DOSING AND ADMINISTRATION
Patients can take charge of their gMG, at home or away1,2
ZILBRYSQ is a once daily subcutaneous self-injection that fits into their daily life and can be taken at home or away.1,2
Ability to use at home or away
Ready-to-use prefilled syringe
Once daily administration in seconds
Keeps at room temp for up to 3 months*
Pharmacy must refrigerate until ready to dispense ZILBRYSQ.1†
ZILBRYSQ prefilled syringes may be stored at room temperature up to 86°F (30°C) in the original carton for a single period of up to 3 months. Once ZILBRYSQ has been stored at room temperature, write the date removed from the refrigerator in the space provided on the carton and discard if not used within 3 months or if the expiration date has passed, whichever occurs first. Do not return ZILBRYSQ to the refrigerator after it has been stored at room temperature. Do not freeze. Store ZILBRYSQ prefilled syringes in the original carton to protect them from light until time of use.1
Pharmacy must keep ZILBRYSQ refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until dispensing.1
The ZILBRYSQ Injection Training video shows patients how to self-administer.
Watch Now
100% of patients who completed the RAISE study opted into RAISE-XT.3
Patient satisfaction and compliance reported with self-administration of ZILBRYSQ4,5
The Self-Injection Assessment Questionnaire© (SIAQ) was administered to patients who participated in RAISE-XT4
89%
(n=56)
were satisfied or very satisfied with the time it took to self-administer ZILBRYSQ
84%
(n=53)
were very or extremely confident in their ability to self-administer ZILBRYSQ
In addition, a majority of the patients surveyed believe that self-injections with ZILBRYSQ were convenient and easy to administer.4 Patients or caregivers may inject ZILBRYSQ after proper training by a healthcare professional.1
SIAQ was developed by UCB Pharma S.A. to assess the perceived advantages and the potential limitations of self-injection of a subcutaneous medication. Although it is meant to be a generic questionnaire for use across diseases, it was developed with the input from subjects with Crohn's disease (CD) and subjects with rheumatoid arthritis (RA). The SIAQ has undergone psychometric validation in RA subjects.5
SIAQ is a self-administered patient-reported outcome survey used to assess the self-injection experience of patients in the RAISE-XT trial. Patients from RAISE-XT who participated in SIAQ received dedicated device training for administration of ZILBRYSQ. The survey was completed at home, directly after self-injection, in 2 assessments approximately 2 weeks apart (first assessment n=63, second assessment n=52).4
SIAQ is composed of 21 questions spanning 6 domains: 5 of these domains are termed “causal domains” (feelings about injections, self-image, self-confidence, injection-site reactions, and ease of use) since these are considered to be determining factors of the sixth domain: satisfaction with self-injection.4,5
Of 63 patients asked at first assessment4:
- 88.9% of patients responded to the question “How satisfied are you with the time it takes to inject the medication?” as either “satisfied” or “very satisfied.” 7.9% responded as being “neither dissatisfied nor satisfied.” 3.2% responded as being “dissatisfied.” 0 patients reported being “very dissatisfied”
- 84.1% of patients responded to the question “After this study, how confident would you be to give yourself an injection at home?” as either “very” or “extremely.” 15.9% responded with “moderately.” 0 patients reported being either “a little” or “not at all”
RAISE-XT post hoc analysis: ZILBRYSQ compliance data6
Over a median exposure of 2.2 years (range: 0.1-5.6), 95% (189/199) of patients reported taking >95% of their medication.
99.2%
In total (n=199), patients reported taking a mean percentage of 99.2% of their medication
Compliance data were analyzed for 199 patients from RAISE-XT. The mean percentage of medication taken was analyzed post hoc for the overall population and subgroups‡ of:
- Age (<65 and ≥65 years)
- Sex (male and female)
- Disease duration (<median and ≥median)
- Baseline MG-ADL score (≤9 and ≥10)
Study limitations:
RAISE-XT was designed to evaluate safety and was not placebo controlled. The percentage of medication taken was not a pre-specified endpoint. Results should be interpreted with caution. Clinical significance has not been established.
