Vyvgart

Efgartigimod alfa must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with neuromuscular disorders. Posology The recommended dose is 10 mg/kg as a 1-hour intravenous infusion to be administered in cycles of once weekly infusions for 4 weeks.

Subsequent treatment cycles should be administered according to clinical evaluation. 1). In the clinical development program, the earliest time to initiate a subsequent treatment cycle was 7 weeks from the initial infusion of the previous cycle.

6). 3 Missed dose If a scheduled infusion is not possible, treatment may be administered up to 3 days before or after the scheduled time point. Thereafter, the original dosing schedule should be resumed until the treatment cycle is completed.

If a dose needs to be delayed for more than 3 days, the dose should not be administered to ensure two consecutive doses are given with an interval of at least 3 days. 2). Renal impairment Limited safety and efficacy data in patients with mild renal impairment is available, no dose adjustment is required for patients with mild renal impairment.

2). Hepatic impairment No data in patients with hepatic impairment are available. 2). Paediatric population The safety and efficacy of efgartigimod alfa in paediatric population have not yet been established. No data are available. Method of administration This medicinal product should only be administered via intravenous infusion.

Do not administer as an intravenous push or bolus injection. 6. This medicinal product should be administered over 1 hour. Appropriate treatment for infusion and hypersensitivity-related reactions should be readily available before administration of efgartigimod alfa.

4). Administration • Inspect the solution visually for particulate matter prior to administration. 2 μm filter. 9%) solution for injection at the end. • Vyvgart should be administered immediately after dilution and the infusion of diluted solution should be completed within 4 hours of dilution.

• Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 8 °C. From a microbiological point of view, unless the method of dilution precludes the risks of microbial contamination, the product should be used immediately.

5%, respectively). Tabulated list of adverse reactions The safety of Vyvgart was evaluated in 167 patients with gMG in the Phase 3 double-blind placebo-controlled clinical study. Adverse reactions are listed in Table 1 by system organ class and preferred term.

Frequency categories are defined as: 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) or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1. 8% [n = 4] of patients treated with placebo). These infections were mild to moderate in severity in patients who received efgartigimod alfa (≤ Grade 2 according to the Common Terminology Criteria for Adverse Events). 3% (n = 31) of patients treated with placebo.

The median time from treatment initiation to emergence of infections was 6 weeks. Incidence of infections did not increase with subsequent treatment cycles. Treatment discontinuation or temporary interruption of treatment due to an infection occurred in less than 2% of patients.

2% of patients treated with placebo. Procedural headache was reported when a headache was judged to be temporally related to the intravenous infusion of efgartigimod alfa. All were mild or moderate except one event which was reported as severe (Grade 3).

All other adverse reactions were mild or moderate with the exception of one case of myalgia (Grade 3). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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. e. myasthenic crisis), defined as intubation with or without mechanical ventilation except in the setting of routine postoperative care, has not been studied.

5). 1). 8). Patients should be monitored for clinical signs and symptoms of infections during treatment with Vyvgart. In patients with an active infection, the benefit-risk of maintaining or withholding treatment with efgartigimod alfa should be considered until the infection has resolved.

If serious infections occur, delaying treatment with efgartigimod alfa should be considered until the infection has resolved. Infusion reactions and hypersensitivity reactions Infusion reactions such as rash or pruritus may occur. In the clinical trial, infusion reactions were mild to moderate and did not lead to treatment discontinuation.

Patients should be monitored during administration and for 1 hour thereafter for clinical signs and symptoms of infusion reactions. Should a reaction occur and based on the severity of the reaction the infusion should be administered at a slower rate, interrupted or discontinued and appropriate supportive measures should be instituted.

Once resolved, administration may be cautiously resumed, based on clinical evaluation. Cases of anaphylactic reaction have been reported in the post-marketing setting. If an anaphylactic reaction is suspected, administration of Vyvgart should be immediately discontinued and appropriate medical treatment initiated.

Patients should be informed of the signs and symptoms of hypersensitivity and anaphylactic reactions and advised to contact their healthcare provider immediately should they occur. Immunisations All vaccines should be administered according to immunisation guidelines.

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