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Important Safety Information
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  • OPSUMIT® (macitentan)

    OPSUMIT® is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH.

    Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%).

    BOXED WARNING: EMBRYO-FETAL TOXICITY

    • Do not administer OPSUMIT® to a pregnant female because it may cause fetal harm.
    • Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception.
    • For all female patients, OPSUMIT® is available only through a restricted program called the OPSUMIT® Risk Evaluation and Mitigation Strategy (REMS).

    CONTRAINDICATIONS

    Pregnancy: OPSUMIT® may cause fetal harm when administered to a pregnant woman. OPSUMIT® is contraindicated in females who are pregnant. If OPSUMIT® is used during pregnancy, advise the patient of the potential risk to a fetus.

    Hypersensitivity: OPSUMIT® is contraindicated in patients with a history of a hypersensitivity reaction to macitentan or any component of the product.

    WARNINGS AND PRECAUTIONS
    Embryo-fetal Toxicity and OPSUMIT® REMS Program

    Due to the risk of embryo-fetal toxicity, OPSUMIT® is available for females only through a restricted program called the OPSUMIT® REMS Program. For females of reproductive potential, exclude pregnancy prior to initiation of therapy, ensure use of acceptable contraceptive methods, and obtain monthly pregnancy tests.

    Notable requirements of the OPSUMIT® REMS Program include:

    • Prescribers must be certified with the program by enrolling and completing training.
    • All females, regardless of reproductive potential, must enroll in the OPSUMIT® REMS Program prior to initiating OPSUMIT®. Male patients are not enrolled in the REMS.
    • Females of reproductive potential must comply with the pregnancy testing and contraception requirements.
    • Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive OPSUMIT®.

    Hepatotoxicity

    • ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. The incidence of elevated aminotransferases in the SERAPHIN study >3 x ULN was 3.4% for OPSUMIT® vs 4.5% for placebo, and >8 x ULN was 2.1% vs 0.4%, respectively. Discontinuations for hepatic adverse events were 3.3% for OPSUMIT® vs 1.6% for placebo.
    • Obtain liver enzyme tests prior to initiation of OPSUMIT® and repeat during treatment as clinically indicated.
    • Advise patients to report symptoms suggesting hepatic injury (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching).
    • If clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin >2 x ULN, or by clinical symptoms of hepatotoxicity, discontinue OPSUMIT®. Consider re-initiation of OPSUMIT® when hepatic enzyme levels normalize in patients who have not experienced clinical symptoms of hepatotoxicity.

    Fluid Retention

    • Peripheral edema and fluid retention are known consequences of PAH and ERAs. In the pivotal PAH study SERAPHIN, edema was reported in 21.9% of the OPSUMIT® group vs 20.5% for placebo.
    • Patients with underlying left ventricular dysfunction may be at particular risk for developing significant fluid retention after initiation of ERA treatment. In a small study of pulmonary hypertension due to left ventricular dysfunction, more patients in the OPSUMIT® group developed significant fluid retention and had more hospitalizations due to worsening heart failure compared to placebo. Postmarketing cases of edema and fluid retention occurring within weeks of starting OPSUMIT®, some requiring intervention with a diuretic or hospitalization for decompensated heart failure, have been reported.
    • Monitor for signs of fluid retention after OPSUMIT® initiation. If clinically significant fluid retention develops, evaluate the patient to determine the cause and the possible need to discontinue OPSUMIT®.

    Hemoglobin Decrease

    • Decreases in hemoglobin concentration and hematocrit have occurred following administration of other ERAs and in clinical studies with OPSUMIT®. These decreases occurred early and stabilized thereafter.
    • In the SERAPHIN study, OPSUMIT® caused a mean decrease in hemoglobin (from baseline to 18 months) of about 1.0 g/dL vs no change in the placebo group. A decrease in hemoglobin to below 10.0 g/dL was reported in 8.7% of the OPSUMIT® group vs 3.4% for placebo. Decreases in hemoglobin seldom require transfusion.
    • Initiation of OPSUMIT® is not recommended in patients with severe anemia. Measure hemoglobin prior to initiation of treatment and repeat during treatment as clinically indicated.

    Pulmonary Edema with Pulmonary Veno-occlusive Disease (PVOD)

    Should signs of pulmonary edema occur, consider the possibility of associated PVOD. If confirmed, discontinue OPSUMIT®.

