DAWNZERA Solution for injection Ref.[116238] Active ingredients: Donidalorsen

Treatment is to be initiated under the supervision of a physician experienced in the diagnosis and management of patients with HAE.

Posology

The recommended starting dose in adult and adolescent patients aged 12 years and older is 80 mg donidalorsen by subcutaneous injection once monthly.

A dosing interval of 80 mg once every 2 months may be considered if the patient is well controlled (e.g., attack free) for at least 3 months while receiving Dawnzera.

Based on the clinical data, a gradual reduction in attack rate is seen as early as Week 1 after the initial dose of donidalorsen with an expected maximum effect after 1 month.

Consideration should be given to discontinuing treatment in patients with normal C1-INH HAE (nC1-INH) who have shown insufficient reduction in attacks after 4 months of treatment (see section 4.4 and 5.1).

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

Missed dose

If a dose is missed, the patient or caregiver should be instructed to administer the dose as soon as possible. Thereafter, dosing should be resumed at the prescribed dosing frequency (once monthly or once every 2 months) from the date of the most recently administered dose.

Special populations

Elderly

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

Hepatic impairment

No dose adjustment of donidalorsen is required for patients with mild hepatic impairment (see section 5.2).

Dawnzera has not been studied in patients with moderate or severe impairment. Donidalorsen should only be used in these patients if the anticipated clinical benefit outweighs the risk.

Renal impairment

No dose adjustment of donidalorsen is required for patients with mild renal impairment. Dawnzera has not been studied in patients with moderate or severe impairment or end stage renal disease. Donidalorsen should only be used in these patients if the anticipated clinical benefit outweighs the risk.

Paediatric population

The safety and efficacy of donidalorsen in children aged <12 years have not yet been established. No data are available. See sections 4.8 and 5.1.

Changing from other HAE prophylactic medicinal products

The following treatment schedules (Table 1) are recommended for patients that are changing their HAE prophylactic therapy from berotralstat, a C1 esterase inhibitor, or lanadelumab to Dawnzera (see section 5.1).

Table 1. Treatment schedule for patients changing from other prophylactic therapy to Dawnzera:

Method of administration

Dawnzera is intended for subcutaneous use only.

Dawnzera is to be administered as a subcutaneous injection in the abdomen, upper thigh region, or for caregivers only, the back of the upper arm. Rotation of the injection site is recommended. Dawnzera must not be injected into areas where the skin is tender, bruised, red, hard, infected or discoloured.

After proper training on correct subcutaneous injection technique, a patient or caregiver may inject Dawnzera if their physician determines it is appropriate. Comprehensive instructions for administration using the pre-filled pen are provided in the package leaflet and the instructions for use.

For further instructions on preparation and special precautions for handling, see section 6.6.

There is no available information to identify potential signs and symptoms of overdose. If symptoms should occur, symptomatic treatment is recommended. There is no antidote available.

3 years.

Dawnzera may be stored in the original carton at room temperature (up to 30°C) for a single period of up to 6 weeks, but not beyond the expiry date.

Store in a refrigerator (2°C – 8°C).

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

0.8 mL sterile solution in a single-use Type I glass syringe with a stainless steel staked needle, rigid needle shield, and siliconised chlorobutyl elastomer plunger stopper. The filled primary container and a pen are assembled to a pre-filled pen, which is labelled and packaged in an opaque carton with a partition to secure the pre-filled pen and protect from light.

Pack size of one pre-filled pen.

Pack size of three pre-filled pens.

Not all pack sizes may be marketed.

Prior to initiation, patients and/or caregivers must be trained on proper preparation and administration of Dawnzera (see Instructions for Use).

• The single-dose pre-filled pen should be removed from the refrigerator 30 minutes prior to the injection to reach room temperature. Other warming methods must not be used.
• The pre-filled pen must be inspected visually before use. The solution should appear clear and colourless to yellow. The solution must not be injected if it appears frozen. The pre-filled pen must not be used if cloudiness, particulate matter, or discolouration is observed prior to administration.

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