doptelet manufacturer

pain in mouth and throat (oropharyngeal pain) The most common side effects of Nplate in children 1 year of age and older include: bruising. Serious adverse reaction that occurred more frequently in patients treated with DOPTELET (9%; 12/128) compared to placebo (5%; 1/22) was headache, occurring in 1.6% (2/128). Doptelet is a prescription medicine used to treat low blood platelet counts in adults with: long-lasting (chronic) liver disease (CLD) who are scheduled to have a medical or dental procedure. What are the possible side effects of DOPTELET? I understand The recommended daily dose is based on the patient's platelet count prior to the scheduled procedure. Care Coordinators are available MondayFriday 8am8pm ET. Pronunciation of DOPTELET with 3 audio pronunciations. Everybodys treatment goals are different. Chronic liver disease who are scheduled to undergo a procedure. 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. It is not known if DOPTELET passes into your breast milk. List of all Manufacturers, Suppliers & Exporters of Doptelet (TN) API listed on PharmaCompass with details of regulatory filings If you take too much DOPTELET, call your healthcare provider or go to the nearest hospital emergency room right away. Additional medications in the 'Prescription Medications' section by AkaRx, Inc. Each blister card contains 10 or 15 tablets. Doptelet Connect has Dedicated Care Coordinators that can help: For more information, call 1-833-368-2663. Talk to your healthcare provider about the best way to feed your baby during this time. 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. Forty-nine patients were randomized (2:1) to receive either Doptelet (n=32) or placebo (n=17). What is Doptelet (avatrombopag), and what is it used for? By continuing to use this website, you consent to ouruse of these cookies. Having a low platelet count increases the risk of too much bleeding during certain procedures. You can ask your pharmacist or healthcare provider for information about DOPTELET that is written for health professionals. 20 MG | Tablet | 10 tablets. Take your next dose at your usual time. Platelets. Throughout the core study and extension phase, 72.3% of patients were exposed to avatrombopag for at least 32 weeks. Doptelet is designed to mimic the effects of TPO, the primary regulator of normal platelet production. For adults with thrombocytopenia in chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. DOPTELET is a drug used to treat adults with low platelet count who are scheduled to have a medical or dental procedure that could lead to increased bleeding. In the open-label extension phase for those patients continuing Doptelet treatment, a response was achieved at 44.2% of visits.4,6, After initiating therapy with Doptelet, assess platelet counts weekly until a stable platelet count of 50109/L has been achieved, and then obtain platelet counts monthly thereafter.1. Provan D et al. Here's the skinny-10/23- 227, Nplate @ 80, Dopt. My count went up to 745k- yikes. You may report side effects to FDA at 1-800-FDA-1088. 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. (2.1) Patients should undergo their procedure within 5 to 8 days after the last dose. Full prescribing information for Doptelet is available on the Doptelet website, www.doptelet.com. Doptelet Connect Case Managers are available Monday-Friday 8 AM-8 PM ET. HighBaseline. Tablet coating film: polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide and ferric oxide yellow. 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. People with chronic immune thrombocytopenia and people with certain blood clotting conditions may have an increased risk of developing blood clots. Shareholders of Dova By continuing to use this website, you consent to ouruse of these cookies. The drug is available in 20mg dose tablets for oral administration. Doptelet (avatrombopag) is an orally administered thrombopoietin receptor agonist (TPO-RA) that mimics the biologic effects of TPO in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count. Formulary status is subject to change and does not imply clinical efficacy or safety.. Patients with thrombocytopenia have reduced number of platelets (components in the blood that help it to clot), which can cause excessive bleeding. 2019; 3 (22):3780-3817. This Patient Information has been approved by the U.S. Food and Drug Administration. . 40 mg (2 tablets) once daily for 5 days with food. By acting like TPO, Doptelet (avatrombopag) helps to raise your platelet levels. Company to Host Conference Call Dova will host a conference call today, May 21, 2018 at 4:30 p.m . Take DOPTELET exactly as your healthcare provider tells you to take it. 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. Inactive ingredients: lactose monohydrate, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. I also had a massive migraine for 4 days (I never get migraines) that week. . Begin Doptelet 10-13 days prior to the scheduled procedure. 