Stelara

Stelara Dosage/Direction for Use

ustekinumab

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Dosage/Direction for Use
STELARA is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which STELARA is indicated.
STELARA concentrate for solution for infusion should only be used for the intravenous induction dose.
Soln for inj in pre-filled syringe: 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 Pharmacology: Pharmacodynamics under Actions, Table 1).
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 12 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established.
Soln for inj in pre-filled syringe & conc for soln for infusion: Crohn's Disease: 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 6 (see Cautions for Usage for preparation). (See Table 6.)

Click on icon to see table/diagram/image

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 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 by week 16 or 16 weeks after switching to the 8-weekly 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.
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 in treatment of Crohn's disease in children less than 18 years have not yet been established. No data are available.
Method of administration: Soln for inj in pre-filled syringe: 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 the package leaflet.
For further instructions on preparation and special precautions for handling, see Cautions for Usage.
Conc for soln for infusion: 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 Cautions for Usage.
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