Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
Zilbrysq is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Zilbrysq is intended for use under the guidance and supervision of healthcare professionals experienced in the management of patients with neuromuscular disorders.
Before starting therapy, patients must be vaccinated against Neisseria meningitidis. If treatment needs to start less than 2 weeks after vaccination, the patient must receive appropriate prophylactic antibiotic treatment until 2 weeks after the first vaccination dose (see sections 4.3 and 4.4).
The recommended dose should be given as a subcutaneous injection once daily and administered about the same time every day.
Table 1. Total daily dose by body weight range:
| Body weight | Dose* | Number of pre-filled syringes by colour |
|---|---|---|
| <56 kg | 16.6 mg | 1 (Rubine red) |
| ≥56 to <77 kg | 23 mg | 1 (Orange) |
| ≥77 kg | 32.4 mg | 1 (Dark blue) |
* The recommended dose corresponds to approximately 0.3 mg/kg.
Zilucoplan has not been studied in gMG patients with a Myasthenia Gravis Foundation of America (MGFA) Class V.
If a dose is missed, it should be administered the same day; then, normal dosing should be continued the following day. No more than one dose should be administered per day.
No dose adjustment is required in elderly patients (see section 5.2). Experience with zilucoplan in elderly patients in clinical studies is limited.
No dose adjustment is required for patients with renal impairment (creatinine clearance ≥15 mL/min). There are no data on patients requiring dialysis.
No dose adjustment is required for patients with mild and moderate hepatic impairment (Child-Pugh score of 9 or lower).
The safety and efficacy of Zilbrysq in patients with severe hepatic impairment have not been established. No dose recommendation can be made (see section 5.2).
The safety and efficacy of Zilbrysq in children below the age of 18 years have not been established. No data are available.
This medicinal product is administered by subcutaneous injection.
Suitable injection sites include front of the thighs, abdomen and the back of the upper arms.
Injection sites should be rotated and injections should not be given in areas where the skin is tender, erythematous, bruised, indurated or where the skin has scars or stretch marks.
Zilbrysq is intended to be self-administered by the patient and/or another person who has been properly trained to administer subcutaneous injections and following the detailed instructions given in the instructions for use at the end of the package leaflet.
In a healthy volunteer study where 32 participants were exposed to doses twice the recommended dose (corresponding to approximately 0.6 mg/kg; Table 1), administered subcutaneously for up to 7 days, safety data were consistent with the safety profile of the recommended dose.
In cases of overdose, it is recommended that patients are monitored closely for any adverse reactions, and appropriate supportive measures should be instituted immediately.
3 years.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Patients may store the pre-filled syringe at room temperature in the original carton up to 30 °C for a single period of maximum 3 months. Once Zilbrysq has been stored at room temperature, it should not be placed back into the refrigerator and should be discarded if not used within the 3 months period or by the expiry date, whichever occurs first.
Pre-filled syringe (type I glass) with a 29G ½" thin wall needle closed with a grey fluoropolymer-laminated bromobutyl rubber plunger stopper. The needle is protected with a rigid needle shield consisting of a thermoplastic elastomer needle shield and a polypropylene rigid shield. Each pre-filled syringe is pre-assembled with a needle safety device, a finger grip and a coloured plunger:
Zilbrysq 16.6 mg solution for injection in pre-filled syringe: 0.416 mL solution for injection in pre-filled syringe with rubine red plunger.
Zilbrysq 23 mg solution for injection in pre-filled syringe: 0.574 mL solution for injection in pre-filled syringe with orange plunger.
Zilbrysq 32.4 mg solution for injection in pre-filled syringe: 0.810 mL solution for injection in pre-filled syringe with dark blue plunger.
Pack size of 7 pre-filled syringes for 16.6 mg, 23 mg and 32.4 mg solution for injection.
Multipack containing 28 (4 packs of 7) pre-filled syringes.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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