section name header

Information ⬇

adalimumab

a-da-lim-ue-mab

Trade Name(s): (Cyltezo, Hadlima, Humira, Yusimry)

BLACK BOX ALERT Increased risk for serious infections. Tuberculosis, invasive fungal infections, bacterial and viral opportunistic infections have occurred. Test for tuberculosis prior to and during treatment. Lymphoma, other malignancies reported in children/adolescents. Hepatosplenic T-cell lymphoma reported primarily in pts with Crohn's disease or ulcerative colitis and concomitant azaTHIOprine or mercaptopurine.

Do not confuse Humira with HumaLOG or HumuLIN, or adalimumab with sarilumab.

Classification ⬆ ⬇

Uses ⬆ ⬇

Reduces signs/symptoms, progression of structural damage and improves physical function in adults with moderate to severe RA. May be used alone or in combination with other disease-modifying antirheumatic drugs. First-line treatment of moderate to severe RA, treatment of psoriatic arthritis, treatment of ankylosing spondylitis, to induce/maintain remission of moderate to severe active Crohn's disease, moderate to severe plaque psoriasis in pts 6 yrs of age and older. Reduces signs and symptoms of moderate to severe active polyarticular juvenile rheumatoid arthritis in pts 2 yrs and older. Treatment of moderately to severely active ulcerative colitis in adults and pediatric pts 5 yrs of age and older. Treatment of moderate to severe hidradenitis suppurativa. Treatment of uveitis (noninfectious intermediate, posterior and panuveitis) in adults.

Precautions ⬆ ⬇

Contraindications: Hypersensitivity to adalimumab. Severe infections (e.g., sepsis, TB). Cautions: Pts with chronic infections or pts at risk for infections (e.g., diabetes, indwelling catheters, renal failure, open wounds), elderly, decreased left ventricular function, HF, demyelinating disorders, invasive fungal infections, history of malignancies.

Action ⬆ ⬇

Binds specifically to tumor necrosis factor (TNF) alpha cell, blocking its interaction with cell surface TNF receptors and cytokine-driven inflammatory processes. Therapeutic Effect: Decreases signs/symptoms of RA, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis. Inhibits progression of rheumatoid and psoriatic arthritis. Reduces epidermal thickness, inflammation of plaque psoriasis.

Pharmacokinetics ⬆ ⬇

Metabolism not specified. Elimination not specified. Half-life: 10–20 days.

Lifespan Considerations ⬆ ⬇

Pregnancy/Lactation: Unknown if distributed in breast milk. Children: Safety and efficacy not established. Elderly: Cautious use due to increased risk of serious infection and malignancy.

Interactions ⬆ ⬇

DRUG: May increase the adverse effects of abatacept, anakinra, belimumab, canakinumab, natalizumab, tofacitinib, vaccines (live), vedolizumab. May decrease the therapeutic effect of BCG (intravesical), vaccines (live). May increase the immunosuppressive effects of certolizumab, infliximab. Tocilizumab may increase immunosuppressive effect. HERBAL: Echinacea may decrease effects. FOOD: None known. LAB VALUES: May increase serum cholesterol, other lipids, alkaline phosphatase.

Availability ⬆ ⬇

Injection Solution: 10 mg/0.2 mL, 20 mg/0.4 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 80 mg/0.8 mL in prefilled syringes.

Administration/Handling ⬆ ⬇

SQ
  • Refrigerate; do not freeze.
  • Discard unused portion.
  • Rotate injection sites. Give new injection at least 1 inch from an old site and never into area where skin is tender, bruised, red, or hard.
  • Give in thigh or lower abdomen.
  • Avoid areas within 2 inches of navel.

Indications/Routes/Dosage ⬆ ⬇

Rheumatoid Arthritis (RA)

SQ: ADULTS, ELDERLY: 40 mg every other wk. Dose may be increased to 40 mg/wk or 80 mg every other wk in pts not taking methotrexate.

Ankylosing Spondylitis, Psoriatic Arthritis

SQ: ADULTS, ELDERLY: 40 mg every other wk (may continue methotrexate, other nonbiologic DMARDS, corticosteroids, NSAIDS, and/or analgesics).

