Afinitor is not for use in people with carcinoid tumors that actively produce hormones. Clinical pharmacy program guidelines for afinitor 1. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. The safety and effectiveness of afinitor in the treatment of patients with carcinoid tumors have not been established. Highlights of prescribing information palmarplantar. Highlights of prescribing information these highlights do not include all the information needed to use moviprep safely and effectively. Learn more about revlimid, a treatment option for multiple myeloma. Afinitor tablets should be swallowed whole with a glass of water. Indication and usage is recognized in nccn drugs and biologics compendium as a category 1 or 2a recommendation afinitor disperz subependymal giant cell. Now you can find the tools you need to help manage your patients, all in one place. Refer to everolimus prescribing information for recommended everolimus dosing information. This web site contains information relating to various medical conditions and treatment.
For patients unable to swallow tablets, afinitor tablets should be dispersed completely in a glass of water containing approximately 30 ml by gently stirring, immediately prior to drinking. This medication guide provides information only about about zortress. Medication policies are developed to help ensure safe, effective and appropriate use of selected medications. See 17 for patient counseling information and fdaapproved patient labeling. Do not take aromasin if you are allergic to aromasin or to anything in it. Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.
Over the course of treatment, patients who tolerate inlyta for at least two consecutive weeks with no adverse reactions grade 2 according to the common toxicity criteria for adverse events ctcae, are normotensive, and are not receiving antihypertension medication, may. Food and drug administration approved everolimus afinitor, novartis for the treatment of adult patients with progressive, welldifferentiated nonfunctional. Highlights of prescribing information these highlights do not include all the information needed to use aromasin safely and effectively. Afinitor afinitor and afinitor disperz everolimus afinitor fep clinical rationale rationale for inclusion in pa program background afinitor is a macrolide immunosuppressant and a mechanistic target of rapamycin mtor inhibitor. Afinitor everolimus tablets for oral administration. Afinitor everolimus tablets is a prescription medicine used to treat adults with a kidney tumor called angiomyolipoma, seen with a genetic condition called tuberous sclerosis complex tsc, when their kidney tumor does not require surgery right away it is not known if afinitor is safe and effective in children to treat kidney tumors called angiomyolipoma, that can happen in children. Breast cancer authorization of 12 months may be granted to members prescribed afinitor in combination with. Page 3 of 44 full prescribing information 1 indications and usage 1. Everolimus is an orally administered inhibitor of the mammalian target of rapamycin mtor, an intracellular protein kinase downstream of the phosphatidylinositol 3kinaseakt pathway involved in. They offer a guide to coverage and are not intended to dictate to providers how to practice medicine. Zortress is indicated for the prophylaxis of organ rejection in adult patients at lowmoderate immunologic risk receiving a kidney transplant see clinical studies 14. Everolimus is an inhibitor of mtorc1 mammalian target of rapamycin complex 1. Adverse event management in patients with advanced cancer. Tablets containing sorafenib tosylate 274 mg equivalent to 200 mg of sorafenib.
Let your doctor know if you are taking or applying any medication that has estrogen in it including hormone replacement therapy or birth control pills or patches, or if you are taking any other medicines including overthe counter medicines, herbal supplements, and vitamins as they. Therapeutic drug monitoring tdm of everolimus and cyclosporine is recommended for all patients receiving these products see dosage and administration 2. Lenvima is used along with another medicine, everolimus, to treat adults with advanced renal cell carcinoma rcc, a type of kidney cancer, after one course of treatment with another anticancer medicine. Afinitor afinitor and afinitor disperz everolimus caremark. Restricted access do not disseminate or copy without approval.
The official website for afinitor everolimus tablets. Refer to the everolimus product monograph for details of nononcologic indications. Highlights of prescribing information these highlights do not include all the information needed to use feraheme safely and effectively. The nccn drugs and biologics compendium nccn compendium. Severe mucocutaneous reactions, some with fatal outcomes 5. Everolimus may also be used for purposes not listed in this medication guide. Mhlwpmda concluded that similar revision of the package insert for afinitor tablets 2. Afinitor is indicated for the treatment of progressive neuroendocrine tumors of pancreatic origin pnet in patients with unresectable, locally advanced or metastatic disease. See full prescribing information for afinitorafinitor disperz. In vitro, palbociclib is not an inhibitor of cyp1a2, 2a6, 2b6, 2c8, 2c9, 2c19, and 2d6, and is not an inducer of cyp1a2, 2b6, 2c8, and 3a4 at clinically relevant concentrations. Afinitor is a prescription medicine used to treat adults with a type of cancer known as neuroendocrine tumor net of the stomach and intestine gastrointestinal or lung that has progressed and cannot be treated with surgery. See full prescribing information for complete boxed warning.
The printed package leaflet of the medicinal product must state the name and. Method of administration afinitor should be administered orally once daily at the same time every day, consistently either with or without food see section 5. Highlights of prescribing information these highlights do not include all the information needed to use xermelo safely and effectively. Find information about afinitor, the conditions it treats, and important safety information. Nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on one side and 200 on the other side. For patients unable to swallow tablets, afinitor tablet s should be dispersed completely in a glass of water containing approximately 30 ml by gently stirring, immediately prior to drinking. Highlights of prescribing information these highlights. Afinitor and afinitor disperz are indicated for the treatment of. The safety and efficacy of afinitor in children aged 0 to 18 years have not been established. Zortress is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. Insert needle and inject all the liquid subcutaneously. Afinitor will be approved based on the following criterion.
Afinitor disperz is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tscassociated partialonset seizures. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Dailymed afinitor everolimus tablet afinitor disperz. The auc inf of everolimus was equivalent between afinitor disperz and afinitor. Modify the dosage for patients with hepatic impairment or for patients taking drugs that inhibit or induce pglycoprotein. On april 10, 2018, the food and drug administration approved everolimus tablets for oral. Afinitor is another brand of everolimus used to treat certain types of cancer. These highlights do not include all the information needed. Youll have access to the site in a moment, or click continue to close this message and advance directly to the site. Do not combine afinitor and afinitor disperz to achieve the total dose. Talk with your health care provider before taking afinitor if you are not sure if you take an ace inhibitor medicine.
Dose increase or reduction is recommended based on individual safety and tolerability. Refer to the qms everolimus assay package insert, included in the reagent kit, for a complete summary and explanation of the test. Select the recommended dosage form based on the indication see indications and usage 1. Afinitor is a macrolide immunosuppressant and a mechanistic target of rapamycin mtor inhibitor. Afinitor everolimus renal angiomyolipoma associated. Afinitor and afinitor disperz are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with tsc who have subependymal giant cell astrocytoma sega that requires therapeutic intervention but cannot be curatively resected. Monitor patients and discontinue rituxan infusion for severe reactions 5. Highlights of prescribing information these highlights do. Zortress is to be administered in combination with basiliximab induction and concurrently with.
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