Jan 23, 2020 ponatinib hcl is an offwhite to yellow powder with pka of 2. Highlights of prescribing information these highlights do not include all the information needed to use tagrisso. Cardiovascular, cerebrovascular, and peripheral vascular thrombosis, including fatal myocardial infarction and stroke have. Australian public assessment report for ponatinib iclusig. This experience therefore highlights the need for systematic studies of ponatinib dosage, pharmacokinetics, efficacy. Ponatinib in refractory philadelphia chromosomepositive.
Link to the pdf file there and select the pdf file, then ok. Apexbio ponatinib ap24534panbcrabl inhibitor,multi. Fda label information for this drug is available at dailymed. May 15, 2015 secondary endpoints included major molecular response mmr, time to and duration of response, progressionfree survival pfs, overall survival os, and safety response assessments were conducted every 3 months for cpcml patients while 45 mg qd was the starting ponatinib dose, dose reductions to 30 mg qd or 15 mg qd were allowed to. Costeffectiveness of ponatinib iclusig as indicated for.
Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Ponatinib in participants with resistant chronic phase chronic myeloid leukemia cpcml to characterize the efficacy and safety of a range of doses optic the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Treatment of adult patients with t315ipositive chronic myeloid. The applicant also provided cost effectiveness results using the full dose of ponatinib 45mg daily in the submission. May 14, 2018 ponatinib can be taken with or without food, but at the same time each day. Ponatinib inhibited the in vitro activity of additional kinases with ic 50 concentrations between 0. D indications treatment of chronic phaseaccelerated phaseblast phase chronic myeloid leukemia cml that is tolerantresistant to previous treatment with tyrosine kinase inhibitors. It is perhaps the most active tyrosine kinase inhibitor tki among those currently licensed. Open the folder that contains the pdf file you want, choose the pdf file, and select ok. Open the powerpoint slide where you want to insert the pdf.
Instruct patient to take ponatinib as directed and not to change dose or stop taking unless advised by health care professional. Mar 28, 2019 usual adult dose for chronic myelogenous leukemia. Trial of ponatinib in patients with bevacizumabrefractory. Ponatinib is classified as a tyrosine kinase inhibitor. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Go to insert and select object to open the insert object dialog box. Talk to your healthcare provider about the risks and benefits of using this medication when pregnant see iclusig and pregnancy. Highlights of prescribing information cardiac dysfunction. Ponatinib binds abl in its inactive form as imatinib. Highlights of prescribing information severe hemorrhage. Interrupt ponatinib at least 1 wk prior to major surgery.
Ponatinib may react with a number of other medications see drug interactions with ponatinib. Iclusig ponatinib posted by mitch fraker see editorial guidelines is your iclusig medication too expensive. Acute lymphoblastic leukemia that is philadelphia chromosome positive and has the t315i mutation chronic myelogenous leukemia that has the t315i mutation for these types of leukemia without the t315i mutation, ponatinib hydrochloride is used when other tyrosine kinase. Novel pathways of ponatinib disposition catalyzed by. The latest revision to the who classification of cml 2016 reflects this by adding provisional response to tki. Ponatinib is the generic name for the trade drug iclusig.
Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for tarceva erlotinib. Iclusig 15mg 30mg and 45mg filmcoated tablets summary. Ponatinib, a thirdgeneration tyrosine kinase inhibitor tki with activity against native and mutant bcrabl1, was initially approved at 45 mg. Leukemia is a type of cancer where the body makes abnormal white blood cells.
Hold eyelids apart and flush eyes with plenty of water for at least 15 minutes. Highlights of prescribing information these highlights do not include all the information needed to use sprycel safely and effectively. Ponatinib was approved at the dose of 45 mgday, producing. This will slowly return to normal once your treatments are over. Lenvima lenvatinib capsules, for oral use initial u. First aid measures description of first aid measures. Ponatinib is predicted to increase the risk of bleeding events when given with phenindione. Contact a pharmacist or medicines information service for advice. Vascular occlusion arterial and venous occlusions and thromboembolic events, including fatal mi, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and requirement for urgent revascularization procedures, occurred in. Arterial occlusion, venous thromboembolism, heart failure, and hepatotoxicity. If hair loss is a problem, refer to for the patient. In addition, ponatinib has activity against other bcrabl mutant forms. In powerpoint, select the slide that you want to add the file to, and then select insert object. If you lose hair, it will grow back once you stop treatment with ponatinib.
