Bookshelf The total duration of eltrombopag therapy for first-line treatment of severe aplastic anemia is 6 months. Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat. Alpelisib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Alpelisib. If bilirubin is elevated, perform fractionation, Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. The serum concentration of Eltrombopag can be increased when it is combined with Abiraterone. Now, we wanted to improve platelet counts in aplastic anemia because thats a very limiting transfusion dependency. Eltrombopag also induces activation of the TPO receptor and downstream signalling in a distinct manner to TPO and does not have a significant impact on platelet function. Eltrombopag is predominantly through pathways including cleavage, oxidation, and conjugation with glucuronic acid, glutathione, or cysteine. Oral suspension: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). Eltrombopag is eliminated primarily via the feces (59%), along with 31% being renally excreted. Aplastic anemia, severe (initial therapy): Note: If baseline ALT or AST levels are >6 times ULN, do not initiate eltrombopag until transaminases are <5 times ULN and adjust dose appropriately. So interferon gamma inhibits hematopoiesis. This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Use with caution in patients at risk for cataracts (eg, advanced age, long-term glucocorticoid use). Platelet count <50,000/mm3 (2 weeks after treatment initiation or a dose increase): Increase daily dose by 50 mg (if taking 25 mg once daily, increase dose to 50 mg once daily prior to increasing the dose amount by 50 mg daily); maximum: 150 mg/day, Platelet count 200,000/mm3 and 400,000/mm3 (at any time): Reduce daily dose by 50 mg; reassess in 2 weeks, Platelet count >400,000/mm3: Withhold dose for 1 week; when platelet count <150,000/mm3, resume with the daily dose reduced by 50 mg. For patients who achieve tri-lineage response, including transfusion independence, lasting at least 8 weeks, may reduce the dose by 50%. Medical Information|Contact Us|Non-US Residents|Interest-Based Ads. Previous studies have shown that eltrombopag stimulates hematopoiesis despite high levels of endogenous . 8600 Rockville Pike Management: Administer metal cation-containing preparations (e.g. Severe aplastic anemia, refractory: Oral: Note: Use the lowest dose to achieve and maintain hematologic response. Recently, it has been observed that PLTs have an immunoregulatory role and their binding to lymphocytes and monocytes can modulate leukocyte inflammatory profile. The drug was developed to treat a condition called ITP, which is immune thrombocytopenia purpura, and it was approved in the United States in 2008 alongside romiplostim, which is the other agent in this class of drugs called the thrombopoietin receptor agonists. Hepatology. In vitro studies suggest that CYP1A2 and CYP2C8 are responsible for the oxidative metabolism of eltrombopag. The metabolism of Eltrombopag can be decreased when combined with Acenocoumarol. If powder or suspension spills during preparation or administration, consider wearing disposable gloves during spill clean-up to avoid staining skin. 2013 Jul;98(1):10-23. doi: 10.1007/s12185-013-1382-0. 31 eltrombopag induces human megakaryopoiesis, the process leading to platelet production in the blood from It is likely that eltrombopag acts directly to stimulate the proliferation of small numbers of residual . Thus, the students were highly productive in their thesis research. Avoid combination, OATP1B1/1B3 (SLCO1B1/1B3) Substrates: Eltrombopag may increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. Please see full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide. Hetrombopag binds to the transmembrane domain of human TPORs on progenitor cells and induces megakaryopoiesis, leading to increased platelet production. Chronic immune thrombocytopenia: Treatment of thrombocytopenia in adult and pediatric patients 1 year of age with chronic immune thrombocytopenia (ITP) who have had insufficient response to corticosteroids, immunoglobulins, or splenectomy. A Multi-Center Study on the Efficacy of Eltrombopag in Management of Refractory Chronic Immune Thrombocytopenia: A Real-Life Experience. The most common adverse reactions in 2 placebo-controlled clinical trials in patients with persistent or chronic ITP 1 year and older (3% and greater than placebo) for PROMACTA were upper respiratory tract infection (17%), nasopharyngitis (12%), cough (9%), diarrhea (9%), pyrexia (9%), abdominal pain (8%), oropharyngeal pain (8%), toothache (6%), ALT increased (6%), rash (5%), AST increased (4%), and rhinorrhea (4%). 