A Janssen CarePath Care Coordinator works with your office, the insurance company, the specialty pharmacy, and your patients. When patients are prescribed a Janssen medication, they will be contacted by a Janssen CarePath Care Coordinator who can help by:

Therapy Access Managers (TAMs)

TAMs provide education on the payer approval process to help your patients start and stay on the prescribed Janssen PAH therapy.

Connecting with financial assistance programs

There are several programs that can provide financial assistance to your patients taking TRACLEER®. For information on these programs, call a Janssen CarePath Care Coordinator at 866-228-3546, Monday-Friday, 8 AM to 8 PM ET.

Commercially insured

Support for patients using commercial or private insurance to pay for medication

Janssen CarePath Oral PAH Savings Program can help eligible patients save on their out-of-pocket medication costs for TRACLEER®. 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. Offer not valid for TRACLEER® in CA or MA, or for MA residents (62.5 and 125 mg only). See full eligibility requirements.

Government insured or no insurance

Support for patients using government-funded healthcare programs or patients without insurance coverage

Janssen CarePath can provide information about other resources that may be able to help your patients with their out-of-pocket medication costs, including Independent Foundations*.

Call a Janssen CarePath Care Coordinator at 866-228-3546, or visit JanssenCarePath.com for more information on affordability programs that may be available.

*Independent co-pay assistance foundations have their own rules for eligibility. We have no control over these independent foundations and can only refer your patients to a foundation that supports their disease state. We do not endorse any particular foundation.

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 PAH to both physicians and patients.

The Scleroderma Foundation offers a site for scleroderma patients, caregivers, and family members—dedicated to support, education, and research.

Contact a Janssen CarePath Care Coordinator today.

Call a Janssen CarePath Care Coordinator at 866-228-3546, Monday-Friday, 8 AM to 8 PM ET.

Other Resources
The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization that is committed to helping eligible patients without insurance coverage receive prescription products donated by Johnson & Johnson operating companies. To see if they might qualify for assistance, please have your patient contact a JJPAF program specialist at 800-652-6227 (Monday–Friday, 9:00 AM–6:00 PM ET) or visit the foundation website at JJPAF.org.
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IMPORTANT SAFETY INFORMATION

Because of the risks of hepatotoxicity and birth defects, TRACLEER® is available only through a restricted program called the Bosentan REMS Program. Under the Bosentan REMS, prescribers, patients, and pharmacies must enroll in the program.

Hepatotoxicity

Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported with TRACLEER®. In a setting of close monitoring, rare cases of liver failure and unexplained hepatic cirrhosis were observed after prolonged (>12 months) treatment. In general, avoid using TRACLEER® in patients with elevated aminotransferases (>3 x ULN) at baseline. Measure liver aminotransferases prior to initiation of treatment and then monthly. Discontinue TRACLEER® if aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin ≥2 x ULN.

Embryo-fetal Toxicity

Based on animal data, TRACLEER® is likely to cause major birth defects if used during pregnancy. Exclude pregnancy before and during treatment. To prevent pregnancy, females of reproductive potential must use 2 reliable forms of contraception during treatment and for 1 month after stopping TRACLEER® unless the patient has an intrauterine device (IUD) or tubal sterilization, in which case no other contraception is needed. Obtain monthly pregnancy tests.

INDICATION

TRACLEER® (bosentan) is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):

  • in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%).
  • in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.
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IMPORTANT SAFETY INFORMATION

Because of the risks of hepatotoxicity and birth defects, TRACLEER® is available only through a restricted program called the Bosentan REMS Program. Under the Bosentan REMS, prescribers, patients, and pharmacies must enroll in the program.

Hepatotoxicity

Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported with TRACLEER®. In a setting of close monitoring, rare cases of liver failure and unexplained hepatic cirrhosis were observed after prolonged (>12 months) treatment. In general, avoid using TRACLEER® in patients with elevated aminotransferases (>3 x ULN) at baseline. Measure liver aminotransferases prior to initiation of treatment and then monthly. Discontinue TRACLEER® if aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin ≥2 x ULN.

Embryo-fetal Toxicity

Based on animal data, TRACLEER® is likely to cause major birth defects if used during pregnancy. Exclude pregnancy before and during treatment. To prevent pregnancy, females of reproductive potential must use 2 reliable forms of contraception during treatment and for 1 month after stopping TRACLEER® unless the patient has an intrauterine device (IUD) or tubal sterilization, in which case no other contraception is needed. Obtain monthly pregnancy tests.

CONTRAINDICATIONS

TRACLEER® is contraindicated:

  • In females who are or may become pregnant
  • With cyclosporine A
  • With glyburide
  • In patients who are hypersensitive to bosentan or any component of TRACLEER®. Observed reactions include Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), anaphylaxis, rash and angioedema.

