LETAIRIS- ambrisentan tablet, film coated
Gilead Sciences, Inc
Read this Medication Guide before you start taking LETAIRIS and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.
LETAIRIS is available only through a restricted program called the LETAIRIS Education and Access Program (LEAP). To receive LETAIRIS, you must talk to your doctor, understand the benefits and risks of LETAIRIS, and agree to all of the instructions in the LEAP program.
What is LETAIRIS?
LETAIRIS is a prescription medicine to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
LETAIRIS can improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms.
Who should not take LETAIRIS?
Do not take LETAIRIS if:
Tell your doctor about all your medical conditions and all the medicines you take including prescription and nonprescription medicines. LETAIRIS and other medicines may affect each other causing side effects. Do not start any new medicines until you check with your doctor.
Especially tell your doctor if you take the medicine cyclosporine (Gengraf, Neoral, Sandimmune). Your doctor may need to change your dose of LETAIRIS. You should not take more than 5 mg of LETAIRIS each day if you also take cyclosporine.
LETAIRIS has not been studied in children.
How should I take LETAIRIS?
LETAIRIS will be mailed to you by a specialty pharmacy. Your doctor will give you complete details.
What should I avoid while taking LETAIRIS?
What are the possible side effects of LETAIRIS?
Serious side effects of LETAIRIS include:
The most common side effects of LETAIRIS are:
Some medicines that are like LETAIRIS can cause liver problems. Tell your doctor if you get any of these symptoms of a liver problem while taking LETAIRIS:
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of LETAIRIS. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store LETAIRIS?
Store LETAIRIS at 68 °F to 77 °F (20 °C to 25 °C), in the package it comes in.
Keep LETAIRIS and all medicines out of the reach of children.
General information about LETAIRIS
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LETAIRIS for a condition for which it was not prescribed. Do not give LETAIRIS to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about LETAIRIS. If you would like more information, ask your doctor. You can ask your doctor or pharmacist for information about LETAIRIS that is written for healthcare professionals.
For more information, call 1-866-664-LEAP (5327) or visit www.letairis.com or www.gilead.com.
What are the ingredients in LETAIRIS?
Active ingredient: ambrisentan
Inactive Ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablets are film-coated with a coating material containing FD&C Red #40 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Gilead Sciences, Inc., Foster City, CA 94404
Revised October 2012
LETAIRIS is a registered trademark of Gilead Sciences, Inc. Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. Other brands noted herein are the property of their respective owners.
© 2012 Gilead Sciences, Inc.