AMBRISENTAN

(AM bri SEN tan) Brand: Letairis

What is the most significant information I must know about ambrisentan?

• Ambrisentan can harm an unborn child or reason birth defects. Do not use if you are pregnant. You may need to have a negative pregnancy test till starting this treatment.

• If you are a woman of child-bearing potential, you will be required to use two forms of birth control to prevent pregnancy during your treatment, and for at least 1 month after your treatment ends (unless you have had a tubal ligation or are using a copper IUD).

• You must not use this medicine if you have idiopathic pulmonary fibrosis (IPF).

• Ambrisentan is accessible only under a particular program called LEAP (Letairis Education and Access Program). You should be registered in the program and sign agreements to use birth control and undergo pregnancy and blood testing as required by the program.

What is ambrisentan?

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

• Ambrisentan is used to treat pulmonary arterial hypertension (PAH). It improves your capacity to exercice and prevents your condition from getting worse.

• Ambrisentan is accessible only under a particular program called LEAP (Letairis Education and Access Program). You should be registered in the program and sign agreements to use birth control and undergo pregnancy and blood testing as required by the program. Read all program brochures and agreements carefully.

• Ambrisentan may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking ambrisentan?

• You must not use this medicine if you are allergic to ambrisentan, or if you have idiopathic pulmonary fibrosis (IPF).

• To create certain ambrisentan is safety for you, speak your doctor if you have:

· anemia (low red blood cell counts);

· liver malady; or

· if you are pregnant or plan to become pregnant while taking ambrisentan.

• FDA pregnancy category X. This medicine can harm an unborn child or reason birth defects. Do not use ambrisentan if you are pregnant. Speak your doctor right away if you become pregnant during treatment.

• If you are a woman of child-bearing potential, you will need to have a negative pregnancy test till you start treatment with ambrisentan. You will also be re-tested every month during your treatment.

• You will be required to use two forms of birth control to prevent pregnancy during your treatment, and for at least 1 month after your treatment ends. If you have had a tubal ligation or are using a copper IUD (intrauterine device), you will not need to use a second form of birth control.

• Recommended combinations of birth control forms include:

· 1 hormone form (birth control pill, skin patch, implant, vaginal ring, or injection) plus 1 barrier form (condom, diaphragm with spermicide, or cervical cap with spermicide).

· a condom and a female barrier form together (diaphragm with spermicide, or cervical cap with spermicide).

· a partner's vasectomy plus 1 hormone form or 1 barrier form.

• Conversation with your doctor about the use of abnormal contraception if you have unprotected sex or if you believe your form of contraception has failed.

• It is not known whether ambrisentan passes into breast milk or if it could harm a nursing child. You must not breast-feed while you are using ambrisentan.

• Ambrisentan may lower a man's sperm bill and could affect fertility (your capacity to have children).

How must I take ambrisentan?

• Ambrisentan is generally taken once daily. Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• Till you start treatment with ambrisentan, your doctor may perform blood trials to create certain it is safety for you to take this medicine. Your blood will need to be tested often during treatment.

• Ambrisentan can be taken with or without food. Take the medication at the same time every day.

• Do not crush, chew, or split the tablet. Swallow the pill whole.

• Store at room temperature away from moisture and heat. Hold this medication in its original container.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while using ambrisentan?

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of ambrisentan?

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

• Call your doctor at once if you have:

· anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, quick or uneven heart rate;

· swelling of the foots, ankles, or legs;

· pounding heartbeats or fluttering in your chest; or

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

• General side effects may include:

· stuffy nose, sinus pain; or

· flushing (warmth, redness, or tingly feeling).

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect ambrisentan?

• Speak your doctor about all medicines you use, and those you start or stop using during your treatment with ambrisentan, especially:

· cyclosporine.

• This list is not complete. Another drugs may interact with ambrisentan, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Not all possible interactions are listed in this medicine manual.

Where can I get more information?

• Your doctor or pharmacist can provide more information about ambrisentan.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.