It's also used with other medications ( interferon and ribavirin) to raise platelet levels in people with long-term hepatitis C. Promacta (eltrombopag) is available as both tablets and an oral suspension, which is helpful for children and people who struggle with swallowing. We comply with the HONcode standard for trustworthy health information. tell your doctor if you are pregnant, or plan to become pregnant. Avatrombopag increases the production of platelets by your body to help prevent too much bleeding. P-gp inhibitors: Clinically important pharmacokinetic interaction not expected. Your doctor may adjust you dose as needed. Following oral administration, peak plasma avatrombopag concentrations occur at 56 hours. Your doctor will order certain lab tests before you start treatment to decide your dose of avatrombopag and on the day of the procedure. The dose is usually 40 (2 tablets) to 60 milligrams (mg) (3 tablets) once a day for 5 days. Drug class: platelet-stimulating agents Avatrombopag systemic is used in the treatment of: Idiopathic Thrombocytopenic Purpura Thrombocytopenia Chemical structure Chemical structure of avatrombopag Further information Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. When used in patients with chronic liver disease undergoing a procedure, obtain a platelet count prior to administration of the drug and on the day of the procedure to ensure an adequate increase in platelet count. Non-Guideline-Supported Use. It is also used to treat thrombocytopenia in patients with chronic immune thrombocytopenia who have had previous treatment that did not work well. Avatrombopag is used to treat thrombocytopenia (low platelets in the blood) in adults with chronic liver disease who are scheduled to have a medical or dental procedure. Avatrombopag comes as a tablet to take by mouth. Patients with chronic ITP (10%): Headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis. Avatrombopag is a thrombopoietin receptor agonist that binds to and activates the thrombopoietin (TPO) receptor, thereby increasing platelet production. The report provides the clinical trials information of . How do you take Doptelet before a medical or dental procedure. Signs of a common cold. If you are taking avatrombopag to treat thrombocytopenia just before a procedure, take the missed dose as soon as you remember it. Avatrombopag is used to treat thrombocytopenia (a lack of platelets in the blood) in adults with chronic liver disease who are scheduled to undergo a medical procedure. If you become pregnant while taking avatrombopag, call your doctor. Recommended dosage is based on patient's platelet count prior to the procedure. Doptelet (avatrombopag) - Drug Insight and Market Forecast report is published on August 6, 2020 and has 80 pages in it. Dose level 4: 20 mg once daily (initial dose for all patients except those taking moderate or strong dual inhibitors or inducers of CYP2C9 and CYP3A4 . Weak inducer of CYP2C8 and CYP2C9 in vitro but does not induce CYP isoenzymes 1A, 2B6, 2C, or 3A or inhibit CYP isoenzymes 1A, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A in vitro. For avatrombopag, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to avatrombopag or any other medicines. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Do not take double dose to make up for a missed dose. This new drug application provides for the use of Doptelet (avatrombopag) tablets for treatment Medically reviewed by Drugs.com on Feb 28, 2022. No dosage adjustment is necessary in patients with chronic liver disease. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of avatrombopag in the elderly. Doptelet belongs to a class of drugs called Thrombopoietic Agents. Adjust dosage based on platelet count response (see Table 1). Follow recommended dosage guidelines to achieve target platelet counts. 1 Drug Class: A small molecule thrombopoietin (TPO) receptor agonist Mechanism of action Thrombopoietin receptor agonists (TPO-RAs) have been associated with thrombotic and thromboembolic complications. Pharmacokinetics are similar between healthy individuals and patients with chronic liver disease. avatrombopag (Rx) Brand and Other Names: Doptelet Classes: Thrombopoietic Agents Print Dosing & Uses AdultPediatric Dosage Forms & Strengths tablet 20mg Thrombocytopenia Patients with chronic. Use the lowest effective dosage to achieve and maintain platelet count 50,000/mm3 as necessary to reduce the risk of bleeding. Phone: 46 8 697 20 00 www.sobi.com. You may have your medical or dental procedure 5 to 8 days after the last dose of avatrombopag. 8,12,13 Prophylactic transfusions prior to the . Take your next dose at the regular time and stay on your once-daily schedule. This study aims to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia in a multicenter, prospective, randomized controlled trial. In healthy volunteers receiving an oral dose of 2.5 mg, 5 mg or 7.5 mg, hetrombopag plasma concentrations peaked twice, first after 1-2 h and the second after 7-10 h [].A high-fat and -calorie meal taken with hetrombopag [] or within 1-2 h postdose [] markedly reduced hetrombopag maximum plasma concentration (C max) and area under the plasma concentration-time curve (AUC) from time zero . tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Information is also available online at https://www.poisonhelp.org/help. Pharm. Using avatrombopag with any of the following medicines is usually not recommended, but may be required in some cases. