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Humira
adalimumab
Black Box Warnings .
Serious Infection Risk
weigh tx benefit vs. risk in patients w/ chronic or recurrent infection; pulmonary and extrapulmonary tuberculosis (TB), invasive fungal infections, and other opportunistic infections incl. Legionella and Listeria observed; some infections have been fatal; most infections occur in combo w/ other immunosuppressants; evaluate for TB risk factors and screen for latent TB infection before and during adalimumab tx; initiate anti-TB tx before adalimumab tx; monitor for infection s/sx during and after adalimumab tx; since active TB has developed in patients w/ negative tuberculin skin test, monitor all patients for active TB s/sx; since histoplasmosis may be present in patients w/ negative antigen and antibody tests, consider empiric antifungal tx in patients w/ severe systemic illness if at risk for invasive fungal infection; D/C adalimumab tx if serious infection or sepsis occurs
Malignancy
lymphoma and other malignancies, some fatal, reported in children and adolescents treated w/ TNF blockers; post-marketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) reported mostly in Crohn dz or ulcerative colitis patients, mostly adolescent and young adult males receiving concomitant azathioprine or mercaptopurine; uncertain whether HSTCL related to TNF-blocker monotherapy or in combo w/ other immunosuppressants
Adult Dosing .
Dosage forms: INJ (pen): 40 mg per 0.4 mL, 40 mg per 0.8 mL, 80 mg per 0.8 mL; INJ (pre-filled syringe): 10 mg per 0.1 mL, 20 mg per 0.2 mL, 40 mg per 0.4 mL, 40 mg per 0.8 mL, 80 mg per 0.8 mL; convenience packs
Dosage Form Details
- [Crohn dz, Ulcerative Colitis, or Hidradenitis Suppurativa 40 mg/0.8 mL pack]
- Info: starter pack contains 40 mg per 0.8 mL pen x6
- [Crohn dz, Ulcerative Colitis, or Hidradenitis Suppurativa 80 mg/0.8 mL pack]
- Info: starter pack contains 80 mg per 0.8 mL pen x3
- [psoriasis or uveitis 40 mg/0.8 mL pack]
- Info: starter pack contains 40 mg per 0.8 mL pen x4
- [psoriasis or uveitis 80 mg - 40 mg pack]
- Info: starter pack contains 80 mg per 0.8 mL pen x1, 40 mg per 0.4 mL pen x2
rheumatoid arthritis, moderate-severe
- [40 mg SC q2wk]
- Info: may incr. dose to 40 mg SC qwk or 80 mg SC q2wk if not on methotrexate
psoriatic arthritis
- [40 mg SC q2wk]
ankylosing spondylitis
- [40 mg SC q2wk]
Crohn dz, moderate-severe
- [40 mg SC q2wk]
- Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on day 15, then 40 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 15, then 40 mg SC q2wk on day 29
ulcerative colitis, moderate-severe
- [40 mg SC q2wk]
- Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on day 15, then 40 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 15, then 40 mg SC q2wk on day 29; Info: D/C if no evidence of remission after 8wk
psoriasis, moderate-severe chronic plaque
- [40 mg SC q2wk]
- Start: 80 mg SC x1 on day 1, then 40 mg SC q2wk on day 8
hidradenitis suppurativa, moderate-severe
- [40 mg SC qwk or 80 mg SC q2wk]
- Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on day 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29
uveitis
- [40 mg SC q2wk]
- Start: 80 mg SC x1 on day 1, then 40 mg SC q2wk on day 8; Info: for non-infectious intermediate, posterior, and panuveitis
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ (pen): 40 mg per 0.4 mL, 40 mg per 0.8 mL, 80 mg per 0.8 mL; INJ (pre-filled syringe): 10 mg per 0.1 mL, 20 mg per 0.2 mL, 40 mg per 0.4 mL, 40 mg per 0.8 mL, 80 mg per 0.8 mL; convenience packs
Dosage Form Details
- [Peds Crohn dz 80 mg - 40 mg pack]
- Info: starter pack contains 80 mg per 0.8 mL pre-filled syringe x1, 40 mg per 0.4 mL pre-filled syringe x1
- [Peds Crohn dz 80 mg/0.8 mL pack]
- Info: starter pack contains 80 mg per 0.8 mL pre-filled syringe x3
- [Peds Ulcerative Colitis 80 mg/0.8 mL pack]
- Info: starter pack contains 80 mg per 0.8 mL pen x4
- [Adolescent Hidradenitis Suppurativa 80 mg - 40 mg pack]
- Info: starter pack contains 80 mg per 0.8 mL pen x1, 40 mg per 0.4 mL pen x2
- [Uveitis or Adolescent Hidradenitis Suppurativa 40 mg/0.8 mL pack]
- Info: starter pack contains 40 mg per 0.8 mL pen x4
polyarticular juvenile idiopathic arthritis, moderate-severe
- [2 yo and older, 10-14 kg]
- Dose: 10 mg SC q2wk
- [2 yo and older, 15-29 kg]
- Dose: 20 mg SC q2wk
- [2 yo and older, >30 kg]
- Dose: 40 mg SC q2wk
Crohn dz, moderate-severe
- [6 yo and older, 17-39 kg]
- Dose: 20 mg SC q2wk; Start: 80 mg SC x1 on day 1, then 40 mg SC x1 on day 15, then 20 mg SC q2wk on day 29
- [6 yo and older, >40 kg]
- Dose: 40 mg SC q2wk; Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on day 15, then 40 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 15, then 40 mg SC q2wk on day 29
ulcerative colitis, moderate-severe
- [5 yo and older, 20-39 kg]
- Dose: 20 mg SC qwk or 40 mg SC q2wk; Start: 80 mg SC x1 on day 1, then 40 mg SC x1 on days 8 and 15, then 20 mg SC qwk or 40 mg SC q2wk on day 29
- [5 yo and older, >40 kg]
- Dose: 40 mg SC qwk or 80 mg SC q2wk; Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on days 8 and 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 8, 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29
hidradenitis suppurativa, moderate-severe
- [12 yo and older, 30-59 kg]
- Dose: 40 mg SC q2wk; Start: 80 mg SC x1 on day 1, then 40 mg SC q2wk on day 8
- [12 yo and older, >60 kg]
- Dose: 40 mg SC qwk or 80 mg SC q2wk; Start: 160 mg SC x1 on day 1, then 80 mg SC x1 on day 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29; Alt: start 80 mg SC x1 on days 1, 2, 15, then 40 mg SC qwk or 80 mg SC q2wk on day 29
uveitis
- [2 yo and older, 10-14 kg]
- Dose: 10 mg SC q2wk Info: for non-infectious intermediate, posterior, and panuveitis
- [2 yo and older, 15-29 kg]
- Dose: 20 mg SC q2wk; Info: for non-infectious intermediate, posterior, and panuveitis
- [2 yo and older, >30 kg]
- Dose: 40 mg SC q2wk; Info: for non-infectious intermediate, posterior, and panuveitis
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]