Medical Education: Exploring Earlier Initiation of Treatment for Pulmonary Arterial Hypertension

Exploring Earlier Initiation of Treatment for Pulmonary Arterial Hypertension

Exploring Earlier Initiation of Treatment for Pulmonary Arterial Hypertension
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Richard Channick, MD, discusses data that explore earlier initiation of treatment for patients with PAH (WHO Group I) FC II and FC III.

  • Overview

    Please see the full Prescribing Information here.

    This program is intended for US healthcare professionals only and is not certified for continuing medical education. Sponsored by Actelion Pharmaceuticals US, the marketer and distributor of UPTRAVI® (selexipag).

    Pulmonary arterial hypertension (PAH) is a progressive disease that falls under the broader category of pulmonary hypertension.1 Newly diagnosed patients with PAH have a poor prognosis and disease progression is inevitable.2-5 Enormous strides have been made over the past two decades in advancing understanding and treatment of the disease.2

    Dr. Richard N. Channick, a Professor of Medicine and Director of the Pulmonary Vascular Disease Program at UCLA Medical Center, joins ReachMD host Dr. Jennifer Caudle to discuss data that explore earlier initiation of treatment for patients with PAH.6,7

    IMPORTANT SAFETY INFORMATION

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

    WARNINGS AND PRECAUTIONS
    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%) 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 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. 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 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. Revert back to twice daily dosing frequency of UPTRAVI when co-administration of moderate CYP2C8 inhibitor is stopped.

    Dosage Strengths
    UPTRAVI tablet strengths:
    200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg.

    Please see full Prescribing Information.

    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 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%).

    ©2019 Actelion Pharmaceuticals US, Inc. All rights reserved. UPTRAVI is a registered trademark of Actelion Pharmaceuticals Ltd. cp-114634

    1. Benza RL, et al. Chest. 2012;142:448-456.
    2. Sitbon O, Galie N. Eur Respir Rev. 2010;19:118, 272–278.
    3. Galie N, et al. Eur Respir J. 2015;46(4):903-975.
    4. Vachiery JL, et al. Eur Respir Rev. 2012;21(126):313-320.
    5. Humbert M, et al. Eur Respir J. 2010; 36:549–555.
    6. Gaine S, et al. Am J Respir Crit Care Med. 2019;199:A2502.
    7. Data on file, Actelion Pharmaceuticals.
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