Atrasentan

Atrasentan is used to lower levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy.

Atrasentan may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Atrasentan is usually taken once per day. You may take it with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your condition may get worse if you change your dose or stop using atrasentan suddenly. Ask your doctor before stopping the medicine.

You may be given other medications to help treat certain side effects. Keep taking these medicines for as long as your doctor has prescribed.

You may need frequent blood tests to check your liver function, and your next dose may be delayed based on the results.

Store at room temperature in the original container away from moisture and heat.

Do not use if you are pregnant. Use effective birth control.

You should not use atrasentan if you are allergic to it.

Tell your doctor if you have ever had:

• liver disease.

May cause birth defects. Do not use if you are pregnant. Use effective birth control before, during and for at least 2 weeks after your last dose. Tell your doctor right away if you become pregnant.

You will need to have a negative pregnancy test before starting this treatment.

Ask your doctor about the best form of birth control if your current method stops working or if you have unprotected sex.

Do not breastfeed while taking atrasentan.

It may be harder for you to get a woman pregnant while you are using this medicine.

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

Atrasentan may cause serious side effects. Call your doctor at once if you have:

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection).

Your treatment may be delayed or permanently discontinued if you have certain side effects.

Common side effects of atrasentan may include:

• swelling of hands, legs, ankles and feet; or
• anemia (low red blood cells).

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

Usual Adult Dose for Primary Immunoglobulin A Nephropathy:

0.75 mg orally once a dayUse: For the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio 1.5 g/g or greater.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking atrasentan?

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

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect atrasentan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.