REMS
Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Idacio, Hyrimoz, Yuflyma, and Yusimry:
- Treatment of the following conditions:
- Moderately to severely active rheumatoid arthritis (may be used alone or with methotrexate or other non-biologic disease-modifying antirheumatic drugs [DMARDs]),
- Psoriatic arthritis (may be used alone or with other non-biologic DMARDs),
- Active ankylosing spondylitis,
- Moderately to severely active Crohn's disease in patients who have responded inadequately to conventional therapy,
- Moderately to severely active ulcerative colitis in patients who have responded inadequately to immunosuppressants such as corticosteroids, azathioprine, or 6–mercaptopurine,
- Moderate to severely active polyarticular juvenile idiopathic arthritis (as monotherapy or with methotrexate),
- Moderate to severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy and when other systemic therapies are deemed inappropriate.
Abrilada, Amjevita, Cyltezo, Hadlima, Humira, Hyrimoz, Yuflyma, and Yusimry only:
- Treatment of the following condition:
Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, and Humira only:
- Treatment of the following condition:
- Non-infectious intermediate, posterior and panuveitis.
CV: hypertension.
Derm: rash, psoriasis.
EENT: optic neuritis.
GI: abdominal pain, nausea.
GU: hematuria.
Hemat: neutropenia, thrombocytopenia.
Local: injection site reactions.
Metab: hyperlipidemia.
MS: back pain.
Neuro: headache, Guillain-Barré syndrome, multiple sclerosis.
Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), INFECTION (INCLUDING REACTIVATION TUBERCULOSIS [TB] AND OTHER OPPORTUNISTIC INFECTIONS DUE TO BACTERIAL, INVASIVE FUNGAL, VIRAL, MYCOBACTERIAL, AND PARASITIC PATHOGENS), MALIGNANCY (INCLUDING LYMPHOMA, HSTCL, LEUKEMIA, AND SKIN CANCER).
Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis
- SC (Adults): 40 mg every other wk. Methotrexate, non-biologic DMARDs, corticosteroids, and/or analgesics may be continued during therapy. Patients not receiving concurrent methotrexate may receive additional benefit by ↑ dose to 40 mg once weekly or 80 mg every other wk.
Crohn's Disease
- SC (Adults): 160 mg initially on Day 1 (given in one day or over two consecutive days), followed by 80 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 40 mg every other wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g. azathioprine, 6–mercaptopurine, methotrexate) may be continued during therapy.
- SC (Children ≥6 yr and ≥40 kg): Abrilada, Amjevita, Hadlima, Hulio, Humira, Idacio, and Hyrimoz only: 160 mg initially on Day 1 (given in one day or over two consecutive days), followed by 80 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 40 mg every other wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g. azathioprine, 6–mercaptopurine, methotrexate) may be continued during therapy.
- SC (Children ≥6 yr and 17–<40 kg): Abrilada, Amjevita, Hadlima, Hulio, and Humira only: 80 mg initially on Day 1, followed by 40 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 20 mg every other wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g. azathioprine, 6–mercaptopurine, methotrexate) may be continued during therapy.
Ulcerative Colitis
- SC (Adults): 160 mg initially on Day 1 (given in one day or over two consecutive days), followed by 80 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 40 mg every other wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g. azathioprine, 6–mercaptopurine, methotrexate) may be continued during therapy. Should be continued only if patients have evidence of clinical remission by wk 8 of therapy.
- SC (Children ≥5 yr and ≥40 kg): Humira only: 160 mg initially on Day 1 (given in one day or over two consecutive days), followed by 80 mg 1 wk later on Day 8, and then followed by 80 mg 1 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of either 80 mg every other wk or 40 mg every wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g. azathioprine, 6–mercaptopurine, methotrexate) may be continued during therapy.
- SC (Children ≥5 yr and 20–<40 kg): Humira only: 80 mg initially on Day 1, followed by 40 mg 1 wk later on Day 8, and then followed by 40 mg 1 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of either 40 mg every other wk or 20 mg every wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g. azathioprine, 6–mercaptopurine, methotrexate) may be continued during therapy.
Juvenile Idiopathic Arthritis
- SC (Children 2–17 yr (Abrilada, Amjevita, Hadlima, Hulio, Humira, Idacio, and Hyrimoz); 4–17 yr (Cyltezo): 10–<15 kg (Abrilada, Hadlima, Humira, and Hyrimoz only): 10 mg every other wk; 15–<30 kg (Abrilada, Amjeveta, Hadlima, Hulio, and Humira only): 20 mg every other wk; ≥30 kg: 40 mg every other wk.
Plaque Psoriasis
- SC (Adults): 80 mg initially, then in 1 wk, begin regimen of 40 mg every other wk.
Uveitis
- SC (Adults): Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, or Humira only: 80 mg initially, then in 1 wk, begin regimen of 40 mg every other wk.
- SC (Children ≥2 yr and ≥30 kg): Humira only: 40 mg every other wk.
- SC (Children ≥2 yr and 15–<30 kg): Humira only: 20 mg every other wk.
- SC (Children ≥2 yr and 10–<15 kg): Humira only: 10 mg every other wk.
Hidradenitis Suppurativa
- SC (Adults): Abrilada, Amjevita, Cyltezo, Hadlima, Humira, or Yusimry: 160 mg initially (given in one day or over two consecutive days), followed by 80 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 40 mg every wk or 80 mg every other wk.
- SC (Children ≥12 yr and ≥60 kg): Humira only: 160 mg initially (given in one day or over two consecutive days), followed by 80 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 40 mg every wk or 80 mg every other wk.
- SC (Children ≥12 yr and 30–59 kg): Humira only: 80 mg initially on Day 1, followed by 40 mg 1 wk later on Day 8. Two wk later (Day 22), begin maintenance dose of 40 mg every other wk.
Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Yuflyma, Yusimry
Therapeutic Classification: antirheumatics
Pharmacologic Classification: dmards, monoclonal antibodies
Absorption: 64% absorbed after SUBQ administration.
Distribution: Synovial fluid concentrations are 31–96% of serum.
Metabolism/Excretion: Unknown.
Half-life: 14 days (range 10–20 days).
(improvement)
*Plasma concentration.
†Following discontinuation.
