Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Results from an eortc soft tissue and bone sarcoma group phase ii study. The recommended dosage of glivec is 400 mgday for adult patients in chronic phase cml and 600 mgday for patients in accelerated phase or blast crisis. Gist support international sometimes poses questions about imatinib gleevec to novartis, the manufacturer of the drug. Monitor patients and discontinue rituxan infusion for severe reactions 5. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. No evidence of disease progression for members who have been receiving imatinibgleevec for 12 months 3. Product monograph including patient medication information prgleevec imatinib mesylate tablets imatinib 100 mg and 400 mg tablets protein kinase inhibitor gleevec, indicated for the adjuvant treatment of adult patients who are at intermediate to high risk of relapse following complete resection of kit cd117 positive gist. Aggrenox is not interchangeable with the individual components of aspirin and dipyridamole tablets. Gleevec imatinib mesylate imatinib mesylate generic policy. Gleevec imatinib mesylatepackage insert east hanover, nj. Zytiga is used to treat men with prostate cancer that has spread to other parts of the body. Gleevec will be approved based on the following criterion.
Imlygictalimogene laherparepvec suspensionfor intralesionalinjection initial. 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. It is not known if zytiga is safe and effective in females or children. Gleevec is also used to treat certain tumors of the stomach and digestive system. Highlights of prescribing information these highlights do. Package insert gleevec imatinib mesylate 80 cyp3a4 substrates. Suboptimal response to or failure of imatinib treatment for chronic myeloid leukemia.
Fatal infusionrelated reactions within 24 hours of rituxan infusion. You will likely have many questions and may, at times, feel overwhelmed by all. Inject air into the vial and withdraw the quantity required for reconstitution. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended see warnings and precautions 5. Tablets containing sorafenib tosylate 274 mg equivalent to 200 mg of sorafenib. Invanz ertapenemfor injection for intravenous iv or intramuscular im use initial u. Highlights of prescribing information cardiac dysfunction. Nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on one side and 200 on the other side. Gleevec will be approved based on both of the following criteria. Dose increase or reduction is recommended based on individual safety and tolerability. The nccn drugs and biologics compendium nccn compendium. 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 anti. Gleevec is approved to treat certain cancers that affect the gastrointestinal tract, skin, blood, and bone marrow.
Zytiga abiraterone acetate is a prescription medicine that is used along with prednisone. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6. Gleevec can cause fetal harm when administered to a pregnant woman. Imatinib increased the mean cmax and auc of simvastatin cyp3a4 substrate 81 by 2 and 3. Imatinib mesylate was teratogenic in rats when administered during organogenesis at doses approximately equal to the maximum human dose of 800 mgday based on body surface area. Hepatotoxicity may be severe, and in some cases fatal. Gleevec for gleevec treatment can be given as a oncedaily dose or alternatively the daily dose may be split into two once in the morning and once in the evening. It is also approved to prevent recurrence of the disease after treatment with surgery. Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite. Imatinib mesylate sti571 glivec, gleevec is an active agent for gastrointestinal stromal tumours, but does not yield responses in other softtissue sarcomas that are unselected for a molecular target. Highlights of prescribing information known hypersensitivity.
Gleevec is approved to treat gist that cannot be treated with surgery or is metastatic. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesisstimulating agents esas to target a hemoglobin levelof greater than 11 gdl5. Review the prescribing information for nivolumab for full dosing and schedule information. Cyp3a4 inducers may decrease gleevec cmax and auc 2. Tasigna nilotinib capsules, for oral use initial u. The recommended dose of gleevec is 400 mgday for adult patients in chronic phase cml and 600 mgday for adult patients in accelerated phase or blast crisis. There is no experience with gleevec treatment in children under 2 years of age.
Hepatotoxicity has been observed in clinical trials and postmarketing experience. In clinical trials in cml, drug discontinuation for drugrelated adverse reactions was observed in. Imatinib treatments have longterm impact on placentation and. Imatinib inhibits bcrabl tyrosine kinase, the fusion protein created by the philadelphia chromosome abnormality that characterizes chronic. Sutent is used to treat advanced kidney cancer advanced renal cell carcinoma or rcc. Studies have not looked at the longterm effects of the drug on cancer recurrence. Zelboraf is not indicated for treatment of patients with wildtype braf melanoma. Suboptimal response to or failure of imatinib treatment.
