BIMZELX Solution for injection Ref.[27933] Active ingredients: Bimekizumab

Bimzelx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.

Posology

The recommended dose for adult patients with plaque psoriasis is 320 mg (given as 2 subcutaneous injections of 160 mg each) at week 0, 4, 8, 12, 16 and every 8 weeks thereafter.

Consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment.

Special populations

Overweight patients

For some patients with a body weight ≥120 kg who did not achieve complete skin clearance at week 16, 320 mg every 4 weeks after week 16 may further improve treatment response (see section 5.1).

Elderly (≥65 years)

No dose adjustment is required (see section 5.2).

Renal or hepatic impairment

Bimekizumab has not been studied in these patient populations. Dose adjustments are not considered necessary based on pharmacokinetics (see section 5.2).

Paediatric population

The safety and efficacy of bimekizumab in children and adolescents below the age of 18 years have not been established. No data are available.

Method of administration

This medicinal product is administered by subcutaneous injection.

Suitable areas for injection include thigh, abdomen and upper arm. Injection sites should be rotated and injections should not be given into psoriasis plaques or areas where the skin is tender, bruised, erythematous, or indurated.

The pre-filled syringe or pre-filled pen must not be shaken.

After proper training in subcutaneous injection technique, patients may self-inject Bimzelx with the pre-filled syringe or pre-filled pen if their physician determines that it is appropriate and with medical follow-up as necessary. Patients should be instructed to inject the full amount of Bimzelx according to the instructions for use provided in the package leaflet.

Single doses of 640 mg intravenously or 640 mg subcutaneously, followed by 320 mg subcutaneously every two weeks for five doses have been administered in clinical studies without dose-limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs and symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.

3 years.

Bimzelx 160 mg solution for injection in pre-filled syringe:

Store in a refrigerator (2°C-8°C).

Do not freeze.

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

The pre-filled syringe may be stored at room temperature (up to 25°C) for a single period of maximum 25 days with protection from light. Once removed from the refrigerator and stored under these conditions, discard after 25 days or by the expiry date printed on the container, whichever occurs first. A field for the date is provided on the carton to record the date removed from the refrigerator.

Bimzelx 160 mg solution for injection in pre-filled pen:

Store in a refrigerator (2°C-8°C).

Do not freeze.

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

The pre-filled pen may be stored at room temperature (up to 25°C) for a single period of maximum 25 days with protection from light. Once removed from the refrigerator and stored under these conditions, discard after 25 days or by the expiry date printed on the container, whichever occurs first. A field for the date is provided on the carton to record the date removed from the refrigerator.

Bimzelx 160 mg solution for injection in pre-filled syringe:

One mL pre-filled syringe (type I glass) with a fluoropolymer-laminated bromobutyl rubber stopper, staked 27G, ½" thin wall needle, and a polypropylene rigid needle shield assembled in a passive safety device.

Pack size of 1 pre-filled syringe.
Pack size of 2 pre-filled syringes.
Multipack containing 3 (3 packs of 1) pre-filled syringes.
Multipack containing 4 (2 packs of 2) pre-filled syringes.

Not all pack sizes may be marketed.

Bimzelx 160 mg solution for injection in pre-filled pen:

One mL pre-filled pen containing a pre-filled syringe (type I glass) with a fluoropolymer-laminated bromobutyl rubber stopper, staked 27G, ½" thin wall needle, and a polypropylene rigid needle shield.

Pack size of 1 pre-filled pen.
Pack size of 2 pre-filled pens.
Multipack containing 3 (3 packs of 1) pre-filled pens.
Multipack containing 4 (2 packs of 2) pre-filled pens.

Not all pack sizes may be marketed.

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