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

• Serious birth defects.
  
  LETAIRIS can cause serious birth defects if taken during pregnancy.
  
  
  • Women must not be pregnant when they start taking LETAIRIS or become pregnant during treatment.
  • Women who are able to get pregnant must have a negative pregnancy test before beginning treatment with LETAIRIS and each month during treatment. Your doctor will decide when to do the test, depending on your menstrual cycle.
  Women who are able to get pregnant must use two acceptable forms of birth control, during LETAIRIS treatment and for one month after stopping LETAIRIS.
  
  
  • If you have had a tubal sterilization or have an IUD, these methods can be used alone and no other form of birth control is needed.
  • Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about how to prevent pregnancy.
  • Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may tell you to use emergency birth control.
  • Tell your doctor right away if you miss a menstrual period or think you may be pregnant.

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.

Who should not take LETAIRIS?

Do not take LETAIRIS if:

• You are pregnant, plan to become pregnant, or become pregnant during treatment with LETAIRIS. LETAIRIS can cause serious birth defects. (See "What is the most important information I should know about LETAIRIS?") Serious birth defects from LETAIRIS happen early in pregnancy.

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.

Please see patient Medication Guide and full prescribing information, including boxed WARNING.

If you have questions or concerns regarding your treatment options, call 1-866-664-LEAP (5327) or visit www.gilead.com for more information.