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. current indications for available tpo-ras include treatment of chronic immune thrombocytopenia (itp) in cases of insufficient response to prior treatment (avatrombopag, eltrombopag, romiplostim), management of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure (avatrombopag, lusutrombopag), Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. For chronic immune thrombocytopenia: Take the missed dose as soon as you remember it. Avatrombopag is a thrombopoietin receptor agonist that is FDA approved for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo . Do not keep outdated medicine or medicine no longer needed. For non-prescription products, read the label or package ingredients carefully. In patients receiving concomitant therapy with a moderate or potent dual inhibitor of CYP2C9 and CYP3A4, reduce initial dosage of avatrombopag to 20 mg 3 times a week. A total of 19.4% of the salts were approved as anti-infectives, 16.1% were approved for CNS disorders, 12.9% for gastrointestinal disorders, 4.8% for autoimmune disorders and 3.2% for heart ailments and glandular disorders. Additional study is ongoing to assess the use of avatrombopag to treat . Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Drug class: Hematopoietic Agents Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Avatrombopag Drug Characteristics. Version: 2.01. Take avatrombopag exactly as directed. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Pharmacokinetics not established in patients with severe renal impairment, including those requiring dialysis. Uses Warnings Before taking Side effects Interactions Dosage LARVOL VERI predictive biomarker news, Doptelet (avatrombopag) Other names: AKR-501, AKR 501, YM-477, AS 1670542, E5501, AKR501, YM477, YM 477, AS1670542, AS-1670542 Do not use avatrombopag to normalize platelet counts. We comply with the HONcode standard for trustworthy health information. Dual CYP2C9 and CYP3A4 inhibitors: Moderate or potent dual inhibitors of CYP2C9 and CYP3A4 may result in increased avatrombopag exposure and increased risk of toxicity. Blood tests will be needed while you are using avatrombopag. Bloating or swelling of the face, arms, hands, lower legs, or feet, pain in the chest, groin, or legs, especially the calves, sudden, severe weakness or numbness in the arm or leg. This data was consistent regardless of age, sex, race, region, MELD score, Child-Turcotte-Pugh class, or disease etiology. Drug class: Platelet-stimulating agents. Nose or throat irritation. The dosage could range from 20mg/week to 60mg/day. Avatrombopag is in a class of medications called thrombopoietin (TPO) receptor agonists. May increase risk for blood clotting problems (eg, thromboembolism). bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds. Sobi Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:SOBI) today announced the commercial launch of Doptelet (avatrombopag) in Europe, with the United Kingdom as the first country for launch. Dublin, Dec. 30, 2020 (GLOBE NEWSWIRE) -- The "Doptelet (Avatrombopag) - Drug Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering. Learn more about Avatrombopag What special precautions should I follow? Alternate Names: E-5501 YM-477 AVATROMBOPAG E5501 chembl:CHEMBL2103883 drugbank:11995 pubchem.compound:9852519 The applicant's response was received on January 8, 2018 and was found to be adequate for the PLLR labeling review. Store at 2025C (excursions permitted to 1530C). Other drugs may affect avatrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. In poor or intermediate CYP2C9 metabolizers (i.e., patients with CYP2C9*2 or *3 polymorphism), systemic exposure is approximately 1.4-fold or 2-fold higher, respectively, compared with CYP2C9 extensive metabolizers. antithrombocytopenics. Brand name: Doptelet May cause fetal harm based on animal findings. Avatrombopag is not a cure for thrombocytopenia and it will not make your platelet counts normal. joint pain. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Upon completion of avatrombopag administration, the platelet count was monitored every 2-4 days from . When you are taking avatrombopag, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Avatrombopag - Get up-to-date information on Avatrombopag side effects, uses, dosage, overdose, pregnancy, alcohol and more. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. It is also used to treat thrombocytopenia in patients with chronic immune thrombocytopenia who have had previous treatment that did not work well. Your doctor may occasionally change your dose. Avatrombopag-drug interactions appear to be generally clinically insignificant. Check with your doctor right away if you have pain, swelling, or tenderness in your leg, or pain in your chest. Avatrombopag may also be used for purposes not listed in this medication guide. Treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP; also known as idiopathic thrombocytopenic purpura) who have had an insufficient response to a prior treatment (designated an orphan drug by FDA for use in this condition). Keep each tablet in the foil blister pack until you are ready to take a dose. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Store at room temperature away from moisture and heat. Drug International Pharma. The probabilities that each drug treatment successfully raised a patient's platelet count, thus avoiding the need for a prophylactic platelet transfusion, were based on the phase 3 multinational clinical trials conducted for avatrombopag and the prescribing information for lusutrombopag . Platelet count increases observed within 35 days and peak after 1013 days. When given before a medical procedure in people with chronic liver disease: Avatrombopag is usually taken once daily for 5 days, beginning 10 to 13 days before your procedure. Increases platelet counts in a dose- and exposure-dependent manner. To use the sharing features on this page, please enable JavaScript. We comply with the HONcode standard for trustworthy health information. Blood clotting problems may occur while you are using avatrombopag. Before a scheduled medical procedure: Call your doctor for instructions if you miss a dose. American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. Do not take a double dose to make up for a missed one. It is also important information to carry with you in case of emergencies. This medication increases the production of platelets by your body to help prevent too much bleeding from the procedure.Avatrombopag is also used to treat people with a certain blood disorder. Promacta, prednisone, dexamethasone, triamcinolone, Decadron, Deltasone, Nplate. Doptelet may be used alone or with other medications. Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases. Administer once daily for 5 days, starting 1013 days prior to the scheduled procedure; patients should undergo the procedure 58 days after the last dose of the drug is administered. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. AHFS DI Essentials. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. This medicine may be used for other purposes . It works by causing the body to produce more platelets. current indications for available tpo-ras include treatment of chronic immune thrombocytopenia (itp) in cases of insufficient response to prior treatment (avatrombopag, eltrombopag, romiplostim), management of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure (avatrombopag, lusutrombopag), Avatrombopag is a thrombopoietin receptor agonist and is currently marketed under the brand name Doptelet. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Avatrombopag | C29H34Cl2N6O3S2 | CID 9852519 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities . Chemical formula: C29H34Cl2N6O3S2Drugbank ID: DB11995. The amount of medicine that you take depends on the strength of the medicine. tell your doctor if you are breastfeeding. Tell your doctor about all your current medicines and any medicine you start or stop using. Pharmacokinetics are dose-proportional over dose range of 1080 mg. Doptelet (avatrombopag . Your doctor will probably tell you not to breastfeed during your treatment and for 2 weeks after your final dose. You should not use avatrombopag if you are allergic to it. What is DOPTELET (avatrombopag) [dop-TELL-it]? You may report side effects to FDA at 1-800-FDA-1088. Please refer to your New Drug Application (NDA) dated September 21, 2017, received September 21, 2017, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Doptelet (avatrombopag) tablets, 20 mg. Avatrombopag is also used to treat chronic immune thrombocytopenia when other treatments have failed. The presence of other medical problems may affect the use of avatrombopag. DOPTELET is a prescription medicine used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) when other treatments have not worked well enough. Duplication for commercial use must be authorized by ASHP. Effects on milk production or on breast-fed infant also not known. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Find information on Avatrombopag (Doptelet) in Davis's Drug Guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. After administration, avatrombopag binds to and stimulates the platelet thrombopoeitin receptor (TPOR), which can lead to the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells. Swedish Orphan Biovitrum AB (publ) Postal address SE-112 76 Stockholm, Sweden. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). Avatrombopag is mainly metabolised by CYP2C9 and CYP3A4 isoenzymes. This segment of the report provides historical and forecasted sales data from 2017 to 2030. Read and follow these instructions carefully. You may report side effects to the FDA at 1-800-332-1088. Do not take more or less of it or take it more often than prescribed by your doctor. Avatrombopag is usually taken once daily to treat chronic immune thrombocytopenia. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Dova's lead drug candidate, avatrombopag, has successfully completed two pivotal Phase 3 clinical trials for the treatment of thrombocytopenia in patients with CLD scheduled to undergo a . It is very important that your doctor check your progress at regular visits to make sure avatrombopag is working properly. Avatrombopag is not a cure for thrombocytopenia and it will not make your platelet counts. This market research report provides information about Drug Pipeline, Research & Development (Pharma & Healthcare), Drug Discovery, Pharma & Healthcare industry. Initially, 20 mg once daily. