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ADALIMUMAB (D2E7)

Medical Diagnosis and Drugs, Medications
ADALIMUMAB (D2E7)
(a-da-lim'u-mab)
Humira
Classifications: biologic response modifier; tumor necrosis factor modifier; disease-modifying antirheumatic drug (dmard);
Therapeutic: antirheumatic agent; dmard
Prototype: Etanercept
Pregnancy Category: B

Availability

40 mg/0.8 mL injection

Action

Adalimumab is a human recombinant IgG1 monoclonal antibody. It neutralizes the effects of tumor necrosis factor (TNF)-alpha, a cytokine, by blocking its interaction with cell surface TNF receptors. This mechanism blocks the normal inflammatory and immune responses controlled by TNF-alpha. In the presence of complement, adalimumab may also lyse TNF-expressing cells.

Therapeutic Effect

Reduces the levels of acute phase inflammatory reactants (C-reactive protein, ESR, interleukin-6) thus decreasing overall joint inflammation; also reduces levels of enzymes that produce tissue remodeling responsible for cartilage destruction. In RA, adalimumab reduces the numerous inflammatory events of polyarthritis. It reduces the overproduction of TNF-alpha principally by macrophages in rheumatoid joints.

Uses

Treatment of moderate to severe rheumatoid arthritis or psoriatic arthritis and to reduce progression of the disease in patients with or without a disease-modifying antirheumatic drug (DMARD), treatment of Crohn's disease.

Contraindications

Hypersensitivity to adalimumab or mannitol; active infection, either chronic or acute; neoplastic disease; sepsis; lactation. Safe use in children has not been established.

Cautious Use

History of recurrent infection or conditions predisposing to infection; recurrent history of sensitivity to monoclonal antibodies; cardiovascular disease; neurological disease; patients residing in areas with endemic TB or histoplasmosis; active or latent TB infection prior to therapy; demyelinating disorders; concurrent administration of immunosuppressants; surgery; pregnancy (category B).

Route & Dosage

Rheumatoid Arthritis
Adult: SC 40 mg every other wk (may use 40 mg every wk if not on concomitant methotrexate)

Crohn's Disease
Adult: SC Initial dose of 160 mg (dose can be administered as 4 injections in 1 d or as 2 injections/d for 2 consecutive d), then 80 mg at wk 2, followed by 40 mg every other wk beginning at wk 4

Administration

Subcutaneous
  • Do not administer to persons with active infections. Evaluate for latent TB with TB skin test prior to initiation of therapy.
  • Inspect prefilled syringe for particulate matter and discoloration prior to SC injection.
  • Rotate injection sites and do not inject into skin that is red, bruised, tender, or hard. After injecting the drug, do not rub the site.
  • Discard any remaining solution in prefilled syringe, as it contains no preservatives.
  • Store in original carton at 2°–4° C (38°–48° F). Protect from light. Do not use beyond the expiration date.

Adverse Effects (≥1%)

Body as a Whole: Infections (especially reactivation of latent tuberculosis), sepsis, may see increase in malignancies (lymphoma), back pain, fever, allergic reactions (including anaphylactic shock), flu-like symptoms, fatigue. CNS: Headache. CV: Hypertension. GI: Nausea, vomiting, abdominal pain. Hematologic: Development of ANA antibodies. Respiratory: Upper respiratory infection, sinusitis. Skin: Injection site reactions (erythema, itching, hemorrhage, pain, swelling), rash, urticaria, fixed drug reaction. Urogenital: Urinary tract infection.

Interactions

Drug: Do not give live virus vaccines to patient on adalimumab; not recommended for use with other tnf blockers (etanercept, infliximab, anakinra).

Pharmacokinetics

Absorption: 64% absorbed from SC injection site. Peak: 131 h. Distribution: Minimal beyond vascular/synovial space. Elimination: Higher clearance in presence of anti-adalimumab antibodies, lower clearance with increasing age. Half-Life: 11.8 d (10–20 d).

Nursing Implications

Assessment & Drug Effects

  • Monitor for and report lupus-like syndrome (e.g., joint pain, rash on cheeks or arms that is sensitive to sun).
  • Monitor for and report promptly S&S of infection.
  • Monitor neurological status closely. Report any change in status such as blurred vision or paresthesia.

Patient & Family Education

  • Live vaccines should not be accepted by persons taking this drug.
  • Report promptly any of the following to the physician: unexplained joint pain, rash on cheeks or arms, fever, sore throat or other signs of infection, changes in vision, numbness or tingling in extremities.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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