Table 1.

The labeled and unlabeled indications approved by Ministry of National Guard Health Affairs, Central Region (MNGHA-CR)

Labeled indications at MNGHA:

Treatment or prevention of bleeding episodes in adults:

Patients with hemophilia A (factor VIII deficiency) or B (factor IX deficiency) with inhibitors to factor VIII or factor IX Patients with congenital/acquired factor VII deficiency Treatment of inherited disorders of platelet function, for example, Glanzmann thrombasthenia

Unlabeled indications (approved at MNGHA):

Preventing peri- and postoperative hemorrhage due to body (not brain) trauma* or surgery Management of patients with massive* uncontrolled life-threatening bleeding

Unlabeled indications (not approved at MNGHA):

Treatment or prevention of refractory bleeding after: Cardiac surgery in non-hemophiliac patients Brain trauma Liver transplantation Gastrointestinal bleeding associated with end-stage liver disease Pulmonary hemorrhage (e.g., diffuse alveolar hemorrhage or massive hemoptysis) Thrombocytopenia Factor XI deficiency Von Willebrand disease Prostatectomy Anticoagulant-related intracerebral hemorrhage Coagulopathy of liver dysfunction