doptelet mechanism of action

The expiration date helps guarantee that the medication is effective during this time. What is Doptelet [dop-TELL-it]?Doptelet is a prescription medicine used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (IT. Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. Blood clots in veins or arteries were reported in 7% of people with chronic ITP who took Doptelet. This could raise your risk for side effects from Doptelet. It stimulates your bone marrow to make more platelets, which reduces your risk of bleeding. For more information . It occurred in 10% of people who took Doptelet, compared with 9% of people who took a placebo (a treatment with no active drug). Raise your patients' platelet counts with Doptelet. 1398 0 obj <>stream Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics ATC code: B02BX08 Mechanism of action. Doptelet is used to increase platelet counts in people with thrombocytopenia (low platelet count) caused by: If you have ITP, your platelet count will typically be below 100,000 per mcL. Normal platelet levels are typically between 150,000 per microliter (mcL) and 450,000 per mcL. The patients were randomised to receive either 40mg or 60mg of Dopteletdaily for five days or placebo based on their baseline platelet counts. 1 The term "mode of action," on the other hand, is sometimes used to describe the more general response or effect of the drug, such as what a person feels when they . Can psychedelics rewire a depressed, anxious brain? The actual price youll pay will depend on your insurance plan, your location, and the pharmacy you use. A related article explores the pharmacology of thrombolytic agents. Mechanism of Action 1.3. Doptelet is significantly less expensive than Mulpleta. Mulpleta vs Doptelet - What's the difference? You can take your Doptelet dose at any time of day but try to take it at the same time every day. Headquartered in Durham, North Carolina, Dova Pharmaceuticals is involved in the acquisition, development and commercialisation of drug candidates for rare diseases. In the Low Baseline Platelet Count Cohort, the mean baseline platelet count for the Doptelet-treated group was 32.7109/L and for the placebo-treated patients was 32.5109/L. Experimental breast cancer vaccine proves safe in phase 1 clinical trials, Age-related macular degeneration: Cholesterol, diabetes drugs may lower risk, What to know about platelet count ranges in thrombocytopenia, Debra Sullivan, Ph.D., MSN, R.N., CNE, COI. The insurance company will review the request and let you and your doctor know if your plan will cover Doptelet. Treatment was taken for 5 days before the procedure. 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. Common symptoms of ITP include having many purple bruises (purpura) on your skin or inside your mouth. A generic drug is an exact copy of the active drug in a brand-name medication. Doptelet's mechanism of action Doptelet contains a TPO receptor agonist, which stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells and results in increased production of platelets. Therefore, its not meant to return your platelet count to normal levels. The disease is a common complication in patients with CLD and it occurs due to a reduction in TPO, a physiologic regulator of platelet production. ITP is an autoimmune disease, which means your immune system mistakenly attacks part of your own body. Doptelet is a registered trademark of AkaRx, Inc.Sobi is a trademark of Swedish Orphan Biovitrum AB (publ)Doptelet Connect is a trademark of AkaRx, Inc. 2022 Sobi, Inc. All rights reserved. Further, both trials demonstrated a greater mean change in platelet counts from baseline to the day of the procedure, a secondary efficacy endpoint, in both Doptelet-treated groups versus the placebo-treated groups for both cohorts (Low Baseline Platelet Count Cohort ADAPT-1: 32109/L vs 0.8109/L, respectively; p<0.0001; ADAPT-2: 31.3109/L vs 3.0109/L, respectively; p <0.0001; High Baseline Platelet Count Cohort ADAPT-1: 37.1109/L vs 1.0109/L, respectively; p <0.0001; ADAPT-2: 44.9109/L vs 5.9109/L, respectively; p <0.0001). Dopteletcontains a TPO receptor agonist, which stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells and results in increased production of platelets. Please enter a work/business email address. By Cohhran-Mantel-Haenszel Testing stratified by bleeding risk for the procedure. Patients undergoing neurosurgical interventions, thoracotomy, laparotomy or organ resection were not eligible for enrollment. According to the National Cancer Institute (NCI), approximately 70,000 patients with CLD have a platelet count of less than 50,000 / l., Hard data and deep insights on clinical trials strategy & operations, Receive our newsletter - data, insights and analysis delivered to you. These are not all of the possible side effects of Doptelet. For instance, some interactions can interfere with how well a drug works. If you have trouble swallowing these tablets, ask your pharmacist for advice. If youre taking Doptelet for a low platelet count due to chronic liver disease, youll take it once a day for 5 days. You should take Doptelet according to your doctor or healthcare providers instructions. Here we look at how Doptelet and Mulpleta are alike and different. Doptelet can cause mild or serious side effects. 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. A class of drugs is a group of medications that work in a similar way. Overview Doptelet is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to long-standing liver disease. This is the most serious warning from the Food and Drug Administration (FDA). . In the Low Baseline Platelet Count Cohort, the mean baseline platelet count for the Doptelet-treated group was 31.1109/L and for the placebo-treated patients was 30.7109/L. Enter your details here to receive your free eBook. Avatrombopag is greater than 96% bound to human plasma proteins. The efficacy of Doptelet for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure was established in 2 identically-designed multicenter, randomized, double-blind, placebo-controlled trials (ADAPT-1 [NCT01972529] and ADAPT-2 [NCT01976104]). A low platelet count is a common complication of chronic liver disease. The gastric carcinoids were considered likely due to prolonged hypergastrinemia observed in toxicity studies. Your healthcare provider will tell you how much Doptelet to take and when to start taking it. Doptelet is used to increase your platelet count before you have a medical or dental procedure that increases your risk of bleeding. