adalimumab

adalimumab,

an antirheumatic immunomodulating agent used to treat patients older than 18 years of age with moderate to severe rheumatoid arthritis.

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adalimumab

Humira

Pharmacologic class: Biological modifier

Therapeutic class: Antirheumatic (disease-modifying), immunomodulator

Pregnancy risk category B

FDA Boxed Warning

• Tuberculosis (TB), invasive fungal infections, and other opportunistic infections (some fatal) have occurred in patients receiving drug. Treatment of latent TB infection reduces reactivation risk; however, active TB has developed in patients who tested negative for latent TB.
• Before and during therapy, evaluate patients for TB risk factors and test them for latent TB infection. Begin treatment of latent TB before starting drug. During therapy, monitor patients for signs and symptoms of active TB, even if they tested negative for latent TB.

Action

Human immunoglobulin (Ig) G1 monoclonal antibody that binds to human tumor necrosis factor (TNF), which plays a role in inflammation and immune responses. Also modulates biological responses induced or modulated by TNF.

Availability

Injection (preservative-free): 40 mg/0.8 ml

⊘Indications and dosages

➣ To reduce signs and symptoms, slow disease progression, and improve physical function of moderately to severely active rheumatoid arthritis and to reduce signs and symptoms of psoriatic arthritis

Adults: 40 mg subcutaneously every other week alone or in combination with methotrexate or other disease modifying antirheumatic drugs

➣ To reduce signs and symptoms of ankylosing spondylitis

Adults: 40 mg subcutaneously every other week

➣ Crohn's disease

Adults: Initially, 160 mg subcutaneously at week 0; 80 mg at week 2; then a maintenance dose of 40 mg every other week beginning at week 4. Initial dose may be given as four injections on 1 day or divided over 2 days.

Contraindications

• Hypersensitivity to drug
• Active infection, including chronic or localized infection

Precautions

Use cautiously in:
• preexisting or recent onset of demyelinating disorders, immunosuppression, or lymphoma
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

• Give subcutaneously; rotate injection sites.
• Be aware that patients not receiving methotrexate concurrently may benefit from dosage increase to 40 mg weekly.
• Store in refrigerator and protect from light.

Route	Onset	Peak	Duration
Subcut.	Slow	75-187 hr	Unknown

Adverse reactions

CNS: headache, demyelinating disease

CV: hypertension, arrhythmias

EENT: sinusitis

GI: nausea, vomiting, abdominal pain

GU: urinary tract infection, hematuria

Metabolic: hyperlipidemia, hypercholesterolemia

Musculoskeletal: back pain

Respiratory: upper respiratory tract infection

Skin: rash

Other: accidental injury, pain and swelling at injection site, flulike symptoms, lupuslike syndrome, fungal infection, allergic reactions, tuberculosis reactivation, malignancies

Interactions

Drug-drug. Immunosuppressants (including corticosteroids): serious infection

Live-virus vaccines: serious illness

Drug-diagnostic tests. Alkaline phosphatase: elevated level

Patient monitoring

☞ Monitor for signs and symptoms of infection if patient is receiving concurrent corticosteroids or other immunosuppressants (because of risk that infection may progress).
• Monitor CBC.

Patient teaching

• Teach patient how to recognize and report signs and symptoms of allergic response and other adverse reactions.
• Inform patient that drug lowers resistance to infection. Instruct him to immediately report fever, cough, breathing problems, and other infection symptoms.
• Instruct patient to minimize GI upset by eating small, frequent servings of healthy food and drinking plenty of fluids.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.