Adalimumab

Brands

DEA Class; Rx

Common Brand Names; Humira, Amjevita, adalimumab-atto, Cyltezo, adalimumab-adbm, Hyrimoz, adalimumab-adaz, Hadlima, adalimumab-bwwd, adalimumab-afzb, Abrilada, Hulio, adalimumab-fkjp, Yusimry, adalimumab-aqvh, Idacio, adalimumab-aacf

  • Antipsoriatics, Systemic; 
  • DMARDs, TNF Inhibitors; 
  • Monoclonal Antibodies; 
  • Inflammatory Bowel Disease Agents

TNF-alpha blocker (TNF-blocker); for subcutaneous use
Used for rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, ankylosing spondylitis, hidradenitis suppurativa, and uveitis
Boxed warning regarding increased risk for serious infection and malignancy

Indicated for the treatment of moderately to severely active rheumatoid arthritis.

For the treatment of moderately to severely active polyarticular juvenile idiopathic arthritis as monotherapy or with methotrexate to reduce signs and symptoms of the disease.
For reducing the signs and symptoms of active psoriatic arthritis, inhibiting the progression of structural damage, and improving physical function.
For reducing the signs and symptoms of active ankylosing spondylitis.
For the treatment of moderate to severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
For the treatment of moderately to severely active Crohn’s disease.
For the treatment of moderately to severely active ulcerative colitis.
For the treatment of moderate to severe hidradenitis suppurativa.
For the treatment of non-infectious uveitis (including intermediate, posterior, and panuveitis).

—

  • Injection site pain (12-20%)
  • Upper respiratory tract infection (URTI) (17%)
  • Increased creatine phosphokinase (15%)
  • Headache (12%)
  • Rash (12%)
  • Sinusitis (11%)
  • Nausea (9%)
  • Urinary tract infection (UTI) (8%)
  • Abdominal pain (7%)
  • Flulike syndrome (7%)
  • Hyperlipidemia (7%)
  • Back pain (6%)
  • Hypercholesterolemia (6%)
  • Hematuria (5%)
  • Hypertension (5%)
  • Increased alkaline phosphatase (5%)

Consider discontinuance if hematologic disorder occurs (thrombocytopenia, pancytopenia, aplastic anemia, leukopenia); use caution in patients with a history of significant hematologic abnormalities

Coadministration with interleukin (IL)-1 blockers (eg, anakinra, ustekinumab) may lead to serious infections and neutropenia

Coadministration of TNF blockers with abatacept showed increased rate of serious infections in controlled trials as compared with TNF blockers alone

Treatment should not be initiated in patients with an active infection, including localized infections

Risk of serious infection, including tuberculosis or hepatitis B virus; despite prophylactic treatment for TB, reactivation has occurred (see Black Box Warnings)

Possible increased risk of demyelinating disorders, including multiple sclerosis, optic neuritis, and peripheral demyelinating disease (including Guillain-Barre syndrome); use caution; discontinue therapy if any of these disorders develop

Decreases immune response of live virus vaccines; also increases risk of infection with concomitant live virus vaccines; safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero unknown; risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants

If possible, patients with JIA should be current with immunization guidelines prior to initiating adalimumab; may receive concurrent vaccinations (except for live vaccines) while taking adalimumab

Autoimmunity may result in formation of autoantibodies and, rarely, development of lupuslike syndrome; if patient develops symptoms suggestive of lupus-like syndrome following treatment with adalimumab, discontinue treatment

Hypersensitivity reactions (eg, anaphylaxis, angioedema) are reported rarely

Worsening or new onset congestive heart failure (HF) reported with TNF blockers; exercise caution when using in patients who have HF; TNFalpha inhibitors should only be considered in patients with HF if there are no other reasonable treatment options, and then consider only in patients with compensated HF

Infection and malignancy reported in elderly at higher rate; use caution

Monitor closely for infection in patients undergoing surgical procedures while on therapy; not studied; consider long half-life

Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects

Limited data from case reports in published literature describe presence of adalimumab in human milk at infant doses of 0.1-1% of maternal serum level;

Adults

40 mg subcutaneously every week or 80 mg subcutaneously every other week for hidradenitis suppurativa and for RA if used without concurrent methotrexate; 40 mg subcutaneously every other week for maintenance dosing for uveitis, psoriatic arthritis, Crohn’s disease, plaque psoriasis, ulcerative colitis, ankylosing spondylitis, or for RA if used with methotrexate.

Geriatric

40 mg subcutaneously every week or 80 mg subcutaneously every other week for hidradenitis suppurativa and for RA if used without concurrent methotrexate; 40 mg subcutaneously every other week for maintenance dosing for uveitis, psoriatic arthritis, Crohn’s disease, plaque psoriasis, ulcerative colitis, ankylosing spondylitis, or for RA if used with methotrexate.

Adolescents

Weighing 60 kg or more: 40 mg subcutaneously every other week for JIA, uveitis, and Crohn’s disease; 40 mg subcutaneously weekly or 80 mg subcutaneously every other week for hidradenitis suppurativa or ulcerative colitis.
Weighing 40 to 59 kg: 40 mg subcutaneously every other week for JIA, uveitis, Crohn’s disease, and hidradenitis suppurativa; 40 mg subcutaneously weekly or 80 mg subcutaneously every other week for ulcerative colitis.
Weighing 30 to 39 kg: 40 mg subcutaneously every other week for JIA, uveitis, and hidradenitis suppurativa; 20 mg subcutaneously every other week for Crohn’s disease; 20 mg subcutaneously weekly or 40 mg subcutaneously every other week for ulcerative colitis.
Weighing 20 to 29 kg: 20 mg subcutaneously every other week for JIA, uveitis, and Crohn’s disease; 20 mg subcutaneously weekly or 40 mg subcutaneously every other week for ulcerative colitis.
Weighing 17 to 19 kg: 20 mg subcutaneously every other week for JIA, uveitis, and Crohn’s disease.
Weighing 15 to 16 kg: 20 mg subcutaneously every other week for JIA and uveitis.

