UZPRUVO Solution for injection Ref.[108273] Active ingredients: Ustekinumab

Uzpruvo is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which Uzpruvo is indicated.

Posology

Uzpruvo is only available as 45 mg and 90 mg solution for injection in pre-filled syringe for subcutaneous use. For intravenous use as well as for subcutaneous administration of doses lower than 45 mg, other ustekinumab products should be used.

Plaque psoriasis

The recommended posology of Uzpruvo is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter.

Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.

Patients with body weight >100 kg

For patients with a body weight >100 kg the initial dose is 90 mg administered subcutaneously, followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter. In these patients, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy (see section 5.1, Table 4).

Psoriatic arthritis (PsA)

The recommended posology of Uzpruvo is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight > 100 kg. Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.

Elderly (≥65 years)

No dose adjustment is needed for elderly patients (see section 4.4).

Renal and hepatic impairment

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

Paediatric population

The safety and efficacy of Uzpruvo in children with psoriasis less than 6 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established. No data are available.

Paediatric plaque psoriasis (6 years and older)

The recommended dose of Uzpruvo based on body weight is shown below (Table 1). Uzpruvo should be administered at Weeks 0 and 4, then every 12 weeks thereafter.

Table 1. Recommended dose of Uzpruvo for paediatric psoriasis:

There is no dosage form for Uzpruvo that allows weight-based dosing for paediatric patients below 60 kg. Uzpruvo is only available as 45 mg and 90 mg solution for injection in pre-filled syringe. Thus, it is not possible to administer Uzpruvo to patients that require less than a full 45 mg dose. If an alternate dose is required, another ustekinumab product 45 mg solution for injection in vials offering weightbased dosing should be used instead.

Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.

Crohn’s disease

Uzpruvo is only available in pre-filled syringes for subcutaneous use. Since treatment of CD should be initiated by intravenous infusion, another ustekinumab product must be used as first intravenous dose (130 mg concentrate for solution for infusion). The first subcutaneous administration of 90 mg Uzpruvo should take place at week 8 after the intravenous dose. After this, dosing every 12 weeks is recommended.

Patients who have not shown adequate response at 8 weeks after the first subcutaneous dose, may receive a second subcutaneous dose at this time (see section 5.1). Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks (see sections 5.1 and 5.2).

Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgment (see section 5.1).

Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose or 16 weeks after switching to the 8-weekly maintenance dose.

Immunomodulators and/or corticosteroids may be continued during treatment with Uzpruvo. In patients who have responded to treatment with Uzpruvo, corticosteroids may be reduced or discontinued in accordance with standard of care.

In Crohn’s disease, if therapy is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.

Elderly (≥65 years)

No dose adjustment is needed for elderly patients (see section 4.4).

Renal and hepatic impairment

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

Paediatric population

The safety and efficacy of ustekinumab for the treatment of Crohn’s disease in children less than 18 years have not yet been established. No data are available.

Method of administration

Uzpruvo 45 mg and 90 mg pre-filled syringes are for subcutaneous injection only. If possible, areas of the skin that show psoriasis should be avoided as injection sites.

After proper training in subcutaneous injection technique, patients or their caregivers may inject Uzpruvo if a physician determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Patients or their caregivers should be instructed to inject the prescribed amount of Uzpruvo according to the directions provided in the package leaflet. Comprehensive instructions for administration are given in the package leaflet. For further instructions on preparation and special precautions for handling, see section 6.6.

Single doses up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity. In case 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.

2 years.

Individual pre-filled syringes may be stored at room temperature up to 30°C for a maximum single period of up to 30 days in the original carton in order to protect from light. Once removed from the refrigerator, record the discard date in the space provided on the outer carton. The discard date must not exceed the original expiry date printed on the carton. Once a syringe has been stored at room temperature (up to 30°C), it should not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature storage or by the original expiry date, whichever is earlier.

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.

If needed, individual pre-filled syringes may be stored at room temperature up to 30°C (see section 6.3).

Uzpruvo 45 mg solution for injection in pre-filled syringe: 0.5 mL solution for injection in a pre-filled type I glass 1 mL syringe with a fixed 29-gauge, extended finger flanges and passive safety needle device, and a plunger stopper (bromobutyl rubber), plunger rod and rigid needle shield (RNS).

Uzpruvo 90 mg solution for injection in pre-filled syringe: 1 mL solution for injection in a pre-filled syringe type I glass 1 mL syringe with a fixed 29-gauge needle, extended finger flanges and passive needle, safety device and a plunger stopper (bromobutyl rubber), plunger rod and rigid needle shield (RNS).

Uzpruvo is available in a pack of 1 pre-filled syringe.

The solution in the Uzpruvo pre-filled syringe should not be shaken. The solution should be visually inspected for particulate matter or discolouration prior to subcutaneous administration. The solution is clear and colourless to slightly yellow and practically free from visible particles. The medicinal product should not be used if the solution is frozen, discoloured or cloudy, or has large particles. Before administration, Uzpruvo should be allowed to reach room temperature (approximately half an hour). Detailed instructions for use are provided in the package leaflet.

Any unused medicinal product remaining in the syringe should not be used. Uzpruvo is supplied as a sterile, single-use pre-filled syringe.

The syringe and needle must never be re-used. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.