Because many drugs are present in the human milk and because of the potential for serious adverse reactions in nursing infants, discontinue nursing or discontinue Uptravi. Uptraviwhich bears a hefty $160,000 price tagis also helping make up for declining sales of aging PAH standout Tracleer. Store Uptravi tablets at room temperature between 68F and 77F (20C and 25C). Uptravi (selexipag) film-coated, round tablets are supplied in the following configurations: Uptravi is also supplied in a Titration Pack [NDC 66215-628-20] that includes a 140 count bottle of 200 mcg tablets and a 60 count bottle of 800 mcg tablets. The patients received either UPTRAVI or placebo. The 1,156 patients enrolled in this trial received treatment for up to 4.2 years. Figures 4A, B, and C show time to first event analyses for primary endpoint components of hospitalization for PAH (A), other disease progression (B), and death (C)all censored 7 days after any primary end point event (because many patients on placebo transitioned to open-label Uptravi at this point). The safety and efficacy of UPTRAVI were established in 1156patients who were treated in one multi-center, double-blind, placebo-controlled, parallel group, event-driven trial. The patients had symptomatic PAH World Health Organization Functional Class I-IV. 2017 Actelion Pharmaceuticals US, Inc. All rights reserved. Uptravi 200 mcg (140)-800 mcg (60) tablets in a dose pack. General information about the safe and effective use of Uptravi, We comply with the HONcode standard for trustworthy health information -, Drug class: agents for pulmonary hypertension. It does not provide medical advice, diagnosis or treatment. Here's where they stand. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. J&J halts studies of coronavirus vaccine due to participant's illness, FDA puts Voyager study on hold in latest gene therapy speed bump, Mallinckrodt, beset by opioid drug suits, files for bankruptcy, Gossamer plummets as its lead drug fails 2 studies, Alkermes' comeback bid boosted by FDA panel backing for schizophrenia drug, Inside the Global Race for a Coronavirus Vaccine, What You Need to Know About Oncology's Research Boom, Trends and Developments in Real-World Evidence. Selexipag and its active metabolite are substrates of OATP1B1 and OATP1B3. Pensacola, FL 32502 Drug Approvals and Databases, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs. Should signs of pulmonary edema occur, consider the possibility of associated PVOD. Avoid use of Uptravi in patients with severe hepatic impairment [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. Manufactured for: The results on in vivo drug interaction studies are presented in Figure 1 and 2.