What's the most important safety information I should know about taking Tracleer?
In order to detect important side effects, you must have regular blood tests. Your doctor will prescribe these tests for you. It’s required that you have liver function tests before you start treatment, and each month thereafter while you are taking Tracleer. If you are female of childbearing potential, you must have a negative pregnancy test before taking Tracleer and every month thereafter, and you should not become pregnant while taking Tracleer.
Why are monthly Liver Function tests so important?
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. This is because, in clinical trials of Tracleer, some patients experienced abnormal liver function, elevated liver enzymes and liver damage.
By checking your liver enzymes each month, your doctor may be able to detect problems with your liver before they become serious or cause permanent harm.
Tell your doctor immediately if you experience any of the following signs of liver damage:
Nausea
Vomiting
Fever
Unusual tiredness
Abdominal (stomach area) pain
Yellowing of the skin or the whites of your eyes (jaundice)
Remember, liver problems may not cause symptoms at first—monthly blood tests performed by your doctor can help your healthcare provider evaluate if your liver is functioning correctly.
What happens if my Liver Function test scores are elevated?
Your healthcare team will guide you on what to do if your liver enzymes are elevated. Your doctor might adjust or stop your treatment or ask you to have more blood tests in order to decide on the best treatment plan for you.
Why shouldn’t I become pregnant while taking Tracleer?
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 while taking Tracleer. 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 doctor should decide which methods are right for you. Your doctor may recommend that you use a different method to decrease your risk of problems with your pulmonary arterial hypertension (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.
IMPORTANT SAFETY INFORMATION
Because of the risks associated with Tracleer, this medication may be prescribed
only by your doctor 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 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 or cyclosporine-A because they may increase your chance of side effects.
Important safety information
