EVUSHELD Solution for injection Ref.[49908] Active ingredients: Tixagevimab and Cilgavimab

Administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Individuals should be observed after administration according to local medical practice.

Posology

The recommended dose in adults and adolescents aged 12 years and older weighing at least 40 kg is 150 mg of tixagevimab and 150 mg of cilgavimab, administered as two separate sequential intramuscular injections.

There are no safety and efficacy data available on repeat dosing.

Elderly

No dose adjustment is required (see section 5.2).

Renal impairment

No dose adjustment is required (see section 5.2).

Hepatic impairment

No dose adjustment is required (see section 5.2).

Paediatric population

No dose adjustment is required in adolescents aged 12 years and older weighing at least 40 kg (see section 5.2). The safety and efficacy of EVUSHELD in children under 12 years of age have not yet been established. No data are available.

Method of administration

For intramuscular injection.

Tixagevimab and cilgavimab must be given as separate sequential intramuscular injections at different injection sites in two different muscles, preferably in the gluteal muscles.

Each carton contains two vials:

• tixagevimab solution for injection (dark grey cap);
• cilgavimab solution for injection (white cap).

Table 1. Recommended dose:

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

There is no specific treatment for overdose with tixagevimab and cilgavimab. Treatment of overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.

In clinical trials, intramuscular doses of up to 150 mg each of tixagevimab and cilgavimab and intravenous doses of up to 1,500 mg each of tixagevimab and cilgavimab have been administered without dose-limiting toxicity.

Unopened vial:

18 months.

Opened vial:

Chemical and physical in-use stability has been demonstrated for 4 hours at 2ºC to 25ºC. From a microbiological point of view, unless the method of opening 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.

Prepared syringes:

The prepared syringes should be administered immediately. If immediate administration is not possible, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 4 hours at 2ºC to 25ºC.

Store in a refrigerator (2°C-8°C).
Store in the original package in order to protect from light.
Do not freeze.
Do not shake.

For storage conditions after initial vial puncture and preparation of the syringes, see section 6.3.

Tixagevimab vial: 1.5 mL of solution for injection in a clear glass vial closed by a chlorobutyl elastomeric stopper sealed with a dark-grey aluminium flip-off top.

Cilgavimab vial: 1.5 mL of solution for injection in a clear glass vial closed by a chlorobutyl elastomeric stopper sealed with a white aluminium flip-off top.

Pack size: Each carton contains 2 vials: 1 vial of tixagevimab and 1 vial of cilgavimab.

Handling instructions

This medicinal product should be handled by a healthcare professional using aseptic technique to ensure the sterility of each dose.

Inspect the vials visually for particulate matter and discolouration. Both tixagevimab and cilgavimab are clear to opalescent, colourless to slightly yellow solutions. Discard the vials if the solution is cloudy, discoloured or visible particles are observed. Do not shake the vials.

Each dose of 1.5 mL of tixagevimab and 1.5 mL of cilgavimab is withdrawn into a separate syringe to be administered intramuscularly in two different muscles, preferably in the gluteal muscles.

For storage conditions after initial vial puncture and preparation of the syringes, see section 6.3.

Any unused solution should be discarded.

Disposal

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