doptelet side effects

Find information about common, infrequent and rare side effects of Doptelet (30 tab pack) oral 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. What are the possible side effects of DOPTELET? If you are taking DOPTELET for chronic immune thrombocytopenia and you miss a dose of DOPTELET, take it as soon as you remember. Chronic Immune Thrombocytopenia: 20 mg orally once a day. Doptelet - patient leaflet, side effects, dosage | Patient info WebMD does not provide medical advice, diagnosis or treatment. You should not breast-feed while using Doptelet, and for at least 2 weeks after your last dose. 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. Bloating or swelling of the face, arms, hands, lower legs, or feet body aches or pain chills cough difficulty with breathing fever headache loss of voice pain in the chest, groin, or legs, especially the calves pale skin rapid weight gain runny nose severe, sudden headache slurred speech sore throat sudden loss of coordination You may also need blood tests for a few weeks after your last dose. The information disclosed will include the date the prescription is filled, the number of pills or product dispensed by the pharmacists, and the amount of your copay that will be paid for by using this Copay Program. Selected from data included with permission and copyrighted by First Databank, Inc. Doptelet (avatrombopag): Basics, Side Effects & Reviews - GoodRx It's not meant to return your platelet levels. Doptelet: Dosage, uses, side effects, and more Doptelet: Uses, Taking, Side Effects, Warnings - Medicine.com This monograph has been modified to include the generic and brand name in many instances. Joint pain. Call your doctor for medical advice about side effects. Doptelet (avatrombopag) is a thrombopoietin receptor agonist indicated for the treatment of low blood platelet count (thrombocytopenia) in adult patients with chronic liver disease who are scheduled to undergo a procedure. This is not a complete list of side effects and others may occur. Breastfeeding is not recommended while using Doptelet and for at least 2 weeks after the final dose. Dova Pharmaceuticals (2018): Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Overview avatrombopag Interaction Characteristics: CYP2C9 substrate CYP3A4 substrate P-gp substrate thrombogenic effects Avoid/Use Alternative efavirenz Your healthcare provider may change your dose of DOPTELET depending on your blood platelet counts. 1996-2022 RxList, Inc. All rights reserved. The safety of DOPTELET was evaluated in two international, identically designed, randomized, double-blind, placebo-controlled trials, ADAPT-1 and ADAPT-2, in which 430 patients with chronic liver disease and thrombocytopenia received either DOPTELET (n=274) or placebo (n=156) daily for 5 days prior to a scheduled procedure, and had 1 post-dose safety assessment. Call your doctor for medical advice about side effects. Common (may affect up to 1 in 10 people) back pain, muscle pain, joint pain, pain in arms or legs. 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. Do not give DOPTELET to other people, even if they have the same symptoms that you have. DOPTELET (avatrombopag) Side Effects & Study Results for ITP Dosage of drugs is not considered in the study. Tell your doctor about all your current medicines and any medicine you start or stop using. Doptelet comes as a tablet that you take by mouth. If you take too much DOPTELET, call your healthcare provider or go to the nearest hospital emergency room right away. Last updated on Aug 24, 2022. 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. This website uses cookies. Doptelet 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. General information about the safe and effective use of DOPTELET. Doptelet and Obesity hypoventilation syndrome (ohs), a phase IV Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. headache. 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. 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. The most common side effects of DOPTELET when used to treat low blood platelet counts in adults with ITP are headache, tiredness, bruising, nosebleeds, upper-respiratory tract infection, joint pain, gum bleeding, purple or red spots on your skin, and a runny nose. Available for Android and iOS devices. What should I know regarding pregnancy, nursing and administering Doptelet Oral to children or the elderly? What are the side effects for Doptelet? Doptelet - Avatrombopag uses, dose and side effects - zeepedia.com The following adverse reactions have been reported with Doptelet treatment in adult patients with primary chronic immunological thrombocytopenia : Very common (may affect more than 1 in 10 people) fatigue headache. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50 x109/L. Side effects that you should report to your doctor or health care professional as soon as possible: Allergic Reactions Like Skin Rash, Itching Or Hives, Swelling Of The Face, Lips, Or Tongue Signs And Symptoms Of A Blood Clot Such As Breathing Problems; Changes In Vision; Chest Pain; Severe, Sudden Headache; Pain, Swelling, Warmth In The Leg; Trouble Speaking; Sudden Numbness Or Weakness Of The Face, Arm Or Leg . Mulpleta vs Doptelet - What's the difference? DOPTELET may affect the way other medicines work, and other medicines may affect the way DOPTELET works. Use: Treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure. A low platelet count increases the risk of excessive bleeding during certain medical procedures. DOPTELET (avatrombopag) Safety Profile for Chronic ITP | HCP 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 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. . Promacta Side Effects: Common, Severe, Long Term - Drugs.com Take your next dose at your usual scheduled time. You could develop a blood clot while using avatrombopag. pain, swelling, or redness in one or both legs; sudden fever or chills, yellowing of your skin or eyes; or. How do you take Doptelet before a medical or dental procedure? Call your doctor for medical advice about side effects. