SAFETY
Examine safety profiles from RAISE and RAISE-XT
RAISE: safety and tolerability were demonstrated in a Phase 3 pivotal study1,2
Adverse reactions in >5% of patients treated with ZILBRYSQ and more frequently than in patients who received placebo.1
%
%
The most common adverse reactions (reported in at least 10% of patients treated with ZILBRYSQ) were injection site reactions, upper respiratory tract infections, and diarrhea.1
Immunize patients with meningococcal vaccines at least 2 weeks before administering the first dose of ZILBRYSQ.1
RAISE-XT primary endpoint: safety and tolerability were evaluated at Week E123
The primary endpoint of RAISE-XT was to evaluate the safety and tolerability of ZILBRYSQ at Week E12.3
In RAISE-XT, morphea was observed in 10 (5%) patients, most cases had a time to onset longer than one year after start of treatment and were mild to moderate in severity. One patient discontinued ZILBRYSQ due to morphea.1
Most common treatment-emergent adverse events (TEAEs)4
n (%)
n (%)
n (%)
Includes deaths.
Safety set, includes all study participants who received at least 1 dose of ZILBRYSQ in RAISE-XT. The “All ZILBRYSQ” group also includes data from patients from ZILBRYSQ 0.1 mg/kg treatment groups, which are not presented separately here.
Additional ZILBRYSQ warnings and precautions1
Other infections
ZILBRYSQ blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae.
Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. Persons receiving ZILBRYSQ are at increased risk for infections due to these bacteria, even after vaccination.
Pancreatitis and other pancreatic conditions
Pancreatitis and pancreatic cysts have been reported in patients treated with ZILBRYSQ.
RAISE-XT
n (%)
During the open-label extension studies, 7 (3.3%) patients experienced pancreatic events, including 4 (1.9%) patients with pancreatitis and 3 (1.4%) with pancreatic cysts.
Patients should be informed of the risk of pancreatitis and other pancreatic conditions before starting ZILBRYSQ.
Discontinue ZILBRYSQ in patients with suspected pancreatitis and initiate appropriate management until pancreatitis is ruled out or
has resolved.
RAISE
n (%)
n (%)
In the 3-month, double-blind Study 1, adverse reactions of increased lipase were reported in 6 (6.9%) patients treated with ZILBRYSQ compared to no patients on placebo, and adverse reactions of increased amylase were reported in 4 (4.7%) patients treated with ZILBRYSQ compared to 1 (1.1%) patient on placebo. Lipase levels exceeded three times the upper limit of normal in 6 (7%) patients after being started on ZILBRYSQ compared to no patients on placebo.
Obtain lipase and amylase levels at baseline before starting treatment with ZILBRYSQ.
References:
- ZILBRYSQ [Prescribing Information]. Smyrna, GA: UCB, Inc.
- Vu T, Genge A, Hussain Y, et al; on behalf of the RAISE investigators. Efficacy and safety of zilucoplan in myasthenia gravis: responder analysis from the randomized phase 3 RAISE trial. Poster presented at: American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting; September 21-24, 2022; Nashville, TN. Poster 200.
- Data on file. UCB, Inc.
- Freimer M, Leite M, Genge A, et al; on behalf of the RAISE-XT study team. RAISE-XT: An interim analysis of safety and efficacy in an open-label extension study of zilucoplan in patients with myasthenia gravis. Poster P1-5-007. Poster presented at: American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting; April 22-27, 2023; Boston, MA.