    Decreased Sperm Counts

    OPSUMIT®, like other ERAs, may have an adverse effect on spermatogenesis. Counsel men about potential effects on fertility.

    ADVERSE REACTIONS

    Most common adverse reactions (more frequent than placebo by ≥3%) were anemia (13% vs 3%), nasopharyngitis/pharyngitis (20% vs 13%), bronchitis (12% vs 6%), headache (14% vs 9%), influenza (6% vs 2%), and urinary tract infection (9% vs 6%).

    DRUG INTERACTIONS

    • Strong inducers of CYP3A4 such as rifampin significantly reduce macitentan exposure. Concomitant use of OPSUMIT® with strong CYP3A4 inducers should be avoided.
    • Strong inhibitors of CYP3A4 like ketoconazole approximately double macitentan exposure. Many HIV drugs like ritonavir are strong inhibitors of CYP3A4. Avoid concomitant use of OPSUMIT® with strong CYP3A4 inhibitors. Use other PAH treatment options when strong CYP3A4 inhibitors are needed as part of HIV treatment.
    • Moderate dual inhibitors of CYP3A4 and CYP2C9 such as fluconazole and amiodarone are predicted to increase macitentan exposure. Avoid concomitant use of OPSUMIT® with moderate dual inhibitors of CYP3A4 and CYP2C9.
    • Concomitant treatment of both a moderate CYP3A4 inhibitor and moderate CYP2C9 inhibitor with OPSUMIT® should also be avoided.

    Please see accompanying full Prescribing Information, including BOXED WARNING.

    cp-113979v5

    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/OPSUMIT-pi.pdf
    https://www.janssenlabels.com/package-insert/product-patient-information/OPSUMIT-medication-guide.pdf

Help Your Patients Start and Stay on OPSUMIT®

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Help Your Patients Start and Stay on OPSUMIT®

  1. Janssen CarePath
  2. OPSUMIT®
  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.

OPSUMIT® Voucher Program

A free 30-day trial offer is available for eligible patients to help them become familiar with OPSUMIT®. At the conclusion of the program, you and your patient decide if it is appropriate to continue treatment.

Subject to 1 (one) use per lifetime for the first 30-day supply of OPSUMIT®. Terms expire at the end of each calendar year and may change. This Voucher Program is open to patients who have commercial insurance, government coverage, or no insurance coverage; however, there is no guarantee of continuous accessibility after the program ends. See Full Program Requirements. Enroll your patients using the OPSUMIT® Prescription and Statement of Medical Necessity (PSMN).

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.

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 OPSUMIT® 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

  • OPSUMIT®

    OPSUMIT® is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH.

    Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%).

    BOXED WARNING: EMBRYO-FETAL TOXICITY

    • Do not administer OPSUMIT® to a pregnant female because it may cause fetal harm.
    • Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception.
    • For all female patients, OPSUMIT® is available only through a restricted program called the OPSUMIT® Risk Evaluation and Mitigation Strategy (REMS).

    CONTRAINDICATIONS

    Pregnancy: OPSUMIT® may cause fetal harm when administered to a pregnant woman. OPSUMIT® is contraindicated in females who are pregnant. If OPSUMIT® is used during pregnancy, advise the patient of the potential risk to a fetus.

    Hypersensitivity: OPSUMIT® is contraindicated in patients with a history of a hypersensitivity reaction to macitentan or any component of the product.

    WARNINGS AND PRECAUTIONS
    Embryo-fetal Toxicity and OPSUMIT® REMS Program

    Due to the risk of embryo-fetal toxicity, OPSUMIT® is available for females only through a restricted program called the OPSUMIT® REMS Program. For females of reproductive potential, exclude pregnancy prior to initiation of therapy, ensure use of acceptable contraceptive methods, and obtain monthly pregnancy tests.

    Notable requirements of the OPSUMIT® REMS Program include:

    • Prescribers must be certified with the program by enrolling and completing training.
    • All females, regardless of reproductive potential, must enroll in the OPSUMIT® REMS Program prior to initiating OPSUMIT®. Male patients are not enrolled in the REMS.
    • Females of reproductive potential must comply with the pregnancy testing and contraception requirements.
    • Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive OPSUMIT®.

