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UPTRAVI® Resources and Support

PAH Therapy Support and Resources: From Prescriptions to Maintenance

Supporting Every Step of Your Patient’s Journey With UPTRAVI®

Janssen is committed to providing you and your patients with a robust selection of educational resources and support programs that will help you navigate their PAH journey.

Step 1: INITIATIONStart Patients on UPTRAVI®

Insurance doesn’t have to be burdensome. Janssen knows the process to help navigate patient coverage.

Janssen CarePath is your one source for access, affordability, and treatment support for your patients. Janssen CarePath helps verify insurance coverage for your patients, helps find financial assistance options for eligible patients, and provides ongoing support to help patients start and stay on prescribed Janssen medications.

When you enroll your patients in Janssen CarePath:

Our Therapy Access Managers (TAMs) field team can help educate you on navigating the PA process to get patients started on therapy.

For more information, call a Janssen CarePath Care Coordinator at 866-228-3546, Monday-Friday, 8 am to 8 pm ET.

Multilingual phone support available.

Print and fill out the UPTRAVI® Patient Enrollment Form to get your patients started with UPTRAVI®. The Patient Enrollment Form is not optimized for mobile devices. Please print, sign, and fax to Janssen CarePath.

Note: An alternate form is available for Veterans Affairs (VA) patients: UPTRAVI® VA PATIENT ENROLLMENT FORM.

Download the Guide to the UPTRAVI® Patient Enrollment Form, which provides detailed instructions to help you fill out the form.

Janssen CarePath Oral PAH Savings Program can help eligible patients save on their out-of-pocket medication costs for UPTRAVI®. Depending on their health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Your eligible patients will pay $5 per prescription fill, with a $20,000 maximum program benefit per calendar year across all oral PAH therapies in the program. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. See full eligibility requirements at Uptravi.JanssenCarePathSavings.com.

Step 2: TITRATION―Choose Nurse Support for Your Patients

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

Help to address potential patient 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.

Step 3: SUPPORT―Help Patients Manage PAH

Once a decision has been made to prescribe a Janssen PAH medication, PAH Companion withMe is a suite of patient support resources customized for your patients’ specific questions, needs, and interests. One-on-one educational conversations with a dedicated PAH Companion—coupled with access to current PAH tools and resources—help your patients take a more active role in their care.

A dedicated PAH Companion is ready to answer your patients’ questions and help them navigate their treatment experience. Patients who have enrolled can connect with their personal PAH Companion by calling 866-300-1818, Monday–Friday, 8 AM–9 PM ET.

PAH Companion withMe is limited to education for patients about their PAH therapy, its administration, and/or their disease, and is not intended to provide medical advice, replace a treatment plan from the patient’s doctor or nurse, or provide case management services.

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UPTRAVI® Dose Adjustment Phase Guide for Patients

This guide helps you set goals and expectations with patients who are starting treatment with UPTRAVI®. It can be used as a conversation tool and is available to patients to help them stay on treatment by tracking and sharing how they’re feeling with their healthcare team.

UPTRAVI® Adverse Reactions Management Tool and Titration Guide

This guide offers dosing, titration, and pill identification information to help get your patients started with UPTRAVI®, as well as adverse reaction management guidance for PAH therapies targeting the prostacyclin pathway.

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.

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

*For commercial and Medicare patients in provider offices that use Janssen CarePath.

Janssen CarePath provides education and assistance throughout the PA and appeals process, but does not complete or submit PAs or appeals.

PA=prior authorization; PAH=pulmonary arterial hypertension.

Reference: 1. Data on file. Janssen Pharmaceuticals, Inc. Janssen PH HUB Transaction Data, 2021 OPSUMIT and UPTRAVI PA approval data for Commercial and Medicare patients. April 2022.