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Patient Simulations in PAH: Understanding Objective Risk Assessment & Exploring Treatment Escalation in PAH Care

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Patient Simulations in PAH: Understanding Objective Risk Assessment & Exploring Treatment Escalation in PAH Care

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What do you need to know about objective risk assessment and appropriate treatment escalation for patients with pulmonary arterial hypertension (PAH)? Find out. 

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Important Safety Information 

  • Sponsored by

  • Overview

    To help identify clinical considerations for the use of UPTRAVI® (selexipag) in patients with pulmonary arterial hypertension (PAH),5 this interactive simulation features three hypothetical patients: a 53-year-old female diagnosed with idiopathic PAH, WHO FC II; a 28-year-old undiagnosed female presenting with symptoms of PAH; and a 46-year-old male diagnosed with idiopathic PAH, WHO FC III.

    The goal of this program is to reinforce the clinical significance of objective risk assessment in patients with PAH and to explore different treatment approaches consistent with the 2022 European Society of Cardiology (ESC) and European Respiratory Society (ERS) Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension (PH).1

    Dr. Bindu Akkanti, Associate Professor of Medicine at UTHealth in Houston, will guide you through these three hypothetical patients’ journeys.

    This promotional educational activity is brought to you by the Janssen Pharmaceutical Companies of Johnson & Johnson and is not certified for continuing medical education. The consultant is a paid speaker for Janssen. The speaker is presenting on behalf of Janssen and must present information in compliance with FDA requirements applicable to Janssen.

    References:

    1. Humbert M, Kovacs G, Hoeper MM, et al. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2023;61(1):2200879. doi:10.1183/13993003.00879-2022
    2. Benza RL, Kanwar MK, Raina A, et al. Development and Validation of an Abridged Version of the REVEAL 2.0 Risk Score Calculator, REVEAL Lite 2, for Use in Patients With Pulmonary Arterial Hypertension. Chest. 2021;159(1):337-346. doi:10.1016/j.chest.2020.08.2069
    3. Vachiéry JL, Gaine S. Challenges in the diagnosis and treatment of pulmonary arterial hypertension. Eur Respir Rev. 2012;21(126):313-320. doi:10.1183/09059180.00005412
    4. Ryan JJ, Melendres-Groves L, Zamanian RT, et al. Care of patients with pulmonary arterial hypertension during the coronavirus (COVID-19) pandemic. Pulm Circ. 2020;10(2):1-7. doi:10.1177/2045894020920153
    5. UPTRAVI® Full Prescribing Information. Actelion Pharmaceuticals US, Inc.

    © 2023 Actelion Pharmaceuticals US, Inc. cp-374525v1 08/23

  • INDICATION

    UPTRAVI® (selexipag) is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

    Effectiveness of UPTRAVI® Tablets was established in a long-term study in PAH patients with WHO Functional Class II-III symptoms. 

    Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), and PAH associated with congenital heart disease with repaired shunts (10%).

  • IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    Concomitant use of strong inhibitors of CYP2C8 (eg, gemfibrozil) with UPTRAVI® is contraindicated.

    Hypersensitivity to the active substance or to any of the excipients is contraindicated.

     

    WARNINGS AND PRECAUTIONS

    Pulmonary Edema with Pulmonary Veno-Occlusive Disease (PVOD)

    Should signs of pulmonary edema occur, consider the possibility of associated PVOD. If confirmed, discontinue UPTRAVI®.

    ADVERSE REACTIONS

    Adverse reactions more frequent compared to placebo (≥3%) seen with UPTRAVI® Tablets are headache (65% vs 32%), diarrhea (42% vs 18%), jaw pain (26% vs 6%), nausea (33% vs 18%), myalgia (16% vs 6%), vomiting (18% vs 9%), pain in extremity (17% vs 8%), flushing (12% vs 5%), arthralgia (11% vs 8%), anemia (8% vs 5%), decreased appetite (6% vs 3%), and rash (11% vs 8%).

    These adverse reactions are more frequent during the dose titration phase.

    Hyperthyroidism was observed in 1% (n=8) of patients on UPTRAVI® Tablets and in none of the patients on placebo.

    DRUG INTERACTIONS 

    CYP2C8 Inhibitors

    Concomitant administration with gemfibrozil, a strong inhibitor of CYP2C8, doubled exposure to selexipag and increased exposure to the active metabolite by approximately 11-fold. Concomitant use of UPTRAVI® with strong inhibitors of CYP2C8 is contraindicated.

    Concomitant administration of UPTRAVI® with clopidogrel, a moderate inhibitor of CYP2C8, had no relevant effect on the exposure to selexipag and increased the exposure to the active metabolite by approximately 2.7-fold.  Reduce the dosing of UPTRAVI® to once daily in patients on a moderate CYP2C8 inhibitor.

    CYP2C8 Inducers

    Concomitant administration with an inducer of CYP2C8 and UGT 1A3 and 2B7 enzymes (rifampin) halved exposure to the active metabolite.  Increase UPTRAVI® dose, up to twice, when co-administered with rifampin.  Reduce UPTRAVI® when rifampin is stopped.

     

    DOSAGE AND ADMINISTRATION

    Recommended Dosage

    Recommended starting dose is 200 mcg twice daily for UPTRAVI® Tablets. Tolerability may be improved when taken with food.  Increase by 200 mcg twice daily, usually at weekly intervals, to the highest tolerated dose up to 1600 mcg twice daily. If dose is not tolerated, reduce to the previous tolerated dose.

     

    Patients With Hepatic Impairment

    For patients with moderate hepatic impairment (Child-Pugh class B), the starting dose of UPTRAVI® Tablets is 200 mcg once daily. Increase by 200 mcg once daily at weekly intervals, as tolerated. Avoid use of UPTRAVI® in patients with severe hepatic impairment (Child-Pugh class C).

     

    Co-administration With Moderate CYP2C8 Inhibitors

    When co-administered with moderate CYP2C8 inhibitors (eg, clopidogrel, deferasirox and teriflunomide), reduce the dosing of UPTRAVI® to once daily

     

    Dosage Strengths

    UPTRAVI® tablet strengths:

    200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg.

     

    Additional Important Safety Information for UPTRAVI® IV

     

    Use UPTRAVI® for injection in patients who are temporarily unable to take oral therapy.

    Administer UPTRAVI® for injection twice daily by intravenous infusion at a dose that corresponds to the patient’s current dose of UPTRAVI® Tablets (see Table 1 in full Prescribing Information). Administer UPTRAVI® for injection as an 80-minute intravenous infusion.

     

    Adverse Reactions: Infusion-site reactions (infusion-site erythema/redness, pain and swelling) were reported with UPTRAVI® for injection.

     

    Please see full Prescribing Information.

     

    cp-126160v5

Schedule18 Jul 2024