"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
AMBRISENTAN - ORAL
COMMON BRAND NAME(S): Letairis
WARNING: This medication must not be used during pregnancy because it can harm an unborn baby. See also Precautions section.
In the US, ambrisentan is only available to female patients enrolled in the Letairis Risk Evaluation and Mitigation Strategy (REMS) program. Male patients do not need to be enrolled in this program to receive this medication. Only doctors and pharmacies enrolled in this program may prescribe or provide ambrisentan. Consult your doctor or pharmacist for more details about this program and about the risks and benefits of using this medication.
These requirements apply in the US. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
USES: Ambrisentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, thereby helping to decrease the blood pressure in the lungs, slow the worsening of symptoms, and improve your ability to exercise.
HOW TO USE: This drug is controlled through a special program. A program worker will call you each month to make sure that you have gotten a pregnancy test if you are a woman who may become pregnant. See also Warning and Precautions sections.
Read the Medication Guide provided by your pharmacist before you start using ambrisentan and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth with or without food, usually once daily or as directed by your doctor. Do not crush, chew, or break the tablets.
The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.
Women who are pregnant or who may become pregnant should not handle the tablets or breathe the dust from this medication.
Tell your doctor if your condition persists or worsens.
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