Usual Adult Dose for Plaque Psoriasis

100 kg or less:
45 mg subcutaneously initially and 4 weeks later, then 45 mg subcutaneously every 12 weeks

Greater than 100 kg:
90 mg subcutaneously initially and 4 weeks later, then 90 mg subcutaneously every 12 weeks

Comments:

• In subjects weighing more than 100 kg, 45 mg was also shown to be effective; however, 90 mg resulted in greater efficacy.

Use: For moderate to severe plaque psoriasis (Ps) in patients who are candidates for phototherapy or systemic therapy

Usual Adult Dose for Psoriatic Arthritis

45 mg subcutaneously initially and 4 weeks later, then 45 mg subcutaneously every 12 weeks

For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg: 90 mg subcutaneously initially and 4 weeks later, then 90 mg subcutaneously every 12 weeks

Use: For patients with active psoriatic arthritis (PsA) alone or in combination with methotrexate (MTX)

Usual Adult Dose for Crohn's Disease - Acute

Initial dose:

• Up to 55 kg: 260 mg IV
• Greater than 55 kg to 85 kg: 390 mg IV
• Greater than 85 kg: 520 mg IV

Maintenance dose (all weight ranges): 90 mg subcutaneously 8 weeks after the initial dose and every 8 weeks thereafter

Comments:

• The IV infusion should be given over at least 1 hour.

Use: For patients with moderately to severely active Crohn's disease (CD)

Usual Adult Dose for Crohn's Disease - Maintenance

Initial dose:

• Up to 55 kg: 260 mg IV
• Greater than 55 kg to 85 kg: 390 mg IV
• Greater than 85 kg: 520 mg IV

Maintenance dose (all weight ranges): 90 mg subcutaneously 8 weeks after the initial dose and every 8 weeks thereafter

Comments:

• The IV infusion should be given over at least 1 hour.

Use: For patients with moderately to severely active Crohn's disease (CD)

Usual Adult Dose for Ulcerative Colitis

Initial dose:

• Up to 55 kg: 260 mg IV
• Greater than 55 kg to 85 kg: 390 mg IV
• Greater than 85 kg: 520 mg IV

Maintenance dose (all weight ranges): 90 mg subcutaneously 8 weeks after the initial dose and every 8 weeks thereafter

Comments:

• The IV infusion should be given over at least 1 hour.

Use: For the treatment of adult patients with moderately to severely active ulcerative colitis

Usual Pediatric Dose for Plaque Psoriasis

12 years and older:

• Weight less than 60 kg: 0.75 mg/kg subcutaneously initially and 4 weeks later, then every 12 weeks
• Weight 60 kg to 100 kg: 45 mg subcutaneously initially and 4 weeks later, then every 12 weeks
• Weight greater than 100 kg: 90 mg subcutaneously initially and 4 weeks later, then every 12 weeks

Use: For moderate to severe plaque psoriasis (Ps) in patients 12 years or older who are candidates for phototherapy or systemic therapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 12 years for psoriasis.
Safety and efficacy have not been established in patients younger than 18 years for psoriatic arthritis, Crohn's disease, or ulcerative colitis.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• It is recommended that each injection be administered at a different anatomic location (such as upper arms, gluteal regions, thighs, or any quadrant of the abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, or indurated.
• Patients may self-administer injections after training in subcutaneous injection technique.

General:

• The needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex). The needle cover should not be handled by persons sensitive to latex.
• Prior to administration, the product should be inspected for particulate matter and discoloration. It should be clear, colorless to light yellow and may contain a few small translucent or white particles.
• The product does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe.
• If necessary, the diluted infusion solution may be kept at room temperature up to 25C (77F) for up to 7 hours.
• The infusion should be completed within 8 hours after dilution.
• Do not freeze. Discard any unused portion of the infusion solution.

Storage requirements:

• Refrigerate (2C to 8C); do not freeze.
• Keep prefilled syringe in outer carton to protect from light.

General:

• Each prefilled syringe is for single use only; any unused product should be disposed of in accordance with local guidelines.

Frequently asked questions

• What are the new drugs for the treatment of plaque psoriasis?
• How quickly or how long before Stelara starts to work?
• How long can you keep Stelara in or out of the fridge?
• Can you get a flu shot or take antibiotics while on Stelara?
• How is Stelara injected or administered?
• What blood tests are needed for Stelara?