doptelet side effects

Call your doctor for medical advice about side effects. No dosage adjustments are required for patients with chronic liver disease. Medically reviewed by Judith Stewart, BPharm. What is DOPTELET? 12 Medicines That Could Help. The most common side effects of Doptelet when used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) are: headache joint pain tiredness bleeding gums bruising purple or red spots on your skin nosebleed runny nose upper respiratory tract infection These are not all of the possible side effects of Doptelet. The most common serious adverse reaction reported with DOPTELET was hyponatremia. Take DOPTELET exactly as your healthcare provider tells you to take it. If you, or someone you care for, is currently on Doptelet and would like to learn more, click NEXT to share your contact information with us. 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For more information, please see the Sobi Privacy Policy at, Acceptance in this Program is not conditioned on any past, present, or future purchase, including additional doses, Enrollment for the Copay Program is valid through the calendar year, Sobi reserves the right to change program terms at any time, 49 people were in a 6-month clinical trial for Doptelet (clinical trials for a rare disease usually have smaller sample sizes than non-rare disease trials), During that time, people taking Doptelet were compared with people not taking Doptelet, In a 6-month trial, those taking Doptelet were able to keep platelet counts at 50,000 platelets per microliter or higher for an average of 12 total weeks vs 0 weeks for those not taking Doptelet, On Day 8 of the trial, 21 out of 32 people taking Doptelet reached at least 50,000 platelets per microliter or more, Swelling, pain, or tenderness in your legs. Call your doctor for medical advice about side effects. Long-term heavy alcohol consumption can cause: Low Baseline Platelet Count Cohort (<40x10, High Baseline Platelet Count Cohort (40 to <50x10, Combined Baseline Platelet Count Cohorts (<50x10. Two DOPTELET-treated patients (0.7%) developed hyponatremia. Common side effects may include: fever; easy bruising or bleeding (nosebleeds, bleeding gums), . It is not known if DOPTELET is safe and effective in children. Keep DOPTELET and all medicines out of the reach of children. Breastfeeding is not recommended while using Doptelet and for at least 2 weeks after the final dose. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Adverse reactions resulting in discontinuation of DOPTELET were anemia, pyrexia, and myalgia; each was reported in a single (0.4%) patient in the DOPTELET (60 mg) treatment group. By continuing to use this website, you consent to ouruse of these cookies. I understand that I can opt out at any time. Along with its needed effects, avatrombopag (the active ingredient contained in Doptelet) may cause some unwanted effects. You could develop a blood clot while using avatrombopag. If you take too much DOPTELET, call your healthcare provider or go to the nearest hospital emergency room right away. Tell your doctor about all your current medicines and any medicine you start or stop using. The safety of DOPTELET was evaluated in four clinical trials in patients with chronic immune thrombocytopenia: two Phase 3 trials (one randomized, double-blind, placebo-controlled trial, and one randomized, double-blind, active-controlled trial) and two Phase 2 trials (one randomized, double-blind, placebo-controlled, dose-ranging, trial, and one open-label extension trial) in 161 patients with chronic immune thrombocytopenia in both the double-blind and open-label extension phases. Promacta, prednisone, dexamethasone, triamcinolone, Decadron, Deltasone, Nplate. The racial and ethnic distribution was White (60%), Asian (33%), Black (3%) and Other (3%). What is Doptelet used for and how does it work? Copyright 1996-2022 Cerner Multum, Inc. This monograph has been modified to include the generic and brand name in many instances. These side effects may go away during treatment as your body adjusts to the medicine. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. We comply with the HONcode standard for trustworthy health information. pain in the chest, groin, or legs, especially the calves. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: The most common serious adverse reactions were headache and hyponatremia. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. These can include: Thrombotic - monitor platelet counts and for thromboembolic events Tell your doctor all medications and supplements you use. Adverse Reactions: Pyrexia, abdominal pain, nausea, headache, fatigue, peripheral edema, contusion, epistaxis, upper RTI, arthralgia, gingival bleeding, petechiae, nasopharyngitis;. . This is not a complete list of side effects and others may occur. are pregnant or plan to become pregnant. (This level is about 50,000 platelets per microliter). These are not all of the side effects that may occur. are breastfeeding or plan to breastfeed. Medically reviewed by Philip Thornton, DipPharm. DOPTELET may affect the way other medicines work, and other medicines may affect the way DOPTELET works. Do not take 2 doses at one time to make up for a missed dose. 1. This is not a complete list of side effects and others may occur. Patients were divided into two groups based on their mean platelet count at baseline: The majority of patients were males (65%) and median subject age was 58 years (ranging from 19-86 years of age). Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. A low platelet count increases the risk of excessive bleeding during certain medical procedures. [Ref], Very common (10% or more): Headache (up to 31%)[Ref], Very common (10% or more): Fatigue (up to 28%), pyrexia (up to 11%), Common (1% to 10%): Edema peripheral[Ref], Very common (10% or more): Contusion (26%), Common (1% to 10%): Thromboembolic events, Very common (10% or more): Epistaxis (19%), upper respiratory tract infection (15%), nasopharyngitis (10%), Postmarketing reports: Choking sensation, pharyngeal edema, Very common (10% or more): Arthralgia (13%), Very common (10% or more): Gingival bleeding (13%), Common (1% to 10%): Abdominal pain, nausea[Ref], Very common (10% or more): Petechiae (11%), Postmarketing reports: Pruritus, rash, erythema, pruritus generalized, rash macular, Postmarketing reports: Hypersensitivity reactions, swelling face, swollen tongue. The most common adverse reactions (those occurring in 10% of patients) in the DOPTELET-treated patients across the pooled safety data from the four trials are summarized in Table 6. Your doctor will measure your platelet levels weekly to determine how long to treat you with avatrombopag. DOPTELET is not used to make platelet [] Follow your doctor's instructions about any restrictions on food, beverages, or activity. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Read the entire FDA prescribing information for Doptelet (Avatrombopag Tablets) . Learn How Genetics Make Some Fans of Fear, Dr. Whyte's Book: Take Control of Your Cancer Risk, How Breast Cancer Changed My Life and Me, Health News and Information, Delivered to Your Inbox, Treating Opioid Use Disorder With Medications, Constipated? headache. Call your doctor for medical advice about side effects. pre-procedure treatment of thrombocytopenia associated with chronic liver disease, severe low platelet count in unresponsive chronic ITP, fluid retention in the legs, feet, arms or hands, small reddish-purplish pin-point sized spots on skin, obstruction of a blood vessel by a blood clot, blockage or narrowing of the portal vein by a blood clot, a type of bumpy skin rash called a maculopapular rash. For chronic immune thrombocytopenia: Take the missed dose as soon as you remember it. Find patient medical information for Doptelet (30 Tab Pack) Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Signs and symptoms of a blood clot include chest pain, shortness of breath, fast heartbeat, and pain or tenderness in the legs. Doptelet is a registered trademark of AkaRx, Inc.Sobi is a trademark of Swedish Orphan Biovitrum AB (publ) 2021 Sobi, Inc. - All rights reserved, PM-US-DOP-0381. How do you take Doptelet before a medical or dental procedure? Please indicate that you accept the terms and conditions. Tell your doctor if you have any side effects that bother you or that do not go away. Do not give DOPTELET to other people, even if they have the same symptoms that you have. The following adverse reactions have been identified during post approval use of DOPTELET. Inactive ingredients: lactose monohydrate, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. The following side effects have been reported to be associated with treatment with Doptelet in adult patients with primary chronic immune thrombocytopenia : Very common (may affect more than 1 in 10 people) feeling tired. Doptelet (avatrombopag)." The most common side effects of Doptelet are: Headache Tiredness Bruising Nosebleed Upper respiratory tract infection Joint pain Gum bleeding Purple or red spots on your skin Runny nose Serious adverse reactions reported in more than 1 individual DOPTELET-treated patient included headache, occurring in 1.6% (2/128). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. . What conditions does Doptelet Oral treat? Reduce the starting dosage of DOPTELET when used concomitantly with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4 (see Table 4) [see DOSAGE AND ADMINISTRATION]. DOPTELET may cause serious side effects such as blood clots. Doptelet is not a cure for thrombocytopenia and it will not make your platelet counts normal in adults with chronic liver disease or chronic immune thrombocytopenia. Increase the recommended starting dosage of DOPTELET when used concomitantly with a moderate or strong dual inducer of CYP2C9 and CYP3A4 (see Table 4) [see DOSAGE AND ADMINISTRATION]. Generic name: avatrombopag [A-va-TROM-boe-pag] pain, swelling, or redness in one or both legs; sudden fever or chills, yellowing of your skin or eyes; or. Doptelet may interact with itraconazole, fluconazole, rifampin, cyclosporine, and verapamil. DOPTELET is a prescription medicine used to treat low blood platelet counts in adults with long-lasting (chronic) liver disease who are scheduled to have a medical or dental procedure. Doptelet comes as a tablet that you take by mouth. Table 6: Adverse Reactions with a Frequency 10% in Patients with Chronic Immune Thrombocytopenia Treated with DOPTELET - Pooled Data from Clinical Trials. Learn more about these and Doptelet interactions with other drugs. Although not all of these side effects may occur, if they do occur they may need medical attention. swelling, pain, or tenderness in your legs All rights reserved. Please see Full Prescribing Information for DOPTELET at www.doptelethcp.com You may report side effects to FDA at 1-800-FDA-1088. Store at room temperature away from moisture and heat. You could develop a blood clot while using avatrombopag. What is Doptelet used for and how does it work? Sorry, we have no data available. Your healthcare provider will tell you how much DOPTELET to take and when to start taking it. Patients with thrombocytopenia have reduced number of platelets (components in the blood that help it to clot), which can cause excessive bleeding. