See full prescribing information for DOPTELET. It stimulates your bone marrow to make more platelets, which reduces your risk of bleeding. More serious internal bleeding is also possible. Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information). When you get Doptelet from the pharmacy, the pharmacist will add an expiration date to the label on the packet. This date is typically 1 year from the date they dispensed the medication. Normal platelet levels are typically between 150,000 per microliter (mcL) and 450,000 per mcL. Raise your patients' platelet counts with Doptelet. 1,2 the estimated prevalence of itp in us adults is 9.5 per 100,000 people, and the incidence of itp increases with age. This e-book looks at the 3 essential tips a project delivery team must consider when delivering a successful Design Build project. The researchers found that Doptelet increased platelet counts faster than Promacta. With this autoimmune disease, your immune system mistakenly causes your spleen to destroy platelets. Two studies compared Doptelet with a placebo (a treatment with no active drug) in people with chronic liver disease who were going to have a procedure with a risk of bleeding. Avatrombopag is not a substrate for OATP1B1, OATP1B3, OCT2, OAT1 or OAT3. Take Doptelet exactly as your health provider tells you to take it. Take your next dose at your usual scheduled time. The symptoms of the disease include easy or excessive bruising, prolonged bleeding from cuts, bleeding from the gums or nose, blood in urine or stools, heavy menstrual flows, fatigue, enlarged spleen and jaundice. To report suspected adverse reactions, contact Sobi North America at 1-866-773-5274 or FDA at 1-800-FDA-1088. Its only used to reduce the risk of bleeding with certain medical or dental procedures.
CYP enzymes: Avatrombopag does not inhibit CYP1A, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A, does not induce CYP1A, CYP2B6, CYP2C, or CYP3A, and weakly induces CYP2C8 and CYP2C9. I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the, Specialty drug launch strategy and operations, The next chapter of clinical trial services, KYNMOBI for the Treatment of OFF episodes in Parkinsons Disease, USA, Sotyktu (deucravacitinib) to Treat Moderate to Severe Plaque Psoriasis, USA, QUVIVIQ (daridorexant) for the Treatment of Insomnia, USA, Cablivi (caplacizumab) for the Treatment of Acquired Thrombotic Thrombocytopenic Purpura, BESREMi (ropeginterferon alfa-2B) for the Treatment of Polycythaemia Vera, US, Opdualag (nivolumab and relatlimab-rmbw) for the Treatment of Unresectable or Metastatic Melanoma, US, Novavax reports Phase III topline data of Omicron subvariant vaccines, Incyte and Mirati enter trial partnership for solid tumour therapy, OneStudyTeam and Antidote partner to boost recruitment in trials. Call your doctor right away if you have serious side effects. By downloading this eBook, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. I understand that the revocation will be effective when my Providers are notified of it. The CYP2C9*2 and CYP2C9*3 loss-of-function polymorphisms result in reduced CYP2C9 enzymatic activity. The amazing story of hepatitis C, from discovery to cure. However, you should still check with your doctor or pharmacist before using any of these products while taking Doptelet. Its not currently available in generic form. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The FDA then approved the drug in May 2018. Clinical studies have found Doptelet to be more effective than a placebo (a treatment with no active drug) at increasing platelet counts and reducing bleeding risk. Prior to treatment, patients should fully understand and be informed of the following risks and considerations for Doptelet: Doptelet is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease or chronic immune thrombocytopenia. Patients received a starting dose of 20 mg once daily, with doses subsequently titrated based on platelet response. What is the product type, route of administration and mechanism of action of Doptelet (avatrombopag) ? You can take Doptelet at any time of day but try to take it at the same time each day. Generics tend to cost less than brand-name drugs. Certain other drugs that affect how your blood clots, such as warfarin, may require changes in your diet. Mechanism of Action: Doptelet (avatrombopag) is an orally bioavailable, small molecule TPO receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in an increased production of platelets. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Call 911 if your symptoms feel life-threatening or if you think youre having a medical emergency. The following were considered rescue therapies to manage the risk of bleeding associated with a procedure: whole blood transfusion, packed red blood cell (RBC) transfusion, platelet transfusion, fresh frozen plasma (FFP) or cryoprecipitate administration, Vitamin K, desmopressin, recombinant activated factor VII, aminocaproic acid, tranexamic acid, or surgical or interventional radiology procedures performed to achieve hemostasis and control blood loss. Your platelet count will be checked again on the day of your procedure to make sure Doptelet has worked for you. Tick the boxes of the newsletters you would like to receive. If your platelets havent increased enough, you may need to have other treatments (such as a platelet transfusion), so that you can have the procedure safely. Patient populations were similar between the pooled Low and High Baseline Platelet Count Cohorts and consisted of 66% male and 35% female; median age 58 years and 61% White, 34% Asian, and 3% Black. Avatrombopag activates TPO receptors on megakaryocyte precursor cells and megakaryocytes in the bone marrow. It can effectively kill cancer cells, but it can also kill healthy cells, especially blood cells. Its known that if your platelet count is very low toward the end of your pregnancy, it raises your risk of severe bleeding during or after childbirth.
