adalimumab (Rx) - Humira
- Class: Monoclonal Antibodies;
- DMARDs, TNF Inhibitors;
- Antipsoriatics, Systemic;
- Inflammatory Bowel Disease Agents
Dosing & Uses
Dosing Forms & Strengths
prefilled syringe/pen
- 40mg/0.8mL
Rheumatoid Arthritis
Reduction of signs and symptoms, induction of major clinical response, inhibition of progression of structural damage, and improvement of physical function in adults with moderate-to-severe active rheumatoid arthritis
40 mg SC every 2 weeks
Dosing considerations
- May be administered as monotherapy or combined with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs); if not taken with concomitant methotrexate, additional benefit may be derived from increasing dosing frequency to once weekly
Psoriatic Arthritis
Reduction of signs and symptoms, inhibition of progression of structural damage, and improvement of physical function in adults with active psoriatic arthritis
40 mg SC every 2 weeks
Dosing considerations
- May be administered as monotherapy or combined with methotrexate or other nonbiologic DMARDs
Ankylosing Spondylitis
Reduction of signs and symptoms
40 mg SC every 2 weeks
Dosing considerations
- May be administered as monotherapy or combined with methotrexate or other nonbiologic DMARDs
Plaque Psoriasis
Treatment of moderate-to-severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy and for whom other systemic therapies are inappropriate
80 mg SC once, then, after 1 week, 40 mg SC every 2 weeks
Crohn Disease
Reduction of signs and symptoms and induction and maintenance of clinical remission in adults with moderately to severely active Crohn disease who have had inadequate response to conventional therapy; may be used in patients who have lost response to or are intolerant of infliximab
160 mg SC either as 4 injections of 40 mg on day 1 or as 2 injections of 40 mg daily on 2 consecutive days, then 80 mg SC 2 weeks later (day 15), then 40 mg SC every 2 weeks for maintenance beginning on day 29
Dosing considerations
- Some patients may require weekly 40-mg dose for maintenance
Ulcerative Colitis
Treatment of ulcerative colitis unresponsive to immunosuppressants (eg, corticosteroids, azathioprine, 6-mercaptopurine [6-MP])
160 mg SC either as 4 injections of 40 mg on day 1 or as 2 injections of 40 mg daily on 2 consecutive days, then 80 mg SC 2 weeks later (day 15), then 40 mg SC every 2 weeks for maintenance beginning on day 29
Continue maintenance dose only if evidence of clinical remission is apparent by 8 weeks of therapy
Uveitis (Orphan)
Orphan designation for the treatment of noninfectious intermediate, posterior, or pan-uveitis, or chronic noninfectious anterior uveitis
Orphan sponsor
- AbbVie Inc; 1 North Waukegan Road; North Chicago, IL 60064
Dosing Forms & Strengths
prefilled syringe/pen
- 20mg/0.4mL
- 40mg/0.8mL
Juvenile Rheumatoid Arthritis
Reduction of signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis
<4 years
- Safety and efficacy not established
≥4 years
- ≥15 kg, <30 kg: 20 mg SC every 2 weeks
- ≥30 kg: 40 mg SC every 2 weeks
- May be administered with methotrexate, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics
Crohn Disease (Orphan)
Orphan designation for pediatric Crohn disease
Orphan sponsor
- Abbott Laboratories; Global Pharmaceutical Research & Development; Abbott Park, IL 60064
Ulcerative Colitis (Orphan)
Orphan designation for pediatric ulcerative colitis
Orphan sponsor
- Abbott Laboratories; Global Pharmaceutical Research & Development; Abbott Park, IL 60064
Drug Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Injection site pain (12-20%)
Upper respiratory tract infection (URTI) (17%)
Increased creatine phosphokinase (15%)
Headache (12%)
Rash (12%)
Sinusitis (11%)
1-10%
Nausea (9%)
Urinary tract infection (UTI) (8%)
Abdominal pain (7%)
Flulike syndrome (7%)
Hyperlipidemia (7%)
Back pain (6%)
Hypercholesterolemia (6%)
Hematuria (5%)
Hypertension (5%)
Increased alkaline phosphatase (5%)
<1%
Allergic reactions
Hematologic disorder (leukopenia, thrombocytopenia, pancytopenia, aplastic anemia)
Postmarketing Reports
General disorders and administration site conditions: Pyrexia
Hepato-biliary disorders: Liver failure, hepatitis
Immune system disorders: Sarcoidosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
Nervous system disorders: Demyelinating disorders (eg, optic neuritis, Guillain-Barré syndrome), cerebrovascular accident
Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis, pulmonary embolism
Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar), alopecia
Vascular disorders: Systemic vasculitis, deep vein thrombosis
Contraindications & Cautions
Black Box Warnings
Serious infection risk
- Increased risk for developing serious infections resulting in hospitalization or death; most patients were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