This makes the pdf file part of the presentation file. Aug 20, 20 the chemical name for ponatinib hydrochloride is 32imidazo1,2bpyridazin3ylethynl4methyln44methylpiperazin1ylmethyl3trifluoromethylphenyl benzamide hydrochloride, and its molecular formula is c 29 h 28 cif 3 n 6 o, with a formula weight of 569. A personalised medicine approach for ponatinibresistant chronic. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Ponatinib in participants with resistant chronic phase. Ponatinib is a tyrosine kinase receptor inhibitor that is used in the therapy of refractory chronic myelogenous leukemia cml positive for the philadelphia chromosome. Ponatinib sometimes causes side effects due to the rapid destruction of cancer cells tumor lysis syndrome. Results for ponatinib use within cpcml, assuming full dosing and dispensing, the icers ranged from 29,000 per qaly, versus dasatinib or nilotinib, to 38,000 per qaly. Iclusig ponatinib treated patients including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Highlights of prescribing information severe hemorrhage may. Leukemia is a type of cancer where the body makes abnormal white blood cells ponatinib is an antineoplastic cancer medicine. The chemical name for ponatinib hydrochloride is 32imidazo1,2bpyridazin3ylethynl4methyln44methylpiperazin1ylmethyl3trifluoromethylphenyl benzamide hydrochloride, and its molecular formula is c 29 h 28 cif 3 n 6 o, with a formula weight of 569.
Administer the medicine immediately by mouth with water. Ponatinib, a panbcrabl tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia cml, causes severe side effects including vascular occlusions, pancreatitis, and liver toxicity, although the underlying mechanisms remain unclear. Acute lymphoblastic leukemia all is a malignant clonal disease of the bone marrow in which early lymphoid precursors proliferate and replace the normal hematopoietic cells of the marrow. Antineoplastic, tyrosine kinase inhibitor effect of food can be given without regard to food. Nov 29, 2012 ponatinib was rationally developed to address the limitations of currently available cmldirected tyrosine kinase inhibitors. Figure 32 is approved by the fda 2012 for the treatment of chronic myeloid leukemia cml and philadelphia chromosomepositive acute lymphoblastic leukemia phpos all. Ponatinib should be taken whole and not crushed, cut, or dissolved. Ponatinib may cause serious or lifethreatening blood clots in your legs or lungs, heart attacks, or strokes. Ponatinib efficacy and safety in philadelphia chromosomepositive leukemia. Ponatinib inhibits the native as well as the mutant bcrabl, including the gatekeeper mutant bcrabl. Jun 23, 2015 for this reason and because ponatinib is known to be teratogenic in animal models, women of childbearing potential and men must agree to use adequate contraception hormonal or barrier method of birth control. It was designed for highaffinity, optimized binding to the active site of bcrabl, with an emphasis on very high potency and the ability to overcome bcrabl mutationbased resistance.
Tagrisso osimertinib tablets, for oral use initial u. It was designed for highaffinity, optimized binding to the active site of bcrabl, with an emphasis on very high potency and the ability to. Ponatinib is the secondgeneration pan inhibitor of bcrabl kinases, which is also effective against the mutant form of bcrabl t315i. Ponatinib can be taken with or without food, but at the same time each day. Remove gloves and do not use them for anything else. If you miss a dose of ponatinib, do not take an extra dose or two doses at one time. Ponatinib inhibited the in vitro tyrosine kinase activity of abl and t315i mutant abl with ic 50 concentrations of 0. Iclusig ponatinib is a kinase inhibitor indicated for the.
Ponatinib is commonly associated with transient elevations in serum aminotransferase levels during treatment, but with only rare instances of clinically apparent acute liver injury. Where exactly does ponatinib fit in chronic myelogenous. Cardiovascular, cerebrovascular, and peripheral vascular thrombosis, including fatal. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. To lower your risk, your doctor may add a medication and tell you to drink plenty of. Ponatinib holds a unique place in the spectrum of drugs in use for the treatment of chronic myelogenous leukemia. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Fulltext pdf targeted transfection of the il3 gene into primary human hematopoietic progenitor cells through the ckit. Iclusig ponatinib dosing, indications, interactions.
