Ambrisentan oral tablets

What is this medication?

AMBRISENTAN (am bri SEN tan) is used to treat pulmonary hypertension. This medicine may help make exercise and breathing easier.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): LETAIRIS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Anemia
• Liver disease
• Pulmonary veno-occlusive disease (PVOD)
• An unusual or allergic reaction to ambrisentan, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day.

You can take this medication with or without food. If it upsets your stomach, take it with food.

Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Cyclosporine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 1 month after stopping it. Patients must have 2 negative pregnancy tests before starting this medication and 1 each month during treatment, even if not sexually active. Two reliable forms of contraception for 1 month before, during, and for 1 month after stopping this medication is recommended. Progestin hormones may not work as well while you are taking this medication. If you become pregnant, miss a menstrual cycle, or stop using contraception, stop taking this medication. Call your care team. Severe birth defects may occur even if just 1 dose is taken. Breast-feeding while taking this medication or for 1 month after stopping treatment is not recommended.

Because of the risks of birth defects, this medication is available only through a special program. Care teams, pharmacies, and patients must meet all the conditions of the program. Your care team will help you get signed up with the program if you need this medication.

This medication has caused reduced sperm counts in some patients. This may interfere with the ability to father a child. You should talk with your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• dizziness
• fast, irregular heartbeat
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• sudden weight gain
• swelling of the ankles or legs
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• congested or runny nose
• flushing of the skin
• headache
• sore throat
• upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F).

Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.