WARNINGS AND PRECAUTIONS

In clinical trials, ALT/AST elevations (>3 x ULN) were observed in 11% of patients treated with TRACLEER®, accompanied by elevated bilirubin in a few cases. In a pooled analysis of pediatric studies conducted in PAH, elevations in liver aminotransferases ≥3 x ULN were observed in 2% of patients. The combination of hepatocellular injury (increases in aminotransferases of >3 x ULN) and increases in total bilirubin (≥2 x ULN) is a marker for potential serious hepatotoxicity. Liver aminotransferase levels must be measured prior to initiation of treatment and then monthly. Avoid using TRACLEER® in patients with moderate or severe liver impairment or elevated ALT/AST >3 x ULN prior to drug initiation.

If clinically significant fluid retention develops, with or without associated weight gain, the cause, such as TRACLEER® or underlying heart failure, must be determined. Patients may require treatment or TRACLEER® therapy may need to be discontinued.

Should signs of pulmonary edema occur, consider the possibility of associated pulmonary veno-occlusive disease and consider whether TRACLEER® should be discontinued.

Decreased sperm counts have been observed in patients receiving TRACLEER®. Preclinical data also suggest that TRACLEER®, like other endothelin receptor antagonists, may have an adverse effect on spermatogenesis.

Treatment with TRACLEER® can cause a dose-related decrease in hemoglobin (Hgb) and hematocrit. Hgb should be checked after 1 and 3 months, and then every 3 months. Upon marked decrease in Hgb, determine the cause and need for specific treatment.

ADVERSE EVENTS

In TRACLEER® pivotal trials, the most common adverse events occurring more often in TRACLEER®-treated patients than in patients taking placebo were respiratory tract infection (22% vs 17%), headache (15% vs 14%), edema (11% vs 9%), chest pain (5% vs 5%), syncope (5% vs 4%), flushing (4% vs 3%), hypotension (4% vs 2%), sinusitis (4% vs 2%), arthralgia (4% vs 2%), abnormal serum aminotransferases (4% vs 2%), palpitations (4% vs 2%), and anemia (3% vs 0%). TRACLEER® was evaluated for safety in pediatric patients in uncontrolled studies. The safety profile was similar to that observed in adult patients with PAH.

DRUG INTERACTIONS

  • TRACLEER® is contraindicated for use with cyclosporine A and with glyburide.
  • TRACLEER® is metabolized by CYP2C9 and CYP3A.
    • Co-administration with agents that are metabolized by these pathways may affect plasma concentrations of one or both agents.
    • Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when TRACLEER® is co-administered.
    • When initiating lopinavir/ritonavir and other ritonavir-containing HIV regimens, dosage adjustment of TRACLEER® is necessary.
    • When co-administered with simvastatin, or other statins that are CYP3A substrates, dosage adjustment of such statins may need to be considered.
    • When co-administered with rifampin, a CYP3A inducer, liver function should be monitored weekly.
    • When co-administered with ketoconazole, a potent CYP3A inhibitor, no dose adjustment of TRACLEER® is necessary, but increased effects of TRACLEER® may need to be considered.
  • There are no clinically relevant interactions between TRACLEER® and warfarin, digoxin, nimodipine, losartan, sildenafil, or tadalafil.
    • Dose adjustments are not necessary when TRACLEER® and sildenafil or tadalafil are co-administered.

LIVER ENZYME ELEVATIONS

  • Measure liver aminotransferases prior to initiation of treatment and then monthly.
  • Use of TRACLEER® should generally be avoided in patients with elevated aminotransferases (>3 x ULN) at baseline because monitoring for hepatotoxicity may be more difficult.
  • It is important to adhere strictly to the monthly monitoring schedule for the duration of treatment.
    • Changes in aminotransferases may occur early or late in treatment.
    • There have been rare postmarketing reports of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring; the contribution of TRACLEER® could not be excluded.
  • For patients whose monthly LFTs are ≤3 x ULN, no change in monitoring schedule or dosage is required.
  • For patients whose monthly LFTs are >3 x ULN, close monitoring and either dose reduction or treatment cessation are necessary.

MONITORING

It is important to adhere strictly to the monthly monitoring schedule for LFTs and, if applicable, pregnancy for the duration of treatment.

Please see full Prescribing Information and Medication Guide for TRACLEER®, including BOXED WARNING about liver injury and birth defects. Provide the Medication Guide to your patients and encourage discussion.

cp-113987

IMPORTANT SAFETY INFORMATION

+

Because of the risks of hepatotoxicity and birth defects, TRACLEER® is available only through a restricted program called the Bosentan REMS Program. Under the Bosentan REMS, prescribers, patients, and pharmacies must enroll in the program.

Hepatotoxicity

Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported with TRACLEER®. In a setting of close monitoring, rare cases of liver failure and unexplained hepatic cirrhosis were observed after prolonged (>12 months) treatment. In general, avoid using TRACLEER® in patients with elevated aminotransferases (>3 x ULN) at baseline. Measure liver aminotransferases prior to initiation of treatment and then monthly. Discontinue TRACLEER® if aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin ≥2 x ULN.

