adalimumab, Amjevita, Humira

 Classification

Therapeutic: antirheumatics

Pharmacologic: DMARDs, monoclonal antibodies

Indications

Amjevita and Humira: Treatment of the following

conditions: Moderately to severely active rheumatoid

arthritis (may be used alone or with methotrexate or

other DMARDs), Psoriatic arthritis (may be used alone

or with other DMARDs), Active ankylosing spondylitis,

Moderately to severely active Crohn’s disease in patients

who have responded inadequately to conventional therapy,

Moderately to severely active ulcerative colitis in

patients who have responded inadequately to immunosuppressants

such as corticosteroids, azathioprine, or

6–mercaptopurine, Moderate to severely active polyarticular

juvenile idiopathic arthritis (to be used as monotherapy

or with methotrexate), Moderate to severe

chronic plaque psoriasis in patients who are candidates

for systemic therapy or phototherapy and when other

systemic therapies are deemed inappropriate. Humira

only: Treatment of the following conditions: Moderate

to severe hidradenitis suppurativa, Non-infectious intermediate,

posterior and panuveitis.

Action

Neutralizes and prevents the action of tumor necrosis

factor (TNF), resulting in anti-inflammatory and antiproliferative

activity. Therapeutic Effects: Decreased

pain and swelling with decreased rate of joint

destruction in patients with rheumatoid arthritis, psoriatic

arthritis, juvenile idiopathic arthritis, and ankylosing

spondylitis. Reduced signs and symptoms and maintenance

of clinical remission of Crohn’s disease.

Induction and maintenance of clinical remission of ulcerative

colitis. Reduced severity of plaques. Reduced

number of abscesses and inflammatory nodules. Decreased

progression of uveitis.

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.

Contraindications/Precautions A

Contraindicated in: Hypersensitivity; Concurrent

use of anakinra or abatacept; Active infection (including

localized); Lactation: Potential for serious side effects

in the infant; discontinue drug or provide formula.

Use Cautiously in: History of chronic or recurrent

infection or underlying illness/treatment predisposing

to infection; History of exposure to tuberculosis; History

of opportunistic infection; Patients residing, or

who have resided, where tuberculosis, histoplasmosis,

coccidioidomycoses, or blastomycosis is endemic; Preexisting

or recent-onset CNS demyelinating disorders;

History of lymphoma; Geri:qrisk of infection/malignancy;

OB: Use only if clearly needed; Pedi: Children

2 yr (safety not established);qrisk of lymphoma (including

hepatosplenic T-cell lymphoma [HSTCL] in patients

with Crohn’s disease or ulcerative colitis), leukemia,

and other malignancies.

Adverse Reactions/Side Effects

CNS: headache, Guillain-Barre syndrome, multiple

sclerosis. CV: hypertension. EENT: optic neuritis. GI:

abdominal pain, nausea. GU: hematuria. Derm: rash,

psoriasis. Hemat: neutropenia, thrombocytopenia.

Local: injection site reactions. Metab: hyperlipidemia.

MS: back pain. Misc: allergic reactions including

ANAPHYLAXIS, ANGIOEDEMA, INFECTIONS (including reactivation

tuberculosis and other opportunistic

infections due to bacterial, invasive fungal, viral, mycobacterial,

and parasitic pathogens), MALIGNANCY (including

lymphoma, HSTCL, leukemia, and skin cancer),

fever.

Interactions

Drug-Drug: Concurrent use with anakinra, abatacept,

or other TNF blocking agentsqrisk of serious

infections and is contraindicated. Concurrent use with

azathioprine and/or methotrexate mayqrisk of

HSTCL. Live vaccinations should not be given concurrently.

Risks and benefits should be considered before

using live vaccinations in an infant exposed to adalimumab

therapy in utero.

Route/Dosage

Rheumatoid Arthritis, Ankylosing Spondylitis,

and Psoriatic Arthritis

Subcut (Adults): 40 mg every other week; patients not

receiving concurrent methotrexate may receive additional

benefit byqdose to 40 mg once weekly.

Crohn’s Disease

Subcut (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 wk later on Day 15. Two wk later (Day 29), begin

maintenance dose of 40 mg every other wk. Aminosalicylates corticosteroids, and/or immunomodulatory

agents (e.g. azathioprine, 6–mercaptopurine, methotrexate)

may be continued during therapy.

Subcut (Children 6 yr and 40 kg): Humira

only—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 wk later

on Day 15 (given as two 40-mg injections in one day).

Two wk later (Day 29), begin maintenance dose of 40

mg every other wk. Aminosalicylates, corticosteroids,

and/or immunomodulatory agents (e.g. azathioprine,

6–mercaptopurine, methotrexate) may be continued

during therapy.

Subcut (Children 6 yr and 17–40 kg): Humira

only—80 mg initially on Day 1 (given as two 40-mg injections

in one day), followed by 40 mg 2 wk later on

Day 15. Two wk later (Day 29), begin maintenance

dose of 20 mg every other wk. Aminosalicylates, corticosteroids,

and/or immunomodulatory agents (e.g.

azathioprine, 6–mercaptopurine, methotrexate) may

be continued during therapy.

Ulcerative Colitis

Subcut (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 wk later on Day 15. Two wk later (Day 29), begin

maintenance dose of 40 mg every other wk. Aminosalicylates,

corticosteroids, and/or immunomodulatory

agents (e.g. azathioprine, 6–mercaptopurine, methotrexate)

may be continued during therapy. Should be

continued only if patients have evidence of clinical remission

by wk 8 of therapy.

Juvenile Idiopathic Arthritis

Subcut (Children 2–17 yr (Humira); 4–17 yr

(Amjevita)): 10–15 kg (Humira only)—10 mg

every other wk; 15–30 kg—20 mg every other wk;

30 kg—40 mg every other wk.

Plaque Psoriasis or Uveitis

Subcut (Adults): 80 mg initially, then in 1 wk, begin

regimen of 40 mg every other wk.

Hidradenitis Suppurativa

Subcut (Adults): 160 mg initially (given as four 40-

mg injections on Day 1 or as two 40-mg injections per

day on Days 1 and 2), followed by 80 mg 2 wk later on

Day 15. Two wk later (Day 29), begin maintenance

dose of 40 mg every wk.

Availability

Solution for subcutaneous injection (prefilled

syringes): 10 mg/0.1 mL, 10 mg/0.2 mL, 20 mg/0.2

mL, 20 mg/0.4 mL, 40 mg/0.4 mL, 40 mg/0.8 mL, 80

mg/0.8 mL. Solution for subcutaneous injection

(vials): 40 mg/0.8 mL. Prefilled pen: 40 mg/0.4 mL,

40 mg/0.8 mL, 80 mg/0.8 mL.