INDICATIONS AND USAGE（适应症）

HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

DOSAGE（服用剂量）

For subcutaneous use only.

The recommended loading dose is 3 mg/kg by subcutaneous injection once weekly for the first 4 weeks, followed by a maintenance dose of:

1.5 mg/kg once every week, or

3 mg/kg once every two weeks, or

6 mg/kg once every four weeks.

The selection of a maintenance dose should be based on healthcare provider preference with consideration of regimens that may increase patient adherence.

Discontinue the prophylactic use of bypassing agents the day before starting HEMLIBRA prophylaxis.

The prophylactic use of factor VIII (FVIII) products may be continued during the first week of HEMLIBRA prophylaxis.

Missed Dose

If a dose of HEMLIBRA is missed administer as soon as possible and then resume usual dosing schedule. Do not administer two doses on the same day to make up for a missed dose.

ADVERSE REACTIONS（不良反应）

Thrombotic Microangiopathy Associated with HEMLIBRA and aPCC

Thromboembolism Associated with HEMLIBRA and aPCC

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/2483adba-fab6-4d1b-96c5-c195577ed071/spl-doc?hl=Emicizumab

Emicizumab Injectioninformation