General

Pronunciation
a-da-li-MU-mab

Trade Name(s)

• Humira

Pregnancy Category
Category B

Ther. class.
antirheumatics

Pharm. class.
dmards
monoclonal antibodies

Indications

• Treatment of moderately to severely active rheumatoid arthritis in patients who have responded inadequately to other DMARDs; may be used with methotrexate or other DMARDs

• Psoriatic arthritis

• Active ankylosing spondylitis

• Crohn's disease

Action

Neutralizes and prevents the action of tumor necrosis factor (TNF), resulting in anti-inflammatory and antiproliferative activity

Therapeutic Effect(s):

• Decreased pain and swelling with decreased rate of joint destruction in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

• Reduced signs and symptoms of Crohn's disease

Pharmacokinetics

Absorption: 64% absorbed after subcut administration

Distribution: Synovial fluid concentrations are 31–96% of serum

Metabolism and Excretion: Unknown

Half-life: 14 days (range 10–20 days)

TIME/ACTION PROFILE (improvement)

ROUTE	ONSET	PEAK	DURATION
Subcut	8–26 wk	131 hr*	2 wk†

*Blood level
†Following discontinuation

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity

• Concurrent use of anakinra

• Active infection (including chronic or localized)

• Lactation: Potential for serious side effects in the infant; discontinue drug or provide formula

Use Cautiously in:

• History of recurrent infection or underlying illness/treatment predisposing to infection

• Patients residing, or who have resided, where tuberculosis or histoplasmosis is endemic

• Pre-existing or recent onset CNS demyelinating disorders

• History of lymphoma

• Geri: risk of infection/malignancy

• OB: Use only if clearly needed

• Pedi: Safety not established

Adverse Reactions/Side Effects

CNS: headache.

CV: hypertension.

GI: abdominal pain, nausea.

GU: hematuria.

Derm: rash.

Hemat: neutropenia, thrombocytopenia.

Local: injection site reactions.

Metabolic: hypercholesterolemia, hyperlipidemia.

MS: back pain.

Misc: ALLERGIC REACTIONS INCLUDING ANAPHYLAXIS, INFECTIONS (INCLUDING REACTIVATION TUBERCULOSIS).

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug

• Concurrent use with anakinra or other TNF blocking agents risk of serious infections and is contraindicated

• Live vaccinations should not be given concurrently

Route/Dosage

Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis

• SC (Adults): 40 mg every other week; patients not receiving concurrent methotrexate may receive additional benefit by increasing dose to 40 mg once weekly.

Crohn's Disease

• SC (Adults): 160 mg initially on Day 1 (given as four 40-mg injections in one day or as two 40 mg injections given in two consecutive days), followed by 80-mg 2 wks later on Day 15. Two wks later (Day 29) begin maintenance dose of 40 mg every other wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during therapy.

Availability

• Solution for subcut injection (pre-filled syringes): 40 mg/0.8 ml

• Pen: Single use pre-filled glass syringe containing 40 mg (0.8 mL)

Assessment

• Assess pain and range of motion before and periodically during therapy

• Assess for signs of infection (fever, dyspnea, flu-like symptoms, frequent or painful urination, redness or swelling at the site of a wound), including tuberculosis, prior to injection. Adalimumab is contraindicated in patients with active infection. New infections should be monitored closely; most common are upper respiratory tract infections, bronchitis, and urinary tract infections. Infections may be fatal, especially in patients taking immunosuppressive therapy

• Monitor for injection site reactions (redness and/or itching, rash, hemorrhage, bruising, pain, or swelling). Rash will usually disappear within a few days. Application of a towel soaked in cold water may relieve pain or swelling

• Assess patient for latex allergy. Needle cover of syringe contains latex and should not be handled by persons sensitive to latex

• Monitor patient for signs of anaphylaxis (urticaria, dyspnea, facial edema) following injection. Medications (antihistamines, corticosteroids, epinephrine) and equipment should be readily available in the event of a severe reaction. Discontinue adalimumab immediately if anaphylaxis or other severe allergic reaction occurs

• Assess patient for latent tuberculosis with a tuberculin skin test prior to initiation of therapy. Treatment of latent tuberculosis should be started before therapy with adalimumab

Lab Test Considerations

• May cause agranulocytosis, granulocytopenia, leukopenia, pancytopenia, and polycythemia

Potential Nursing Diagnoses

• Acute pain (Indications)

• Risk for infection (Side Effects)

Implementation

• Administer a tuberculin skin test prior to administration of adalimumab. Patients with active latent TB should be treated for TB prior to therapy

» Administer initial injection under supervision of a health care professional

» Do not administer solutions that are discolored or contain particulate matter. Discard unused solution

» Other DMARDs should be continued during adalimumab therapy

• SC: Administer at a 45° angle in upper thighs or abdomen, avoiding the 2 inches around the navel. Put pressure on injection site for 10 sec, do not rub. Rotate injection sites; avoid areas that are tender, bruised, hard, or red

Patient/Family Teaching

• Instruct patient on the correct technique for administering adalimumab. Review patient information sheet, preparation of dose, administration sites and technique, and disposal of equipment into a puncture-resistant container

• Advise patient to use calendar stickers provided to by manufacturer to assist in remembering when dose is due. If a dose is missed, instruct patient to administer as soon as possible, then take next dose according to regular schedule. If more than prescribed dose is taken, caution patient to consult health care professional or the HUMIRA Patient Resource Center at 1-800-4HUMIRA (448-6472)

• Caution patient to notify health care professional immediately if signs of infection, severe rash, swollen face, or difficulty breathing occurs while taking adalimumab

• Advise patient to consult health care professional before taking other Rx or OTC medications or herbal products

• Instruct patient to notify health care professional of medication regimen prior to treatment or surgery

• Pen: Clean area for injection with alcohol swab. Hold pen with gray cap pointing up. Check solution through window; if discolored, cloudy, or contains flakes, discard solution. Turn pen over and point cap down to make sure solution reaches fill line; if not, do not use and contact pharmacist. Remove gray cap exposing the needle and the plum cap exposing the button; removing the plum cap activates the pen. Pinch skin and place pen, with window visible, against skin at a 90° angle and press button until a click is heard. Hold pen in place until all solution is injected (10 seconds) and yellow marker is visible in window and has stopped moving. Continue to pinch skin throughout injection. Remove needle and press with a gauze pad or cotton ball for 10 seconds. Do not rub injection site. Dispose of pen into a puncture-resistant container

Evaluation/Desired Outcomes

• Decreased pain and swelling with decreased rate of joint destruction in patients with rheumatoid arthritis

• Decreased signs and symptoms, slowed progression of joint destruction, and improved physical function in patients with psoriatic arthritis

• Reduced signs and symptoms of ankylosing spondylitis

• Decreased signs and symptoms and maintenance of remission in patients with Crohn's disease

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