What are the possible side effects of LETAIRIS?

The most serious side effects of LETAIRIS are:

• 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. (Please see the Important Safety Information for more information on this WARNING.)
• Swelling all over the body (fluid retention) can happen within weeks after starting LETAIRIS. Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while taking LETAIRIS. These may be symptoms of a serious health problem. You may need to be treated with medicine or need to go to the hospital.
• Sperm count reduction. Reduced sperm counts have been observed in some men taking a drug similar to LETAIRIS, an effect which might impair their ability to father a child. Tell your doctor if remaining fertile is important to you.
• Low red blood cell levels (anemia) can happen during the first weeks after starting LETAIRIS. If this happens, you may need a blood transfusion. Your doctor will do blood tests to check your red blood cells before starting LETAIRIS. Your doctor may also do these tests during treatment with LETAIRIS.

The most common side effects of LETAIRIS are:

• Swelling of hands, legs, ankles, and feet (peripheral edema)
• Stuffy nose (nasal congestion)
• Inflamed nasal passages (sinusitis)
• Hot flashes or getting red in the face (flushing)

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.

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.