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. You may report side effects to FDA at 1-800-FDA-1088. Get Avatrombopag Medication Sheet Published: 19 September 2021 Last Updated: 27 December 2021 What is the drug for? DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic complications in patients with chronic liver disease (0.4%; (1/274) in DOPTELET-treated patients) and thromboembolic complications in patients with chronic immune thrombocytopenia (7%; (9/128) in DOPTELET-treated patients). 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. DOPTELET is not used to make platelet counts normal in adults with chronic immune thrombocytopenia. If you think youve taken more Doptelet than your doctor prescribed, call your healthcare provider or go to the nearest hospital emergency room right away. LowBaseline. 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. Platelet Count 40109/L to <50109/L. Any questions? . 2019; 3 (23):3829-3866. 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. Your healthcare provider will tell you how much DOPTELET to take and when to start taking it. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Doptelet (avatrombopag) is a member of the platelet-stimulating agents drug class and is commonly used for Idiopathic Thrombocytopenic Purpura, and Thrombocytopenia.,Doptelet Coupon & Prices - Cost $49 per month ,We do not offer printable Doptelet manufacturer coupons, Doptelet discounts, rebates, Doptelet savings cards, trial offers, or free . Doptelet helps patients produce more of their own platelets.1, Our support specialists can help answer your questions about Doptelet and access options call us at 855-4LIFTUP (855-454-3887), Doptelet worked to raise platelet counts in patients with ITP in the Phase 3 clinical study. Schedule Usual starting dose for ITP: avatrombopag (Doptelet) 20 mg oral tablet by mouth every day with food Note: unlike EL trombopag (Promacta), AVA trombopag is taken WITH food Avatrombopag is usually taken at home by the patient. It is not known if DOPTELET is safe and effective in children. DOPTELET may harm your unborn baby. 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. 556038-9321 TEl: +4686972000 E-mail: medical.info@sobi.commedical.info@sobi.com 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. You can ask your pharmacist or healthcare provider for information about DOPTELET that is written for health professionals. It is not known if DOPTELET passes into your breast milk. Patients should undergo their procedure 5 to 8 days after the last dose of Doptelet. Difficult. What is DOPTELET (avatrombopag) [dop-TELL-it]? Doptelet is a type of drug called a thrombopoietin receptor agonist. Common Doptelet 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. Manufacturer Coupons and Offers Available. What is Doptelet? Avatromobopag (Doptelet) is used to treat patients with low platelet count either due to liver disease or immune thrombocytopenia. 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. You are about to leave DOPTELET.com/itp and go to an external page. upper respiratory tract infection. This medication increases the production . DOPTELET may harm your unborn baby. Open-label extension: Patients could enter the open-label extension phase if they completed the 6-month core study, or if they experienced a lack of efficacy during that period. It is not known if DOPTELET is safe and effective in children. 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. Use Caution/Monitor. Doptelet is an FDA (U.S. Food and Drug Administration) approved medication manufactured by AkaRx, Inc. Durham, North Carolina 27707. Swedish Orphan Biovitrum (Sobi) said that the first patient has been dosed with Doptelet (avatrombopag) in a phase 3 trial for the treatment of immune thrombocytopenia (ITP) in pediatric patients. September 2021For US Residents Only. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. It is estimated that approximately 20% of individuals receiving a TPO-RA will be able to eventually discontinue these treatments while . 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-0380. 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. I authorize Doptelet Connect to transmit the above prescription to the appropriate pharmacy for my patient. DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic complications in patients with chronic liver disease (0.4%; (1/274) in DOPTELET-treated patients) and thromboembolic complications in patients with chronic immune thrombocytopenia (7%; (9/128) in DOPTELET-treated patients). Doptelet Connect can assist your patients with insurance questions, financial support options, educational materials, and coordination around the specialty pharmacy process. You can ask your pharmacist or healthcare provider for information about DOPTELET that is written for health professionals. 