Hemlibra 30 mg/ml (SC Injection)

Indications

• Prevents or reduces frequency of bleeding episodes in hemophilia A patients

Mode of Action

• Mimics function of coagulation factor VIII
• Binds to activated form of Factor IX and Factor X
• Restores blood coagulation process
• Reduces hemorrhagic episodes

Dosage Administration

• Loading dose: 3 mg/kg subcutaneous injection once weekly for first 4 weeks
• Maintenance dose options: 1.5 mg/kg once weekly, 3 mg/kg once every two weeks, 6 mg/kg once every four weeks

Interaction

• Hypercoagulability with concomitant use of aPCC

Side Effects

• Thrombotic microangiopathy associated with Hemlibra and aPCC
• Thromboembolism associated with Hemlibra and aPCC
• Immunogenicity

Pregnancy Lactation

• Unknown risk of major birth defects and miscarriage in pregnant women
• Unknown presence of emicizumab-kxwh in human milk
• Consideration of potential benefit for the mother versus risk to fetus during pregnancy
• Health benefits of breastfeeding should be considered along with clinical need for emicizumab

Precautions Warnings

• Development of anti-Hemlibra antibodies in treated patients
• Interference with clotting time and coagulation laboratory tests

Storage Conditions

• Refrigerate at 2°C to 8°C in original carton
• Do not freeze or shake
• Unopened vials can be stored out of refrigeration and then returned
• Discard if not used immediately after removal from vial

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