The bosentan risk evaluation and mitigation strategy rems program. Safety concerns regarding selexipag in pulmonary arterial. Bosentan tracleer is an endothelin receptor antagonist. Sections or subsections omitted from the full prescribing information. The following pages contain important safety information about treatment with bosentan accord.
Tracleer bosentan prescription and statement of medical. I authorize my healthcare providers, pharmacies, health plans, or payers my healthcare organizations to share personal and health information about me. Use this medicine bosentan tablets as ordered by your doctor. Full prescribing information is contained in the approved summary of product characteristics, which can be found on.
Ventavis iloprost inhalation solution, for oral inhalation use initial u. Elevations of liver aminotransferases alt, ast and liver failure have been reported with tracleer 5. Highlights of prescribing information these highlights do not include all the information needed to use remodulin safely and effectively. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Bosentan is available only through a restricted distribution program called the bosentan rems program because of these risks 5. Endothelin antagonistsambrisentan letairis, bosentan tracleer, and macitentan opsumitare indicated to treat pulmonary arterial hypertension. Bosentan tracleer treatments for pulmonary hypertension issued by phas scientific leadership council. Bosentan tablets fda prescribing information, side. Tracleer can be prescribed and dispensed only through a restricted distribution program tracleer access program because of these risks. Bosentan accord may cause liver damagehepatotoxicity in clinical studies, bosentan caused at least a 3fold upper limit of normal. Current status in pediatric patients with pulmonary arterial hypertension. Highlights of prescribing information these highlights do not include all the information needed to use cribing information for tracleer. Dose increase or reduction is recommended based on individual safety and tolerability.
See 17 for patient counseling information and fdaapproved patient labeling revised. The delay in clinical worsening was demonstrated when revatio was added to background epoprostenol therapy see clinical studies 14. You are encouraged to report negative side effects of prescription drugs to the fda. The physician is to comply with their statespecific prescription requirements, such as e prescribing, statespecific prescription form, fax language, etc. Medicinal product subject to restricted medical prescription see annex i. See full prescribing information for complete boxed. Nda 204819 adempas fda approved 12 jan 2018 full prescribing information warning. The bosentan risk evaluation and mitigation strategy rems program is a single shared program for brand and generic bosentan medication for the treatment of pulmonary arterial hypertension pah. Study 1 revatio monotherapy 20 mg, 40 mg, and 80 mg three times a day a randomized, doubleblind, placebocontrolled study of revatio study 1 was conducted in 277 patients with pah defined as a mean pulmonary artery pressure of greater than or equal to 25 mmhg at rest with a pulmonary capillary wedge pressure less than 15 mmhg. Over the course of treatment, patients who tolerate inlyta for at least two consecutive weeks with no adverse reactions grade 2 according to the common toxicity criteria for adverse events ctcae, are normotensive, and are not receiving antihypertension medication, may. Highlights of prescribing information hepatic toxicity.
Due to the risks of hepatotoxicity and embryofetal toxicity. Bosentan tablets can cause your body to hold too much water, and you may get swelling of your ankles and legs. See 17 for patient counseling information and fdaapproved patient labeling. Highlights of prescribing information these highlights do not include all the information needed to use letairis safely and effectively. Tracleer can improve your ability to exercise as measured by 6minute walk test and can slow the worsening of your physical condition and symptoms. Mepron oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia pcp in adults and adolescent s aged years and older who cannot tolerate trimethoprim. Embryofetal toxicity see full prescribing information for complete boxed.
Revatio sildenafil clinical studies pfizer medical. Highlights of prescribing information these highlights do not include all the information needed to use ofev safely and effectively. Completing the bosentan rems program testing and patient counseling reporting form online at calling the bosentan rems program at 18663592612. Tracleer bosentan tablets, for oral use tracleer bosentan tablets for oral suspension initial u. Fda approved indications tracleer is indicated for the treatment of pulmonary arterial hypertension pah world health organization who group 1 to improve exercise ability and to decrease clinical worsening. See full prescribing information for complete boxed warning. In patients with pulmonary hypertension not receiving concomitant bosentan, the mean. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. You must be familiar with this information before prescribing bosentan accord. Due to the risks of hepatotoxicity and embryofetal toxicity, bosentan is only available through the bosentan rems program. This guide contains important information for pharmacies about the risks of bosentan, including boxed warnings for. Currently, in the united states, there are no prescribing restrictions or risk evaluation and mitigation strategy rems programs in place for. Dear healthcare professional letter regarding important prescribing information for tracleer bosentan.
