Bosentan

What is the most important information I should know about bosentan?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

Bosentan can cause severe liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking Bosentan, and again each month during your treatment.

Do not stop taking Bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.

What is bosentan?

Bosentan prevents thickening of the blood vessels, especially those in the lungs and heart. Bosentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Bosentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

Bosentan may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking bosentan?

Do not use this medication if you are allergic to Bosentan, or if you:

• are also using glyburide (Micronase, DiaBeta, Glynase Pres Tab);
• are pregnant or might become pregnant during treatment; or
• are also using cyclosporine (Sandimmune, Neoral, Gengraf).

Bosentan can cause severe liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use bosentan if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

It is not known whether bosentan passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

How should I take bosentan?

Take bosentan exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor.

Take each dose with a full glass (8 ounces) of water.

Bosentan can be taken with or without food.

Bosentan is usually taken twice a day, morning and evening.

Do not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Store bosentan at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a Bosentan overdose may include headache, nausea, vomiting, increased heart rate and fainting or dizziness (low blood pressure).

What should I avoid while using bosentan?

There are no restrictions on food, beverages, or activity during treatment with Bosentan unless otherwise directed by your doctor.

What are the possible side effects of bosentan?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• nausea, stomach pain, loss of appetite;
• dark urine, clay-colored stools; or
• jaundice (yellowing of the skin or eyes).

Other less serious side effects are more likely to occur, such as:

• headache;
• flushing;
• swelling of the feet, ankles, or legs;
• dizziness;
• upset stomach;
• fatigue; or
• itching.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect bosentan?

Do not take Bosentan without first talking to your doctor if you are taking any of the following medicines:

• an antifungal antibiotic such as ketoconazole (Nizoral), fluconazole (Diflucan), itraconazole (Sporanox), or voriconazole (Vfend);
• tacrolimus (Prograf);
• a blood thinner such as warfarin (Coumadin);
• rifampin (Rifadin, Rifater, Rifamate, Rimactane);
• ritonavir (Norvir); or
• a cholesterol-lowering medicine such as simvastatin (Zocor), lovastatin (Mevacor), or atorvastatin (Lipitor).

There may be other drugs not listed that can affect Bosentan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about Bosentan written for health professionals that you may read.

What does my medication look like?

Bosentan is available with a prescription under the brand name Tracleer. Other brand or generic formulations may also be available. Ask your healthcare provider or pharmacist any questions you have about this medication, especially if it is new to you.

• Tracleer-62.5 mg round, orange-white tablets
• Tracleer-125 mg oval, orange-white tablets

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 2.02. Revision date: 05/01/2007.