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    For U.S. Healthcare Professionals
  • Prescribing
    Information
  • Important Safety
    Information
  • For
    Patients
  • UPTRAVI Logo
  • For U.S. Healthcare Professionals
  • Important Safety Information
  • For Patients
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  • About PAH
    • Risk in PAH
    • Treatment Recommendations
    • Mechanism of Action
  • GRIPHON Trial
    • Study Design
    • Disease Progression
    • Hospitalization
    • Safety
    • Triple-combination Subgroup
    • Time-from-diagnosis Subgroups
    • CTD Subgroup
  • Additional Analyses
    • Real-world Hospitalization Analysis
    • 7-year Data
  • Dosing
    • Start UPTRAVI®
    • UPTRAVI® IV
  • Resources and Support Resources and Support
  • Patient Enrollment Patient Enrollment
    • Patient Enrollment Form
    • Prescribe Online (iAssist)
  • Other Products
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      Please see full Prescribing Information, including BOXED WARNING for OPSUMIT®.
    • TRACLEER® (bosentan)
      Please see full Prescribing Information, including BOXED WARNING for TRACLEER®.
    • VELETRI® (epoprostenol) for Injection
      Please see full Prescribing Information for VELETRI®.
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GRIPHON Trial

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PAH-Related Hospitalization

UPTRAVI® Is the Only Prostacyclin Pathway Therapy Indicated to Delay Disease Progression AND Reduce Risk of PAH-related Hospitalization1*

Pivotal trial overall population: Probability of hospitalization event†

Hospitalization event in patients graph key Probability of hospitalization event in patients on UPTRAVI® vs placebo desktop curve Probability of hospitalization event in patients on UPTRAVI® vs placebo mobile curve

PAH-related hospitalizations are a key indicator of disease progression2,3

Percentage of patients hospitalized for PAH as a first event occurring as part of the composite endpoint

UPTRAVI®: 13.6% (n=78)
Placebo: 18.7% (n=109)

PAH-related hospitalizations are a key indicator of disease progression2,3

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.

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%).

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.

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%).

Please see full Prescribing Information for UPTRAVI®.

cp-126160v5

*Other prostacyclin pathway therapies include epoprostenol (Flolan®, VELETRI®), iloprost (VENTAVIS®), and treprostinil (Orenitram®, Remodulin®, Tyvaso®).

†Not adjusted for multiplicity.

References: 1. UPTRAVI® (selexipag) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 2. Sitbon O, Channick R, Chin KM, et al. Selexipag for the treatment of pulmonary arterial hypertension. N Engl J Med. 2015;373:2522-2533. 3. Gomberg-Maitland M, Bull TM, Saggar R, et al. New trial designs and potential therapies for pulmonary artery hypertension. J Am Coll Cardiol. 2013;62(25 Suppl):D82-D91.

About PAH

  • Risk in PAH
  • Treatment Recommendations
  • Mechanism of Action

GRIPHON Trial

  • Study Design
  • Disease Progression
  • Hospitalization
  • Safety
  • Triple-combination Subgroup
  • Time-from-diagnosis Subgroups
  • CTD Subgroup

Additional Analyses

  • Real-world Hospitalization Analysis
  • 7-year Data

Dosing

  • Start UPTRAVI®
  • UPTRAVI® IV

Resources and Support

Patient Enrollment

  • Patient Enrollment Form
  • Prescribe Online (iAssist)
Janssen Pharmaceuticals Logo
  • Contact Medical Information

THIS SITE IS INTENDED FOR U.S. HEALTHCARE PROFESSIONALS ONLY.

©2023 Actelion Pharmaceuticals US, Inc. cp-142655v13 04/23

    About PAH

    • Risk in PAH
    • Treatment Recommendations
    • Mechanism of Action

    GRIPHON Trial

    • Study Design
    • Disease Progression
    • Hospitalization
    • Safety
    • Triple-combination Subgroup
    • Time-from-diagnosis Subgroups
    • CTD Subgroup

    Additional Analyses

    • Real-world Hospitalization Analysis
    • 7-year Data

    Dosing

    • Start UPTRAVI®
    • UPTRAVI® IV

    Resources and Support

    Patient Enrollment

    • Patient Enrollment Form
    • Prescribe Online (iAssist)
Janssen Pharmaceuticals Logo
  • Contact Medical Information

THIS SITE IS INTENDED FOR U.S. HEALTHCARE PROFESSIONALS ONLY.

