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Janssen CarePath can:

  • Review your health plan benefits to help answer questions you may have about insurance coverage for TRACLEER®
  • Identify options that may help make TRACLEER® more affordable, if needed
  • Identify and coordinate with a specialty pharmacy to arrange shipment of your Janssen medication

Getting Started with TRACLEER®

TRACLEER® is delivered by a specialty pharmacy—it's not something that's kept in stock at your local retail pharmacy. The following is a typical process when starting out with TRACLEER®, though your experience may vary.

  1. Prescription Prescription

    Your doctor selects TRACLEER® as your new treatment.

    • Your healthcare team completes all the forms necessary to start you on the Janssen medicine. For TRACLEER®, this includes enrollment in the Bosentan REMS Program to monitor liver function and to make sure that females who are able to get pregnant use effective birth control during TRACLEER® treatment and for 1 month after treatment discontinuation

    Bosentan REMS Program enrollment

    TRACLEER® can cause serious side effects, including liver damage and birth defects. When starting TRACLEER®, you must enroll in the Bosentan Risk Evaluation and Mitigation Strategy (REMS) Program.

    Your healthcare team will enroll you in the Bosentan REMS Program at the start of treatment.

  2. Insurance Verification Insurance verification

    The insurance company may ask your healthcare provider for additional information before they pay for your medicine.

    • A Janssen CarePath Care Coordinator can help with this process by gathering additional information from your healthcare team
  3. Delivery of Medicine Delivery of medicine

    TRACLEER® is shipped to you by a specialty pharmacy.

    • A Janssen CarePath Care Coordinator will help you connect with a specialty pharmacy that delivers TRACLEER® in your area
    • Each month, the specialty pharmacy will call you to confirm details of the delivery, arrange your refill, and confirm your monthly tests
    • The shipment is usually quick, but the process leading up to your first delivery could take more than 2 weeks
    • Before shipping, the specialty pharmacy will call you to confirm some details, including the shipment date and verification that you've completed a pregnancy test (if required). Be sure to answer, or call the specialty pharmacy back if they leave a message

    Remember, the call from your specialty pharmacy may come from a phone number that you don't know. If you miss the call, it's important that you call back.

  4. Refills Refills

    You will need to complete required monthly testing and your doctor must verify your prescription. Then the specialty pharmacy will ship your refill.

Your Janssen CarePath Care Coordinator may need additional information from you at the start of treatment

When you speak with a Care Coordinator, they may ask for additional information, including:

  • Details of your healthcare plan, including the name and contact information for the insurance company and your policy number
  • The name and contact information of your prescribing doctor (including the fax number)
  • Further details from your healthcare team, if your initial claim is denied

If you change insurance plans or healthcare providers, speak with your healthcare team and a Care Coordinator in a timely manner to make sure you can continue your treatment.

Contact a Care Coordinator with questions at 866-228-3546, Monday–Friday, 8:00 AM to 8:00 PM ET.

If your health plan does not approve TRACLEER® treatment

Sometimes you may not be able to obtain the medication that your doctor has ordered for you. For example, your health plan might not cover the medication because it is not on the plan’s drug list (formulary) or the cost is higher than you think you should have to pay. In these situations, you and your doctor have the right to ask the health plan to explain its decision and to consider making the medication available to you as an exception to its policies.

Support Resources

  • Patient education and tools, including internet resources

Need Help? Call a Janssen CarePath Care Coordinator at 866-228-3546, Monday–Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support is available.

Connecting with others in your community

Resources are available online that can offer support and help you connect with others who are living with your condition. These include local support groups, fundraising walks, outreach programs, online communities, and volunteer opportunities. The websites below can help you learn more about your condition and connect with others.

TRACLEER® Website
TRACLEER.com
This website contains information about treatment with TRACLEER®. On this website, you can also get helpful information about your condition.

Pulmonary Hypertension Association
phassociation.org
The Pulmonary Hypertension Association is dedicated to increasing awareness and advocacy by providing information about PAH to both physicians and patients.

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

IMPORTANT SAFETY INFORMATION

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WHAT IS TRACLEER®?

TRACLEER® is a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs.

TRACLEER® can improve your ability to exercise and can slow the worsening of your physical condition and symptoms.

TRACLEER® lowers high blood pressure in your lungs and lets your heart pump blood more efficiently.

TRACLEER® is only:

  • Prescribed by healthcare providers who are enrolled in the Bosentan REMS Program
  • Available to people who understand and agree to enroll in the Bosentan REMS Program

Important Safety Information

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT TRACLEER®?

