1. Rheumatoid Arthritis 2. Juvenile Idiopathic Arthritis 3. Psoriatic Arthritis 4. Ankylosing Spondylitis 5. Crohn's Disease 6. Ulcerative Colitis 7. Plaque Psoriasis 8. Hidradenitis Suppurativa 9. Uveitis

Disease-Modifying Antirheumatic Agents

1. Onset of action: Response best determined after 3 to 4 months (AAD-NPF [Menter 2019]). 2. Distribution: Vd: 4.7 to 6 L; Synovial fluid concentrations: 31% to 96% of serum. 3. Bioavailability: Absolute: 64%. 4. Half-life elimination: Terminal: ~2 weeks (range: 10 to 20 days). 5. Time to peak, serum: SUBQ: 131 ± 56 hours.

Canadian labeling: Known hypersensitivity to adalimumab or any component of the formulation; severe infection (eg, sepsis, tuberculosis, opportunistic infection); moderate-to-severe heart failure (NYHA class III/IV)

Based on available data, an increased risk of adverse maternal or fetal effects has not been observed following adalimumab exposure during pregnancy (Nielsen 2020).

Based on information from three cases, adalimumab concentrations in breast milk are 0.1% to 1% of the maternal serum concentrations (Ben-Horin 2010; Fritzsche 2012). However, tumor necrosis factor alpha blocking agents are considered compatible with breastfeeding (AAD-NPF [Menter 2019]; ACOG 776 2019; Mahadevan 2019).

Skin rash (12%), positive ANA titer (12%), antibody development (3% to 26%), injection-site reaction (5% to 20%), headache (12%), increased creatine phosphokinase in blood specimen (children, adolescents: 15%), sinusitis (11%), upper respiratory tract infection (17%)

SUBQ Axial spondyloarthritis: 40 mg every other week. Crohn disease: Initial: 160 mg (given over 1 or 2 days), then 80 mg 2 weeks later (day 15). Maintenance: 40 mg every other week beginning day 29. Hidradenitis suppurativa: Initial: 160 mg (given over 1 or 2 days), then 80 mg 2 weeks later (day 15). Maintenance: 40 mg every week beginning day 29 or 80 mg every other week beginning day 29. Plaque psoriasis: Initial: 80 mg as a single dose. Maintenance: 40 mg every other week beginning 1 week after initial dose. Psoriatic arthritis: 40 mg every other week. Rheumatoid arthritis: Initial: 40 mg every other week; for select patients with an inadequate response, may increase dose to 40 mg every week or 80 mg every other week. Ulcerative colitis: Initial: 160 mg (given over 1 or 2 days), then 80 mg 2 weeks later (day 15). Maintenance: 40 mg every other week beginning day 29. Uveitis: Initial: 80 mg as a single dose. Maintenance: 40 mg every other week beginning 1 week after initial dose.

SUBQ Crohn disease: Children ?6 years and Adolescents: 17 kg to <40 kg: Initial: 80 mg on day 1, then 40 mg administered 2 weeks later (day 15). Maintenance (beginning day 29): 20 mg every other week. ?40 kg: Initial: 160 mg (administered on day 1 or split and administered over 2 consecutive days), then 80 mg administered 2 weeks later (day 15). Maintenance (beginning day 29): 40 mg every other week. Hidradenitis suppurativa: Children ?12 years and Adolescents: 30 to <60 kg: Initial: 80 mg on day 1. Maintenance (beginning day 8): 40 mg every other week. ?60 kg: Initial: 160 mg (administered as full dose on day 1 or dose split and administered over 2 consecutive days), then 80 mg 2 weeks later (day 15). Maintenance (beginning day 29): 40 mg weekly or 80 mg every other week. Juvenile idiopathic arthritis (JIA): Children ?2 years and Adolescents: 10 kg to <15 kg: 10 mg every other week. 15 to <30 kg: 20 mg every other week. ?30 kg: 40 mg every other week. Ulcerative colitis: Children ?5 years and Adolescents: 20 to <40 kg: Initial: 80 mg on day 1, then 40 mg administered weekly for 2 weeks (a dose on day 8 and day 15). Maintenance (beginning day 29): 40 mg every other week or 20 mg every week. ?40 kg: Initial: 160 mg on day 1 (administered as full dose on day 1 or dose split and administered over 2 consecutive days), then 80 mg administered weekly for 2 weeks (a dose on day 8 and day 15). Maintenance (beginning day 29): 80 mg every other week or 40 mg every week. Uveitis: Children ?2 years and Adolescents: 10 kg to <15 kg: 10 mg every other week. 15 to <30 kg: 20 mg every other week. ?30 kg: 40 mg every other week.

No dosage adjustment necessary. (In a pharmacokinetic study, no difference in clearance was noted for patients with eGFR ≥15 mL/minute/1.73 m2)

There are no dosage adjustments provided in the manufacturer's labeling.

Idacio must be refrigerated at 2°C to 8°C. When traveling, Idacio may be stored at room temperature up to a maximum of 25°C for a period of up to 28 days, with protection from light.