"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)./"...
Letairis Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fast heartbeat, extreme tiredness, swelling ankles/feet, sudden/unexplained weight gain, trouble breathing.
Other medications that are like ambrisentan may rarely cause very serious liver problems. Tell your doctor immediately if you develop symptoms of liver disease, including: persistent nausea/vomiting, loss of appetite, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.
This medication can decrease sperm production in some men, an effect that may lower male fertility. Consult your doctor for more details.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Letairis (ambrisentan tablets) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking ambrisentan, tell your doctor or pharmacist if you are allergic to it; or to other endothelin receptor blockers (e.g., bosentan); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, certain lung conditions (pulmonary fibrosis), anemia.
Older adults may be at greater risk for swelling ankles/feet while using this drug.
This medication must not be used during pregnancy. It may harm an unborn baby. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor immediately. Women who may become pregnant must have a negative pregnancy test before starting this medication, once a month while taking it, and for 1 month after stopping the medication. Consult your doctor for more details and to discuss reliable forms of birth control. Unless otherwise directed by your doctor, it is recommended that at least 2 reliable forms of birth control (e.g., birth control pills, condoms) be used while taking this medication and for 1 month after stopping the medication. Birth control should still be used, even if your partner had a vasectomy.
It is not known whether this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
Additional Letairis Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get tips on handling your hypertension.