Highlights of prescribing information visual disturbance. Ponatinib interactions bnf content published by nice. Acute lymphoblastic leukemia all clinical presentation. Ponatinib has caused serious sometimes fatal blood clots such as heart attack, stroke, pulmonary emboluspe, deep vein thrombosisdvt.
Pdf potential of ponatinib to treat chronic myeloid. Ponatinib is a pregnancy category d medication, which means it may harm an unborn child. Talk to your doctor about the risks and benefits of this. Tell your doctor if you have or have ever had a blood clot in your lungs or legs. Open your powerpoint presentation on the page you want to insert the pdf within. Are you looking for a place to get your iclusig ponatinib medication at an affordable price. Secondary endpoints included major molecular response mmr, time to and duration of response, progressionfree survival pfs, overall survival os, and safety response assessments were conducted every 3 months for cpcml patients while 45 mg qd was the starting ponatinib dose, dose reductions to 30 mg qd or 15 mg qd were allowed to. Efficacy and safety of low dose ponatinib in a case of ph. Ponatinib is a potent pan bcrabl inhibitor with structural elements, including a carboncarbon triplebond, that enable high affinity binding to native bcrabl and mutant forms of the abl kinase. Insert pdf file content into a powerpoint presentation. If neither of those two methods work for your needs, you can also add a pdf file into a powerpoint presentation as an action. These highlights do not include all the information needed to use alunbrig safely and effectively. Hepatotoxicity see full prescribing information for complete boxed warning.
Medlineplus information on ponatinib hydrochloride a lay language summary of important information about this drug that may include the following. It was developed using computational and structurebased design to have activity against bcrabl forms with mutations that convey resistance to other tkis, in particular t315i mutation. Some forms of cml, those that have the t315i mutation, are resistant to. Prior to tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies.
Iclusig summary of product characteristics dated august 2019. The recommended dose should be reduced to 30 mg once daily when administering iclusig with strong cyp3a inhibitors. The starting dose in clinical trials was 45 mg once a day. Ponatinib is commonly associated with transient elevations in serum aminotransferase levels during treatment, but with only rare instances of clinically apparent acute liver in. If you are unable to swallow ponatinib, talk to your care provider or pharmacist for possible options.
Ponatinib is recommended, within its marketing authorisation, as an option for treating chronic, accelerated or blastphase chronic myeloid leukaemia in adults when. In some cases, health care professionals may use the trade name iclusig when referring to the generic drug name ponatinib. Phenobarbital is predicted to decrease the exposure to. In the insert object box, select create from file, and then enter the pdf file location. Novel pathways of ponatinib disposition catalyzed by cyp1a1. The molecular formula is c 29 h 28 clf 3 n 6 o which corresponds to a formula weight of 569. The chemical name for ponatinib hydrochloride is 3imidazo1,2bpyridazin3ylethynyl4methyln44methylpiperazin1ylmethyl3trifluoromethylphenylbenzamide hydrochloride.
For this reason and because ponatinib is known to be teratogenic in animal models, women of childbearing potential and men must agree to use adequate contraception hormonal or barrier method of birth control. See full prescribing information for complete boxed warning. Ponatinib was rationally developed to address the limitations of currently available cmldirected tyrosine kinase inhibitors. We carried out wgs on a ponatinibresistant cml patient and demonstrated an effective. Feb 20, 2020 acute lymphoblastic leukemia all is a malignant clonal disease of the bone marrow in which early lymphoid precursors proliferate and replace the normal hematopoietic cells of the marrow. Mutations in the bcrabl kinase is the frequent cause of the cml and phpos all. Prior authorization protocol iclusig ponatinib natl confidential and proprietary page 1. Arterial occlusion has occurred in at least 35% of iclusigtreated patients including fatal myocardial infarction, stroke, stenosis of.
Ponatinib definition of ponatinib by medical dictionary. Modifications of critical proteins through reactive metabolites are thought to be responsible for a number of adverse drug reactions. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Ponatinib is the only approved tyrosine kinase inhibitor tki with clinically relevant activity. Ponatinib is a thirdgeneration, dual srcabl inhibitor.
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