WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT TRACLEER®?
TRACLEER® is only available through the Bosentan REMS Program. Before you begin taking TRACLEER®, you must read and agree to all of the instructions in the Bosentan REMS Program.
TRACLEER® can cause serious side effects including:
- Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. You must have your blood tested to check your liver function before you start TRACLEER® and each month after that. Your healthcare provider will order these tests. Regular blood tests are important because they will help your healthcare provider adjust or stop your treatment before there is permanent damage.
- 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 TRACLEER®:
- unusual tiredness
- stomach area (abdominal) pain
- 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 be 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 with TRACLEER®, each month during treatment with TRACLEER®, and 1 month after stopping treatment with TRACLEER®.
- Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do a pregnancy test and will order a pregnancy test for you depending on your menstrual cycle.
- Females who are able to get pregnant are females who:
- have entered puberty, even if they have not started their menstrual period, and
- have a uterus, and
- have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
- Females who are not able to get pregnant are females who:
- have not yet entered puberty, or
- do not have a uterus, or
- have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed or
- are infertile for other medical reasons and this infertility is permanent and cannot be reversed.
- Females who are able to get pregnant must use two acceptable forms of birth control during treatment with TRACLEER®, and for one month after stopping TRACLEER® because the medicine may still be in the body.
- If you have had a tubal sterilization or have an IUD (intrauterine device), these methods can be used alone and no other form of birth control is needed.
- Talk with your healthcare provider or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with TRACLEER®.
- If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another acceptable form of birth control.
- Do not have unprotected sex. Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control.
- Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.
If you are the parent or caregiver of a female child who started taking TRACLEER® before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your healthcare provider right away if you notice that she is developing breast buds or any pubic hair. Your healthcare provider should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.
Who should not take TRACLEER®?
Do not take TRACLEER® if you:
- are pregnant, plan to become pregnant, or become pregnant during TRACLEER® treatment. TRACLEER® can cause serious birth defects. All females should read the birth defects section of “What is the most important information I should know about TRACLEER®?”
- take one of these medicines:
- cyclosporine A used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of heart, liver, and kidney transplants
- glyburide used to treat diabetes
- are allergic to bosentan or any of the ingredients in TRACLEER®. If you have a rash, hives or your lips swell after taking TRACLEER®, it may be a sign of an allergy. You should stop taking your TRACLEER® and talk to your healthcare provider.
What should I tell my healthcare provider before taking TRACLEER®?
TRACLEER® may not be right for you. Tell your healthcare provider about all your medical conditions, including if you:
- have liver problems.
- are breast-feeding or plan to breast feed. It is not known if TRACLEER® passes into your milk. You and your healthcare provider should decide if you will take TRACLEER® or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRACLEER® and other medicines may affect how each other works and cause side effects.
What are the possible side effects of TRACLEER®?
TRACLEER® can cause serious side effects, including:
- Fluid retention and swelling of your 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 a concern for you.
- Low red blood cell levels (anemia). Your healthcare provider will do blood tests to check your red blood cells during treatment with TRACLEER®.
The most common side effects of TRACLEER® include:
- respiratory tract infection
- low blood pressure
- inflamed nose passages (sinusitis)
- joint pain
- irregular heart beats
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRACLEER®. For more information, ask your doctor or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS about liver injury and birth defects, and Medication Guide for TRACLEER® and discuss any questions you have with your doctor.