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Emicizumab-kxwh

Pronunciation

(em i SIZ ue mab kxwh)

Index Terms

  • Hemlibra

Pharmacologic Category

  • Antihemophilic Agent
  • Monoclonal Antibody

Use: Labeled Indications

Routine prophylaxis of bleeding events in patients with hemophilia: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Adverse Reactions

>10%:

Central nervous system: Headache (15%)

Immunologic: Antibody development (≤22%)

Local: Injection site reaction (19%)

1% to 10%:

Dermatologic: Injection site pruritus (5%)

Gastrointestinal: Diarrhea (6%)

Local: Erythema at injection site (7%), pain at injection site (5%)

Neuromuscular & skeletal: Arthralgia (10%), myalgia (5%)

Miscellaneous: Fever (7%)

ALERT: U.S. Boxed Warning

Thrombotic microangiopathy and thromboembolism:

Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 units/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving emicizumab-kxwh prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of emicizumab-kxwh if symptoms occur.

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