ADALIMUMAB (D2E7)
| 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