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Contact: UCB
General Information
Rystiggo (rozanolixizumab-noli) is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRN), resulting in the reduction of circulating IgG.
Rystiggo is specifically indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
Rystiggo is supplied as an injection for subcutaneous administration.
Because Rystiggo causes transient reduction in IgG levels, immunization with live attenuated or live vaccines is not recommended during treatment with Rystiggo. Evaluate the need to administer age-appropriate immunizations according to immunization guidelines before initiation of a new treatment cycle with Rystiggo.
The recommended dosage of Rystiggo is based on body weight, as shown below:
Body Weight of Patient | Dose | Volume to be Infused |
Less than 50 kg | 420 mg | 3 mL |
50 kg to less than 100 kg | 560 mg | 4 mL |
100 kg and above | 840 mg | 6 mL |
Administer the recommended dosage as a subcutaneous infusion using an infusion pump at a rate of up to 20 mL/hour once weekly for 6 weeks.
Administer subsequent treatment cycles based on clinical evaluation. The safety of initiating subsequent cycles sooner than 63 days from the start of the previous treatment cycle has not been established.
If a scheduled dose is missed, Rystiggo may be administered up to 4 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed.
Mechanism of Action
Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
Side Effects
Adverse effects associated with the use of Rystiggo may include, but are not limited to, the following:
- headache
- infections
- diarrhea
- pyrexia
- hypersensitivity reactions
- nausea
Clinical Trial Results
The FDA approval of Rystiggo was based on the pivotal Phase 3 MycarinG study. The primary efficacy endpoint was the comparison of the change from baseline between treatment groups in the MG-ADL total score at day 43. MG-ADL is a measurement tool which assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG. These include activities such as breathing, talking, swallowing, and being able to rise from a chair. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. A total score ranges from 0 to 24, with the higher scores indicating more impairment. A statistically significant difference favoring Rystiggo was observed in the MG-ADL total score change from baseline (-3.4 points in Rystiggo -treated group at either dose vs -0.8 points in the placebo-treated group).
The secondary endpoint was the change between treatment groups from baseline to day 43 in the QMG. The QMG is a 13-item categorical grading system that assesses muscle weakness. Each item is assessed on a 4-point scale where a score of 0 represents no weakness and a score of 3 represents severe weakness. A total possible score ranges from 0 to 39, where higher scores indicate more severe impairment. A statistically significant difference favoring Rystiggo was observed in the QMG total score change from baseline (-5.4 points and -6.7 points in Rystiggo -treated group at ≈7mg/kg and ≈10 mg/kg dose level, respectively, vs -1.9 points in the placebo-treated group).
Approval Date: 2023-06-01
Company Name: UCB