Imaavy

Treatment should be supervised by a physician experienced in the management of patients with neuromuscular disorders and must be administered by a healthcare professional. Posology The recommended dose regimen is shown in Table 1. 3 Table 1: Recommended dose regimen Population Recommended dose (IV) Initial single dose Maintenance dose (every 2 weeks) Adults and adolescents (12 years and older) 30 mg/kg 15 mg/kg Missed dose(s) If a scheduled infusion appointment is missed, the maintenance dose should be administered as soon as possible.

Dosing should be resumed every 2 weeks thereafter. 2). 2). 2). Paediatric population The safety and efficacy of nipocalimab in children below 12 years of age have not been established. No data are available. 6. Do not administer as an intravenous push or bolus injection.

The initial single dose of medicinal product should be administered over approximately 30 minutes and the maintenance dose should be administered over approximately 15 minutes. Patients should be monitored for 30 minutes after each infusion for signs or symptoms of an infusion-related or hypersensitivity reaction.

4). 9%) solution for infusion. 6.

Summary of the safety profile The most commonly reported adverse reactions were muscle spasms (12%) and peripheral oedema (12%). Tabulated list of adverse reactions A total of 250 adult gMG patients were treated with nipocalimab in Phase 2 and Phase 3 studies.

Of these, 205 patients were treated in the Phase 3 study, including 98 in the double-blind phase. 2) for at least 6 months, and 132 were exposed for at least 12 months. Adverse reactions are listed in Table 2 below, classified by MedDRA System Organ Class (SOC).

Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first. Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100) or rare (≥ 1/10 000 to < 1/1 000).

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

Table 2:

Adverse reactions System organ class Adverse reaction Frequency category Infections and infestations Herpes zoster1 Common Urinary tract infection* Common Lower respiratory tract infection*2 Common Metabolism and nutrition disorders Lipids increased*3 Very common Decreased serum albumin* Very common Psychiatric disorders Insomnia Common Nervous system disorders Dizziness Common Gastrointestinal disorders Diarrhoea Common Abdominal pain4 Common Nausea Common Musculoskeletal and connective tissue disorders Muscle spasms Very Common General disorders and administration site conditions Peripheral oedema5 Very Common Pyrexia Common * See paragraph Description of selected adverse reactions 1 Includes Herpes zoster and Herpes zoster oticus; evaluation and frequency based on completed placebo-controlled Phase 2 and Phase 3 studies across several indications under study 2 Includes pneumonia and bronchitis 3 Includes hypercholesterolaemia, low density lipoproteins increased, blood cholesterol increased and hyperlipidaemia.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. , myasthenic crisis), defined as intubation with or without mechanical ventilation except in the setting of routine postoperative care, has not been studied.

5). Infusion-related and hypersensitivity reactions Administration of nipocalimab may result in infusion-related and hypersensitivity reactions. The most commonly reported infusion-related reactions were headache, rash, nausea, fatigue, dizziness, chills, and erythema.

The most commonly reported hypersensitivity reactions were rash, urticaria and eczema. Most infusion-related and hypersensitivity reactions were non-serious, mild or moderate and did not lead to treatment discontinuation. A case of anaphylaxis has been reported that led to the discontinuation of treatment.

The patient should be monitored for 30 minutes after each infusion for clinical signs and symptoms of infusion-related or hypersensitivity reactions. If a serious infusion-related or hypersensitivity reaction occurs during administration, the infusion should be discontinued and appropriate supportive measures should be instituted, if needed.

2). 8). Plasma lipid levels should therefore be measured approximately 12 weeks following treatment initiation. g. ≥125 kg or BMI >35 kg/m²), consider closer periodic monitoring thereafter. The evaluation whether to continue treatment with Imaavy should consider the potential negative impact on long-term cardiovascular risk, considering also other risk factors, and weigh this against the expected gMG treatment benefit.

Continued monitoring of plasma lipid levels and alternative treatment options should be considered. 8). Initiation of treatment administration should be delayed in patients with an active infection until the infection is resolved. During treatment, patients should be monitored for clinical signs and symptoms of infection.

1.