VYVGART CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML [SIN17402P]

Product Info

VYVGART CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML

[SIN17402P]

Indication

4.1 Therapeutic indications

Vyvgart is indicated as an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

Dosing

4.2 Posology and method of administration

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. The frequency of treatment cycles may vary by patient (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

In patients weighing 120 kg or more, the recommended dose is 1 200 mg (3 vials) per infusion (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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. It should be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection prior to administration as described in section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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. In case of infusion reactions, the infusion should be administered at a slower rate, interrupted or can be discontinued (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Administration

• Inspect the solution visually for particulate matter prior to administration.

• Infuse the total 125 mL of diluted medicinal product over 1 hour using a 0.2 micrometre 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 should be administered at a slower rate, interrupted or discontinued (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Other medicinal products should not be injected into infusion side ports or mixed with Vyvgart.

For instructions on dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.