USTEFAV SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 90MG/1ML [SIN17542P]

Product Info

USTEFAV SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 90MG/1ML

[SIN17542P]

Indication

4.1 Therapeutic indications

Plaque psoriasis

Ustefav is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric plaque psoriasis

Ustefav is indicated for the treatment of pediatric patients (children and adolescents) (6 years and older) with moderate to severe plaque psoriasis, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Psoriatic arthritis (PsA)

Ustefav, alone or in combination with MTX, is indicated for

• the treatment of adult patients (18 years or older) with active psoriatic arthritis when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• inhibiting the progression of structural damage

Crohn’s Disease

Ustefav is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have

• failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or

• failed or were intolerant to treatment with one or more TNF blockers

Dosing

4.2 Posology and method of administration

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

4.2.1 Posology – Adults

Plaque psoriasis

Patients with body weight ≤ 100 kg
The recommended posology of Ustefav 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 in these patients (see section 5.1, Table 4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Re-treatment:
Re-treatment with a dosing regimen of Weeks 0 and 4, followed by 12 weeks dosing after interruption of therapy has been shown to be safe and effective.

Psoriatic arthritis (PsA)
The recommended posology of Ustefav 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.

Crohn’s disease
Ustefav 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 recommended treatment regimen is a single intravenous (IV) tiered dose based on body weight, followed by 90 mg subcutaneous dosing 8 weeks later, then every 8 weeks thereafter.

For some patients, a single IV dose based on body weight followed by 90 mg subcutaneous dosing 8 weeks later, then every 12 weeks thereafter may be acceptable according to clinical judgment. Patients who inadequately respond to 90 mg subcutaneous dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks (see Section 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Immunomodulators and/or corticosteroids may be continued during treatment with Ustefav. In patients who have responded to treatment with Ustefav, 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.

4.2.2 Posology – Paediatric population (6 years and older)

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

There is no dosage form for Ustefav that allows weight-based dosing for paediatric patients below 60 kg. Ustefav is only available as 45 mg and 90 mg solution for injection in pre-filled syringe. Thus, it is not possible to administer Ustefav 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 weight-based 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.

4.2.3 General Consideration and Method of administration
Ustefav 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. Do not inject ustekinumab into areas where the skin is tender, bruised, red, hard, thick, scaly or affected by psoriasis. In paediatric patients, it is recommended that ustefav be administered by a health-care provider.

After proper training in subcutaneous injection technique, patients or their caregivers may inject Ustefav 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 Ustefav 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2.4 Special populations

Elderly (≥ 65 years)

No overall differences in efficacy or safety in patients age 65 and older who received ustekinumab were observed compared to younger patients in clinical studies in approved indications, however the number of patients aged 65 and older is not sufficient to determine whether they respond differently from younger patients. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.

Renal and hepatic impairment

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

Paediatric population
The safety and efficacy of Ustefav in children with psoriasis less than 6 years of age or in children with psoriatic arthritis or Crohn’s disease less than 18 years of age have not yet been established. No data is available.

Contraindications

4.3 Contraindications

Severe hypersensitivity to ustekinumab or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.