TRACLEER® is only available through the Bosentan REMS Program. Before you begin taking TRACLEER®, you must read and agree to all of the instructions in the Bosentan REMS Program.

TRACLEER® can cause serious side effects including:

Liver Damage

  • Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. You must have your blood tested to check your liver function before you start TRACLEER® and each month after that. Your healthcare provider will order these tests. Regular blood tests are important because they will help your healthcare provider adjust or stop your treatment before there is permanent damage.
  • Tell your healthcare provider if you have had liver problems, including liver problems while taking other medicines. Call your healthcare provider right away if you have any of these symptoms of liver problems while taking TRACLEER®:
    • nausea
    • vomiting
    • fever
    • unusual tiredness
    • stomach area (abdominal) pain
    • yellowing of the skin or the whites of your eyes (jaundice)

Serious birth defects.

TRACLEER® can cause serious birth defects if taken during pregnancy. You must not be pregnant when you start taking TRACLEER® or during TRACLEER® treatment. Serious birth defects from TRACLEER® can happen early in pregnancy. Females who are able to get pregnant must have a negative pregnancy test before starting treatment with TRACLEER®, each month during treatment with TRACLEER®, and 1 month after stopping treatment with TRACLEER®.

  • Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do a pregnancy test and will order a pregnancy test for you depending on your menstrual cycle.
  • Females who are able to get pregnant are females who:
    • have entered puberty, even if they have not started their menstrual period, and
    • have a uterus, and
    • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
  • Females who are not able to get pregnant are females who:
    • have not yet entered puberty, or
    • do not have a uterus, or
    • have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed or
    • are infertile for other medical reasons and this infertility is permanent and cannot be reversed.
  • Females who are able to get pregnant must use two acceptable forms of birth control during treatment with TRACLEER®, and for one month after stopping TRACLEER® because the medicine may still be in the body.
    • If you have had a tubal sterilization or have an IUD (intrauterine device), these methods can be used alone and no other form of birth control is needed.
    • Talk with your healthcare provider or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with TRACLEER®.
    • If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another acceptable form of birth control.
    • Do not have unprotected sex. Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control.
    • Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.

If you are the parent or caregiver of a female child who started taking TRACLEER® before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your healthcare provider right away if you notice that she is developing breast buds or any pubic hair. Your healthcare provider should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.

Who should not take TRACLEER®?

Do not take TRACLEER® if you:

  • are pregnant, plan to become pregnant, or become pregnant during TRACLEER® treatment. TRACLEER® can cause serious birth defects. All females should read the birth defects section of “What is the most important information I should know about TRACLEER®?”
  • take one of these medicines:
    • cyclosporine A used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of heart, liver, and kidney transplants
    • glyburide used to treat diabetes
  • are allergic to bosentan or any of the ingredients in TRACLEER®. If you have a rash, hives or your lips swell after taking TRACLEER®, it may be a sign of an allergy. You should stop taking your TRACLEER® and talk to your healthcare provider.

What should I tell my healthcare provider before taking TRACLEER®?

TRACLEER® may not be right for you. Tell your healthcare provider about all your medical conditions, including if you:

  • have liver problems.
  • are breast-feeding or plan to breast feed. It is not known if TRACLEER® passes into your milk. You and your healthcare provider should decide if you will take TRACLEER® or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRACLEER® and other medicines may affect how each other works and cause side effects.

What are the possible side effects of TRACLEER®?

TRACLEER® can cause serious side effects, including:

  • Fluid retention and swelling of your ankles and legs. TRACLEER® can cause your body to hold too much water, and you may get swelling of your ankles and legs. Tell your healthcare provider if you have swelling of your ankles and legs that happens either with or without weight gain, or if you have more trouble with your breathing than normal. Your healthcare provider will look for the cause of this.
  • Lower Sperm Count. Some men who take TRACLEER® may have lower sperm counts. This may affect your ability to father a child. Tell your healthcare provider if fertility is a concern for you.
  • Low red blood cell levels (anemia). Your healthcare provider will do blood tests to check your red blood cells during treatment with TRACLEER®.

The most common side effects of TRACLEER® include:

  • respiratory tract infection
  • headache
  • fainting
  • flushing
  • low blood pressure
  • inflamed nose passages (sinusitis)
  • joint pain
  • irregular heart beats

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRACLEER®. For more information, ask your doctor or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS about liver injury and birth defects, and Medication Guide for TRACLEER® and discuss any questions you have with your doctor.

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