets, for oral use vfend voriconazole for oral suspension vfend voriconazole for injection, for intravenous use initial u. Nov 27, 2018 this medication guide summarizes the most important information about cellcept. Mycophenolate mofetil fda prescribing information, side.
These highlights do not include all the information needed to use tanzeum safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use cellcept safely and effectively. Roche also submitted recommendations to the fda for including information about pml in. These highlights do not include all the information needed to use vfend safely and effectively. Always seek the advice of your own physician or other qualified health care professional regarding any medical questions or conditions. The content on this site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. These highlights do not include all the information needed to use flolan safely and effectively. Preserve your branded choice remember to indicate daw dispense as written on each prescription, to preserve your branded choice. Cellcept oral suspension contains aspartame, a source of phenylalanine 0.
Highlights of prescribing information these highlights. If you experience side effects after starting what is cellcept. Highlights of prescribing information these highlights do. By indicating daw dispense as written on your cellcept prescription or through your eprescribing tool, your patient will get brandname medicine at the pharmacy. These highlights do not include all the information needed to. Prescribing brandname cellcept mycophenolate mofetil.
These highlights do not include all the information needed to use thymoglobulin safely and effectively. The mycophenolate rems is a program to tell doctors, nurses, pharmacists and patients about the risks of taking mycophenolate during pregnancy. Flolan epoprostenol sodium for injection, for intravenous use. Roche is committed to ensuring patients understand the benefits and risks associated with cellcept therapy. Call your doctor for medical advice about side effects. Shared care prescribing guideline mycophenolate mofetil for. Highlights of prescribing information an initial dose. Webmd does not endorse any specific product, service or treatment. Dec 01, 2019 cellcept official prescribing information for healthcare professionals. Mycophenolate reference guide for safe and effective use from the american society of. Prograf tacrolimus capsules, for oral use prograf tacrolimus injection, for intravenous use prograf granules tacrolimus for oral suspension. C ellcept mycophenolate mofetil is an immunosuppressive medication used to lower the bodys natural immunity in patients who receive organ transplants. The adverse event profile associated with the administration of cellcept intravenous has been shown to be similar to that observed after administration of oral dosage forms of cellcept. If you have any questions or require additional information regarding the use of cellcept, please.
The physician responsible for maintenance therapy should have complete information requisite for the followup of the patient. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesisstimulating agents esas to target a. Citalopram marketed as celexa is included in the class of drugs called selective serotonin reuptake inhibitors ssris. By indicating daw dispense as written on your cellcept prescription or through your e prescribing tool, your patient will get brandname medicine at the pharmacy. See full prescribing information for cellcept cellcept mycophenolate mofetil capsules, for oral use cellcept mycophenolate mofetil tablets, for oral use cellcept oral suspension mycophenolate mofetil, for oral suspension cellcept intravenous mycophenolate mofetil for.
Patient information cellcept mycophenolate mofetil. See full prescribing information for mycophenolate mofetil. This medication guide does not take the place of talking with your doctor about your medical condition or treatment. Enclosed are copies of the cellcept medication guide and complete prescribing information. Remodulin treprostinil injection, for subcutaneous or intravenous initial u. Esas increase the risk of death, myocardial infarction. Female users of childbearing potential must use contraception. Highlights of prescribing information these highlights do not include all the information needed to use prograf safely and effectively. Cellcept mycophenolate mofetil for oral suspension.
There is not one specific trigger that is associated with the disease. Highlights of prescribing information these highlights do not. You and your doctor will decide if you will take cellcept or breastfeed. Aih can affect any ethnicity, and it appears to occur in women more frequently than in men. The chemical name for mycophenolate mofetil mmf is 2 morpholinoethyl e61,3. This is not a complete list of side effects and others may occur. Cellcept capsules should only be prescribed to patients with a body surface area of at least 1. The current prescribing information is also available on. Each state has its own laws to govern generic substitution by a pharmacist.
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