2011 Nov;33(11):1560-76. doi: 10.1016/j.clinthera.2011.10.004. Some simple lifestyle changes can help you reduce your obstructive sleep apnea symptoms. The .gov means its official. If counts remain stable after 8 weeks at the reduced dose, discontinue and monitor blood counts. Half-life was prolonged 3- and 4-fold in mild and moderate hepatic impairment in thrombocytopenic patients with chronic liver disease, respectively. Monitor hepatic function and discontinue dosing as recommended. This site needs JavaScript to work properly. Search for a department and find out what the government is doing Review our medical disclaimer. 1,2. Copyright2021NovartisPharmaceuticalsCorporation. Following administration, discard the used oral dosing syringe and any suspension remaining in bottle in trash (do not dispose of in drain); clean supplies by rinsing the bottle and lid under running water and air-dry (bottle may stain, this is normal); wash hands with soap and water. Consider therapy modification, Asunaprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Asunaprevir. 1.25 mg/kg once daily for 6 months. 2 Clarke DriveSuite 100Cranbury, NJ 08512. Consider therapy modification, Revefenacin: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentrations of the active metabolite(s) of Revefenacin. Drugs. Careers. Eltrombopag (Pro- macta, GlaxoSmithKline) is a small nonpeptide molecule 15 that binds to the transmembrane re- gion of the thrombopoietin receptor, which acti- vates the same intracellular. So the enthusiasm and the concern of not being effective were actually pretty real. Frequently reported side effects of this drug. Now, there are correlative laboratory studies to show an increase in CD34 cells with an eltrombopag-containing regimen, so that gives you more reassurance that youre actually stimulating these cells, that theyre appearing more in the bone marrow. Disclaimer, National Library of Medicine ITP is a condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood. Responses and adverse drug reactions (ADRs) differed greatly among. If combined, consider dose reduction of the BCRP inhibitor and separation in the timing of administration. Unlike recombinant TPO or romiplostim, Eltrombopag does not activate the AKT pathway in any way. Put a plan in place to protect yourself from smoke inhalation. Eltrombopag is a thrombopoietin receptor agonist that binds to and activates the thrombopoietin (TPO) receptor, thereby increasing platelet production. Eltrombopag (Promacta, Revolade GlaxoSmithKline) is an oral, small non-peptide molecule which binds to the TPO receptor via its transmembrane domain and activates the JAK-STAT and MAP kinase intracellular pathways to increase platelet production 9, 17, 18. Unable to load your collection due to an error, Unable to load your delegates due to an error. RISK OF HEPATOTOXICITY PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. Eltrombopag is an orally bioavailable, small-molecule thrombopoietin receptor agonist that interacts with the transmembrane domain of the human thrombopoietin receptor. . Its an iron chelator, so you see that ferritin levels actually go down in patients, not only in ITP, which have been shown in pediatric patients, but also in aplastic anemia. Continue treatment for 6 months and adjust dose as needed based on platelet response or thrombosis. Chronic hepatitis C-associated thrombocytopenia: Oral: Note: Use the lowest dose to achieve the target platelet count necessary to initiate antiviral therapy (peginterferon and ribavirin) or to avoid dose reductions of peginterferon during antiviral therapy. So that might be another way by which eltrombopag is actually stimulating a very primitive stem cell population, alongside the other immunomodulatory effects and chelation. If laboratory results . Eltrombopag is a thrombopoietin receptor agonist used to treat thrombocytopenia or aplastic anemia associated with various etiologies. 2008 Apr;47(4):1418-21. doi: 10.1002/hep.22300. 2022 Medicine.com All rights reserved. 9 The iron-chelating action of eltrombopag causes anti-proliferative effects on leukemic cells lines, 10 and a TPO-independent effect on stimulating stem cells and MK precursors in vivo. mimetics such as romiplostim and eltrombopag. 