3 /5. DOPTELET is not used to make platelet counts normal in adults with chronic immune thrombocytopenia. Doptelet AVATROMBOPAG helps your body make more platelets. Do not breastfeed during your treatment with DOPTELET and for at least 2 weeks after the last dose. Doptelet Connect support services to my patient, including contacting my patient by telephone or mail for these purposes. 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. Patients had previously received one or more prior chronic ITP therapies and had average screening and baseline platelet counts of <30109/L. These are not all the possible risks associated with DOPTELET. upper respiratory tract infection. (2.1) DOPTELET should be taken orally with food once daily for 5 consecutive days. If you take too much DOPTELET, call your healthcare provider or go to the nearest hospital emergency room right away. These are not all the possible risks associated with DOPTELET. 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. Distributed and Marketed by Dova Pharmaceuticals, Inc. swelling, pain, or tenderness in your legs. Doptelet (avatrombopag) is a thrombopoietin (TPO) receptor agonist. Cilatus Manufacturing Services Limited. Doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. 4 Nov, 2020 08:30. Store DOPTELET tablets in the original package. You may report side effects to FDA at 1-800-FDA-1088. Take your next dose at your usual scheduled time. This website uses cookies. Portal vein thrombosis has been reported in patients with chronic liver disease, and thromboembolic events (arterial and venous) have been reported in patients with chronic immune thrombocytopenia treated with TPO receptor agonists. Moderate. Please indicate that you accept the terms and conditions. Doptelet is a thrombopoietin receptor agonist (TPO-RA) approved for the treatment of severe thrombocytopenia in adult patients . General information about the safe and effective use of DOPTELET. Take your next dose at your usual scheduled time. DOPTELET administered to adult patients resulted in dose- and exposure-dependent elevations in platelet counts. DOPTELET was also shown to be superior to placebo in both secondary efficacy endpoints in each trial, i.e., the proportion of patients achieving a platelet count equal to or greater than 50,000 . Dova Pharmaceuticals, a wholly owned subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi), presented data on the cost effectiveness of Doptelet (avatrombopag) for the treatment of thrombocytopenia in patients with chronic liver diseases (CLD) who are scheduled to undergo a procedure at the 61st Annual Meeting of the American Society of Hematology (ASH) taking place in Orlando, 7-10 . durham, n.c., june 27, 2019 (globe newswire) -- dova pharmaceuticals, inc. (nasdaq: dova), a pharmaceutical company focused on acquiring, developing and commercializing drug candidates for diseases. DOPTELET should not be administered to patients with chronic liver disease or chronic immune thrombocytopenia in an attempt to normalize platelet counts. DOPTELET is a prescription medicine used to treat low blood platelet counts in adults with: DOPTELET is not used to make platelet counts normal in adults with chronic liver disease or chronic immune thrombocytopenia. Patients can take Doptelet with any food (food required); no administration concerns with minerals like calcium or magnesium.1, Doptelet does not require additional liver-function monitoring; no significant hepatotoxicity seen in Doptelet clinical trials.1,4, Doptelet can be taken anytime, anywhere, without adding trips to the doctor (platelet monitoring required).1, Throughout the core study and extension phase, 72.3% of patients were exposed to avatrombopag for at least 32 weeks. 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. istradefylline. 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. (2.1) The recommended dose of DOPTELET is based on a patient's platelet Page 3: AkaRx, Inc.: DOPTELET is a thrombopoietin receptor agonist indicated for the treatment of: Thrombocytopenia in adult patients with chronic liver. Inactive ingredients: lactose monohydrate, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Provides the required information to enroll in Doptelet Connect, Facilitates patient/caregiver authorization to enroll in Doptelet Connect. Tell your healthcare provider right away if you have signs and symptoms of a blood clot, including: The most common side effects of DOPTELET when used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) are: These are not all the possible side effects of DOPTELET. Do not breastfeed during your treatment with DOPTELET and for at least 2 weeks after the last dose. This effect was not observed with istradefylline 20 mg/day. Following the approval of DOPTELET, hypersensitivity reactions involving the immune system, including, but not limited to, pruritus, rash, choking sensation, swollen face, and swollen tongue have been reported. DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. What are the possible side effects of DOPTELET? nausea. You are about to leave DOPTELET.com/itp and go to an external page. 