VYVGART Solution for injection Ref.[116200] Active ingredients: Efgartigimod alfa

Treatment must be initiated and supervised by a physician experienced in the management of patients with neuromuscular disorders.

Posology

Generalised myasthenia gravis

The first treatment cycle and first administration of the second treatment cycle must be administered either by or under the supervision of a healthcare professional. Subsequent treatment should be administered by a healthcare professional or may be administered at home by a patient or caregiver after adequate training in the subcutaneous injection technique.

The recommended dose is 1 000 mg to be administered subcutaneously in cycles of once weekly injections for 4 weeks. Subsequent treatment cycles should be administered 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.

For patients currently receiving efgartigimod alfa intravenously, the solution for subcutaneous injection may be used as an alternative. It is recommended to switch between formulations at the start of a new treatment cycle. No safety and efficacy data in patients switching formulations during the same cycle is available.

Chronic inflammatory demyelinating polyneuropathy

The first 4 injections must be administered either by or under the supervision of a healthcare professional. Subsequent injections should be administered by a healthcare professional or may be administered at home by a patient or caregiver after adequate training in the subcutaneous injection technique.

The recommended dose is 1 000 mg administered subcutaneously as once-weekly injections.

Treatment is initiated with a weekly dose regimen and may be adjusted to every other week based on clinical evaluation. In case of worsening of symptoms, administration of once-weekly injections should be resumed.

For those patients transitioning from their current CIDP therapies, Vyvgart treatment should preferably be initiated before the clinical effect of these prior therapies starts to decrease.

Clinical response is usually achieved within 3 months of initiation of treatment with efgartigimod alfa subcutaneous. Clinical evaluation should be considered 3 to 6 months after treatment initiation to assess the treatment effect and at regular intervals thereafter.

Missed dose

An interval of at least 3 days should be observed between two consecutive administrations. When administrations cannot be done at the scheduled time point, they should be performed as soon as possible and at least 3 days ahead of the following administration. If there are less than 3 days to the next administration, the missed dose should be skipped and the next dose should be administered at the scheduled time point.

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 or 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 subcutaneous injection. Do not administer intravenously.

After removing the vial from the refrigerator, wait for at least 15 minutes before injecting to allow the solution to reach room temperature. Use aseptic technique when preparing and administering the medicinal product solution. Do not shake the vial.

The solution for injection can be administered using a polypropylene syringe, stainless steel transfer needles and polyvinyl chloride winged infusion set, with a maximum priming volume of 0.4 mL.

• Withdraw the entire content of the efgartigimod alfa solution from the vial using a transfer needle.
• Change the needle on the syringe to the winged infusion set.
• Prior to administration, the volume in the syringe should be adjusted to 5.6 mL.

During the initial administrations of efgartigimod alfa (see section 4.2), appropriate treatment for injection and hypersensitivity-related reactions should be readily available (see section 4.4). The recommended injection sites (abdomen) should be rotated and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red or hard. The volume of 5.6 mL should be injected over 30 to 90 seconds. The injection may be slowed if the patient experiences discomfort.

The first self-administration must always be conducted under the supervision of a healthcare professional. After adequate training in subcutaneous injection technique, patients or caregivers may inject the medicinal product at home if a healthcare professional determines that it is appropriate.

Patients or caregivers should be instructed to inject Vyvgart according to the directions provided in the package leaflet.

For comprehensive instructions for the administration of the medicinal product, please refer to the Instructions for Use in the package leaflet.

There are no known specific signs and symptoms of overdose with efgartigimod alfa. In the event of an overdose the adverse events that may occur are not expected to be different from those that may be 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.

18 months.

If needed, unopened vials may be stored at room temperature (up to 30°C) for up to 3 days. After storage at room temperature, unopened vials may be returned to the refrigerator. If stored out of and then returned to refrigeration, the total combined time out of refrigeration should not exceed 3 days.

From a microbial point of view, unless the method of preparation of the syringe precludes the risk 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.

5.6 mL solution in a 6 mL Type I glass vial with rubber stopper, aluminium seal and polypropylene flip-off cap.

Pack size of 1 vial.

Vyvgart comes as a ready-to-use solution in single-use vial. The medicinal product does not need to be diluted.

Visually inspect that the vial content is a yellowish, clear to opalescent solution, and devoid of particulate matter. If visible particles are observed the vial must not be used.

After removing the vial from the refrigerator, wait for at least 15 minutes before injecting to allow the solution to reach room temperature (see section 6.3).

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