Rebeca porto, md has kindly agreed to forward our questions to novartis, so replies may be addessed to her. Glivec, innimatinib european medicines agency europa eu. Gleevec imatinib mesylate tablets for oral use initial u. The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. Follow applicable special handling and disposal procedures. The nccn compendium is a derivative work of the nccn guidelines.
Imlygictalimogene laherparepvec suspensionfor intralesionalinjection initial u. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid. Gleevec should be taken with food and a large glass of water to minimize this problem. Highlights of prescribing information these highlights. No formal study of cyp3a4 inducers has been conducted, but a patient on chronic. Highlights of prescribing information these highlights do not include all the information needed to use imlygicsafely and effectively. Highlights of prescribing information these highlights do not. Cml resistant to or intolerant to prior therapy that included imatinib. Gleevec can lower blood cells that help your body fight infections and help your blood to clot. Aug 11, 2019 provides accurate and independent information on more than 24,000 prescription drugs, overthecounter medicines and natural products. Insert the needle of the syringe into the histidine diluent vial. There is no experience with gleevec treatment in children under 1 year.
In studies, gleevec helped prevent the return of cancer for an average of 14 months. Gleevec imatinib mesylate tablets, for oral use initial u. Gleevec imatinib gleevec fep clinical rationale rationale for inclusion in pa program background gleevec is an anticancer medicine that works as an inhibitor of bcrabl tyrosine kinase enzyme. It can be given to children as young as one year old.
Sutent is used to treat adults with kidney cancer that has not spread localized and who are at high risk of rcc coming back again after having kidney surgery. The printed package leaflet of the medicinal product must state the name and. There have been rare reports, including deaths, of stomach or intestinal perforation a small hole or tear. Prescription treatment with zytiga abiraterone acetate. Hepatotoxicity see full prescribing information for complete boxed warning. See full prescribing information for complete boxed warning. Sprycel dasatinib is a prescription medicine used to treat. Dose adjustments for lymphopenia low absolute lymphocyte count alc lab valuecellsmm3 recommendation alcgreater than or equal to500 maintain dose alcless than500 interrupt olumiant until alcgreater than or equal to500. Myelodysplastic disease mds myeloproliferative disease mpd 1.
The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Jul 01, 2019 gleevec is used to treat certain types of leukemia blood cancer, bone marrow disorders, and skin cancer. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults.
This enzyme is the abnormal tyrosine kinase created by the philadelphia chromosome abnormality in chronic myeloid leukemia. Use only the supplied adjuvant suspension component liquid for reconstitution. The initial discovery of kit mutations in gist by hirota in 1998 fortuitously coincided with the clinical application of imatinib gleevec for the treatment of the bcrabl kinase mutation that drives chronic myelogenous leukemia. Gleevec is sometimes associated with stomach or intestinal irritation. In children, gleevec treatment can be given as a oncedaily dose or alternatively the daily dose may be split into two once in the morning and once in the evening. Gleevec reference guide for safe and effective use from the american society of. If you are experiencing any of the abovementioned side effects, please be sure. The recommended dose of aggrenox is one capsule given orally twice daily, one in the morning and one in the evening. Insert the syringe needle containing the diluent into the novoseven rt vial through the center of the rubber stopper, aiming the needle against the side so that the stream of liquid. The recommended dosing parameters for all fdaapproved indications fall within the standard limits. Highlights of prescribing information these highlights do not include all the information needed to use tasignasafely and effectively.
All doses of gleevec should be taken with a meal and a large glass of water. These highlights do not include all the information needed to use gleevec safely and effectively. Referenced with permission from the nccn drugs and biologics compendium nccn compendium imatinib. Structural similarities between the bcrabl and kit kinases prompted administration of imatinib to a patient with advanced gist that resulted in a. The metabolism of clopidogrel to its active metabolite can be impaired by genetic variations in cyp2c19 see boxed warning. Severe mucocutaneous reactions, some with fatal outcomes 5. Sep 18, 2019 gleevec can cause fetal harm when administered to a pregnant woman. The metabolism of clopidogrel can also be impaired by drugs that inhibit cyp2c19, such. Learn about avastin bevacizumab solution for iv infusion, including benefits, risks, possible side effects, patient support, and options for financial help. Gleevec treatment can be given as a once daily dose or the daily dose may be split into twoone portion dosed in the morning and one portion in the evening. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for gleevec imatinib.
795 821 396 768 1395 823 286 99 1297 531 1261 675 1195 1191 38 576 1040 1191 393 54 211 326 1045 1500 384 667 54 161 575 1211 116 1067 384 1407 477 1474 988 394 396 555 1467 57 559 159 904 814 889