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IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA

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.

  • Complete or update vaccinations for encapsulated bacteria at least 2 weeks prior to the first dose of FABHALTA, unless the risks of delaying therapy with FABHALTA outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.

  • Patients receiving FABHALTA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.

Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the FABHALTA REMS.

INDICATION

FABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).

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Definitions
ARC, absolute reticulocyte count; bid, twice daily; C5i, C5 inhibitor; Ci, complement inhibitor; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; Hb, hemoglobin; LDH, lactate dehydrogenase; MAVE, major adverse vascular event; PNH, paroxysmal nocturnal hemoglobinuria; RBC, red blood cell; ULN, upper limit of normal; WBC, white blood cell.

References
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.