INDICATIONS AND USAGE

Treatment of Thrombocytopenia in Patients with Chronic Liver Disease (CLD)

Avatrombopag is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

Treatment of Thrombocytopenia in Patients with Chronic Immune Thrombocytopenia (ITP)

Avatrombopag is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

DOSAGE

Recommended Dosage for Patients with Chronic Liver Disease

Begin avatrombopag dosing 10 to 13 days prior to the scheduled procedure. The recommended daily dose of avatrombopag is based on the patient’s platelet count prior to the scheduled procedure. Patients should undergo their procedure 5 to 8 days after the last dose of avatrombopag.

Avatrombopag should be taken orally once daily for 5 consecutive days with food. In the case of a missed dose, patients should take the next dose of avatrombopag as soon as they remember. Patients should not take two doses at one time to make up for a missed dose, and should take the next dose at the usual time the next day; all 5 days of dosing should be completed.

Recommended Dosage for Patients with Chronic Immune Thrombocytopenia

Use the lowest dose of avatrombopag needed to achieve and maintain a platelet count greater than or equal to 50×109/L as necessary to reduce the risk for bleeding. Dose adjustments are based on platelet count response. Do not use avatrombopag to normalize platelet counts.

Initial Dose Regimen: Begin avatrombopag at a starting dose of 20 mg once daily with food.

Monitoring: After initiating therapy with avatrombopag, assess platelet counts weekly until a stable platelet count greater than or equal to 50×109/L has been achieved, and then obtain platelet counts monthly thereafter. Obtain platelet counts weekly for at least 4 weeks following discontinuation of avatrombopag.

ADVERSE REACTIONS

The most common side effects of avatrombopag when used to treat low blood platelet counts in adults with chronic liver disease (CLD) who are scheduled to have a medical or dental procedure are:

fever

headache

stomach (abdominal) pain

tiredness

nausea

swelling of hands or feet

The most common side effects of avatrombopag when used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) are:

headache

joint pain

tiredness

bleeding gums

bruising

purple or red spots on your skin

nosebleed

runny nose

upper respiratory tract infection

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/e2d5960d-6c18-46cc-86bd-089222b09852/spl-doc?hl=Avatrombopag

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