    Hepatotoxicity

    • ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. The incidence of elevated aminotransferases in the SERAPHIN study >3 x ULN was 3.4% for OPSUMIT® vs 4.5% for placebo, and >8 x ULN was 2.1% vs 0.4%, respectively. Discontinuations for hepatic adverse events were 3.3% for OPSUMIT® vs 1.6% for placebo.
    • Obtain liver enzyme tests prior to initiation of OPSUMIT® and repeat during treatment as clinically indicated.
    • Advise patients to report symptoms suggesting hepatic injury (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching).
    • If clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin >2 x ULN, or by clinical symptoms of hepatotoxicity, discontinue OPSUMIT®. Consider re-initiation of OPSUMIT® when hepatic enzyme levels normalize in patients who have not experienced clinical symptoms of hepatotoxicity.

    Fluid Retention

    • Peripheral edema and fluid retention are known consequences of PAH and ERAs. In the pivotal PAH study SERAPHIN, edema was reported in 21.9% of the OPSUMIT® group vs 20.5% for placebo.
    • Patients with underlying left ventricular dysfunction may be at particular risk for developing significant fluid retention after initiation of ERA treatment. In a small study of pulmonary hypertension due to left ventricular dysfunction, more patients in the OPSUMIT® group developed significant fluid retention and had more hospitalizations due to worsening heart failure compared to placebo. Postmarketing cases of edema and fluid retention occurring within weeks of starting OPSUMIT®, some requiring intervention with a diuretic or hospitalization for decompensated heart failure, have been reported.
    • Monitor for signs of fluid retention after OPSUMIT® initiation. If clinically significant fluid retention develops, evaluate the patient to determine the cause and the possible need to discontinue OPSUMIT®.

    Hemoglobin Decrease

    • Decreases in hemoglobin concentration and hematocrit have occurred following administration of other ERAs and in clinical studies with OPSUMIT®. These decreases occurred early and stabilized thereafter.
    • In the SERAPHIN study, OPSUMIT® caused a mean decrease in hemoglobin (from baseline to 18 months) of about 1.0 g/dL vs no change in the placebo group. A decrease in hemoglobin to below 10.0 g/dL was reported in 8.7% of the OPSUMIT® group vs 3.4% for placebo. Decreases in hemoglobin seldom require transfusion.
    • Initiation of OPSUMIT® is not recommended in patients with severe anemia. Measure hemoglobin prior to initiation of treatment and repeat during treatment as clinically indicated.

    Pulmonary Edema with Pulmonary Veno-occlusive Disease (PVOD)

    Should signs of pulmonary edema occur, consider the possibility of associated PVOD. If confirmed, discontinue OPSUMIT®.

    Decreased Sperm Counts

    OPSUMIT®, like other ERAs, may have an adverse effect on spermatogenesis. Counsel men about potential effects on fertility.

    ADVERSE REACTIONS

    Most common adverse reactions (more frequent than placebo by ≥3%) were anemia (13% vs 3%), nasopharyngitis/pharyngitis (20% vs 13%), bronchitis (12% vs 6%), headache (14% vs 9%), influenza (6% vs 2%), and urinary tract infection (9% vs 6%).

    DRUG INTERACTIONS

    • Strong inducers of CYP3A4 such as rifampin significantly reduce macitentan exposure. Concomitant use of OPSUMIT® with strong CYP3A4 inducers should be avoided.
    • Strong inhibitors of CYP3A4 like ketoconazole approximately double macitentan exposure. Many HIV drugs like ritonavir are strong inhibitors of CYP3A4. Avoid concomitant use of OPSUMIT® with strong CYP3A4 inhibitors. Use other PAH treatment options when strong CYP3A4 inhibitors are needed as part of HIV treatment.
    • Moderate dual inhibitors of CYP3A4 and CYP2C9 such as fluconazole and amiodarone are predicted to increase macitentan exposure. Avoid concomitant use of OPSUMIT® with moderate dual inhibitors of CYP3A4 and CYP2C9.
    • Concomitant treatment of both a moderate CYP3A4 inhibitor and moderate CYP2C9 inhibitor with OPSUMIT® should also be avoided.

    Please see accompanying full Prescribing Information, including BOXED WARNING.

    cp-113979v5

    INDICATION

IMPORTANT SAFETY INFORMATION

INDICATIONS
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