Steqeyma Dosage/Direction for Use

STEQEYMA is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which STEQEYMA is indicated.
Posology: 45 mg and 90 mg solution for injection: Plaque psoriasis: The recommended posology of STEQEYMA 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 Table 3 under Pharmacology: Pharmacodynamics under Actions).
Psoriatic arthritis (PsA): The recommended posology of STEQEYMA 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 Precautions).
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 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 STEQEYMA based on body weight is shown as follows (Table 8).
STEQEYMA should be administered at Weeks 0 and 4, then every 12 weeks thereafter.
There is no dose form for STEQEYMA that allows weight-based dosing for paediatric patients below 60 kg. For paediatric plaque psoriasis, STEQEYMA is available only as 45 mg and 90 mg solution for injection in pre-filled syringe. (See Table 8.)

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Patients weighing less than 60 kg should be accurately dosed on a mg/kg basis using another ustekinumab product for which a 45 mg solution for injection in vial presentation enabling weight-based dosing is available.
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Crohn's Disease: In the treatment regimen, the first dose of STEQEYMA is administered intravenously. For the posology of the intravenous dosing regimen, see 130 mg concentrate for solution for infusion: Crohn's Disease as follows.
The first subcutaneous administration of 90 mg STEQEYMA 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 Pharmacology: Pharmacodynamics under Actions).
Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgment (see Pharmacology: Pharmacodynamics under Actions).
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 STEQEYMA. In patients who have responded to treatment with STEQEYMA, 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 Precautions).
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 in children less than 18 years have not yet been established. No data are available.
130 mg concentrate for solution for infusion: STEQEYMA concentrate for solution for infusion should only be used for the intravenous induction dose.
Crohn's Disease: STEQEYMA treatment is to be initiated with a single intravenous dose based on body weight. The infusion solution is to be composed of the number of vials of STEQEYMA 130 mg as specified in Table 9 (see Special precautions for disposal and other handling under Cautions for Usage for preparation). (See Table 9.)

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The first subcutaneous dose should be given at week 8 following the intravenous dose. For the posology of the subsequent subcutaneous dosing regimen, see 45 mg and 90 mg solution for injection: Crohn's Disease as previously mentioned.
Elderly (≥65 years): No dose adjustment is needed for elderly patients (see Precautions).
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: 45 mg and 90 mg solution for injection: STEQEYMA 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 STEQEYMA 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 STEQEYMA according to the directions provided in the monograph. Comprehensive instructions for administration are given in the package leaflet.
For further instructions on preparation and special precautions for handling, see Special precautions for disposal and other handling under Cautions for Usage.
130 mg concentrate for solution for infusion: STEQEYMA 130 mg is for intravenous use only. It should be administered over at least one hour. For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.