Approved September 25, 2009

USTEKINUMAB
(FDA Category 1S)

STELARA(TM) (Centocor Ortho Biotech Inc) is a IgG1-kappa monoclonal antibody which binds to interleukin (IL)-12 and IL-23 cytokines and disrupts IL-12 and IL-23 mediated signaling and cytokine cascades.

DOSING INFORMATION: The recommended dose is 45 milligrams (mg) subcutaneously (subQ) initially and 4 weeks (wk) later then every 12 wk thereafter for patients weighing 100 kilograms (kg) (220 pounds) or less, or 90 mg subQ initially and 4 wk later then every 12 wk thereafter for patients weighing greater than 100 kg.

PHARMACOKINETICS: The median time to peak concentration was 13.5 days following a single 45 mg subQ dose in patients with psoriasis. The median time to peak concentration was 7 and 8.5 days following a single 90 mg subQ dose in patients with psoriasis and healthy subjects, respectively. The mean steadystate trough concentrations following multiple 45 mg or 90 mg subQ doses ranged from 0.31 +/- 0.33 and 0.64 +/- 0.64 micrograms/milliliters (mcg/mL). In patients with psoriasis, the mean apparent volume of distribution during the terminal phase was 161 +/- 65 mL/kg after a 45 mg subQ dose and 179 +/- 85 mL/kg after a 90 mg subQ dose. The mean systemic clearance following a single intravenous (IV) dose administered to patients with psoriasis ranged from 1.9 +/- 0.28 to 2.22 +/- 0.63 mL/day/kg. The mean half-life ranged from 14.9 +/- 4.6 to 45.6 +/- 80.2 days following IV or subQ administration to patients with psoriasis.

CAUTIONS: Serious infections and one case of reversible posterior leukoencephalopathy syndrome have been reported. May increase risk of malignancy or activation of latent infections (eg, tuberculosis). The most common adverse events include nasopharyngitis, upper respiratory tract infection, headache, and fatigue.

FDA APPROVED INDICATIONS: Ustekinumab is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy.