KYNTHEUM Solution for injection Ref.[6630] Active ingredients: Brodalumab

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

Posology

The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.

Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.

Special populations

Elderly (aged 65 years and over)

No dose adjustment is recommended in elderly patients (see section 5.2).

Renal and hepatic impairment

Kyntheum has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population

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

Method of administration

Kyntheum is administered by subcutaneous injection. Each pre-filled syringe is for single use only. Kyntheum should not be injected into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. The pre-filled syringe must not be shaken.

After proper training in subcutaneous injection technique, patients may self-inject Kyntheum when deemed appropriate by a physician. Patients should be instructed to inject the full amount of Kyntheum according to the instructions provided in the package leaflet. Comprehensive instructions for administration are given in the package leaflet.

Doses up to 700 mg intravenously have been administered in clinical trials with no evidence of dose limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.

Shelf life: 4 years.

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.

Kyntheum may be stored at room temperature (up to 25°C) once, in the outer carton, for a maximum single period of 14 days. Once Kyntheum has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 14 days or discarded.

1.5 ml solution in a type I glass pre-filled syringe with stainless steel 27G x ½" needle, covered with an elastomeric needle cap.

Kyntheum is available in unit packs containing 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.

Not all pack sizes may be marketed.

Kyntheum is a sterile solution for injection in pre-filled syringe. Each pre-filled syringe is for single use only. The ‘Instructions for Use’ should be consulted for detailed instructions on administration of Kyntheum.

To avoid discomfort at the site of injection, at least 30 minutes should be allowed for the pre-filled syringe to reach room temperature before injecting. The pre-filled syringe should not be warmed in any other way. The pre-filled syringe should not be shaken. The grey needle cap on the pre-filled

syringe should not be removed while allowing to reach room temperature. Kyntheum should be visually inspected for particles and discoloration prior to administration. Kyntheum is a clear to slightly opalescent, colourless to slightly yellow solution, free from particles. This medicine should not be used if the solution is cloudy or discoloured or contains lumps, flakes, or particles.

The pre-filled syringe should not be used if it has been dropped on a hard surface.

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