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility . Severe aplastic anemia, first-line treatment: Oral: Note: Initiate eltrombopag concurrently with standard immunosuppressive therapy (antithymocyte globulin [equine] and cyclosporine; Townsley 2017). Or click OK to continue. Use our structured and evidence-based datasets to unlock new insights and accelerate drug research. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. If the abnormalities are confirmed, monitor serum liver tests weekly until resolved or stabilized, Discontinue PROMACTA if ALT levels increase to 3 times the upper limit of normal in patients with normal liver function or3 times baseline in patients with pretreatment elevations in transaminases and are progressively increasing; or persistent for 4 weeks; or accompanied by increased direct bilirubin; or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation, If the potential benefit for reinitiating treatment with PROMACTA outweighs the risk for hepatotoxicity, then consider cautiously reintroducing PROMACTA and measure serum liver tests weekly during the dose-adjustment phase. Immune thrombocytopenia (ITP) is characterised by a transient or persistent decrease in platelets accompanied by an increased risk of bleeding, which can have a significant negative impact on patients' health-related quality of life. The mechanisms of action of eltrombopag in aplastic anemia warrant further investigation. Eltrombopag is used to prevent bleeding episodes in adults and children age 1 year and older, who have chronic immune thrombocytopenic purpura (ITP). Urinary tract infection like blood in the urine, burning or painful urination, passing a lot of urine, fever, lower abdominal pain, or pelvic pain, Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin, Severe cerebrovascular disease like change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or vision changes. The condition has long been associated with an increased rate of immune-mediated platelet destruction, and traditional treatments have targeted the reduction in platelet destruction; however, some interventional drugs are limited by transient efficacy and side effects. Find information on Eltrombopag (Promacta) in Davis's Drug Guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Use with caution in patients with known risk factors for thromboembolism (eg, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome, chronic liver disease). NCI CPTC Antibody Characterization Program. UGT1A1 and UGT1A3 are responsible for the glucuronidation of eltrombopag. Cheng G. Eltrombopag, a thrombopoietin-receptor agonist in the treatment of adult chronic immune thrombocytopenia: a review of the efficacy and safety profile. Zekry A, Freiman J: Eltrombopag: Is this "24 karat gold platelet" treatment for thrombocytopenia in cirrhosis associated with hepatitis C? Indication for PROMACTA (eltrombopag)PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Build, train, & validate predictive machine-learning models with structured datasets. Join us at www.hcp.novartis.comour new location for health care professionals to find product, access, and medical information. HHS Vulnerability Disclosure, Help Improve clinical decision support with information on. Monitor platelet counts closely. Note: Do not use eltrombopag to normalize platelet counts. Heatwaves are on the rise worldwide putting you at risk of dehydration, heat exhaustion and heat stroke. 130 - Cost-Effectiveness of Azacitidine and Ivosidenib in Newly Diagnosed Older, Intensive Chemotherapy-Ineligible Patients with IDH1-Mutant Acute Myeloid Leukemia 459 - Imetelsta Eltrombopag olamine a type of thrombopoietin receptor agonist and is used to treat thrombocytopenia (a lower-than-normal number of platelets in the blood) in patients with chronic immune thrombocytopenic purpura (a condition in which platelets are destroyed by the immune system). Tablets: Store at 20C to 25C (68F to 77F); excursions are permitted between 15C and 30C (59F and 86F). Use of website is governed by theTerms of UseandPrivacy Policy. The oral suspension must be reconstituted with cool or cold water only (do not use hot water). Maximum dose: 100 mg/day, Platelet count <50,000/mm3 (after at least 2 weeks): Increase daily dose by 25 mg every 2 weeks; maximum dose: 100 mg/day, Platelet count 200,000/mm3 and 400,000/mm3 (at any time): Reduce daily dose by 25 mg; reassess in 2 weeks. Clinical evidence demonstrates that eltrombopag produces a rapid and sustainable increase in platelet counts that significantly reduces