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Serious risk of infections

Serious infections caused by encapsulated bacteria1

FABHALTA, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.1

Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is available only through a REMS program called the FABHALTA REMS.1

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FABHALTA is contraindicated:   

  • In patients with serious hypersensitivity to FABHALTA or any of the excipients1

  • For initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B1

BTH, breakthrough hemolysis; Ci, complement inhibitor; C5i, C5 inhibitor; LDL, low-density lipoprotein; PNH, paroxysmal nocturnal hemoglobinuria; REMS, Risk Evaluation and Mitigation Strategy; ULN, upper limit of normal.

1. Fabhalta. Prescribing information. Novartis Pharmaceuticals Corp. 
2. Data on file. Study CLNP023C12302 CSR. Novartis Pharmaceuticals Corp; 2022. 
3. Data on file. Study CLNP023C12301 CSR. Novartis Pharmaceuticals Corp; 2022. 
4. Data on file. Study CLNP023C12301 and Study CLNP023C12302 supporting analyses for USPI clinical efficacy section. Novartis Pharmaceuticals Corp; 2023.