What is PAH?

  What is PAH?

Pulmonary arterial hypertension (PAH) is high blood pressure in the arteries of your lungs. It's a serious condition that can make it difficult for your blood to flow through your lungs. This can force your heart to work harder. Over time, PAH will get worse and may limit your physical activities.1

PAH is a rare disease, and not all causes are known. Although anyone can develop PAH, it affects almost 4 times as many women as men in the United States.2

The most common symptoms of PAH

The symptoms of PAH are similar to those of other heart and lung conditions. That’s why it may take a long time to get the right diagnosis.3

The most common PAH* symptoms are4:

  • Shortness of breath
  • Dizziness and/or fainting
  • Chest pain or discomfort
  • Swollen ankles, arms, or legs
  • Feeling tired or worn out
  • Swollen abdomen
  • Rapid, hard, or irregular heartbeat
  • Cough

*Please note: TRACLEER does not improve all symptoms of PAH

  About TRACLEER® (bosentan)

TRACLEER is a medicine called an endothelin receptor antagonist (ERA). An ERA is a medication that helps PAH patients by blocking the effects of the extra endothelin their bodies produce. Endothelin is a naturally occurring chemical in your body and is involved in blood flow.5

Patients with PAH have levels of endothelin that may be higher than normal. Researchers have found that too much endothelin can cause blood vessels to tighten. When this happens, it is more difficult for blood to flow through tightened blood vessels, and this can affect how well the heart works.1,5,6

  How to take TRACLEER for adult patients

Your healthcare provider will give you detailed information about the TRACLEER REMS Program.

  • Take TRACLEER as prescribed by your healthcare professional—usually one tablet in the morning and one in the evening.
  • You can take TRACLEER with or without food.
  • Consider taking TRACLEER at the same time each day. It may be easier to remember that way.
  • If you miss a dose of TRACLEER, take your tablet as soon as you remember. Do not take two doses at the same time. If it's time for your next dose, skip the missed dose. Just take the next dose at your regular time.
  • Do not stop taking TRACLEER unless your healthcare professional tells you to. Suddenly stopping your treatment may cause your symptoms to get worse. If you need to stop taking TRACLEER, speak with your healthcare professional about the right way to stop.
  • If you take more than the prescribed dose of TRACLEER, call your healthcare professional right away.
  • Immediately tell your healthcare professional about any side effects while taking TRACLEER.
  • Your healthcare professional will tell you how much TRACLEER to take and when to take it.

In most cases, your healthcare professional will:

  • Start your treatment with TRACLEER at 62.5 mg (round tablet) twice daily for the first four weeks
  • Increase your dose to 125 mg (oblong tablet) twice daily thereafter

Dosing schedule

  How to take TRACLEER® for pediatric patients

Your child’s healthcare provider will give you detailed information about the Tracleer REMS Program.

The pediatric formulation is designed to help with dosing and administration for children

  • Formulation dispersible in water to help children who have trouble swallowing pills.
  • Fruit flavor designed with children in mind.
  • If necessary, the 32 mg dispersible tablet can be divided into halves by breaking along the lines cut into the surface.
    • Hold the tablet between the thumb and index finger on either side of one of the lines, with the line facing upwards.
    • Break the tablet along the line.
    • The dispersible tablet should not be broken into quarters.

Administering the dispersible formulation

  • Each 32 mg dispersible tablet, or tablet part, can be dispersed in a minimal amount of water to make a liquid medicine immediately before administration.
    • When the tablet has fully dispersed, the liquid should be administered to the patient.
  • Dispersible tablets that have been broken to adjust the dose of medicine can be stored at room temperature, between 68°F to 77°F (20°C to 25°C).
    • Tablet pieces should be used within 7 days of having been broken.
    • Tablet pieces may be returned to the opened blister and stored there out of reach of children for up to 7 days.

How should TRACLEER be taken?

  • Be sure TRACLEER is taken exactly as prescribed. Talk to your child's healthcare provider if you have any questions.
  • In most cases, your child will take 1 dose in the morning and 1 in the evening.
  • TRACLEER can be taken orally with or without food.
  • If a dose of TRACLEER is missed, give your child their dose as soon as you remember. Do not give 2 doses at the same time. If it is almost time for the next dose, skip the missed dose. Just give the next dose at your child’s regular time.
  • Your child should not stop taking TRACLEER unless their healthcare provider says otherwise. Suddenly stopping treatment may cause your child’s symptoms to get worse. If your child needs to stop taking TRACLEER, speak with their healthcare provider about the right way to stop.
  • If more than the prescribed dose of TRACLEER is taken, call your child’s healthcare provider right away.
  • Your child’s healthcare provider will tell you how much TRACLEER your child should take and when they should take it.
  • TRACLEER will be mailed to you by a specialty pharmacy. You will only receive a 30-day supply of TRACLEER at one time.

In most cases, your child’s healthcare professional will start treatment with TRACLEER at a dose appropriate for your child’s age and weight.

Dosing recommendations in pediatric patients

REFERENCES: 1. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension.
J Am Coll Cardiol. 2009;53:1573-1619. 2. Frost AE, Badesch DB, Barst RJ, et al. The changing picture of patients with pulmonary arterial hypertension in the United States: how REVEAL differs from historic and non-US Contemporary Registries. Chest. 2011;139:128-137.
3. Gibbs JR. Making a diagnosis in PAH. Eur Respir Rev. 2007;16:8-12. 4. Brown LM, Chen H, Halpern S, et al. Delay in recognition of pulmonary arterial hypertension: factors identified from the REVEAL registry. Chest. 2011;140:19-26. 5. TRACLEER® (bosentan) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 6. Humbert M. Advances in therapeutic interventions for patients with pulmonary arterial hypertension. Circulation. 2014;130(24):2189-2208.

Indication and Important Safety Information