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Doptelet is a prescription medicine used to treat the symptoms of Thrombocytopenia (lack of platelets in the blood). Do not attempt to normalize platelet counts. Mulpleta vs Doptelet - What's the difference? Consider potential increased risks of thrombotic and thromboembolic complications in patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (e.g., factor V Leiden, prothrombin 20210A, antithrombin deficiency, protein C or S deficiency). If a dose is missed, take the dose as soon as it is remembered. Keep this medication in the container it came in, tightly closed, and out of reach of children. Importance of advising women to avoid breast-feeding while receiving the drug and for 2 weeks after the last dose is administered. Ask your healthcare professional how you should dispose of any medicine you do not use. Avatrombopag is used to treat thrombocytopenia (a low number of platelets [type of blood cell needed for blood clotting]) in people with chronic (ongoing) liver disease who are scheduled to have a medical or dental procedure to help prevent bleeding complications. The Orphan Drug Designation programme provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare . We comply with the HONcode standard for trustworthy health information. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient. <50,000/mm3 after at least 2 weeks of avatrombopag therapy, Increase dosage by 1 dose level (see Table 2); wait 2 weeks to assess the effects of this and any subsequent dosage adjustments, Decrease dosage by 1 dose level (see Table 2); wait 2 weeks to assess the effects of this and any subsequent dosage adjustments, Interrupt therapy and monitor platelet count twice weekly; once platelet count <150,000/mm3, restart at a dosage reduced by 1 dose level (see Table 2), <50,000/mm3 after 4 weeks of therapy with avatrombopag 40 mg daily (highest recommended dosage), >400,000/mm3 after 2 weeks of therapy with avatrombopag 20 mg weekly (lowest recommended dosage), 40 mg once daily (highest recommended dosage), 40 mg 3 times a week and 20 mg on the 4 remaining days of each week, 20 mg once daily (usual initial recommended dosage), 20 mg once weekly (lowest recommended dosage). It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. Paula Treutiger, Head of Communication & Investor Relations. Comparison of avatrombopag 60 mg vs. placebo, adjusted for the number of chemotherapy agents currently receiving per IWRS (1, 2). How do you take Doptelet before a medical or dental procedure. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. tell your doctor and pharmacist if you are allergic to avatrombopag, any other medications, or any of the ingredients in avatrombopag tablets. DOPTELET (avatrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Follow your doctor's instructions about any restrictions on food, beverages, or activity. Advise women not to breast-feed during therapy and for at least 2 weeks after the last dose is administered. Slightly higher avatrombopag exposures observed in intermediate or poor CYP2C9 metabolizers compared with CYP2C9 extensive metabolizers; not considered clinically important. Call your doctor or get emergency medical help if you have: pain, swelling, or redness in one or both legs; sudden fever or chills, yellowing of your skin or eyes; or. Appropriate studies have not been performed on the relationship of age to the effects of avatrombopag in the pediatric population. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Market Research Report Summary. http://www.upandaway.org. Yes - Idiopathic thrombocytopenic purpura; Thrombocytopenia. AHFS Patient Medication Information. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. antithrombocytopenics Pharm. Avatrombopag is used to treat thrombocytopenia (a low number of platelets [type of blood cell needed for blood clotting]) in people with chronic (ongoing) liver disease who are scheduled to have a medical or dental procedure to help prevent bleeding complications. Available for Android and iOS devices. There was no significant difference in the effective rate between the two groups ( p = 0.417). For the assessment of the worstcase scenario for a dual substrate, regulatory guidance recommends investigation using a dual inhibitor/inducer approach. Class. upper respiratory tract infection. If the drug is used for brief periods (i.e., prior to a procedure in patients with chronic liver disease) in a lactating woman, manufacturer recommends that breast-feeding be interrupted and affected milk discarded during treatment and for 2 weeks after the last dose is administered. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In vitro, inhibits breast cancer resistance protein (BCRP) and organic anion transporter (OAT) 3, but does not inhibit organic anion transporting polypeptide (OATP) 1B or 1B3, organic cation transporter (OCT) 2, or OAT1. You should not breast-feed while using avatrombopag, and for at least 2 weeks after your last dose. For the treatment of thrombocytopenia in people with chronic liver disease who are scheduled to have a procedure, it is usually taken with food once a day for 5 days, starting 10 to 13 days before the procedure. Carefully follow your doctor's dosing instructions about the timing of this medicine and the procedure. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. You could develop a blood clot while using avatrombopag. Mechanism of Action Thrombopoietin receptor agonists. Class. Follow recommended dosage guidelines to achieve target platelet counts to minimize risk of bleeding; do not use to normalize platelet counts. What are the possible side effects of Doptelet? Platelet count <40,000/mm3: 60 mg once daily for 5 days. Avatrombopag is used to treat thrombocytopenia (low platelets in the blood) in adults with chronic liver disease who are scheduled to have a medical or dental procedure. CAS number: 677007-74-8. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. 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