VYVGART Concentrate for solution for infusion Ref.[50188] Active ingredients: Efgartigimod alfa

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. Administer subsequent treatment cycles according to clinical evaluation. The frequency of treatment cycles may vary by patient (see section 5.1).

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. The safety of initiating subsequent cycles sooner than 7 weeks from the start of the previous treatment cycle has not been established.

In patients weighing 120 kg or more, the recommended dose is 1 200 mg (3 vials) per infusion (see section 6.6).

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.

Special populations

Elderly

No dose adjustment is required in patients aged 65 years and older (see section 5.2).

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. There is very limited safety and efficacy data in patients with moderate renal impairment and none in patients with severe renal impairment (see section 5.2).

Hepatic impairment

No data in patients with hepatic impairment are available. No dose adjustment is required in patients with hepatic impairment (see section 5.2).

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 as described in section 6.6. Do not administer as an intravenous push or bolus injection. It should be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection prior to administration.

This medicinal product should be administered over 1 hour. In case of infusion reactions, the infusion can be either temporarily discontinued or slowed down (see section 4.4).

For instructions on dilution of the medicinal product before administration, see section 6.6.

There are no known specific signs and symptoms of overdose with efgartigimod alfa. In the event of an overdose the adverse events are not expected to be different from those observed at the recommended dose. Patients should be monitored for adverse reactions, and appropriate symptomatic and supportive treatment initiated. There is no specific antidote for overdose with efgartigimod alfa.

24 months.

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. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Store in the original package in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

Concentrate in single-dose 20 mL glass vials (Type I) with rubber stopper (butyl, siliconised), aluminium seal and polypropylene flip-off cap.

Pack size of 1 vial.

The efgartigimod alfa solution diluted in sodium chloride 9 mg/mL (0.9%) solution for injection can be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene vinyl acetate (EVA) and ethylene/polypropylene copolymer bags (polyolefins bags), as well as with PE, PVC and polyurethane/polypropylene infusion lines, together with PE, PVC, polyethersulfone (PES) and PVCfree in-line filters.

Using the formula in the table below, calculate the following:

• The dose of Vyvgart required based on the patient’s bodyweight at the recommended dose of 10 mg/kg. For patients weighing over 120 kg use a bodyweight of 120 kg to calculate the dose. The maximum total dose per infusion is 1 200 mg. Each vial contains 400 mg of efgartigimod alfa at a concentration of 20 mg/mL.
• The number of vials needed.
• The volume of sodium chloride 9 mg/mL (0.9%) solution for injection. The total volume of diluted medicinal product is 125 mL.

Table 4. Formula:

Dilution:

• Visually inspect that the vial content is clear to slightly opalescent, colourless to slightly yellow, and devoid of particulate matter. If visible particles are observed and/or the liquid in the vial is discoloured, the vial must not be used. Do not shake the vials.
• Using aseptic technique throughout the preparation of the diluted solution:
  • Gently withdraw the required amount of Vyvgart from the appropriate number of vials with a sterile syringe and needle (see Table 4). Discard any unused portion of the vials.
  • Transfer the calculated dose of the product into an infusion bag.
  • Dilute the withdrawn product by adding the calculated amount of sodium chloride 9 mg/mL (0.9%) solution for injection to make a total volume of 125 mL.
  • Gently invert the infusion bag containing the diluted product without shaking to ensure thorough mixing of the product and the diluent.

Administration:

• Inspect the solution visually for particulate matter prior to administration.
• Infuse the total 125 mL of diluted medicinal product over 1 hour using an in-line filter. Administer the full amount of solution, flushing the entire line with sodium chloride 9 mg/mL (0.9%) 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. If not used immediately, in-use storage times and conditions are the responsibility of the user. Do not freeze. Allow the diluted medicinal product to reach room temperature before administration. Complete the infusion within 4 hours of removal from the refrigerator. The diluted medicinal product should not be heated in any other manner than via ambient air.
• Should infusion reactions occur, the infusion can be either temporarily discontinued or slowed down (see section 4.4).
• Other medicinal products should not be injected into infusion side ports or mixed with Vyvgart.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.