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Exploring Risk Assessment Strategies and a Treatment Option for Pulmonary Arterial Hypertension

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Exploring Risk Assessment Strategies and a Treatment Option for Pulmonary Arterial Hypertension

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Program Information

Exploring Risk Assessment Strategies and a Treatment Option for Pulmonary Arterial Hypertension
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Pulmonary arterial hypertension is a rapidly progressive disease with no known cure, which is why timely and regular risk assessments are recommended.1-3 

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  • Overview

    While the need for timely and regular risk assessment in pulmonary arterial hypertension (PAH) is widely acknowledged, real-world evidence indicates that risk assessment in the clinical setting may be suboptimal due to barriers, including complexity of tools and invasive procedures.4,5 But could a recently developed risk assessment tool help reduce this burden?

    Dr. Raymond Benza, professor of medicine at The Ohio State University Wexner Medical Center, joins ReachMD host Dr. Paul Doghramji to discuss a noninvasive PAH risk stratification tool called REVEAL Lite 2.0 and a treatment option for PAH.

    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 the Janssen Pharmaceutical Companies of Johnson & Johnson, the marketer and distributor of UPTRAVI® (selexipag). 

    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%).

    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.
    cp-126160 

    ©2020 Actelion Pharmaceuticals US, Inc. All rights reserved. cp-168781v2 1220

    References

    1. Galiè N, Humbert M, et al. Eur Heart J 2016; 37:67-119.
    2. Vachiéry JL, Gaine S. Eur Respir Rev 2012; 21:313-20.
    3. Hoeper MG, Gibbs SR. Eur Respir Rev 2014; 23:450-7.
    4. Simons JE, Mann ED, et al. Adv Ther. 2019;36:2351–2363.
    5. Wilson M, Keeley J, et al. Risk assessment tools in pulmonary arterial hypertension (PAH): a survey of real-world practices and barriers to use. Presented at the PAH PHPN Symposium; September 5–7, 2019; Washington DC. Abstract 1001.
Programs 7/27/21