Classifications: biologic response modifier; tumor necrosis factor modifier; disease-modifying antirheumatic drug (dmard); Therapeutic: antirheumatic agent; dmard
Pregnancy Category: B
40 mg/0.8 mL injection
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.
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.
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.
Hypersensitivity to adalimumab or mannitol; active infection, either chronic or acute; neoplastic disease; sepsis; lactation.
Safe use in children has not been established.
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
Route & Dosage
Adult: SC 40 mg every other wk (may use 40 mg every wk if not on concomitant methotrexate)
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
- 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
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
Do not give live virus vaccines
to patient on adalimumab; not recommended for use with other tnf blockers
(etanercept, infliximab, anakinra
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 (1020 d).
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.