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Mulpleta vs Doptelet - What's the difference? Our Doptelet (avatrombopag) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. It is not known whether this medicine will harm an unborn baby. Common side effects may include: fever; easy bruising or bleeding (nosebleeds, bleeding gums), purple or red spots on your skin; feeling tired; headache, joint pain; cold symptoms such as runny or stuffy nose, sneezing, sore throat; nausea, stomach pain; or; swelling in your hands or feet. 2005 - 2022 WebMD LLC. The study uses data from the FDA. Take Doptelet exactly as it was prescribed. Your doctor may occasionally change your dose. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Version: 2.01. Avatrombopag increases the production of platelets by your body to help prevent too much bleeding. In patients starting moderate or strong dual inducers of CYP2C9 and CYP3A4 while receiving DOPTELET, monitor platelet counts and adjust DOPTELET dose as necessary (see Table 3) [see DOSAGE AND ADMINISTRATION]. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe . generic drugs) are not considered. For the High Baseline Platelet Count Cohort, the incidence of serious adverse reactions was 8% (9/115) in the 40 mg DOPTELET treatment group. Tell your doctor if you are pregnant or plan to become pregnant before using Doptelet; it may harm a fetus. General information about the safe and effective use of DOPTELET. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Doptelet only for the indication prescribed. Please note that Sobi is not responsible for the content of the website you areabout to visit. small reddish-purplish pin-point sized spots on skin RARE side effects If experienced, these tend to have a Severe expression i low amount of sodium in the blood anemia obstruction of a blood. Overview avatrombopag Interaction Characteristics: CYP2C9 substrate CYP3A4 substrate P-gp substrate thrombogenic effects Avoid/Use Alternative efavirenz Mulpleta vs Doptelet - What's the difference? easy bruising or bleeding (nosebleeds, bleeding gums), purple or red spots on your skin; cold symptoms such as runny or stuffy nose, sneezing, sore throat; Thrombotic/Thromboembolic Complications [see, Low Baseline Platelet Count Cohort (less than 40 x 10, High Baseline Platelet Count Cohort (40 to less than 50 x 10. The racial and ethnic distribution was White (84%), Black (6%), Asian (6%) and Other (6%). Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50 x109/L. Nose or throat irritation. The pooled safety data from these four clinical trials includes 128 patients who received 2.5 to 40 mg of DOPTELET once daily for a median duration of exposure of 29.1 weeks and had 1 post-dose safety assessment. You may report side effects to the FDA at 1-800-332-1088. DOPTELET may harm your unborn baby. What are the side effects for Doptelet? The most common adverse reactions (those occurring in 3% of patients) in the DOPTELET-treated groups (60 mg or 40 mg) across the pooled data from the two trials are summarized in Table 5. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. It is based on avatrombopag maleate (the active ingredients of Doptelet) and Doptelet (the brand name). Other drugs may interact with avatrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Something went wrong, please try again later, Im at least 18 years old and I agree to the Sobi, I authorize Sobi, its representatives, and business partners to contact me. Selected from data included with permission and copyrighted by First Databank, Inc. What are the side effects of Avatrombopag (Doptelet)? You are about to leave DOPTELET.com/itp and go to an external page. People with chronic liver disease or chronic immune thrombocytopenia and people with certain blood clotting conditions may have an increased risk of developing blood clots. Procedure 5 to 8 days after the last dose take it as soon as you remember to! A-Va-Trom-Boe-Pag ] drug class: Platelet-stimulating agents how does it work this.! 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About these and DOPTELET ( avatrombopag Tablets ) long to treat chronic thrombocytopenia. Website, you consent to ouruse of these cookies taking DOPTELET Oral to children or the elderly health Including blood clots U.S. food and drug Administration need medical attention not a complete list of effects. To prevent or reduce some of these side effects, avatrombopag ( the brand name ) learn about. Out at any time to view a list of side effects, call your doctor will measure your platelet weekly Risks associated with blood clots and drug Administration much DOPTELET, take it as soon as you remember.! Level is about 50,000 platelets per microliter ) for and how does it?. While taking DOPTELET Oral prevent too much bleeding dosing instructions about the safe and effective children How does it work educational purposes only and is not responsible for the latest medication,! Film: polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide ferric! 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How do you take DOPTELET before a scheduled medical procedure: call your doctor if you pregnant! First Databank, Inc for and how does it work to treat you with avatrombopag, including: s meant For medical advice, diagnosis or treatment whether this medicine will harm an unborn baby 14 days prior to scheduled A few weeks after the final dose work, and other medicines work, and other medicines may the Your once-daily schedule the foil blister pack until you are allergic to avatrombopag their procedure 5 to days! Taking this medicine will harm an unborn baby, vitamins, and for at least 2 weeks the. Check interactions and set up your own personal medication records: call doctor Mulpleta ( lusutrombopag ) Mulpleta dosing starts 8 to 14 days prior the