• 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
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

  • 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

Helping Patients Afford OPSUMIT®

Downloadable Forms
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Helping Patients Afford OPSUMIT®

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking OPSUMIT®. 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 OPSUMIT® 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 OPSUMIT® 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

  • 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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INDICATIONS

IMPORTANT SAFETY INFORMATION