LETAIRIS- ambrisentan tablet, film coated 
Gilead Sciences, Inc

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Medication Guide
Letairis® (le-TAIR-is)
(ambrisentan)
Tablets

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.

What is the most important information I should know about Letairis?

If you are the parent or caregiver of a female child who started taking Letairis before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your doctor right away if you notice that she is developing breast buds or any pubic hair. Your doctor should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.

Females can only receive Letairis through a restricted program called the Letairis Risk Evaluation and Mitigation Strategy (REMS) program. If you are a female who can get pregnant, you must talk to your doctor, understand the benefits and risks of Letairis, and agree to all of the instructions in the Letairis REMS program.

Males can receive Letairis without taking part in the Letairis REMS program.

What is Letairis?

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.

How should I take Letairis?

Letairis will be mailed to you by a certified pharmacy. Your doctor will give you complete details.

What should I avoid while taking Letairis?

It is not known if Letairis passes into your breast milk. You should not breastfeed if you are taking Letairis. Talk to your doctor about the best way to feed your baby if you take Letairis.

What are the possible side effects of Letairis?

Letairis can cause serious side effects including:

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:

  • loss of appetite
  • nausea or vomiting
  • fever
  • achiness
  • generally do not feel well
  • pain in the upper right stomach (abdominal) area
  • yellowing of your skin or the whites of your eyes
  • dark urine
  • itching

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 room temperature between 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 health professionals.

For more information, call 1-866-664-5327 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.

Revised: 05/2014
 
Gilead Sciences, Inc