Safety profile of FABHALTA® (iptacopan)
Serious risk of infections
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.1
Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is available only through a restricted program under a REMS program called the FABHALTA REMS.1
Please click here to learn more.
Contraindications
FABHALTA is contraindicated1:
- In patients with serious hypersensitivity to FABHALTA or any of the excipients
- For initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b
Safety profile of FABHALTA in the APPEAR-C3G study
Click on image to enlarge.
One patient (3%) on FABHALTA and none on placebo had a serious adverse reaction of pneumonia and bacteremia secondary to an encapsulated organism (S pneumoniae).1
No new adverse reactions were identified during the 6-month placebo-controlled period of APPEAR-C3G.1
Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is only available through a REMS program that requires vaccinations.1 See Getting Started for more details.