Children

12 years weighing 60 kg or more: 40 mg subcutaneously every other week for JIA, uveitis, and Crohn’s disease; 40 mg subcutaneously weekly for hidradenitis suppurativa; 40 mg subcutaneously weekly or 80 mg subcutaneously every other week for ulcerative colitis.
12 years weighing 40 to 59 kg: 40 mg subcutaneously every other week for JIA, uveitis, Crohn’s disease, and hidradenitis suppurativa; 40 mg subcutaneously weekly or 80 mg subcutaneously every other week for ulcerative colitis.
12 years weighing 30 to 39 kg: 40 mg subcutaneously every other week for JIA, uveitis, and hidradenitis suppurativa; 20 mg subcutaneously every other week for Crohn’s disease; 20 mg subcutaneously weekly or 40 mg subcutaneously every other week for ulcerative colitis.
12 years weighing 20 to 29 kg: 20 mg subcutaneously every other week for JIA, uveitis, and Crohn’s disease; 20 mg subcutaneously weekly or 40 mg subcutaneously every other week for ulcerative colitis.
12 years weighing 17 to 19 kg: 20 mg subcutaneously every other week for JIA, uveitis, and Crohn’s disease.
12 years weighing 15 to 16 kg: 20 mg subcutaneously every other week for JIA and uveitis.
6 to 11 years weighing 40 kg or more: 40 mg subcutaneously every other week for JIA, uveitis, and Crohn’s disease; 40 mg subcutaneously weekly or 80 mg subcutaneously every other week for ulcerative colitis.
6 to 11 years weighing 30 to 39 kg: 40 mg subcutaneously every other week for JIA and uveitis; 20 mg subcutaneously every other week for Crohn’s disease; 20 mg subcutaneously weekly or 40 mg subcutaneously every other week for ulcerative colitis.
6 to 11 years weighing 20 to 29 kg: 20 mg subcutaneously every other week for JIA, uveitis, and Crohn’s disease; 20 mg subcutaneously weekly or 40 mg subcutaneously every other week for ulcerative colitis.
6 to 11 years weighing 17 to 19 kg: 20 mg subcutaneously every other week for JIA, uveitis, and Crohn’s disease.
6 to 11 years weighing 15 to 16 kg: 20 mg subcutaneously every other week for JIA and uveitis.
5 years and weighing 40 kg or more: 40 mg subcutaneously every other week for JIA and uveitis; 40 mg subcutaneously weekly or 80 mg subcutaneously every other week for ulcerative colitis.
5 years and weighing 30 to 39 kg: 40 mg subcutaneously every other week for JIA and uveitis; 20 mg subcutaneously weekly or 40 mg subcutaneously every other week for ulcerative colitis.
5 years and weighing 20 to 29 kg: 20 mg subcutaneously every other week for JIA and uveitis; 20 mg subcutaneously weekly or 40 mg subcutaneously every other week for ulcerative colitis.
5 years and weighing 15 to 19 kg: 20 mg subcutaneously every other week for JIA and uveitis.
5 years and weighing 10 to 14 kg: 10 mg subcutaneously every other week for JIA and uveitis.
2 to 4 years weighing 30 kg or more: 40 mg subcutaneously every other week for JIA and uveitis.
2 to 4 years weighing 15 to 29 kg: 20 mg subcutaneously every other week for JIA and uveitis.
2 to 4 years weighing 10 to 14 kg: 10 mg subcutaneously every other week for JIA and uveitis.
1 year or weighing less than 10 kg: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Adalimumab 

injection, prefilled glass syringe

  • 10mg/0.1mL (Humira)
  • 10mg/0.2mL (Humira, Abrilada, Hyrimoz)
  • 20mg/0.2mL (Humira)
  • 20mg/0.4mL (Humira, Amjevita, Cyltezo, Abrilada)
  • 40mg/0.4mL (Humira)
  • 40mg/0.8mL (Humira, Cyltezo, Abrilada, Amjevita, Hadlima, Hyrimoz, Idacio, Yusimry)
  • 80mg/0.8mL (Humira)

injection, prefilled syringe/pen

  • 20mg/0.4mL (Amjevita, Hulio)
  • 40mg/0.4mL (Humira)
  • 40mg/0.8mL (Humira, Abrilada, Amjevita, Hadlima, Hulio, Hyrimoz, Idacio)
  • 80mg/0.8mL (Humira)

injection, vial

  • 40mg/0.8mL (Humira)

Biosimilars to Humira

  • Abrilada (adalimumab-afzb)
  • Amjevita (adalimumab-atto)
  • Cyltezo (adalimumab-adbm)
  • Hadlima (adalimumab-bwwd)
  • Hulio (adalimumab-fkjp)
  • Hyrimoz (adalimumab-adaz)
  • Idacio (adalimumab-aacf)
  • Yusimry (adalimumab-aqvh)
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