Important Safety Information about Tracleer

Tracleer can cause serious side effects including liver damage and birth defects. To help detect these side effects, you must have monthly liver function and, if applicable, pregnancy testing.¹ Because of these risks, you must be enrolled in the Tracleer Access Program (T.A.P.^®) to receive your medication. Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

Liver damage

Patients on Tracleer need to have a blood test to check their liver function before starting treatment with Tracleer and each month for as long as they continue to take Tracleer. By checking your liver each month, your healthcare provider may be able to detect problems with your liver before they become serious or cause permanent harm. Even with regular liver function testing, complications such as liver cirrhosis and liver damage can still occur.¹

What is a liver function test (LFT)?

The LFT is a simple test that shows the level of liver enzymes, or proteins, in your blood. To get an LFT, a blood sample will be drawn either at a lab or at your healthcare provider's office. This will happen both before you start Tracleer and every month that you continue to take Tracleer.

Why do I have to get an LFT every month while taking Tracleer?

• Tracleer can increase liver enzymes in some patients.¹
• Regular LFTs are important because they will help your healthcare provider keep track of your liver enzymes in order to adjust or stop your treatment if necessary.

Elevated liver enzymes are a sign of possible problems. Regular LFTs alert your healthcare provider to take action.

Tell your healthcare provider if you have had liver problems, including liver problems while taking other medicines. Call your healthcare provider right away if you have any of these symptoms of liver problems while taking Tracleer¹:

• Nausea
• Fever
• Stomach area (abdominal) pain
• Vomiting
• Unusual tiredness
• Yellowing of the skin or the whites of your eyes (jaundice)

Serious birth defects

Tracleer can cause serious birth defects if taken during pregnancy. You must not become pregnant when you start taking Tracleer or during Tracleer treatment. Serious birth defects from Tracleer can happen early in pregnancy. Females who are able to get pregnant must have a negative pregnancy test before starting treatment and each month during Tracleer treatment. Talk with your healthcare provider or gynecologist (a doctor who specializes in female reproduction) to find out about how to prevent pregnancy. Do not have unprotected sex. Tell your healthcare provider right away if you miss a menstrual period or you think you may be pregnant.

What should I know about birth control?

Females who are able to get pregnant must use effective birth control (contraception) while taking Tracleer and for one month after stopping treatment. You must choose and use two reliable forms of birth control at the same time, unless you have a tubal sterilization, Copper T 380A IUD, or LNg 20 IUS—these methods can be used alone.

The chart below lists reliable forms of birth control. However, you and your healthcare team should decide which 2 methods of reliable birth control you should use. Your healthcare provider may recommend that you use a different method of birth control to help lower your risk of problems with your PAH.

Reliable methods of contraception during treatment with Tracleer
Methods to use alone	Hormone (choose 1 and use with a barrier method)	Barrier (use both OR choose 1 and use with a hormone method)
Intrauterine devices (IUDs) —Copper T 380A IUD —LNg-20 IUS (progesterone IUD) Tubal Sterilization	Estrogen and progesterone —Oral contraceptives —Transdermal patch —Vaginal ring Progesterone only —Injection —Implant	Male condom with spermicide Diaphragm with spermicide OR Cervical cap with spermicide
	A partner's vasectomy still requires 1 additional method of contraception.

Additional Safety Information

Fluid retention and swelling of ankles and legs. Tracleer can cause your body to hold too much water, and you may get swelling of your ankles and legs. Tell your healthcare provider if you have swelling of your ankles and legs that happens either with or without weight gain, or if you have more trouble with your breathing than normal. Your healthcare provider will look for the cause of this.
Lower sperm count. Some men who take Tracleer may have lower sperm counts. This may affect your ability to father a child. Tell your healthcare provider if fertility is important to you.
Low red blood cell levels (anemia). Your healthcare provider will do blood tests to check your red blood cells during treatment with Tracleer.

Do not take Tracleer with glyburide because it may increase your chance of liver injury. Do not take Tracleer with cyclosporine-A because it may increase your chance of side effects.

The most common side effects of Tracleer

The following side effects occur most often in people taking Tracleer: respiratory tract infection, headache, fainting, flushing, low blood pressure, inflamed nose passages (sinusitis), joint pain, and irregular heart beats.¹

Immediately tell your healthcare provider about any side effects you experience while taking Tracleer. You may report side effects to FDA at 1-800-FDA-1088.

Learn about what to expect from Tracleer

IMPORTANT SAFETY INFORMATION
Because of the risks associated with Tracleer, this medication may be prescribed by your doctor only through the Tracleer Access Program.

Liver damage: Tracleer can cause serious liver damage, including in rare cases liver failure and, in situations with regular liver testing, unexplained liver cirrhosis. So you must have a blood test to check your liver function before you start Tracleer and each month after that. Call your doctor right away if you have any of these symptoms of liver problems: nausea, vomiting, fever, unusual tiredness, abdominal (stomach area) pain, or yellowing of the skin or the whites of your eyes (jaundice).

Serious birth defects: Tracleer is very likely to cause serious birth defects. It is important not to be or to become pregnant while taking Tracleer or one month after stopping treatment and to have a pregnancy test before you start the drug and each month thereafter. It is very important for you to use reliable forms of birth control while taking Tracleer. Hormonal contraceptives should not be used alone because they may not be effective in patients taking Tracleer.

Do not take Tracleer with glyburide because it may increase your chance of liver injury. Do not take Tracleer with cyclosporine-A because it may increase your chance of side effects.

Please see Additional Safety Information.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

REFERENCE:

1. TRACLEER^® (bosentan) full Prescribing Information. Actelion Pharmaceuticals US, Inc., August 2009.