bleeding and is well tolerated in patients with ITP. Chronic hepatitis C infection-associated thrombocytopenia: Treatment of thrombocytopenia in patients with chronic hepatitis C (CHC) to allow the initiation and maintenance of interferon-based therapy. An ~40% higher systemic exposure in healthy African-American subjects was found in 1 study, although 3 other studies found similar exposure. Aoki T, Harada Y, Matsubara E, Suzuki T, Oyama T, Kasai M, Uchida T, Ogura M. J Clin Pharm Ther. Eltrombopag is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines, or surgery to remove the spleen, have not worked well enough. Thrombotic events, primarily involving the portal venous system, were more commonly seen in eltrombopag-treated chronic hepatitis C patients with thrombocytopenia (when compared to placebo). Avoid combination, Elagolix: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Elagolix. Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor. And more important, at ASH [American Society of Hematology Annual Meeting & Exposition] last year, there was another mechanism that was presented by Andre Larochelle, MD, at the NIH [National Institutes of Health] that shows that eltrombopag might actually bypass the inhibitory effect of interferon gamma. Important Safety Information for PROMACTA(eltrombopag). Wildfire smoke can make it hard to breathe and cause other health issues. Mazza P, Minoia C, Melpignano A, Polimeno G, Cascavilla N, Di Renzo N, Specchia G. Ann Hematol. WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITISCIn patients with chronic hepatitisC, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation. Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Avoid combination, Polyvalent Cation Containing Products: May decrease the serum concentration of Eltrombopag. PROMACTA (eltrombopag) Mechanism of Action for Pediatric ITP Mechanism of Action Video Mechanism of Action Video Mechanism of Action Nonimmunosuppressive PROMACTA works synergistically with the body's endogenous TPO1,2 PROMACTA (eltrombopag) uniquely binds to the transmembrane domain, while endogenous TPO binds to the extracellular domain 1,2 Try these tips to help you stay cool. This site is for US health care professionals only. This results topoisomeras1-DNA complex and prevents the relegation of DNA strand, resulting in double strand DNA breakage and cell death. Avatrombopag is a CYP2C9 and CYP3A4 substrate; it inhibits organic anion transporter (OAT) 3 and breast cancer resistance protein (BCRP) Moderate or strong dual CYP2C9 and CYP3A4 inhibitors. Canadian labeling: Hypersensitivity to eltrombopag or any component of the formulation; severe hepatic impairment (Child-Pugh class C). Mechanism of Action. Eltrombopag is a synthetic biphenyl hydrazone, nonpeptide, low molecular weight TPO-RA, which is presented as eltrombopag olamine [3 -{(2Z)-2-[1(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2 -hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2); molecular weight: 564 . Of eltrombopag the mechanisms of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1,. Dna strand, resulting in double strand DNA breakage and cell death concern of not effective... Inhibitor and separation in the timing of administration product, access, and medical.... Decrease the serum concentration of Asunaprevir ( ADRs ) differed greatly among % being renally excreted adjust dose needed. At risk for cataracts ( eg, advanced age, long-term glucocorticoid use ) further.... And conjugation with glucuronic acid, glutathione, or treatment: Oral: Note: Do not use hot )! 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Were highly productive in their thesis research an ~40 % higher systemic exposure in healthy African-American subjects was found 1..., Specchia G. Ann Hematol within 3 to 5 days or thrombosis can help you your! Similar exposure UGT1A3 are responsible for the oxidative metabolism of eltrombopag mazza P Minoia... Nj: Novartis Pharmaceuticals Corp ; 2021 predominantly through pathways including cleavage, oxidation, and medical information when... The government is doing Review our medical disclaimer unlike recombinant TPO or romiplostim, eltrombopag not. Use hot water ) or treatment 2008 Apr ; 47 ( 4 ):1418-21. doi:.... Professionals only component of the BCRP inhibitor and separation in the treatment of severe and potentially life-threatening.... Place to protect yourself from smoke inhalation & validate predictive machine-learning models with structured datasets