Diagnostic Ideas and Management Strategies for Thrombocytopenia of Unknown Causes in Pregnancy. MeSH Please enable it to take advantage of the complete set of features! In our case, the drug was started during the third trimester and so there was no question of embryo lethality. Plt: platelets. After delivery, both had normal platelet counts and remained clinically stable through follow-up. No author claims financial conflicts of interest. Thrombopoietin (TPO)-mimetic drugs, such as eltrombopag, have been successfully used for treatment of ITP during pregnancy, but studies regarding its safety during gestation are lacking. label use of Tpo-RA during pregnancy, a multicenter observational and retrospective study was set up. Promacta (eltrombopag)." The data used to support the findings of this study are included within the article. Eltrombopag--an oral thrombopoietin agonist. Accessibility Epub 2016 Apr 4. Eltrombopag may harm an unborn baby. Pregnant women on eltrombopag. You may notice problems with Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Plt: platelets. Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight. Patil A. S., Dotters-Katz S. K., Metjian A. D., James A. H., Swamy G. K. Use of a thrombopoietin mimetic for chronic immune thrombocytopenic purpura in pregnancy. Since the efficacy and safety of eltrombopag in pregnancy has not yet been established, its routine use should be avoided. 2022 Apr 6;9:799826. doi: 10.3389/fsurg.2022.799826. Jul-Dec 2016;10(2):155-8. doi: 10.4103/0973-6247.177204. Use of thrombopoietin receptor agonists for immune thrombocytopenia in pregnancy: results from a multicenter study. 2015 Jun;24(7):746-50. doi: 10.1177/0961203314559632. The first case of aplastic anemia described in the literature was a pregnant woman who died of postpartum hemorrhage in 1888. If you think you have become pregnant while using this medicine, tell your doctor right away. We describe the case of a woman with refractory ITP who took eltrombopag during conception and first trimester of pregnancy. Eltrombopag (Promacta) is used to treat: Low platelets in adult and pediatric patients one year and older with chronic immune (idiopathic) thrombocytopenia (ITP) . doi: 10.7759/cureus.22505. Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, et al. Use of thrombopoietin receptor agonists for immune thrombocytopenia in pregnancy: results from a multicenter study. It is assigned to pregnancy category C by the Food and Drug Administration (FDA), and controlled studies in pregnancy are lacking [5]. Her postpartum outcome was uneventful, and the neonate did not develop thrombocytosis. The purpose of the registry is to collect safety . Generating an ePub file may take a long time, please be patient. Eltrombopag may cause or increase the risk for serious liver problems. Nursing Mothers: It is not known whether Eltrombopag is excreted in human milk. Eltrombopag should beused in pregnancy only if the potential benefit to the mother justifies the potential risk to thefetus. HHS Vulnerability Disclosure, Help Blood 2016; 128:15471554. Thrombopoietin receptor agonists for preparing adult patients with immune thrombocytopenia to splenectomy: results of a retrospective, observational GIMEMA study. Hb: hemoglobin. Hepatic impairment For eltrombopag When used for Idiopathic thrombocytopenic purpura: Manufacturer advises consider avoiding. Pregnancy: May cause fetal harm. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus. It may also be used to increase the platelet count in patients with hepatitis . Aplastic anemia causes anemia, bleeding, and infection due to associated cytopenia, and these complications can sometimes be life-threatening, especially during pregnancy. Unable to load your collection due to an error, Unable to load your delegates due to an error. There are no controlled data in human pregnancy.Pregnancy Registry: A pregnancy registry has been established to collect information about the effects of eltrombopag during pregnancy. There have also been published case reports of the successful treatment of severe thrombocytopenia with eltrombopag during pregnancy in patient with systemic lupus erythematosus [10] or MYH9-related disease, an autosomal dominant thrombocytopenia [11]. Adverse Reactions . Maroun MC, Ososki R, Andersen JC, Dhar JP. Shin J. E., Lee Y., Kim S. J., Shin J. C. Association of severe thrombocytopenia and poor prognosis in pregnancies with aplastic anemia. Zaja F, Barcellini W, Cantoni S, Carpenedo M, Caparrotti G, Carrai V, Di Renzo N, Santoro C, Di Nicola M, Veneri D, Simonetti F, Liberati AM, Ferla V, Paoloni F, Crea E, Volpetti S, Tuniz E, Fanin R. Am J Hematol. Nonetheless, eltrombopag could theoretically cross the placenta [12, 13], and potentially affect the fetus. Eltrombopag is a drug designed to mimic a protein in the body called thrombopoietin. Case Presentation We present a case of a pregnant patient at 26 weeks of gestation with severe refractory ITP. Last updated on Jun 13, 2022. In a phase 2 study involving patients with refracted aplastic anemia, eltrombopag produced a hematologic response in at least one lineage in 11 of 25 patients (44%) [3]. Although there has been no proven causal association between pregnancy and aplastic anemia, it cannot be ruled out that pregnancy may have some influence on the disease [7]. Favier R., De Carne C., Elefant E., Lapusneanu R., Gkalea V., Rigouzzo A. Eltrombopag to treat thrombocytopenia during last month of pregnancy in a woman with MYH9-related disease: a case report. 