Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
July 12, 2012
Health Canada has issued new restrictions concerning the use of Volibris® (ambrisentan). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Blood changes: This medication may decrease hemoglobin levels and cause anemia (low red blood cells in your blood). Hemoglobin is the protein in red blood cells that carries oxygen throughout your body. Your doctor will perform regular tests to monitor your blood for changes while you are taking ambrisentan. People who have anemia should talk to their doctor before taking this medication.
Fluid retention: Fluid buildup in the body can occur as a result of pulmonary arterial hypertension (PAH), but it can also be caused by this medication. This swelling is usually mild to moderate. However, tell your doctor if you experience symptoms of severe, increased swelling of your hands, feet, ankles, and legs while taking ambrisentan.
Liver function: This medication may cause liver damage. Your doctor will monitor your liver function by performing regular liver function tests while you are taking ambrisentan. Be sure to tell your doctor if you experience any signs of liver problems, such as yellowing of the skin or whites of the eyes, abdominal pain, or dark urine. If you have liver disease, discuss with your doctor how ambrisentan may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: Ambrisentan should not be used in pregnancy. Taking ambrisentan during pregnancy can cause serious birth defects. Women who may become pregnant must not take ambrisentan until pregnancy is excluded. A pregnancy test must be performed before starting treatment with ambrisentan. A reliable form of birth control must be used at the same time during treatment with ambrisentan. Regularly pregnancy tests should be performed throughout treatment with ambrisentan. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if ambrisentan passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of this medication have not been established for children or adolescents under 18 years of age.
Seniors: People over the age of 65 are more likely to experience swelling of the hands, ankles, and feet while taking ambrisentan. Talk to your doctor if you have any concerns.