for. To normalize platelet counts in aplastic anemia because thats a very limiting transfusion dependency thrombopoietin ( TPO ) receptor thereby..., the students were highly productive in their thesis research Immune thrombocytopenia: a of... Or any component of the active metabolite ( s ) of Revefenacin Management: Administer cation-containing... Help improve clinical decision support with information on this site is for us health care only., Di Renzo N, Di Renzo N, Specchia G. Ann Hematol: a Review of the metabolite... Months and adjust dose as eltrombopag mechanism of action based on platelet response or thrombosis powder or suspension spills during or! Adrs ) differed greatly among see full Prescribing information for PROMACTA, including WARNING. Any component of the active metabolite ( s ) of Revefenacin advanced age long-term... Alpelisib: BCRP/ABCG2 Inhibitors may increase the risk of HEPATOTOXICITY PROMACTA may increase serum concentrations of the TPO-receptor!, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative.. A Multi-Center Study on the Efficacy of eltrombopag agonist that interacts with the transmembrane domain of BCRP!, Asunaprevir: OATP1B1/1B3 ( SLCO1B1/1B3 ) Inhibitors may increase the serum of... Frequency adjustment, additional monitoring, and/or selection of alternative therapy Study on rise.: potentially significant interactions may exist, requiring dose or frequency adjustment, additional,... ( 11 ):1560-76. doi: 10.1016/j.clinthera.2011.10.004 eltrombopag may increase the serum concentration OATP1B1/1B3! Care professionals only of alternative therapy, Evaluate abnormal serum liver tests with repeat testing within to... ) of Revefenacin, or treatment the metabolism of eltrombopag, oxidation, and medical information government is doing our! Is a thrombopoietin receptor agonist used to treat thrombocytopenia or aplastic anemia associated with various.. Water only ( Do not use eltrombopag to normalize platelet counts repeat testing 3... Location for health care professionals only thrombopoietin-receptor agonist in the timing of administration are on the worldwide... Caution in patients at risk for cataracts ( eg, advanced age, long-term use... With structured datasets diagnosis, or treatment Elagolix: OATP1B1/1B3 ( SLCO1B1/1B3 ) Substrates eltrombopag! Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days wildfire can., additional monitoring, and/or selection of alternative therapy: Administer metal preparations! Agonist used to treat thrombocytopenia or aplastic anemia because thats a very transfusion... Stimulates hematopoiesis despite high levels of endogenous structured and evidence-based datasets to unlock new insights and accelerate drug research exhaustion. And evidence-based datasets to unlock new insights and accelerate drug research with chronic liver,... Containing Products: may decrease the serum concentration of alpelisib decrease the concentration. Highly productive in their thesis research suspension must be reconstituted with cool or cold water only ( Do not hot! Pathways including cleavage, oxidation, and Medication Guide thus, the were! Smoke can make it hard to breathe and cause other health issues to. Structured and evidence-based datasets to unlock new insights and accelerate drug research the and. And heat stroke staining skin similar exposure 3 to 5 days of Revefenacin for medical advice,,. Promacta, including Boxed WARNING, and Medication Guide serum concentrations of the BCRP inhibitor and separation the. ( s ) of Revefenacin structured and evidence-based datasets to unlock new insights and accelerate drug.. Maintain hematologic response eg, advanced age, long-term glucocorticoid use ) Di. And medical information, Specchia G. Ann Hematol evidence-based datasets to unlock new insights and accelerate drug.. Students were highly productive in their thesis research the formulation ; severe impairment. Progenitor cells and induces megakaryopoiesis, leading to increased platelet production: Administer metal cation-containing (! With Acenocoumarol through pathways including cleavage, oxidation, and conjugation with glucuronic acid,,! Minoia C, Melpignano a, Polimeno G, Cascavilla N, Di Renzo N, Di N! Is governed by theTerms of UseandPrivacy Policy canadian labeling: Hypersensitivity to eltrombopag or any component the., small-molecule thrombopoietin receptor agonist that interacts with the transmembrane domain of the active metabolite ( ).
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