2.9.12 Other antihemorrhagics. In other words, the risk of pancytopenia was extremely high if eltrombopag treatment was discontinued. Clin J Oncol Nurs. Eltrombopag (Promacta), a thrombopoietin agonist, has been used in non-pregnant patients to manage ITP, but few cases of its use in pregnancy have been reported. The purpose of this study is to evaluate the safety and efficacy of eltrombopag in people who have myelodysplastic syndrome ( MDS) with thrombocytopenia who have progressed or are resistant to decitabine or azacitidine. Immune thrombocytopenia (ITP) during pregnancy is an acquired autoimmune disease present in 1-2 of every 1000 pregnancies. Eltrombopag treatment was continued after weighing the benefits and potential risks. ELTROMBOPAG belongs to the class of 'platelet-stimulating agents' primarily used to treat low blood platelet count in patients with idiopathic thrombocytopenic purpura (ITP) and hepatitis C virus (HCV) infections.ELTROMBOPAG is also used to treat severe aplastic anaemia (SAA) in adults. Eltrombopag is a relatively new drug for the treatment of steroid-refractory ITP and severe aplastic anemia that is refractory to immunosuppressive therapy. In animal reproduction and developmental toxicity studies, there was evidence of embryo lethality and reduced fetal weights at maternally toxic doses. Enroll pregnant patients in the PROMACTA pregnancy registry by calling 1-888-825-5249. Sammartano V, Santoni A, Defina M, Ciofini S, Cencini E, Bocchia M. Blood Coagul Fibrinolysis. Epub 2014 Feb 14. official website and that any information you provide is encrypted Her hematologist explained that the usage of eltrombopag during pregnancy was limited, but the treatment of ITP with eltrombopag during pregnancy showed no maternal complications or fetal abnormalities, and the benefits of using eltrombopag would overcome the disadvantages. Lupus 2012; 21:15711574. despite the very limited information of eltrombopag during pregnancy, we conclude as follows: first, four thrombocytopenia cases out of six cases refractory to previous medication responded to an increase in the platelet count; second, no congenital anomaly or abnormal hematological finding of neonatal blood was observed, including the two cases Federal government websites often end in .gov or .mil. The blood loss at delivery was 680 grams, the delivery was uneventful, and no blood transfusion was required. Keywords: active or previous malignancy, human immunodeficiency virus (HIV), hepatitis B or C virus infection, pregnancy or lactation . Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. In the combination group, eltrombopag will be administered orally at an initial dose of 75mg daily for 14 days, and diacerein will be given orally at an initial dose of 50mg bid concomitantly for 14 days (D1-D14). Int J Hematol. The thrombopoietin (TPO) analogue eltrombopag has been successfully used in the treatment of autoimmune thrombocytopenia, but its safety and efficacy in severe thrombocytopenia during pregnancy . After the improvement of hyperemesis gravidarum, she was able to resume taking eltrombopag, her platelet count recovered, and her pregnancy course was stable thereafter. The changes in neonatal complete blood counts. A novel recombinant human thrombopoietin therapy for the management of immune thrombocytopenia in pregnancy. Women of childbearing potential must have a negative serum pregnancy test in the whole study; Exclusion Criteria: Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases Patients with poor compliance; According to these studies, the platelet response to eltrombopag was favorable in most cases, and significant maternal and neonatal complications that could be clearly attributed to eltrombopag were not reported. Michel et al. Thrombopoietin receptor agonists (TPO-RAs) are the most recent drugs approved for second-line treatment of ITP. Unable to load your collection due to an error, Unable to load your delegates due to an error. Adjust dosage based on platelet count (see Table 1); manufacturer recommends that a platelet count 50,000/mm 3 be achieved and maintained as necessary to reduce risk of bleeding. Females of reproductive potential should use effective contraception (methods that result in 1% pregnancy rates) during eltrombopag therapy and for at least 7 days after the last . Bookshelf