WYOST Solution for injection Ref.[110543] Active ingredients: Denosumab

Wyost should be administered under the responsibility of a healthcare professional.

Posology

Supplementation of at least 500 mg calcium and 400 IU vitamin D daily is required in all patients, unless hypercalcaemia is present (see section 4.4).

Patients treated with Wyost should be given the package leaflet and the patient reminder card.

Prevention of skeletal related events (SREs) in adults with advanced malignancies involving bone

The recommended dose is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm.

Giant cell tumour of bone

The recommended dose of Wyost is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy.

Patients in the phase II study who underwent complete resection of giant cell tumour of bone did receive an additional 6 months of treatment following the surgery as per study protocol.

Patients with giant cell tumour of bone should be evaluated at regular intervals to determine whether they continue to benefit from treatment. In patients whose disease is controlled by Wyost, the effect of interruption or cessation of treatment has not been evaluated, however limited data in these patients does not indicate a rebound effect upon cessation of treatment.

Renal impairment

No dose adjustment is required in patients with renal impairment (see section 4.4 for recommendations relating to monitoring of calcium, 4.8 and 5.2).

Hepatic impairment

The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2).

Elderly patients (age ≥65)

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

Paediatric population

The safety and efficacy of Wyost have not been established in paediatric patients (age <18) other than skeletally mature adolescents (aged 12–17 years) with giant cell tumour of bone.

Wyost is not recommended in paediatric patients (age <18) other than skeletally mature adolescents (aged 12–17 years) with giant cell tumour of bone (see section 4.4).

Treatment of skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity: the posology is the same as in adults.

Inhibition of receptor activator of nuclear factor-κB (RANK)/RANK ligand (RANKL) in animal studies has been coupled to inhibition of bone growth and lack of tooth eruption, and these changes were partially reversible upon cessation of RANKL inhibition (see section 5.3).

Method of administration

For subcutaneous use.

For instructions for use, handling and disposal see section 6.6.

There is no experience with overdose in clinical studies. Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks and 120 mg weekly for 3 weeks.

3 years.

Once removed from the refrigerator, Wyost may be stored at room temperature (up to 25°C) for up to 30 days in the outer carton in order to protect from light. It must be used within this 30 day period.

Store in a refrigerator (2°C–8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

1.7 mL solution in a single use vial (type I glass) with stopper (fluoropolymer coated elastomeric) and seal (aluminium) with flip-off cap.

Pack size of one vial.

• Before administration, the Wyost solution should be inspected visually. Do not inject the solution if it is cloudy or contains visible particles.
• Do not shake.
• To avoid discomfort at the site of injection, allow the vial to reach room temperature (up to 25ºC) before injecting and inject slowly.
• The entire contents of the vial should be injected.
• A 27 gauge needle is recommended for the administration of denosumab.
• The vial should not be re-entered.

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