|
|
|
|||||||||||||||||||||
| Prescribing Information | Medication Guide | Important Safety Information | |||||||||||||||||||||||
|
A proven medication for PAHTracleer (pronounced tra•KLEER) is used to treat WHO Functional Class II, III, and IV pulmonary arterial hypertension (PAH). However, it is not a cure.Tracleer is the only oral PAH treatment with over 8 years of proven experience worldwide. It has been thoroughly studied and prescribed for more than 75,000 patients.1 Tracleer may improve your exercise ability and may slow the worsening of your PAH.2* Tracleer also may lower high blood pressure in your lungs and help your heart pump blood more efficiently.3† It's been shown to work as early as four weeks in some patients. Other patients may need as long as several months to realize the benefits of Tracleer.4 Remember, individual results may vary. How Tracleer worksTracleer 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. However, patients with PAH have levels of endothelin that are higher than normal.4,5 Researchers believe that too much endothelin can cause blood vessels to tighten.5,6†† These changes can make it more difficult for blood to flow easily through the blood vessels, and this can affect how well the heart works.5 Tracleer was the first oral endothelin receptor antagonist approved for PAH. Tracleer is currently approved for PAH (WHO Group I) WHO Class II, III, IV. If you have any questions, speak to your healthcare team.Benefits of taking TracleerThere are benefits that you may be able to feel and those you may not be able to feel.With Tracleer, you may find that:
You may also experience benefits that you may not be able to feel, for example:
Remember that every patient is different and may respond to treatment in different ways. It may take time for Tracleer to make a difference in your PAH and any change will likely be gradual. It's important to discuss this with your healthcare team and to have realistic expectations of what your treatment can do for you. As with any medication, the optimal benefits of Tracleer are experienced by patients who take it as directed by their healthcare team. Tracleer DosingYour healthcare provider will tell you how much Tracleer to take and when to take it. In most cases, you will take 1 tablet in the morning and 1 in the evening. You can take Tracleer with or without food.*In a clinical study of 213 patients with WHO functional class III–IV,
researchers compared two groups of patients for 16 weeks: one group received Tracleer, either
125 mg or 250 mg twice per day while the other received placebo (sugar pill). Walking distance
was somewhat greater with 250 mg twice daily, but the potential for increased liver injury
causes this dose not to be approved.
Clinical worsening is defined as any one of the following: A need to go to the hospital for PAH, stopping treatment because of worsening of PAH, a need for intravenous (IV) treatment (epoprostenol), or death.2 †In one study of 32 patients with WHO functional class III–IV,
researchers compared 2 groups of patients for 12 weeks: one group received Tracleer 125 mg twice a
day, the other received placebo. Researchers measured the blood pressure and resistance in the
pulmonary artery and they also measured Cardiac Index or the amount of blood pumped out of the heart.
††Statements are based on observations reported from in vitro or
animal trials. The clinical significance in humans is not known.
IMPORTANT SAFETY INFORMATION Because of the risks associated with Tracleer, this medication may be prescribed by your doctor only through the Tracleer Access Program. Liver damage: Tracleer can cause serious liver damage, including in rare cases liver failure and, in situations with regular liver testing, unexplained liver cirrhosis. So you must have a blood test to check your liver function before you start Tracleer and each month after that. Call your doctor right away if you have any of these symptoms of liver problems: nausea, vomiting, fever, unusual tiredness, abdominal (stomach area) pain, or yellowing of the skin or the whites of your eyes (jaundice). Serious birth defects: Tracleer is very likely to cause serious birth defects. It is important not to be or to become pregnant while taking Tracleer or one month after stopping treatment and to have a pregnancy test before you start the drug and each month thereafter. It is very important for you to use reliable forms of birth control while taking Tracleer. Hormonal contraceptives should not be used alone because they may not be effective in patients taking Tracleer. Do not take Tracleer with glyburide because it may increase your chance of liver injury. Do not take Tracleer with cyclosporine-A because it may increase your chance of side effects. Please see Additional Safety Information. Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
REFERENCES:
|
||||||||||||||||||||||
|
|||||||||||||||||||||||
