Avatrombopag is used to treat thrombocytopenia (a lack of platelets in the blood) in adults with chronic liver disease who are scheduled to undergo a medical procedure.

Avatrombopag is also used to treat chronic immune thrombocytopenia when other treatments have failed.

Avatrombopag is not a cure for thrombocytopenia and it will not make your platelet counts normal.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take avatrombopag with food.

Avatrombopag is usually taken once daily to treat chronic immune thrombocytopenia.

When given before a medical procedure in people with chronic liver disease: Avatrombopag is usually taken once daily for 5 days, beginning 10 to 13 days before your procedure. Carefully follow your doctor's dosing instructions about the timing of this medicine and the procedure.

Your doctor will measure your platelet levels weekly to determine how long to treat you with avatrombopag. You may also need blood tests for a few weeks after your last dose.

Store at room temperature away from moisture and heat. Keep each tablet in the foil blister pack until you are ready to take a dose.

Usual Adult Dose for Thrombocytopenia:

Chronic Liver Disease:
Platelet count less than 40 x 10(9)/L: 60 mg orally once a day starting 10 to 13 days prior to the scheduled procedure
Platelet count 40 to less than 50 x 10(9)/L: 40 mg orally once a day starting 10 to 13 days prior to the scheduled procedure

Duration of therapy: 5 days

Comments:
-Patients should undergo their procedure 5 to 8 days after the last dose of this drug.
-Do not use this drug to normalize platelet counts.

Use: Treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure.

Chronic Immune Thrombocytopenia:
Initial dose: 20 mg orally once a day with food

Maximum dose: 40 mg/day

Comments:
-Use the lowest dose needed to achieve and maintain a platelet count greater than or equal to 50 x 10(9)/L as necessary to reduce the risk for bleeding.
-Do not use this drug to normalize platelet counts.

Use: Treatment of thrombocytopenia in patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

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

Tell your doctor if you have ever had:

• a blood clot; or

• a bleeding or blood clotting disorder other than thrombocytopenia.

Your doctor will measure your platelet levels with a blood test before you start taking avatrombopag.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using avatrombopag, and for at least 2 weeks after your last dose.

For chronic immune thrombocytopenia: Take the missed dose as soon as you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take two doses at one time.

Before a scheduled medical procedure: Call your doctor for instructions if you miss a dose.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

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

You could develop a blood clot while using avatrombopag. Call your doctor or get emergency medical help if you have:

• chest pain, shortness of breath;

• fast heartbeats;

• pain, swelling, or redness in one or both legs;

• stomach pain or tenderness;

• sudden fever or chills, yellowing of your skin or eyes; or

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of avatrombopag may include:

• fever;

• easy bruising or bleeding (nosebleeds, bleeding gums), purple or red spots on your skin;

• feeling tired;

• headache, joint pain;

• cold symptoms such as runny or stuffy nose, sneezing, sore throat;

• nausea, stomach pain; or

• swelling in your hands or feet.

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.

Other drugs may affect avatrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before you start treatment to decide your dose of avatrombopag and on the day of the procedure.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.