Tracleer is the proprietary name for bosentan, an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. Remodulin treprostinil injection, for subcutaneous or intravenous initial u. Fluid retention and swelling of your ankles and legs. Revatio is indicated for the treatment of pulmonary arterial hypertension who group i in adults to improve exercise ability and delay clinical worsening. In order to prescribe tracleer, healthcare providers must enroll in the bosentan rems program and agree to comply with the requirements of the program. Although these drugs have similar pharmacologic activity, they differ in their potential for their plasma concentrations to be altered by other medications. A rems is a strategy to manage known or potential serious risks associated with a drug product and is required by the food and drug administration fda to ensure the benefits of a drug outweigh its risks. Bosentan tablets are available only through a restricted distribution program called the bosentan rems program because of these risks. Embryofetal toxicity do not administer adempas to a pregnant female because it may cause fetal harm see contraindications 4. Food and drug administrationapproved indications and dosages for use in pediatric patients the therapeutic dosing recommendations for antidepressant medications are based on u. A patient alert card providing important safety information that patients need to be aware of.
Tracleer tablets contain bosentan, which blocks a naturally occurring. Further information about bosentan and the bosentan rems program is available at. Bosentan the therapeutic generic equivalent of tracleer. Information is based on the united states food and drug administration drug labeling. Policycriteria it is the policy of health plans affiliated with centene corporation that tracleer is medically necessary when the following criteria are met.
Elevations of liver aminotransferases alt, ast and liver failure have been reported with bosentan 5. For complete information on the bosentan rems program, or for complete prescribing information about bosentan, visit report suspect or adverse side effects. Tracleer bosentan risk evaluation and mitigation strategy rems, rems modification. Please see full prescribing information on each of our product pages for fdaapproved indications and dosage. Tracleer is a prescription medicine indicated for patients with certain types of pulmonary arterial hypertension pah, who group 1, which is high blood pressure in the vessels of the lungs. Highlights of prescribing information patients 12 years of. However, the manufacturers eu prescribing information recom mends that the combination. Product titles in highlights of prescribing information consistent with requirements under 21 cfr 201. Noncompliance with statespecific requirements could result in outreach to the prescriber. Highlights of prescribing information these highlights do not include all the information needed to use ventavis safely and effectively.
Black box warning as shown in the drug prescribing information. All available through risk evaluation and mitigation strategy rems program. Epoprostenol flolan epoprostenol diluted to concentrations of 3,000 ngml, 5,000 ngml, 10,000 ngml, 15,000 ngml. Highlights of prescribing information reduce the dose and. Tracleer, innbosentan european medicines agency europa eu. Product titles in highlights of prescribing information.
Highlights of prescribing information these highlights do not include all the information needed to use tracleer safely and effectively. Flolan epoprostenol sodium for injection, for intravenous use. Highlights of prescribing information these highlights do not. As was observed with ambrisentan, rifampin produced an 6fold increase in the auc of bosentan, but with steadystate rifampin dosing, the net effect was nearly a 60% reduction in bosentan auc. Adding sildenafilto bosentan therapy does not result inany beneficial effecton exercise capacity. Elevations of liver aminotransferases alt, ast and liver failure have been reported with bosentan tablets. For additional information about the bosentan rems program, please call 18663592612. Submitting a bosentan rems program testing and patient counseling reporting form by fax to the bosentan rems program at 18007308231. Currently, in the united states, there are no prescribing restrictions or risk evaluation and mitigation strategy rems programs in place for selexipag. Description the intent of the criteria is to ensure that patients follow selection elements established by centene clinical policy for bosentan tracleer. The bosentan rems program was designed to manage serious risks associated with tracleer. See what is the most important information i should know about bosentan tablets. Bosentan is an oral medication classified as an endothelin receptor antagonist era which is approved for the treatment of. Sections or subsections omitted from the full prescribing information are not.
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