Important Safety Information and Indication
Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
• In adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%).
What is the most important information I should know about bosentan tablets?
Bosentan tablets are only available through the Bosentan REMS Program. Before you begin taking bosentan tablets, you must read and agree to all of the instructions in the Bosentan REMS Program.
- 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 bosentan tablets 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 bosentan tablets:
- unusual tiredness
- stomach area (abdominal) pain
- yellowing of the skin or whites of your eyes (jaundice)
Serious birth defects.
If you are the parent or caregiver of a female child who started taking bosentan 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.
Acceptable Birth Control Options
See "What are the possible side effects of Bosentan Tablets?" for more information about side effects.
What are bosentan tablets?
Bosentan tablets are a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs.
Bosentan tablets can improve your ability to exercise and can slow the worsening of your physical condition and symptoms. Bosentan tablets lowers high blood pressure in your lungs and lets your heart pump blood more efficiently.
Bosentan tablets are only:
Prescribed by healthcare providers who are enrolled in the Bosentan REMS Program.
Available to people who understand and agree to enroll in the Bosentan REMS Program.
Who should not take bosentan tablets? Do not take bosentan tablets if you:
- are pregnant, plan to become pregnant, or become pregnant during treatment with bosentan tablets. Bosentan tablets can cause serious birth defects. All females should read the birth defects section of "What is the most important information I should know about bosentan tablets?"
- take any 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 bosentan tablets. See the end of this Medication Guide for a complete list of the ingredients in bosentan tablets. If you have a rash, hives or your lips swell after taking bosentan tablets, it may be a sign of allergy. You should stop taking your bosentan tablets and talk to your healthcare provider.
What should I tell my healthcare provider before taking bosentan tablets?
Bosentan tablets 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 bosentan passes into your milk. You and your healthcare provider should decide if you will take bosentan tablets or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Bosentan tablets and other medicines may affect how each other works and cause side effects. Especially tell your healthcare provider if you take:
- hormone-based birth control, such as pills, shots, patches, and implants.
These birth control methods may not work as well when taken with bosentan tablets.
- simvastatin or other "-statin" medicines used to lower cholesterol
- rifampin used for tuberculosis
- ketoconazole, fluconazole, itraconazole, or voriconazole used for fungal infections
- warfarin sodium used to prevent blood clots
- ritonavir used to treat HIV
There may be more than one brand name medicine. Ask your healthcare provider if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine.
How should I take Bosentan tablets?
Your healthcare provider will give you detailed information about the Bosentan REMS Program.
- Bosentan tablets will be mailed to you by a specialty pharmacy. You will only receive a 30-day supply of bosentan tablets at one time.
- Take bosentan tablets exactly as prescribed.
- Your healthcare provider will tell you how much bosentan tablets to take and when to take it.
- In most cases, you will take 1 tablet in the morning and 1 in the evening.
- You can take bosentan tablets orally with or without food.
- If you take more than the prescribed dose of bosentan tablets, call your healthcare provider right away.
- If you miss a dose of bosentan tablets, take your tablet as soon as you remember. Do not take 2 doses at the same time. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time.
- Do not stop taking bosentan tablets unless your healthcare provider tells you to. Suddenly stopping your treatment may cause your symptoms to get worse. If you need to stop taking bosentan tablets, speak with your healthcare provider about the right way to stop.
What are the possible side effects of bosentan tablets?
Bosentan tablets can cause serious side effects, including:
- See "What is the most important information I should know about bosentan tablets?"
- Fluid retention and swelling of your ankles and legs. Bosentan tablets 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 bosentan tablets 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 bosentan tablets.
The most common side effects of bosentan tablets 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 bosentan tablets. 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.
If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about bosentan tablets that is written for healthcare professionals.
Please address medical inquiries to: MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.