• UPTRAVI® (selexipag)

    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%).

    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
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

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

Helping Patients Afford UPTRAVI®

Downloadable Forms
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JCP
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Helping Patients Afford UPTRAVI®

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking UPTRAVI®. Download a summary of affordability options or see a full list of options below.

Select your patient’s coverage status for relevant resources. 

For Patients with Commercial or Private Insurance

Janssen CarePath Oral PAH Savings Program
Eligible patients pay as little as
$5
per fill
Your eligible patients with commercial or private insurance pay as little as $5 per prescription fill for their UPTRAVI® medication

There is a limit to savings each year. Savings may apply to co-pay, co-insurance, or deductible.

Patients may participate without sharing their income information.

We provide cost support directly to patients through the Janssen CarePath Oral PAH Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners.

If your patients are having any difficulty accessing cost support through the Janssen CarePath Oral PAH Savings Program, please have them contact us at 866-228-3546.

In addition to the Janssen CarePath Oral PAH Savings Program, here are some independent programs that may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

For Patients with Government Coverage

Even if your patients have government coverage like Medicare, we can identify programs that may help them afford their medications. Here are some independent programs that may be right for them.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicare Savings Program
Many states have programs that offer support for people with limited income and resources. They may help with Medicare premiums, deductibles, and co-insurance.
Medicare Part D Extra Help — Low-Income Subsidy
This program gives "extra help" to patients with limited income and resources. It can help them:
  • Pay their monthly premiums
  • Reduce or eliminate their deductible
  • Reduce or eliminate their co-insurance and co-payments
  • Have no gap in coverage
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

For Patients with No Insurance Coverage

If your patients need help with drug costs, we can identify programs that may help them afford their medications.

Here are some programs that are not offered by Janssen. Each program has its own eligibility rules.

Take a look and see which ones may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Patients Looking for Coverage?
The Health Insurance Marketplace may have a plan that is right for your patient. Some patients may qualify for savings on premiums.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. Patients may be eligible if they don’t have insurance.

Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 833-919-3510 (toll free) / 308-920-4358 (direct dial), Monday through Friday, 8:00 AM to 8:00 PM ET.

Janssen CarePath Oral PAH Savings Program
Eligible patients pay as little as
$5
per fill
Your eligible patients with commercial or private insurance pay as little as $5 per prescription fill for their UPTRAVI® medication

There is a limit to savings each year. Savings may apply to co-pay, co-insurance, or deductible.

Patients may participate without sharing their income information.

We provide cost support directly to patients through the Janssen CarePath Oral PAH Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners.

If your patients are having any difficulty accessing cost support through the Janssen CarePath Oral PAH Savings Program, please have them contact us at 866-228-3546.

In addition to the Janssen CarePath Oral PAH Savings Program, here are some independent programs that may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicare Savings Program
Many states have programs that offer support for people with limited income and resources. They may help with Medicare premiums, deductibles, and co-insurance.
Medicare Part D Extra Help — Low-Income Subsidy
This program gives "extra help" to patients with limited income and resources. It can help them:
  • Pay their monthly premiums
  • Reduce or eliminate their deductible
  • Reduce or eliminate their co-insurance and co-payments
  • Have no gap in coverage
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Patients Looking for Coverage?
The Health Insurance Marketplace may have a plan that is right for your patient. Some patients may qualify for savings on premiums.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. Patients may be eligible if they don’t have insurance.

Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 833-919-3510 (toll free) / 308-920-4358 (direct dial), Monday through Friday, 8:00 AM to 8:00 PM ET.

Important Safety Information For

  • UPTRAVI®

    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%).

    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