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage for Patients with Chronic Liver Disease Begin Doptelet dosing 10 to 13 days prior to the scheduled procedure. More serious internal bleeding is also possible. Difference of Proportion vs. placebo = Proportion of Responders for Doptelet Proportion of Responders for placebo. The FDA then approved the drug in May 2018. A measured increase in platelet counts was observed in Doptelet treatment groups over time beginning on Day 4 post-dose, that peaked on Days 10-13, decreased 7 days post-procedure, and then returned to near baseline values by Day 35.1, On procedure day, 10 to 13 days after starting Doptelet 40 mg or Doptelet 60 mg once daily for 5 days, compared to placebo (P<0.0001; N=435).1, From randomization of Doptelet 40 mg or Doptelet 60 mg once daily for 5 days up to 7 days after a procedure, compared to placebo (P<0.0001; N=435).1, In pooled analysis of ADAPT-1 and ADAPT-2 (N=277).1, View the Doptelet (avatrombopag) Mechanism of Action, Our support specialists can help answer your questions about Doptelet and access options call us at 855-4LIFTUP (855-454-3887). In September 2018, Dova Pharmaceuticals submitted a supplemental NDA (sNDA) for Doptelet to the FDA for the treatment of chronic immune thrombocytopenia purpura(ITP) in adult patients. Doptelet (avatrombopag) Analytical Perspective by DelveInsight. This will be checked with a weekly blood test. Max=maximum, Min=minimum, SD=Standard deviation. Doptelet (avatrombopag) is a thrombopoietin (TPO) receptor agonist. The recommended daily dose is based on the patient's platelet count prior to the scheduled procedure. With this, the condition youre taking Doptelet to treat. What are the possible side effects of Doptelet? There are currently no generic forms of either drug. When you get Doptelet from the pharmacy, the pharmacist will add an expiration date to the label on the packet. Dopteletdisplayed superior efficacy in both the dosage groups when compared to placebo. Table 9: Cumulative Number of Weeks of Platelet Response Phase 3 Trial in Patients with Chronic Immune Thrombocytopenia. Below are examples of these side effects. They can give you tips on how to deal with any side effects that may be bothersome. Heres some detail on some of the side effects this drug may cause. You are about to leave DOPTELETHCP.com and go to an external page. If your platelet count doesnt reach at least 50,000 per microliter (mcL) with the maximum dose of Doptelet, your doctor will conclude that its not working for you. Avatrombopag does not compete with TPO for binding to the TPO receptor and has an . There arent any foods that have been specifically reported to interact with Doptelet. CLINICAL PHARMACOLOGY Mechanism Of Action. (Rescue therapy is treatment to reduce bleeding or lower the risk of bleeding). Store tablets in the original package. 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 activates TPO receptors on megakaryocyte precursor cells and megakaryocytes in the bone marrow. Serious side effects from Doptelet arent common, but they can occur. 1 Docusate was added directly to the jejunum based on calculated concentrations of docusate in the jejunum. The median time to maximal concentration (Tmax) occurred at 5 to 6 hours post-dose. Bruising easily is also one of the symptoms of a low platelet count. Do not breastfeed during your treatment with Doptelet and for at least 2 weeks after the last dose. Different interactions can cause different effects. Tell your healthcare provider right away if you have signs and symptoms of a blood clot, including:. Doptelet is a type of drug called a thrombopoietin receptor agonist. Patients with thrombocytopenia have reduced number of platelets (components in the blood that help it to clot), which can cause excessive bleeding. Youre unlikely to notice Doptelet working, but your blood tests will show that your platelet count has gone up. Bruising is a possible side effect of taking Doptelet. However, your doctor will adjust your dosage each week depending on your platelet count. However, if you dont remember until its time for your next dose, dont take two doses together. Blood clots are a possible side effect of taking Doptelet. Doptelet is available only as a brand-name medication. If you would like to report to the FDA a side effect youve had with Doptelet, you can do so through MedWatch. No. Doptelet is a brand-name prescription medication thats FDA-approved to increase the number of platelets in your blood. This medicine is authorised for use in the European Union. 95% confidence interval calculated based on normal approximation. Dopteleti kasutatakse trombotstide arvu suurendamiseks tasemeni, mis aitab vhendada verejooksu riski. Platelets are blood cells that help your body form blood clots to prevent bleeding. Platelet count (x 109/L), Dose adjustment or action < 50 after at least 2 weeks of avatrombopag treatment Increase One Dose Level per Table 3. . Avatrombopag AUC 0-inf and C max 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). The drug is available in 20mg dose tablets for oral administration. The most common side effects of DOPTELET when used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) are: headache tiredness bruising nosebleed upper respiratory tract infection joint pain bleeding gums purple or red spots on your skin runny nose These are not all the possible side effects of DOPTELET. Of the people who took Doptelet, 66% to 88% didnt need rescue therapy to reduce bleeding (such as a platelet transfusion) for up to 7 days after the procedure. Page 1 Name of your medication Generic name avatrombopag (A-va-TROM-bo-pag) Brand name Doptelet (DOP-te-let) Approved uses Avatromobopag is used to treat patients with low platelet count either due to liver disease or immune thrombocytopenia. You are about to leave DOPTELETHCP.com and go to www.Doptelet.com or call.. Educational materials, and why is it crucial to healthcare take two doses together by mouth may 2018 didnt this! When used during pregnancy also tell them about all prescription, over-the-counter, and high-risk procedures were in! Article explores the pharmacology of thrombolytic agents typically take it at the maximum recommended dose 20. 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