Zilbrysq

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.

4). Posology 3 The recommended dose should be given as a subcutaneous injection once daily and administered about the same time every day. 3 mg/kg. Zilucoplan has not been studied in gMG patients with a Myasthenia Gravis Foundation of America (MGFA) Class V.

Missed dose 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. 2). Experience with zilucoplan in elderly patients in clinical studies is limited.

Renal impairment No dose adjustment is required for patients with renal impairment (creatinine clearance ≥15 mL/min). There are no data on patients requiring dialysis. Hepatic impairment 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. 2). Paediatric population The safety and efficacy of Zilbrysq in children below the age of 18 years have not been established. No data are available.

Method of administration 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.

5%)). Tabulated list of adverse reactions Table 2 presents the adverse reactions from the pooled placebo-controlled (n=115) and open-label extension (n=213) studies in gMG together with a classification of the frequency in the zilucoplan treated patients, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Table 2:

Adverse reactions System organ class Frequency Adverse reaction Infections and infestations Very common Upper respiratory tract infections* Gastrointestinal disorders Common Diarrhoea Skin and subcutaneous tissue disorders Common Morphoea*a 6 General disorders and administration site conditions Very common Injection site reactions* Investigations Common Lipase increased* Common Amylase increased* Uncommon Blood eosinophils increased* *See paragraph Description of selected adverse reactions.

aMorphoea was reported only in long-term open-label clinical studies. The maximum duration of exposure to ZLP during the long-term clinical studies was more than 4 years. Description of selected adverse reactions Injection site reactions The most common reactions were injection site bruising, pain, nodule, pruritus and haematoma.

All cases were mild or moderate in severity, and less than 3% of reactions led to treatment discontinuation. Upper respiratory tract infections The most common infections were nasopharyngitis, upper respiratory tract infection and sinusitis.

More than 95% of the cases were mild or moderate in severity and did not lead to treatment discontinuation. 8% of patients treated with placebo. 1%) were observed. These elevations were transient and rarely led to treatment discontinuation.

Neisseria infections Meningococcal infection Due to its mechanism of action, the use of zilucoplan may increase the patient’s susceptibility to infections with Neisseria meningitidis. As a precautionary measure, all patients must be vaccinated against meningococcal infections, at least 2 weeks prior to the start of treatment.

If treatment needs to start less than 2 weeks after vaccination against meningococcal infections, the patient must receive appropriate prophylactic antibiotic treatment until 2 weeks after the first vaccination dose. Meningococcal vaccines reduce but do not completely eliminate the risk of meningococcal infections.

Vaccines against serogroups A, C, Y, W, and where available, serogroup B, are recommended for preventing the commonly pathogenic meningococcal serogroups. Vaccination and prophylactic antibiotic treatment should occur according to most current relevant guidelines.

During treatment, patients should be monitored for signs and symptoms of meningococcal infection and evaluated immediately if infection is suspected. In case of a suspected meningococcal infection, appropriate measures such as treatment with antibiotics and discontinuation of treatment, should be taken until the meningococcal infection can be ruled out.

Patients should be instructed to seek immediate medical advice if signs or symptoms of meningococcal infections occur. Prescribers should be familiar with the educational materials for the management of meningococcal infections and provide a patient alert card and patient/carer guide to patients treated with zilucoplan.

Other Neisseria infections In addition to Neisseria meningitidis, patients treated with zilucoplan may also be susceptible to infections with other Neisseria species, such as gonococcal infections. Patients should be informed on the importance of gonorrhea prevention and treatment.

1. 4). Patients with unresolved Neisseria meningitidis infection.