therapy.
1.2 Psoriatic Arthritis (PsA)
STELARA® is indicated for the treatment of adult patients with active psoriatic arthritis. STELARA® can be used alone or in combination with methotrexate (MTX).
1.3 Crohn's Disease (CD)
STELARA® is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have:
failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or
failed or were intolerant to treatment with one or more TNF blockers.
2 DOSAGE AND ADMINISTRATION
2.1 Psoriasis
Subcutaneous Adult Dosage Regimen
For patients weighing 100 kg or less, the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
For patients weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects [see CLINICAL STUDIES (14)].
2.2 Psoriatic Arthritis
Subcutaneous Adult Dosage Regimen
The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
2.3 Crohn's Disease
Intravenous Induction Adult Dosage Regimen
A single intravenous infusion dose of STELARA® using the weight-based dosage regimen specified in Table 1 [see INSTRUCTIONS FOR DILUTION OF STELARA® 130 MG VIAL FOR INTRAVENOUS INFUSION (2.6)].
Table 1: Initial Intravenous Dosage of STELARA®
Body Weight of Patient at the time of dosing Dose Number of 130 mg/26 mL (5 mg/mL) STELARA® vials
55 kg or less 260 mg 2
more than 55 kg to 85 kg 390 mg 3
more than 85 kg 520 mg 4
Subcutaneous Maintenance Adult Dosage Regimen
The recommended maintenance dosage is a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.
2.4 General Considerations for Administration
After proper training in subcutaneous injection technique, a patient may self-inject with STELARA® if a physician determines that it is appropriate. Patients should be instructed to follow the directions provided in the Medication Guide [see MEDICATION GUIDE].
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.
It is recommended that each injection be administered at a different anatomic location (such as upper arms, gluteal regions, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, or indurated. When using the single-dose vial, a 27 gauge, ½ inch needle is recommended.
STELARA® is intended for use under the guidance and supervision of a physician. STELARA® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Prior to administration, visually inspect STELARA® for particulate matter and discoloration. STELARA® is clear, colorless to light yellow and may contain a few small translucent or white pa |