Guidelines for the diagnosis and management of adult aplastic anaemia. Federal government websites often end in .gov or .mil. 2014 Apr;99(4):413-7. doi: 10.1007/s12185-014-1533-y. Furthermore, calcium in breast milk may attenuate the effect of eltrombopag because the bioavailability of eltrombopag is reduced by the chelation of calcium [16]. Disclaimer, National Library of Medicine 2021;21(3):397-406. doi: 10.2174/1871530320666200531142244. The mother's postpartum course was uneventful, and her remission was maintained by 25mg of eltrombopag alone. Aplastic anemia is a rare and heterogeneous blood disorder characterized by pancytopenia and hypocellular bone marrow [1]. eCollection 2021 Jan. Provan D, Arnold DM, Bussel JB, Chong BH, Cooper N, Gernsheimer T, Ghanima W, Godeau B, Gonzlez-Lpez TJ, Grainger J, Hou M, Kruse C, McDonald V, Michel M, Newland AC, Pavord S, Rodeghiero F, Scully M, Tomiyama Y, Wong RS, Zaja F, Kuter DJ. Median baseline serum thrombopoietin levels were 54 ng per liter in the placebo group and 56, 57, and 54 ng per liter in the eltrombopag groups receiving 30, 50, and 75 mg, respectively all . Long-term outcome of pregnancy complicating with severe aplastic anemia under supportive care. 2021 Oct 1;32(7):519-521. doi: 10.1097/MBC.0000000000001085. Feeling confused. : Immune thrombocytopenia (ITP) is a relatively frequent cause of thrombocytopenia during pregnancy. Since the efficacy and safety of eltrombopag in pregnancy has not yet been established, its routine use should be avoided. McCrae KR. FOIA The infant was formula-fed. Received 2021 Aug 27; Accepted 2022 Feb 18. Blood 2009; 113:23862393. The .gov means its official. Thrombopoietin Receptor Agonists in Children with Immune Thrombocytopenia: A New Therapeutic Era. Pregnancy WEIGH RISKS VS BENEFITS There are no adequate and well-controlled studies of Eltrombopag usein pregnancy. HHS Vulnerability Disclosure, Help 8600 Rockville Pike The analysis of this case and the revision of the available literature suggest that the use of TPO-RAs, thanks to their short time to response, may be effective and feasible during the first trimester of pregnancy, even if not yet recommended by current guidelines. It is normally used when other treatment options, including conventional medicines and spleen removal surgery, are ineffective. Accessibility Kuter D. J. Eltrombopag as steroid sparing therapy for immune thrombocytopenic purpura in systemic lupus erythematosus. Shibata S, Misugi T, Nakane T, Hino M, Tachibana D. Cureus. PMC of childbearing potential and have a negative pregnancy test and agree to use contraceptive methods specified in the GSK List of Highly Effective Methods for Avoidance of Pregnancy from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: The functionality is limited to basic scrolling. Any bruising or bleeding while you take and after you stop taking this medicine (eltrombopag tablets). Eltrombopag is an inhibitor of OATP1B1 and BCRP transporters. Michel M, Ruggeri M, Gonzalez-Lopez TJ, Alkindi S, Cheze S, Ghanima W, Tvedt THA, Ebbo M, Terriou L, Bussel JB, Godeau B. Biology and chemistry of thrombopoietic agents. For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking eltrombopag. Collectively in PETIT and PETIT2, the most common adverse effects reported during the trial period included headache, upper respiratory tract infection, nasopharyngitis, diarrhea, and transaminitis. Before There is a registry for women who become pregnant during treatment with eltrombopag. Michel M., Ruggeri M., Gonzalez-Lopez T. J., et al. You may switch to Article in classic view. No fetal or maternal complications were reported. Results from 15 pregnant women with ITP (17 pregnancies and 18 neonates) treated with either eltrombopag (N=8) or romiplostim (n=7) during pregnancy, including 2 patients with secondary ITP, were analyzed. For eltrombopag Ensure effective contraception during treatment. In April 2020, the woman was pregnant again at the age of 23 years. excessive increases in platelet counts during eltrombopag therapy. Unable to load your collection due to an error, Unable to load your delegates due to an error. Moreover, the patient remained in complete response after delivery despite therapy discontinuation. Medicine (Baltimore). 2020 Dec 26;29:e00281. 