Doptelet: Liu lng, cch s dng, tc dng ph, v.v. - Y Khoa - 2022 DOPTELET should not be administered to patients with chronic liver disease or chronic immune thrombocytopenia in an attempt to normalize platelet counts. This helps prevent others, including children and pets, from taking the drug by accident. A medication timer may be useful, too. Doptelet (avatrombopag) is a second generation, once daily, orally administered TPO receptor agonist approved for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure. The term "mechanism of action" is a pharmacological term commonly used when discussing medications or drugs. Platelets are blood cells that help your body form blood clots to prevent bleeding. Also tell them about any vitamins, herbs, and supplements you use. If you have any questions about eating certain foods with Doptelet, talk with your doctor. Examples of drugs that may be used to treat chronic immune thrombocytopenia (ITP) include: Examples of other drugs that may be used to treat thrombocytopenia in chronic liver disease include: You may wonder how Doptelet compares with other medications that are prescribed for similar uses. Healthy subjects administered 40 mg of avatrombopag had a geometric mean (%CV) maximal concentration (Cmax) of 166 (84%) ng/mL and area under the time-concentration curve extrapolated to infinity (AUC0-inf) of 4198 (83%) ng.hr/mL. Mechanism of Action. In addition, a larger proportion of patients in the Doptelet treatment group had platelet counts 50109/L at Day 8 compared to placebo (21/32; 66% vs 0/17; 0.0%, respectively; p<0.0001). Doptelet (avatrombopag) is a second generation, once daily, orally administered TPO receptor agonist approved for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to. The most common* mild side effects of Doptelet (depending on the condition being treated) can include: Most of these side effects may go away within a few days or a couple of weeks. The following information is provided for clinicians and other healthcare professionals. A measured increase in platelet counts was observed in both Doptelet treatment groups over time beginning on Day 4 post-dose, that peaked on Day 10-13, decreased 7 days post-procedure, and then returned to near baseline values by Day 35. If youre sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while youre using Doptelet. Eligible patients were scheduled to undergo their procedure (low, moderate, or high bleeding risk) 5 to 8 days after their last dose of treatment. Your doctor will check your platelet count to see if Doptelet is working for you. Common symptoms of ITP include having many purple bruises (purpura) on your skin or inside your mouth. *Promacta has a boxed warning for this side effect. At this point, your platelet count will be checked once a month. In ADAPT-1, a total of 231 patients were randomized, 149 patients were treated with Doptelet and 82 patients were treated with placebo. They are both used to increase platelet counts before medical or dental procedures. Post treatment, platelet counts decreased gradually, returning to near baseline values. If you take Doptelet with the antibiotic drug rifampin (Rifadin, Rimactane), rifampin may reduce the amount of Doptelet in your body. The FDAs approval for Dopteletwas based on results obtained from global Phase III clinical trials ADAPT-1 and ADAPT-2. Therefore, if your body doesnt make enough TPO, your platelet count will fall. who have had an insufficient response to a previous treatment. This means you can bruise or bleed easily. This post is an overview on antiplatelet drugs, we will focus on the classification of agents and their mechanism of action. 1 It is not known if Doptelet passes into your breast milk. Doptelet can be used when platelet counts havent responded sufficiently to other treatments. Then take your regular dose the next day as scheduled. Forty-nine patients were randomized, 32 to Doptelet and 17 to placebo, with similar mean [SD] baseline platelet counts in the 2 treatment groups (14.1 [8.6]109/L and 12.7 [7.8]109/L, respectively). Avatrombopag AUC0-inf and Cmax were not affected when Doptelet was co-administered with a low fat meal (500 calories, 3 g fat, 15 g protein, and 108 g carbohydrates) or a high fat meal (918 calories, 59 g fat, 39 g protein, and 59 g carbohydrates).
Docusate: Uses, Interactions, Mechanism of Action - DrugBank
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