©2023 Actelion Pharmaceuticals US, Inc. cp-142655v13 04/23

IMPORTANT SAFETY INFORMATION

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%) 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 with UPTRAVI® Tablets.

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. 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

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%).

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GRIPHON—The FIRST and ONLY COMPLETED PAH Outcomes Trial That Included Patients Treated With TRIPLE-Combination Therapy1-4

THE LARGEST OUTCOMES TRIAL CONDUCTED IN PAH (N=1156)

  • Multicenter, long-term, double-blind, placebo-controlled, parallel-group, event-driven, phase 3 trial
1156 patients with symptomatic PAH (UPTRAVI®: n=574; placebo: n=582) desktop study design for GRIPHON

After the starting dose of 200 mcg twice daily, all patients completed titration to their maintenance dose within the first 12 weeks, up to a maximum dose of 1600 mcg twice daily.

Primary endpoint: time to first PAH disease progression event

  • Death
  • Hospitalization for PAH
  • Need for lung transplantation or balloon atrial septostomy for worsening of PAH
  • Parenteral prostanoid or
    chronic oxygen therapy
  • Other disease progression (decrease in 6MWD plus worsening of FC or need for other therapy)

Baseline patient characteristics

  • Mean age: 48 years
  • Female: 80%
baseline patient characteristics chart
*Other=drugs and toxins (2%) and HIV (1%).
6MWD=6-minute walk distance; ERA=endothelin receptor antagonist; FC=Functional Class; GRIPHON=Prostacyclin (PGI2) Receptor Agonist In Pulmonary Arterial HypertensiON; HIV=human immunodeficiency virus; HPAH=heritable PAH; IPAH=idiopathic PAH; PAH-CHD=PAH associated with congenital heart disease with repaired shunts; PAH-CTD=PAH associated with connective tissue disease; PDE-5i=phosphodiesterase type-5 inhibitor; WHO=World Health Organization.
References: 1. UPTRAVI® (selexipag) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 2. Ruopp NF, Cockrill BA. Diagnosis and treatment of pulmonary arterial hypertension: a review. JAMA. 2022;327(14):1379-1391. 3. Sitbon O, Channick R, Chin KM, et al. Selexipag for the treatment of pulmonary arterial hypertension. N Engl J Med. 2015;373:2522-2533. 4. Coghlan JG, Channick R, Chin K, et al. Targeting the prostacyclin pathway with selexipag in patients with pulmonary arterial hypertension receiving double combination therapy: insights from the randomized controlled GRIPHON study. Am J Cardiovasc Drugs. 2018;18(1):37-47.
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UPTRAVI® WAS STUDIED IN GRIPHON, A LARGE OUTCOMES TRIAL IN PAH (N=1156)1

  • Multicenter, long-term, double-blind, placebo-controlled, parallel-group, event-driven, phase 3 trial
1156 patients with symptomatic PAH (UPTRAVI®: n=574; placebo: n=582) desktop study design for GRIPHON

After the starting dose of 200 mcg twice daily, all patients completed titration to their maintenance dose within the first 12 weeks, up to a maximum dose of 1600 mcg twice daily.

Primary endpoint: time to first PAH disease progression event

  • Death
  • Hospitalization for PAH
  • Need for lung transplantation or balloon atrial septostomy for worsening of PAH
  • Parenteral prostanoid or
    chronic oxygen therapy
  • Other disease progression (decrease in 6MWD plus worsening of FC or need for other therapy)

Baseline patient characteristics

  • Mean age: 48 years
  • Female: 80%
baseline patient characteristics chart
*Other=drugs and toxins (2%) and HIV (1%).
6MWD=6-minute walk distance; ERA=endothelin receptor antagonist; FC=Functional Class; GRIPHON=Prostacyclin (PGI2) Receptor Agonist In Pulmonary Arterial HypertensiON; HIV=human immunodeficiency virus; HPAH=heritable PAH; IPAH=idiopathic PAH; PAH-CHD=PAH associated with congenital heart disease with repaired shunts; PAH-CTD=PAH associated with connective tissue disease; PDE-5i=phosphodiesterase type-5 inhibitor; WHO=World Health Organization.
Reference: 1. UPTRAVI® (selexipag) full Prescribing Information. Actelion Pharmaceuticals US, Inc.
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