- Patients older than 65 years may be at greater risk
- Discontinue if patient develops serious infection or sepsis
- Reported infections include the following:
- (1) Active TB, including reactivation of latent TB (frequently present with disseminated or extrapulmonary disease); test for latent TB before use and during therapy; treat latent infection before use
- (2) Invasive fungal infections (eg, histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis); may present with disseminated, rather than localized, disease; antigen/antibody testing for histoplasmosis may yield negative results in some patients with active infection; initiate empiric antifungal therapy if severe systemic illness develops
- (3) Other bacterial (eg, Legionella, Listeria), mycobacterial (eg, tuberculosis), and viral (eg, hepatitis B) opportunistic pathogens
Malignancy
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers
- Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in rheumatoid arthritis (RA) and other indications; patients with RA may be at higher risk (approximately 2-fold) for leukemia than general population
- Manufacturers are required to report all malignancies to FDA for complete and consistent analysis
Hepatosplenic T-cell lymphoma
- HSTCL is an aggressive, rare type of T-cell lymphoma (usually fatal)
- Rare postmarketing cases of hepatosplenic T-cell lymphome (HSTCL) reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with TNF blockers
- Reports have also included 1 patient being treated for psoriasis and 2 patients being treated for RA
- Most reported cases with TNF blockers have occurred with concomitant treatment with azathioprine or 6-MP, though cases have been reported with azathioprine or 6-MP alone
- In the FDA Adverse Event Reporting System (AERS) database, the literature, and the HSTCL Cancer Survivors' Network, HSTCL cases have been identified in association with the following agents: infliximab (20), etanercept (1), adalimumab (2), infliximab/adalimumab (5), certolizumab (0), golimumab (0), azathioprine (12), 6-MP (3)
Contraindications
None listed on FDA-approved label
Cautions
Worsening or new-onset congestive heart failure reported with TNF blockers
Consider discontinuance if hematologic disorder occurs (thrombocytopenia, pancytopenia, leukopenia)
Coadministration with interleukin (IL)-1 blockers (eg, anakinra, ustekinumab) may lead to serious infections and neutropenia
Coadministration of TNF blockers with abatacept showed increased rate of serious infections in controlled trials as compared with TNF blockers alone
Risk of serious infection, including tuberculosis or hepatitis B virus; despite prophylactic treatment for TB, reactivation has occurred (see Black Box Warnings)
Possible increased risk of demyelinating disorders, including multiple sclerosis, optic neuritis, and peripheral demyelinating disease (including Guillain-Barre syndrome)
Increased risk of lymphoma and other cancers reported in children and adolescents (see Black Box Warnings)
Occurrence of leukemia and new-onset psoriasis reported in patients treated with TNF blockers (see Black Box Warnings)
Potential increased risk of malignancy when coadministered with azathioprine or 6-mercaptopurine
Enhanced safety surveillance requirements to capture malignancy data: Manufacturers are required to report all malignancies to FDA for complete and consistent analysis
Decreases immune response of live virus vaccines; also increases risk of infection with concomitant live virus vaccines
If possible, patients with JIA should be current with immunization guidelines prior to initiating adalimumab; may receive concurrent vaccinations (except for live vaccines) while taking adalimumab
Autoimmunity may result in formation of autoantibodies and, rarely, development of lupuslike syndrome
Hypersensitivity reactions (eg, anaphylaxis, angioedema) are reported rarely
Pregnancy & Lactation
Pregnancy category: B (pregnancy registry established; 1-877-311-8972)
IgG1 is actively transferred across the placenta during the third trimester of pregnancy
Lactation: Limited data from published literature indicate that adalimumab is present in low levels in human milk and is not likely to be absorbed by a breastfed infant
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Recombinant human anti-TNF-α IgG1 monoclonal antibody; blocks inflammatory activity of TNF-α; specifically binds to TNF-α and blocks its interaction with p55 and p75 cell surface TNF receptors; also lyses surface TNF-expressing cells in vitro and modulates biologic responses responsible for leukocyte migration
Absorption
Bioavailability: 64%
Peak plasma time (40-mg dose): 131 ± 56 hr
Peak plasma concentration: 4.7 ± 1.6 mcg/mL
Distribution
Vd: 4.7-6 L
Elimination
Half-life: 10-20 days
Total body clearance: 12 mL/hr
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