Adalimumab (Humira): Drug Monograph
- Rheumatoid Arthritis (RA)
- Juvenile Idiopathic Arthritis (JIA)
- Psoriatic Arthritis (PsA)
- Ankylosing Spondylitis (AS):
- Crohn's Disease in adults who have had an inadequate response to conventional therapy or are intolerant to infliximab.
- Ulcerative Colitis in adults who had an inadequate
response to immunosuppressants such as corticosteroids, azathioprine or
- Plaque Psoriasis (Ps)
- Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis:
- 40 mg subcutaneously every other week.
- Juvenile Idiopathic Arthritis:
- 15 kg (33 lbs) to <30 kg (66 lbs): 20 mg subcutaneously every other week. ≥ 30 kg (66 lbs): 40 mg every other week.
- Crohn's Disease and Ulcerative Colitis:
- Initial dose (Day 1): 160 mg (four 40 mg subcutaneous injections in one day or two 40 mg injections per day for two consecutive days). Second dose two weeks later (Day 15): 80 mg subcutaneously. Two weeks later (Day 29): Begin a maintenance dose of 40 mg subcutaneously every other week.
- For patients with Ulcerative Colitis only:
- Only continue adalimumab in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.
- Plaque Psoriasis:
- 80 mg subcutaneous initial dose, followed by 40 mg subcutaneously every other week starting one week after initial dose.
- Injection: 40 mg/0.8mL in a single-use prefilled pen (HUMIRA Pen)
- Injection: 20 mg/0.4 mL or 40 mg/0.8 mL in a single-use prefilled glass syringe
- Injection: 40 mg/0.8 mL in a single-use glass vial for institutional use only
- Serious infections (most commonly in patients taking concomitant immunosuppressants such as methotrexate or corticosteroids). Discontinue if serious infection or sepsis develops.
- Infections may include active tuberculosis, invasive
fungal infections, or bacterial, viral, or other infections due to
opportunistic pathogens, including Legionella and Listeria.
- Malignancy, including lymphoma, some fatal. More common in patients with Crohn's disease or ulcerative colitis, majority in adolescent and young adult males.
- Serious infections
- Invasive fungal infections: For patients who develop a systemic illness on adalimumab, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic.
- Anaphylaxis or serious allergic reactions
- Hepatitis B virus reactivation
- Demyelinating disease
- Cytopenias, pancytopenia
- Heart failure Lupus-like syndrome
- Infections (upper respiratory (~17%), sinusitis (~11%))
- Injection site reactions (12% to 20%; redness, pain , minor swelling)
- Development of antibodies against adalimumab
- Monitor patient for any signs or symptoms of adverse reactions or effects
- Institute appropriate symptomatic treatment immediately
- Abatacept: Increased risk of serious infection
- Anakinra: Increased
risk of serious infection
- Live vaccine: Avoid use with adalimumab
- Pregnancy: Pregnancy Category B
- Labor and Delivery:
- Nursing Mothers: Caution should be exercised when adalimumab is administered to a nursing woman.
- Renal Impairment: None
- Hepatic Impairment: None
- Pediatric Patients: Safety and efficacy of adalimumab in pediatric patients for uses other than juvenile idiopathic arthritis (JIA) have not been established. The safety of adalimumab in pediatric patients in the JIA trial was generally similar to that observed in adults with certain exceptions.
- Geriatric Patients: No overall difference in effectiveness observed between patients 65 years of age and older and younger patients.
- Adalimumab binds specifically to the cytokine, TNF-alpha and antagonizes its interaction with the p55 and p75 cell surface TNF receptors that are known to be involved in propagating the inflammatory response.
- Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10 -10M).
- Decreases c-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) and serum cytokines (IL-6).
- Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodeling responsible for cartilage destruction is also decreased after adalimumab use.
- Bioavailability: following a single 40 mg subcutaneous dose was 64%.
- Volume of Distribution: ranged from 4.7 to 6.0 L.
- Clearance: approximately 12 mL/hr.
- Mean terminal half-life: approximately 2 weeks, ranging from 10 to 20 days.
- No gender-related pharmacokinetic differences were observed after correction for a patient's body weight.
- No pharmacokinetic data are available in patients with hepatic or renal impairment.
- Provide the Medication Guide to patients or their caregivers, and provide them an opportunity to read it and ask questions prior to initiation of therapy and prior to each time the prescription is renewed.
- If patients develop signs and symptoms of infection, instruct them to seek medical evaluation immediately.
- Advise patients of the potential benefits and risks of adalimumab, including:
- Inform patients that adalimumab may lower the ability of their immune system to fight infections.
- Instruct patients of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections.
- Counsel patients about the risk of malignancies while receiving adalimumab.
- Advise patients to seek immediate medical attention if they experience any symptoms of severe allergic reactions.
- Advise latex-sensitive patients that the needle cap of the prefilled syringe contains latex.
- Advise patients to report any signs or new or worsening medical conditions such as congestive heart failure, neurological disease, autoimmune disorders, or cytopenias.
- Advise patients to report any symptoms suggestive of a cytopenias such as bruising, bleeding, or persistent fever.
- Inform patients that the first injection is to be performed under the supervision of a qualified health care professional. If a patient or caregiver is to administer adalimumab, instruct them in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of adalimumab.
- Instruct patients to dispose of their used needles and syringes or used Pen in a FDA-cleared sharps disposal container immediately after use. Instruct patients not to dispose of loose needles and syringes or Pen in their household trash. Instruct patients that if they do not have a FDA-cleared sharps disposal container, they may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting and puncture-resistant lid without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container.
Black Box Warnings
Mechanism of Action
MESH Terms & Keywords