Stelara Dosage/Direction for Use

Dosage: (Adults): Plaque Psoriasis: For the treatment of plaque psoriasis, Ustekinumab (Stelara) is administered by subcutaneous injection. The recommended dose of Ustekinumab (Stelara) is 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg.
Dose Adjustment: For patients who inadequately respond to 45 mg every 12 weeks, consideration may be given to treating with 90 mg every 12 weeks. For patients who inadequately respond to dosing every 12 weeks, a 90 mg dose every 8 weeks may be considered.
Re-treatment: Re-treatment with a dosing regimen of Weeks 0 and 4 after interruption of therapy has been shown to be safe and effective.
Psoriatic Arthritis: For the treatment of psoriatic arthritis, Ustekinumab (Stelara) is administered by subcutaneous injection. The recommended dose of Ustekinumab (Stelara) is 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg.
Crohn's Disease and Ulcerative Colitis: In patients with Crohn's disease and ulcerative colitis, the recommended treatment regimen is a single intravenous (IV) tiered dose of Ustekinumab (Stelara) based on body weight (Table 29), followed by 90 mg subcutaneous dosing 8 weeks later, then every 8 weeks thereafter (see Instructions for Use, Handling and Disposal under Cautions for Usage). (See Table 29.)

Click on icon to see table/diagram/image

For some patients, a single IV dose based on body weight (Table 29) followed by 90 mg subcutaneous dosing 8 weeks later, then every 12 weeks thereafter may be acceptable. 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 Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Immunomodulators and/or corticosteroids may be continued during treatment with Ustekinumab (Stelara). In patients who have responded to treatment with Ustekinumab (Stelara) corticosteroids may be reduced or discontinued in accordance with standard of care.
If therapy in Crohn's disease or Ulcerative Colitis is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.
General Consideration for Administration: Subcutaneous administration: Ustekinumab (Stelara) is intended for use under the guidance and supervision of a physician. In pediatric patients, it is recommended that Ustekinumab (Stelara) be administered by a healthcare provider. A patient may self-inject with Ustekinumab (Stelara) if a physician determines that it is appropriate and with medical follow-up as necessary, after proper training in subcutaneous injection technique and disposal (see Instructions for Use, Handling and Disposal under Cautions for Usage).
Patients should be instructed to inject the prescribed amount of Ustekinumab (Stelara) according to the directions provided in the patient information leaflet. The needle cover on the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
Intravenous infusion (Crohn's Disease and Ulcerative Colitis): Ustekinumab (Stelara) 130 mg vial is for IV infusion only. Intravenous infusion of Ustekinumab (Stelara) should be administered by qualified health care professionals (For preparation, see Instructions for Use, Handling and Disposal under Cautions for Usage).
Special populations: Pediatrics: Studies of Ustekinumab (Stelara) in pediatric patients below 12 years of age have not been conducted. No studies have been conducted in pediatric patients with Crohn's disease or ulcerative colitis.
Elderly: Of the 6709 patients exposed to Ustekinumab (Stelara), a total of 353 were 65 years or older (183 patients with psoriasis, 69 patients with psoriatic arthritis, 58 with Crohn's disease, and 43 patients with ulcerative colitis). No major age-related differences in clearance or volume of distribution were observed in clinical studies. Although no overall differences in safety or efficacy were observed between older and younger patients in clinical studies in approved indications, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.
Renal impairment: Specific studies have not been conducted in patients with renal insufficiency.
Hepatic impairment: Specific studies have not been conducted in patients with hepatic insufficiency.