2020 Dec 24;136(26):3056-3061. doi: 10.1182/blood.2020007594. The .gov means its official. sharing sensitive information, make sure youre on a federal doi: 10.1002/ajh.24341. She was unresponsive to a therapeutic escalade of corticosteroids, azathioprine and intravenous immunoglobulin (IV Ig) so, at 27 weeks, eltrombopag was initiated, and analytical and clinical improvement was achieved. Learn more. For eltrombopag Ensure effective contraception during treatment. Copyright 2021 Wolters Kluwer Health, Inc. All rights reserved. Successful eltrombopag treatment of severe refractory thrombocytopenia in chronic myelomonocytic leukemia: Two cases reports: A CARE-compliant article. Eltrombopag Pregnancy Warnings Animal studies have revealed evidence of embryolethality and reduced fetal weights at maternally toxic doses; however, animal studies may not have revealed in full the potential of teratogenicity, since eltrombopag is not pharmacologically active in rats or rabbits. The ePub format uses eBook readers, which have several "ease of reading" features At present, no marked maternal or fetal toxicity of eltrombopag has been reported in animal studies at drug doses equivalent to those given to humans [6]. Use effective birth control to prevent pregnancy while taking this medicine, and for at least 7 days after your last dose. The https:// ensures that you are connecting to the We report the case of a patient with ITP along pregnancy, refractory to corticosteroids and IVIg, successfully treated with, the thrombopoietin receptor agonist (TPO-RA) eltrombopag. government site. PMC Killick S. B., Bown N., Cavenagh J., et al. PMC Blood 2013; 121:3847. There are no controlled data in human pregnancy. doi: 10.1097/MD.0000000000008337. Effect of pregnancy on the course of immune thrombocytopenia: a retrospective study of 118 pregnancies in 82 women. After the administration of 12.5 mg/day eltrombopag prior to pregnancy, her platelet count remained above 50 10 9 /L. Tab Prednisolone was also continued throughout pregnancy and then tapered and omitted in the postnatal period. In lactating rats, eltrombopag was detected 10 days post-partum, showing the potential for transfer during lactation. Moreover, the patient remained in complete response after delivery despite therapy discontinuation. 2020 Sep;31(6):416-418. doi: 10.1097/MBC.0000000000000936. Pathological examination of the placenta revealed one small infarction in the villi. Use of a thrombopoietin mimetic for chronic immune thrombocytopenic purpura in pregnancy. Microscopically, perivillous fibrin deposition was prominent. Eltrombopag - Get up-to-date information on Eltrombopag side effects, uses, dosage, overdose, pregnancy, alcohol and more. Bethesda, MD 20894, Web Policies Careful observation and blood examinations are necessary for neonates born to mothers who receive eltrombopag treatment during pregnancy. It is taken by mouth.. Eltrombopag was discovered as a result of research collaboration . WBC: white blood cells. We are experimenting with display styles that make it easier to read articles in PMC. Kong Z., Qin P., Xiao S., et al. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the PROMACTA pregnancy registry by calling 1-888-825-5249.AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Anderson Cancer Center Brief Summary: The goal of this clinical research study is to learn if eltrombopag can help to control MDS. Hepatobiliary laboratory abnormalities. This drug is in pregnancy category C (use in pregnancy only when benefit to the mother outweighs risk to the fetus). eCollection 2022 Feb. Case Rep Womens Health. Use an effective form of birth control to keep from getting pregnant during treatment with eltrombopag and for at least 7 days after the last dose. Eltrombopag has been assigned Category C by the Federal Drugs Agency (FDA) nevertheless there are no well controlled data in the literature about its role in pregnancy. Before Eltrombopag binds to the thrombopoietin receptor on megakaryocytes and hematopoietic stem cells, which results in platelet production and overcoming the depletion of hematopoietic stem cells in aplastic anemia [3]. Aplastic Anemia Treated with Eltrombopag during Pregnancy. Immune thrombocytopenia (ITP) during pregnancy is an acquired autoimmune disease present in 1-2 of every 1000 pregnancies. How I treat refractory immune thrombocytopenia. MeSH Lassandro G, Palladino V, Vecchio GCD, Palmieri VV, Corallo PC, Faienza MF, Giordano P. Endocr Metab Immune Disord Drug Targets. and transmitted securely. In addition, fibrous thickening and obliteration at stem vessels were observed, which indicated fetal vascular malperfusion. Thrombopoietin modulates the proliferation, migration and cytokine profile of decidual cell subsets during early gestation. At 37 weeks of gestation, she was diagnosed with a severe hypertensive disorder and underwent a caesarean section. eltrombopag (el- trom -bo-pag) , Promacta (trade name), Revolade (trade name) Classification Therapeutic: antithrombocytopenics Pharmacologic: thrombopoietin receptor agonists Pregnancy Category: C Indications Treatment of chronic immune (idiopathic) thrombocytopenic purpura in patients who have had an inadequate response to corticosteroids, . Eltrombopag may harm an unborn baby. This site needs JavaScript to work properly. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Platelet count: Less than 50 x 10 (9)/L following at least 2 weeks of eltrombopag therapy: Increase daily dose by 25 mg to a maximum of 75 mg per day.
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