‡Data for the subgroups were consistent with those of the overall population. Mean percentage of medication taken for all subgroups was ≥98.4% of doses.6
The primary objective of RAISE-XT was to evaluate the long-term safety and tolerability of ZILBRYSQ in study participants with gMG. Long-term efficacy was also studied through multiple measures as select secondary endpoints. The open-label extension is an ongoing study with the current interim data cut (May 11, 2023) at Week E84.3,7
Administering ZILBRYSQ1
Patients or caregivers may self-inject ZILBRYSQ after proper training by a healthcare professional. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of ZILBRYSQ according to the Instructions for Use.
ZILBRYSQ can be injected into areas of the:
- Abdomen
- Front of the thighs
- Back of the upper arms (only if administered by a caregiver)
Injection areas selected should not be:
- Tender
- Bruised
- Red
- Hard
- Swollen
Areas with scars or stretch marks should be avoided, as well as the 2-inch area around the navel. Rotate injection sites for each administration.
Direct patients to administer ZILBRYSQ at approximately the same time each day. If a dose is missed, patients should administer the dose as soon as possible. ZILBRYSQ should only be administered once per day.
When using ZILBRYSQ prefilled syringes, patients should inject the full contents of the single-dose prefilled syringe and discard after use. Do not reuse.
Simple storage for patient use at home or away1,2
ZILBRYSQ prefilled syringe
- Portable
- Ready to use
- Self-injectable
ZILBRYSQ can be stored at room temperature in the original carton up to 3 months if refrigeration isn’t available.*
ZILBRYSQ is available in 3 doses based on patient's weight1
- 16.6 mg/0.416 mL — Less than 56 kg (123 lbs)
- 23 mg/0.574 mL — 56 kg to less than 77 kg (123-170 lbs)
- 32.4 mg/0.81 mL — 77 kg and above (>170 lbs)
Complete or update meningococcal vaccination according to the full ZILBRYSQ Prescribing Information at least 2 weeks prior to administering the first dose of ZILBRYSQ.
Color of packaging and plunger differ by dose.
Get your patients started with ONWARD™
ONWARD is here to support your prescribed patients with gMG during every step of their ZILBRYSQ treatment.
ONWARD is provided as a service of UCB and is intended to support the appropriate use of UCB medicines. ONWARD may be amended or canceled at any time without notice. Some program and eligibility restrictions may apply.
References:
- ZILBRYSQ [Prescribing Information]. Smyrna, GA: UCB, Inc.
- Howard JF Jr, Bresch S, Genge A, et al; RAISE Study Team. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, Phase 3 study. Lancet Neurol. 2023;22(5):395-406. doi:10.1016/S1474-4422(23)00080-7
- Howard JF Jr, Bresch S, Farmakidis C, et al. Long-term safety and efficacy of zilucoplan in patients with generalized myasthenia gravis: interim analysis of the RAISE-XT open-label extension study. Ther Adv Neurol Disord. 2024;17(3):1–16. doi:10.1177/17562864241243186
- Data on file. UCB, Inc.
- Keininger D, Coteur G. Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ). Health Qual Life Outcomes. 2011;9(2):1-11. doi:10.1186/1477-7525-9-2
- Ruzhansky K, Freimer M, Leite MI, et al; on behalf of the RAISE-XT study team. Compliance to daily self-administered subcutaneous zilucoplan in patients with generalized myasthenia gravis: a post hoc analysis of the RAISE-XT study. Poster presented at: American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting; October 15-18, 2024; Savannah, GA. Poster 264.
- Leite MI, Bresch S, Hewamadduma C, et al; on behalf of the RAISE-XT study team. Long-term zilucoplan in generalised myasthenia gravis: 96-week follow-up interim analysis of RAISE-XT. Presented at European Academy of Neurology 2024 Annual Meeting; April 13-18, 2024; Helsinki, Finland. Presentation EPR-254.
