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Important Safety Information
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  • 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 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

    INDICATION
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INDICATIONS

IMPORTANT SAFETY INFORMATION

Prescribing Information
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  • https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/UPTRAVI-pi.pdf

Help Your Patients Start and Stay on UPTRAVI®

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Help Your Patients Start and Stay on UPTRAVI®

  1. Janssen CarePath
  2. UPTRAVI®
  3. Treatment Support

We understand that you want to get your patients the help they may need while going through treatment. That’s why we’ve put together some support resources that can help them, whether they’re just starting a new medication or they’ve been taking it for years.

Care Coordination

Janssen CarePath gives your patients one-on-one support through our Care Coordinators. Our Care Coordinators will work closely with you and your patients to provide the support you direct and additional support that your patients may need.

Therapy Access Managers

Janssen Therapy Access Managers (TAMs) provide education and assistance throughout the payer approval and patient access processes to help your patients start and stay on their prescribed Janssen PAH therapy. You may engage with a Janssen TAM if there are questions about access and insurance coverage, insurance plan resources and processes, or patient support programs for Janssen PAH therapies.

The PAH Companion* Program

The PAH Companion Program provides one-on-one educational support to help patients start and stay on their prescribed Janssen PAH medication. A dedicated PAH Companion can share personalized resources to meet patients where they are in their treatment, whether they prefer to connect with a dedicated PAH Companion, manage their health with digital tools, or engage with others in the PAH community.

Patients currently enrolled in the program have appreciated:

  • Education: Access to ongoing education on managing and living with PAH.
  • Connection: One-on-one connection with a dedicated PAH Companion through email, phone, and/or text.
  • Empowerment: A program built around their needs and daily life to help them take an active role in managing their PAH.

All communications and materials are also available in Spanish.

As part of the program, PAH Companions are ready to answer patients’ questions. Patients who have enrolled can talk to a PAH Companion by calling 866-300-1818, Monday–Friday, 8 AM to 9 PM ET.

Please have your patients visit www.pahcompanion.com for more information. For Spanish-speaking patients, visit PAH Companions en Español.

*The PAH Companion Program is limited to education for patients about their Janssen therapy, its administration, and/or PAH. It is intended to supplement a patient's understanding of their therapy, and does not provide medical advice or replace a treatment plan from a patient's doctor, nurse, or healthcare team.

UPTRAVI® Specialty Pharmacy (SP) Titration Education Support Program (sponsored by Janssen)

After you, as the treating healthcare professional (HCP), have made the decision to prescribe UPTRAVI®, you may choose for your patient to receive nurse education support as they start therapy.

For patients to receive this service, you must check “yes” on the enrollment form to opt in to the nurse support and titration education program.

Within 48 hours of your patient’s receipt of their first UPTRAVI® shipment, an SP Nurse can have an interaction with your patient.

During these visits with your patient, the nurse can:

  • Educate the patient on what to expect as they start therapy with UPTRAVI®
  • Ensure the patient’s understanding of reaching their personal dose
  • Educate the patient to help address potential misconceptions about UPTRAVI® dosing
  • Provide the patient and/or their caregiver with recommendations on when to call their HCP

The information provided is educational in nature and not intended to provide medical advice, replace a treatment plan from the patient’s doctor or nurse, provide case management services, or serve as a reason to prescribe.

Patient Brochures and Guides

Patients often have many questions about getting started with a new medicine.
The following tools may be helpful for your patients who want to better understand the process:
 

Additional Support Resources

There are also independent patient advocacy organizations that may be able to offer support to your patients.

  • The Pulmonary Hypertension Association is dedicated to increasing awareness and advocacy by providing information about PH to both physicians and patients.
  • The Scleroderma Foundation offers a site for scleroderma patients, caregivers, and family members–dedicated to support, education, and research.

Call a Janssen CarePath Care Coordinator at 866-228-3546, Monday–Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support available.

Sign up or log in to the PATHwatch® Portal where you can electronically complete the UPTRAVI® Prescription and Statement of Medical Necessity (PSMN). You can also set up alerts about pending actions and missing information, and view the status of patient shipments and prior authorizations.

Important Safety Information For

  • UPTRAVI®

    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

    INDICATION

IMPORTANT SAFETY INFORMATION

INDICATIONS
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INDICATIONS

IMPORTANT SAFETY INFORMATION