Crohn's Disease

SQ: ADULTS, ELDERLY, CHILDREN 6 YRS AND OLDER WEIGHING 40 KG OR MORE: Initially, 160 mg given as 4 injections on day 1 or 2 injections/day over 2 days, then 80 mg 2 wks later (day 15). Maintenance: 40 mg every other wk beginning at day 29. CHILDREN 6 YRS AND OLDER WEIGHING 17–39 KG: 80 mg (2 40-mg injections on day 1), then 40 mg 2 wks later. Maintenance: 20 mg every other wk beginning at day 29.

Plaque Psoriasis, Uveitis

SQ: ADULTS, ELDERLY: Initially, 80 mg as a single dose, then 40 mg every other wk starting 1 wk after initial dose.

Juvenile Rheumatoid Arthritis

SQ: CHILDREN 2 YRS AND OLDER, WEIGHING 10–14 KG: 10 mg every other wk. WEIGHING 15–29 KG: 20 mg every other wk. WEIGHING 30 KG OR MORE: 40 mg every other wk.

Ulcerative Colitis

SQ: ADULTS, ELDERLY: Initially, 160 mg (4 injections in 1 day or 2 injections over 2 consecutive days), then 80 mg 2 wks later (day 15), then 40 mg every other wk beginning on day 29. CHILDREN 5 YRS AND OLDER, WEIGHING 40 KG OR MORE: Initially, 160 mg on day 1 (administered as full dose on day 1 or as a split dose given over 2 consecutive days), then 80 mg wkly for 2 wks (on day 8 and day 15). Maintenance (beginning day 29): 80 mg q2wks or 40 mg every wk. WEIGHING 20–39 KG: Initially, 80 mg on day 1, then 40 mg given wkly for 2 wks (a dose on day 8 and day 15). Maintenance (beginning day 29): 40 mg q2wks or 20 mg every wk.

Hidradenitis Suppurativa

SQ: ADULTS, ELDERLY: Initially, 160 mg (4 injections day 1) or 80 mg (2 injections on days 1 and 2), then 80 mg 2 wks later (day 15), then 40 mg weekly or 80 mg every other wk beginning day 29.

Dosage in Renal/Hepatic Impairment

No dose adjustment.

Side Effects ⬆ ⬇

Frequent (20%): Injection site erythema, pruritus, pain, swelling. Occasional (12%–9%): Headache, rash, sinusitis, nausea. Rare (7%–5%): Abdominal or back pain, hypertension.

Adverse Effects/Toxic Reactions ⬆ ⬇

Hypersensitivity reactions (rash, urticaria, hypotension, dyspnea), infections (primarily upper respiratory tract, bronchitis, urinary tract) occur rarely. May increase risk of serious infections (pneumonia, tuberculosis, cellulitis, pyelonephritis, septic arthritis). May increase risk of reactivation of hepatitis B virus in pts who are chronic carriers. May cause new onset or exacerbation of central nervous demyelinating disease; worsening and new-onset HF. May increase risk of malignancies. Immunogenicity (anti-adalimumab autoantibodies) occurred in 12% of pts.

Nursing Considerations ⬆

  • BASELINE ASSESSMENT Assess onset, type, location, duration of pain or inflammation. Inspect appearance of affected joints for immobility, deformities, skin condition. Review immunization status/screening for TB. If pt is to self-administer, instruct on SQ injection technique, including areas of the body acceptable for injection sites. INTERVENTION/EVALUATION Monitor lab values, particularly CBC. Assess for therapeutic response: relief of pain, stiffness, swelling; increased joint mobility; reduced joint tenderness; improved grip strength. PATIENT/FAMILY TEACHING
  • Injection site reaction generally occurs in first month of treatment and decreases in frequency during continued therapy.
  • Do not receive live vaccines during treatment.
  • Report rash, nausea.
  • A healthcare provider will show you how to properly prepare and inject your medication. You must demonstrate correct preparation and injection techniques before using medication.