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. What are the side effects of Avatrombopag (Doptelet)? Table 5: Adverse Reactions with a Frequency 3% in Patients with Chronic Liver Disease Treated with DOPTELET - Pooled Data ADAPT-1 and ADAPT-2. Tell your doctor if you are pregnant or plan to become pregnant before using Doptelet; it may harm a fetus. DOPTELET (Avatrombopag) - Oncopod- Chemotherapy Drugs Information Talk to your healthcare provider about the best way to feed your baby during this time. Tablet coating film: polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide and ferric oxide yellow. Store DOPTELET at room temperature between 68F to 77F (20C to 25C). 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]. Doptelet | European Medicines Agency Concomitant use with a moderate or strong dual inducer of CYP2C9 and CYP3A4 decreases avatrombopag AUC [see CLINICAL PHARMACOLOGY] which may reduce DOPTELET efficacy. 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]. Call your doctor or get emergency medical help if you have: The following clinically significant adverse reactions are discussed in detail in other sections of the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Some side effects may not be reported. For the High Baseline Platelet Count Cohort, the incidence of serious adverse reactions was 8% (9/115) in the 40 mg DOPTELET treatment group. September 2021For US Residents Only. If you have questions about side effects, call your doctor. 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. This is not a complete list of side effects and others may occur. Doptelet for Liver Disease: Drug Side Effects & Dosage - MedicineNet Check with your doctor immediately if any of the following side effects occur while taking avatrombopag: Some side effects of avatrombopag may occur that usually do not need medical attention. 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. Some dosage forms listed on this page may not apply to the brand name Doptelet. Take Doptelet exactly as it was prescribed. Other drugs that have the same active ingredients (e.g. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Keep DOPTELET and all medicines out of the reach of children. How do you take Doptelet before a medical or dental procedure. Use the medicine exactly as directed. bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds. Tell your doctor if you have any side effects that bother you or that do not go away. Last reviewed on RxList: 10/21/2021 Common (may affect up to 1 in 10 people) back pain, muscle aches, joint pain, pain in arms or legs Patients must not seek reimbursement from any health savings, flexible spending, or other healthcare reimbursement accounts for the amount of assistance received from the Copay Program, Certain information pertaining to your use of the Copay Program will be shared with Sobi, Inc., the sponsor of the Copay Program. Copyright 1996-2022 Cerner Multum, Inc. Table 6: Adverse Reactions with a Frequency 10% in Patients with Chronic Immune Thrombocytopenia Treated with DOPTELET - Pooled Data from Clinical Trials. DOPTELET is not used to make platelet [] avoid: breastfeeding during tx and for at least 2wk after D/C caution: thromboembolism risk caution: intermediate CYP2C9 metabolizers caution: poor CYP2C9 metabolizers Drug Interactions . Do not take 2 doses at one time to make up for a missed dose. 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. Note: This document contains side effect information about avatrombopag. You may report side effects to the FDA at 1-800-332-1088. Doptelet may interact with itraconazole, fluconazole, rifampin, cyclosporine, and verapamil. Doptelet is used to increase your platelet count before you have a medical or dental procedure that increases your risk of bleeding. swelling, pain, or tenderness in your legs. For chronic immune thrombocytopenia: Take the missed dose as soon as you remember it. 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? DOPTELET (dop-TEL-et) Avatrombopag Chemotherapy Have a Question ? 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. Mulpleta vs Doptelet - What's the difference? - Drugs.com The most common serious adverse reaction reported with DOPTELET was hyponatremia. If you take DOPTELET to treat your low blood platelet counts due to chronic immune thrombocytopenia, your healthcare provider will check your platelet count before, during and for at least 4 weeks after stopping your treatment with DOPTELET. 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. This Patient Information has been approved by the U.S. Food and Drug Administration. Before you take DOPTELET, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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. Copay Program has an annual calendar cap of $15,000, The Copay Saving Program is void where prohibited by law, taxes, or restricted, This offer is non-transferable, no substitutions are permissible, and this offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription, Sobi, Inc. reserves the right to rescind, revoke, or amend this offer at any time without notice, The Patient Copay Program for Doptelet is not insurance and is not intended to substitute for insurance, Patients, pharmacists, and healthcare providers must not seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this Copay Program. ; s the difference ( 20C to 25C ) and for at least 2 weeks after your last.. Patient information has been approved by the U.S. Food and Drug Administration immune. 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Provider to ensure the information displayed on this page applies to your personal circumstances, rifampin, cyclosporine and. Maintain platelet count increases the risk of bleeding with DOPTELET was hyponatremia: 20 mg orally once day!