Tracleer Warnings and Precautions

Some people who take Tracleer may have an increased risk for problems like liver damage, serious allergic reactions, and other dangerous complications. Other important warnings for using Tracleer safely include precautions for potential drug interactions. There is also a risk for people who have liver disease, heart disease, or anemia.


What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Tracleer® (bosentan) if you have:
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Heart disease
  • Swelling in the arms, hands, legs, ankles, or feet (edema)
  • Anemia
  • Any allergies, including to foods, dyes, or preservatives.
In addition, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings for Tracleer

Some warnings and precautions to be aware of prior to taking Tracleer include the following:
  • This medicine can cause liver problems. You may not have any symptoms of liver problems early on. Therefore, your healthcare provider will order blood tests to check your liver function before you start Tracleer and at least monthly during treatment. If you begin to show signs of liver damage, your healthcare provider may reduce your dosage or recommend you stop treatment. Let your healthcare provider know if you develop any signs of liver problems, such as:
    • Nausea and vomiting
    • Fever
    • Abdominal (stomach) pain
    • Yellowing of the skin or whites of the eyes (jaundice)
    • Constant fatigue or tiredness.
  • Because of risks associated with its use, Tracleer is only available through a special program. You, your healthcare provider, and the pharmacy that sends you the medicine must be enrolled in this program. Your healthcare provider will enroll you in the program, and you will need to re-enroll each year you are on treatment. This program ensures that you and your healthcare provider understand the risks and benefits of this medication.
  • Tracleer should generally not be used in people who have moderate-to-severe liver disease. Your healthcare provider will check your liver function before beginning treatment. If your liver enzymes are elevated too much, which could be a sign of liver damage, this drug may not be the best treatment for you.
  • This medicine can cause swelling of the legs, ankles, and feet due to fluid retention. This is known as edema. Edema can also be a symptom of pulmonary arterial hypertension (PAH), the condition Tracleer is used to treat. Let your healthcare provider know if you have any unusual swelling or unexplained weight gain. He or she will evaluate you to determine whether the symptom is due to the medication, worsening PAH, or something else.
  • This medicine is not likely to work for treating pulmonary veno-occlusive disease, a rare form of high blood pressure in the lungs. Some people who are diagnosed with pulmonary arterial hypertension may actually have pulmonary veno-occlusive disease. Let your healthcare provider know if you develop signs of pulmonary veno-occlusive disease, such as a cough, shortness of breath, or fatigue.
  • If you are a male, you should know that Tracleer may decrease your sperm count, which could affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.
  • There have been reports of anemia (low red blood cell levels) occurring in people taking Tracleer. In some cases, the anemia was severe enough to require a blood transfusion. Your healthcare provider will check for anemia periodically during treatment using blood tests. 
  • Tracleer is a pregnancy Category X medication, which means there is evidence it can harm an unborn child, and it should not be used by a pregnant woman (see Tracleer and Pregnancy).
  • It is unknown if Tracleer passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the medication (see Tracleer and Breastfeeding).

Tracleer Medication Information

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