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. The recommended daily dose of DOPTELET is based on the patient's platelet count prior to the scheduled procedure (see Table 1). Platelet Count <40109/L. It may harm them. DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. By continuing to use this website, you consent to our use of these cookies. People with chronic immune thrombocytopenia and people with certain blood clotting conditions may have an increased risk of developing blood clots. Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions. 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. If you miss a dose of Doptelet, take it as soon as you remember. DOPTELET may harm your unborn baby. Tell your healthcare provider right away if you have signs and symptoms of a blood clot, including: The most common side effects of DOPTELET in people with chronic liver disease are: The most common side effects of DOPTELET when used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) are: These are not all the possible side effects of DOPTELET. DOPTELET may affect the way other medicines work, and other medicines may affect the way DOPTELET works. Your healthcare provider may change your dose of DOPTELET depending on your blood platelet counts. DOPTELET may cause serious side effects, including blood clots. DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with: Thrombotic/Thromboembolic Complications. long-lasting (chronic) liver disease (CLD) who are scheduled to have a medical or dental procedure. Please see Full Prescribing Information for DOPTELET at www.doptelethcp.com. Eligible patients who have commercial insurance may pay as little as $0. cough. 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. The onset of the platelet count increase was observed within 3 to 5 days of the start of treatment, with peak effect after 10 to 13 days. You must meet eligibility criteria For more information, call 1-833-368-2663. which would expand the size of the market to enable the drug manufacturers to penetrate . For specific information, please contact the patient's insurer. 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. 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. Do not use DOPTELET for a condition for which it was not prescribed. Begin dosing DOPTELET 10 to 13 days prior to a scheduled procedure. Do not give DOPTELET to other people, even if they have the same symptoms that you have. Do not give DOPTELET to other people, even if they have the same symptoms that you have. Were looking for real patients, like you, to share their experiences on Doptelet and what its like to live with chronic ITP, to inform and inspire others living with and learning how to manage their own ITP. Do not take 2 doses at one time to make up for a missed dose. 60 mg (3 tablets) once daily for 5 days with food. DOPTELET may cause serious side effects, including blood clots. Company: Sobi, Inc. No. Please see full Prescribing Information, including the Patient Information Leaflet. If you have questions about how long youll be taking Doptelet, talk to your doctor or care teamtheyre there to help. Also by this Manufacturer. For more information, call 1-833-368-2663. Compare thrombopoiesis stimulating agents. Please indicate that you accept the terms and conditions. An influential pharmaceutical sales leader, adept at building high-performing cultures and teams, achieving consistent top 20% results nationally. 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. Thrombotic/Thromboembolic Complications. DOPTELET is not used to make platelet counts normal in adults with chronic immune thrombocytopenia. Doptelet is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to long-standing liver disease. A management consultant for Fortune 500 companies . Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with DOPTELET. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Third-party payment for prescriptiondrugs is affected by numerous factors, and Sobi makes no representation or guarantee concerning reimbursement or coverage for Doptelet or any other service or item. I understand that I can opt out at any time. Your healthcare provider will tell you how much DOPTELET to take and when to start taking it. Also by this Manufacturer. This website uses cookies. If you are taking DOPTELET for chronic immune thrombocytopenia and you miss a dose of DOPTELET, take it as soon as you remember. Talk to your healthcare provider about the best way to feed your baby during this time. 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. What are the possible side effects of DOPTELET? At a Pharmacy. Do not take 2 doses at once to make up for missing a dose. 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. It is designed to imitate the effects of TPO for normal platelet production. 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.