ANDEMBRY Solution for injection Ref.[114884] Active ingredients: Garadacimab

This medicinal product should be initiated under the supervision of a healthcare professional experienced in the management of patients with HAE.

Posology

The recommended dose of ANDEMBRY, in adults and children 12 years of age and above, is an initial loading dose of 400 mg administered subcutaneously as two 200 mg injections on the first day of treatment, followed by a monthly dose of 200 mg.

Consideration should be given to discontinuing treatment in patients with normal C1-INH HAE (nC1-INH) who have shown insufficient reduction in attacks after 3 months of treatment (see section 4.4 and 5.1).

ANDEMBRY is not intended for the treatment of acute HAE attacks (see section 4.4).

Missed doses

If a dose of ANDEMBRY is missed, the patient should be instructed to administer the dose as soon as possible.

Special populations

Elderly

No dose adjustment is required for patients above 65 years of age (see section 5.2).

Renal and hepatic impairment

No dose adjustment is required in patients with renal or hepatic impairment (see section 5.2).

Paediatric population

The safety and efficacy of garadacimab in children less than 12 years have not been established. No data are available.

Method of administration

ANDEMBRY is intended for subcutaneous use only.

Each ANDEMBRY unit (pre-filled syringe or pre-filled pen) is intended for single use only (see section 6.6).

The injection should be restricted to the following injection sites: the abdomen, the thighs and the upper outer arms (see section 5.2). Rotation of the injection site is recommended.

ANDEMBRY may be self-administered or administered by a caregiver only after training on subcutaneous injection technique by a healthcare professional.

There is no available information to identify potential signs and symptoms of overdose.

3 years.

ANDEMBRY may be stored at room temperature (up to 25°C) for a single period of up to 2 months, but not beyond the expiry date.

Store in a refrigerator (2°C–8°C).

Do not freeze.

Keep the pre-filled syringe or pre-filled pen in the outer carton in order to protect from light.

Do not return ANDEMBRY to refrigerated storage after storage at room temperature.

ANDEMBRY 200 mg solution for injection in pre-filled syringe:

1.2 mL of solution in a pre-filled glass syringe (type I glass) with a bromobutyl stopper, 27G x ½ 5B special thin-walled (STW) staked needle, and is assembled with an extended finger flange and needle safety device.

ANDEMBRY is available as unit packs containing 1 assembled pre-filled syringe and in multipacks containing 3 (3 packs of 1) assembled pre-filled syringes.

ANDEMBRY 200 mg solution for injection in pre-filled pen:

1.2 mL of solution in a pre-filled glass syringe (type I glass) with a bromobutyl stopper, 27G x ½ 5B special thin-walled (STW) staked needle. Each pre-filled syringe is assembled with a pen.

ANDEMBRY is available as unit packs containing 1 assembled pre-filled pen and in multipacks containing 3 (3 packs of 1) assembled pre-filled pens.

Not all pack sizes may be marketed.

Before use, ANDEMBRY should be visually inspected for appearance by gentle inversion. The solution should be slightly opalescent to clear, brownish-yellow to yellow. Solutions that are discoloured or contain particles should not be used.

Do not shake.

Administration steps

ANDEMBRY 200 mg solution for injection in pre-filled syringe

After removing the pre-filled syringe with needle safety device from the refrigerator, wait 30 minutes before injecting to allow the solution to reach room temperature. Inject ANDEMBRY subcutaneously into the abdomen, thigh or upper arm. Rotation of the injection site is recommended (see section 4.2).

Each pre-filled syringe with needle safety device is for single use only. Discard the pre-filled syringe with needle safety device after injection is completed in a sharps container or closed puncture resistant container.

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

ANDEMBRY 200 mg solution for injection in pre-filled pen

After removing the pre-filled pen from the refrigerator, wait 30 minutes before injecting to allow the solution to reach room temperature. Inject ANDEMBRY subcutaneously into the abdomen, thigh or upper arm. Rotation of the injection site is recommended (see section 4.2).

Injection with the pre-filled pen may take up to 15 seconds.

Listen for the first ‘click’ (this signals the start of injection, and the yellow plunger will start to move across the window). Keep pressing and watch the yellow plunger move down to fill the window. A second ‘click’ will be heard and the viewing window will be completely yellow. Wait an extra 5 seconds to make sure the full dose was received.

Each pre-filled pen is for single use only. Discard the pre-filled pen after injection is completed in a sharps container or closed puncture resistant container.

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