Embryo-fetal Toxicity

Based on animal data, TRACLEER® is likely to cause major birth defects if used during pregnancy. Exclude pregnancy before and during treatment. To prevent pregnancy, females of reproductive potential must use 2 reliable forms of contraception during treatment and for 1 month after stopping TRACLEER® unless the patient has an intrauterine device (IUD) or tubal sterilization, in which case no other contraception is needed. Obtain monthly pregnancy tests.

CONTRAINDICATIONS

TRACLEER® is contraindicated:

  • In females who are or may become pregnant
  • With cyclosporine A
  • With glyburide
  • In patients who are hypersensitive to bosentan or any component of TRACLEER®. Observed reactions include Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), anaphylaxis, rash and angioedema.

WARNINGS AND PRECAUTIONS

In clinical trials, ALT/AST elevations (>3 x ULN) were observed in 11% of patients treated with TRACLEER®, accompanied by elevated bilirubin in a few cases. In a pooled analysis of pediatric studies conducted in PAH, elevations in liver aminotransferases ≥3 x ULN were observed in 2% of patients. The combination of hepatocellular injury (increases in aminotransferases of >3 x ULN) and increases in total bilirubin (≥2 x ULN) is a marker for potential serious hepatotoxicity. Liver aminotransferase levels must be measured prior to initiation of treatment and then monthly. Avoid using TRACLEER® in patients with moderate or severe liver impairment or elevated ALT/AST >3 x ULN prior to drug initiation.

If clinically significant fluid retention develops, with or without associated weight gain, the cause, such as TRACLEER® or underlying heart failure, must be determined. Patients may require treatment or TRACLEER® therapy may need to be discontinued.

Should signs of pulmonary edema occur, consider the possibility of associated pulmonary veno-occlusive disease and consider whether TRACLEER® should be discontinued.

Decreased sperm counts have been observed in patients receiving TRACLEER®. Preclinical data also suggest that TRACLEER®, like other endothelin receptor antagonists, may have an adverse effect on spermatogenesis.

Treatment with TRACLEER® can cause a dose-related decrease in hemoglobin (Hgb) and hematocrit. Hgb should be checked after 1 and 3 months, and then every 3 months. Upon marked decrease in Hgb, determine the cause and need for specific treatment.

ADVERSE EVENTS

In TRACLEER® pivotal trials, the most common adverse events occurring more often in TRACLEER®-treated patients than in patients taking placebo were respiratory tract infection (22% vs 17%), headache (15% vs 14%), edema (11% vs 9%), chest pain (5% vs 5%), syncope (5% vs 4%), flushing (4% vs 3%), hypotension (4% vs 2%), sinusitis (4% vs 2%), arthralgia (4% vs 2%), abnormal serum aminotransferases (4% vs 2%), palpitations (4% vs 2%), and anemia (3% vs 0%). TRACLEER®was evaluated for safety in pediatric patients in uncontrolled studies. The safety profile was similar to that observed in adult patients with PAH.

DRUG INTERACTIONS

  • TRACLEER® is contraindicated for use with cyclosporine A and with glyburide.
  • TRACLEER® is metabolized by CYP2C9 and CYP3A.
    • Co-administration with agents that are metabolized by these pathways may affect plasma concentrations of one or both agents.
    • Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when TRACLEER® is co-administered.
    • When initiating lopinavir/ritonavir and other ritonavir-containing HIV regimens, dosage adjustment of TRACLEER® is necessary.
    • When co-administered with simvastatin, or other statins that are CYP3A substrates, dosage adjustment of such statins may need to be considered.
    • When co-administered with rifampin, a CYP3A inducer, liver function should be monitored weekly.
    • When co-administered with ketoconazole, a potent CYP3A inhibitor, no dose adjustment of TRACLEER® is necessary, but increased effects of TRACLEER® may need to be considered.
  • There are no clinically relevant interactions between TRACLEER® and warfarin, digoxin, nimodipine, losartan, sildenafil, or tadalafil.
    • Dose adjustments are not necessary when TRACLEER® and sildenafil or tadalafil are co-administered.

LIVER ENZYME ELEVATIONS

  • Measure liver aminotransferases prior to initiation of treatment and then monthly.
  • Use of TRACLEER® should generally be avoided in patients with elevated aminotransferases (>3 x ULN) at baseline because monitoring for hepatotoxicity may be more difficult.
  • It is important to adhere strictly to the monthly monitoring schedule for the duration of treatment.
    • Changes in aminotransferases may occur early or late in treatment.
    • There have been rare postmarketing reports of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring; the contribution of TRACLEER® could not be excluded.
  • For patients whose monthly LFTs are ≤3 x ULN, no change in monitoring schedule or dosage is required.
  • For patients whose monthly LFTs are >3 x ULN, close monitoring and either dose reduction or treatment cessation are necessary.

MONITORING

It is important to adhere strictly to the monthly monitoring schedule for LFTs and, if applicable, pregnancy for the duration of treatment.

Please see full Prescribing Information and Medication Guide for TRACLEER®, including BOXED WARNING about liver injury and birth defects. Provide the Medication Guide to your patients and encourage discussion.

cp-113987


INDICATION

+

TRACLEER® (bosentan) is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):

  • in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%).
  • in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.