SAFETY AND TOLERABILITY

 

RYSTIGGO safety and tolerability were demonstrated in a Phase 3 clinical study1,2

Adverse reactions occurring in ≥5% of patients treated with RYSTIGGO and more frequently than in patients treated with placebo1

Adverse Reaction
RYSTIGGO
(n=133)
Placebo
(n=67)
Headache
44%
19%
Any infection
23%
19%
Upper respiratory tract infection
8%
6%
Diarrhea
20%
13%
Pyrexia
17%
2%
Hypersensitivity reactions
11%
5%
Nausea
10%
8%
Administration site reactions
8%
3%
Abdominal pain
8%
6%
Arthralgia
7%
3%

RYSTIGGO Warnings and Precautions

Infections1

RYSTIGGO may increase the risk of infection.

  • Delay RYSTIGGO administration in patients with an active infection until the infection is resolved
  • During treatment with RYSTIGGO, monitor for clinical signs and symptoms of infection
  • If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved

In clinical studies, common infections (at least 5% frequency) were upper respiratory tract infections (17%), COVID-19 (14%), urinary tract infections (9%), and herpes simplex (6%). Serious infections were reported in 4% of patients treated with RYSTIGGO. Three fatal cases of pneumonia were identified caused by COVID-19 infection in two patients and an unknown pathogen in one patient. Six cases of infections led to discontinuation of RYSTIGGO.

Immunization

Immunization with vaccines during RYSTIGGO treatment has not been studied. The safety of immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because RYSTIGGO causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO.

Aseptic Meningitis1

Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported in patients treated with RYSTIGGO.

  • If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care

Hypersensitivity Reactions1

Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with RYSTIGGO.

  • Management of hypersensitivity reactions depends on the type and severity of the reaction
  • Monitor patients during treatment and for 15 minutes after completion of the administration for clinical signs and symptoms of hypersensitivity reactions
  • If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention

The most common adverse reactions (≥10%) in patients treated with RYSTIGGO were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.1

References:

  1. RYSTIGGO [Prescribing Information]. Smyrna, GA: UCB, Inc.
  2. Bril V, Drużdż A, Grosskreutz J, et al. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023;22(5):383-394. doi:10.1016/S1474-4422(23)00077-7

UP NEXT

learn about dosing