BOSENTAN

Liver damage: Bosentan may rarely cause serious (possibly fatal) liver damage. Rarely, liver problems have happened in people after stopping treatment with bosentan. Your doctor will perform liver function tests before you start treatment and once a month during treatment. Tell your doctor right away if you notice dark urine, loss of appetite, persistent nausea/vomiting, stomach/abdominal pain, or yellowing eyes/skin.

Pregnancy: Bosentan must not be used during pregnancy because it may cause serious harm (such as birth defects) in an unborn baby. Women of childbearing age must have a negative pregnancy test before starting this medication and monthly during treatment. Use at least two reliable forms of birth control while taking bosentan and for at least one month after stopping bosentan as directed by your doctor to prevent pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

Common Side effects:

• dizziness
• flushing
• upset stomach
• tiredness

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• fast/pounding heartbeat
• extreme tiredness
• swelling of the ankles/feet
• sudden/unexplained weight gain

Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, shortness of breath, coughing up blood.

In men, this medication can decrease sperm production, which may affect the ability to father a child. Talk to your doctor for more details.

Precautions

• Allergy: Before taking bosentan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
• Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, anemia.

Pregnancy Risk: Category X. This medication must not be used during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while using this medication.

Breastfeeding: It is not known whether this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Interactions

• Some products that may interact with this drug include: cyclosporine, glyburide.
• Other medications can affect the removal of bosentan from your body, which may affect how bosentan works. Examples include amiodarone, cimetidine, tacrolimus, St. John’s wort, anti-seizure drugs including carbamazepine, azole antifungals including itraconazole/ketoconazole, macrolide antibiotics including erythromycin, HIV protease inhibitors including ritonavir, rifamycins including rifabutin, among others.
• This drug can speed up the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include “statin” cholesterol medications (such as simvastatin, lovastatin), warfarin, among others.
• This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist about using an additional reliable birth control method while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

Symptoms of overdose may include: severe headache, severe dizziness, nausea, vomiting.

Notes: Do not share this medication with others.

Laboratory and/or medical tests (such as liver function tests, pregnancy tests, hemoglobin, hematocrit) should be performed before you start treatment, and periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.