EXDENSUR Solution for injection Ref.[116332] Active ingredients: Depemokimab

This medicinal product should be prescribed by physicians experienced in the diagnosis and treatment of asthma or CRSwNP.

Posology

This medicinal product is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on the patient's level of disease control.

Asthma

Adults and adolescents aged 12 years and over

The recommended dose of depemokimab is 100 mg administered subcutaneously once every 6 months.

CRSwNP

Adults

The recommended dose of depemokimab is 100 mg administered subcutaneously once every 6 months.

Missed dose

If a dose is missed, it should be administered as soon as possible. If the missed dose is taken 1 month or longer after the scheduled dose, the 6-monthly injection schedule should be resumed from the date when the missed dose was given.

Special populations

Elderly

No dose adjustment is required for elderly patients aged ≥ 65 years old (see section 5.2).

Renal or hepatic impairment

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

Paediatric population

Asthma:

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

CRSwNP:

There is no relevant use of depemokimab in the paediatric population for the treatment of CRSwNP.

Method of administration

The pre-filled pen or pre-filled syringe must be used for subcutaneous injection only.

This product may be self-administered by adult or adolescent patients or administered by a caregiver if their healthcare professional determines that it is appropriate, and the patient or caregiver are trained in injection techniques.

For self-administration the recommended injection sites are the abdomen or thigh, except for the 5 cm around the navel. A caregiver can also inject the solution into the upper arm. It should not be injected into areas where the skin is bruised, tender, erythematous, or hardened.

Comprehensive instructions for administration are provided in the instructions for use at the end of the package leaflet.

Single doses of up to 300 mg have been administered subcutaneously without evidence of dose-related toxicities.

There is no specific treatment for an overdose with depemokimab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

2 years.

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Do not shake.

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

The pre-filled pen and pre-filled syringe can be removed from the refrigerator and kept in the unopened carton for up to 7 days at room temperature (up to 30°C), when protected from light. Discard if left out of the refrigerator for more than 7 days.

The pre-filled pen or pre-filled syringe must be administered within 8 hours once the carton is opened. Discard if not administered within 8 hours.

EXDENSUR 100 mg solution for injection in pre-filled pen:

1 mL solution in a Type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen.

Pack size: 1 pre-filled pen.

EXDENSUR 100 mg solution for injection in pre-filled syringe:

1 mL solution in a Type 1 glass syringe with a fixed needle (stainless steel) and passive safety needle guard.

Pack size: 1 pre-filled syringe.

Before administration, the solution must be inspected visually. If the solution is cloudy, discoloured or contains particles, the solution must not be used.

After removing the pre-filled pen or pre-filled syringe from the refrigerator, the pen or syringe should be allowed to reach room temperature for at least 30 minutes before injecting the solution.

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