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Posology: Crohn's Disease and Ulcerative Colitis: Concentrate for solution for infusion (IV): STELARA 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 STELARA 130 mg as specified in Table 10 (see Special precautions for disposal and other handling under Cautions for Usage for preparation). (See Table 10.)
Click on icon to see table/diagram/imageThe first subcutaneous dose should be given at week 8 following the intravenous dose. For the posology of the subsequent subcutaneous dosing regimen, see Solution for injection (SC) as follows.
Solution for injection (SC): In the treatment regimen, the first dose of STELARA is administered intravenously. For the posology of the intravenous dosing regimen, see Concentrate for solution for infusion (IV) (Table 10) as previously mentioned.
The first subcutaneous administration of 90 mg STELARA 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 STELARA. In patients who have responded to treatment with STELARA, 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 Precautions).
Renal and hepatic impairment: STELARA has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population: The safety and efficacy of STELARA for the treatment of Crohn's disease or ulcerative colitis in children less than 18 years have not yet been established. No data are available.
Solution for injection (SC): Plaque psoriasis: The recommended posology of STELARA 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 5 in Pharmacology: Pharmacodynamics under Actions.)
Psoriatic arthritis (PsA): The recommended posology of STELARA 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: STELARA has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population: The safety and efficacy of STELARA 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 STELARA based on body weight is shown as follows (Tables 11 and 12). STELARA should be administered at Weeks 0 and 4, then every 12 weeks thereafter. (See Table 11.)
Click on icon to see table/diagram/imageTo calculate the volume of injection (mL) for patients < 60 kg, use the following formula: body weight (kg) x 0.0083 (mL/kg) or see Table 12. The calculated volume should be rounded to the nearest 0.01 mL and administered using a 1 mL graduated syringe. A 45 mg vial is available for paediatric patients who need to receive less than the full 45 mg dose. (See Table 12.)
Click on icon to see table/diagram/imageConsideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Method of administration: Solution for injection (SC): STELARA 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 STELARA 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 STELARA according to the directions provided in the package leaflet. Comprehensive instructions for administration are given in Instructions for administration under Patient Counselling Information.
For further instructions on preparation and special precautions for handling, see Special precautions for disposal and other handling under Cautions for Usage.
Concentrate for solution for infusion (IV): STELARA 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.
