Posology : מינונים

4.2 Posology and method of administration

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

Posology

Ustekinumab Kamada 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 Ustekinumab Kamada 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 3)

Psoriatic arthritis (PsA)
The recommended posology of Ustekinumab Kamada 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
Ustekinumab Kamada has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population
The safety and efficacy of Ustekinumab Kamadain 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.

Paediatric plaque psoriasis (6 years and older)
The recommended dose of Ustekinumab Kamada based on body weight is shown below (Table 1).
Ustekinumab Kamada should be administered at Weeks 0 and 4, then every 12 weeks thereafter.

Table 1 Recommended dose of Ustekinumab Kamada for paediatric psoriasis Body weight at the time of dosing                    Recommended Dose < 60 kg                                            -
≥ 60 kg to ≤ 100 kg                                    45 mg
> 100 kg                                          90 mg

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

Crohn’s Disease (CD) and Ulcerative Colitis (UC)
Ustekinumab Kamada is only available in pre-filled syringes for subcutaneous use. Since treatment of CD and UC 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 Ustekinumab Kamada 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 section 5.1, section 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 Ustekinumab Kamada. In patients who have responded to treatment with Ustekinumab Kamada, corticosteroids may be reduced or discontinued in accordance with standard of care.

In Crohn’s disease or Ulcerative Colitis, 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).
In ulcerative colitis -The number of patients aged 65 and over is not sufficient to determine whether they response 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
Ustekinumab has not been studied in these patient populations. No dose recommendations can be made.



Paediatric population
The safety and efficacy of ustekinumab in treatment of Crohn’s disease or ulcerative colitis in children less than 18 years have not yet been established. No data are available.

Method of administration
Ustekinumab Kamada 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 Ustekinumab Kamada 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 Ustekinumab Kamada 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.