Trade Names:Humira- Injection 20 mg per 0.4 mL- Injection 40 mg per 0.8 mL
Blocks interaction of human tumor necrosis factor (TNF)–alpha with receptors and modulates biological responses induced or regulated by TNF.
C max is approximately 4.7 mcg/mL following a single 40 mg subcutaneous injection. T max is approximately 131 h. The average absolute bioavailability is 64%.
Vd ss is 4.7 to 6 L.
Mean terminal half-life is approximately 14 days. Systemic Cl is approximately 12 mL/h.
No pharmacokinetic data are available.Hepatic Function Impairment
No pharmacokinetic data are available.Elderly
In patients with rheumatoid arthritis (RA), there was a trend toward lower Cl with increasing age in patients 40 to older than 75 yr of age.Gender
No differences in pharmacokinetics were observed based on gender.
Reduce signs and symptoms, induce major clinical response, inhibit the progression of structural damage, and improve physical function in patients with moderate to severe active RA; reduce signs and symptoms of active arthritis, inhibit the progression of structural damage, and improve physical function in patients with psoriatic arthritis; reduce signs and symptoms in patients with active ankylosing spondylitis; reduce signs and symptoms and induce and maintain clinical remission in patients with moderately to severely active Crohn disease; reduce signs and symptoms of moderate to severe active polyarticular juvenile idiopathic arthritis; treatment of moderate to severe chronic plaque psoriasis in patients who are candidates for systemic treatment or phototherapy when other systemic therapies are medically less appropriate.
None well documented.
Subcutaneous 40 mg every other wk. Patients with RA not receiving methotrexate concurrently may benefit from 40 mg every wk.Crohn DiseaseAdults
Subcutaneous 160 mg initially, then 80 mg at wk 2 followed by a maintenance dosage of 40 mg every other wk starting at wk 4.Juvenile Idiopathic ArthritisChildren 4 to 17 yr of age 15 kg (33 lb) to less than 30 kg (66 lb)
Subcutaneous Administer 20 mg every other wk.30 kg (66 lb) or more
Administer 40 mg every other wk.Plaque PsoriasisAdults
Subcutaneous 80 mg initially, followed by 40 mg every other wk starting 1 wk after the initial dose.
Refrigerate syringes at 36° to 46°F. Do not freeze. Store in original carton until time of administration. Protect from light.
Do not use in combination; increased risk of serious infections and neutropenia.Live vaccines
Do not give concurrently.Methotrexate
Reduces apparent Cl of adalimumab; however, adjustments in the dose of either drug do not appear necessary.
None well documented.
Hypertension (5%); arrhythmia, atrial fibrillation, cardiovascular disorder, chest pain, CHF, coronary artery disorder, heart arrest, hypertensive encephalopathy, MI, palpitation, pericardial effusion, pericarditis, syncope, tachycardia, vascular disorder (less than 5%).
Headache (12%); confusion, multiple sclerosis, paresthesia, subdural hematoma, tremor (less than 5%).
Rash (12%); cellulitis, erysipelas, herpes zoster (less than 5%); cutaneous vasculitis, erythema multiforme (postmarketing).
Cataract (less than 5%); streptococcal pharyngitis.
Nausea (9%); abdominal pain (7%); cholecystitis, cholelithiasis, esophagitis, gastroenteritis, GI disorder and hemorrhage, vomiting (less than 5%); appendicitis.
UTI (8%); cystitis, kidney calculus, menstrual disorder, pyelonephritis (less than 5%); metrorrhagia.
Agranulocytosis, granulocytopenia, leukopenia, lymphoma-like reaction, pancytopenia, polycythemia (less than 5%); neutropenia, thrombocytopenia (postmarketing).
Hepatic necrosis (less than 5%).
Anaphylaxis, angioneurotic edema (postmarketing)
Mild to moderate increase in CPK (15%); hyperlipidemia (7%); hypercholesterolemia (6%); hematuria, increased alkaline phosphatase (5%); increased aminotransferases.
Injection-site pain (19%); injection-site reactions (16%).
Abnormal healing, dehydration, ketosis, paraproteinemia, peripheral edema (less than 5%).
Back pain (6%); arthralgia (3%); arthritis, bone disorder, bone fracture, bone necrosis, joint disorder, muscle cramps, myasthenia, pyogenic arthritis, synovitis, tendon disorder (less than 5%); myositis.
Upper respiratory tract infection (17%); sinusitis (11%); flu syndrome (7%); asthma, bronchospasm, decreased lung function, dyspnea, lung disorder, pleural effusion, pneumonia (less than 5%); interstitial lung disease, including pulmonary fibrosis (postmarketing).
Patients with negative antinuclear antibody titers who developed positive titers (12%); accidental injury (10%); low-titer antibodies to adalimumab (5%); adenoma, carcinoma, fever, infection, leg thrombosis, lupus erythematosus syndrome, lymphoma, malignancies, melanoma, pain in extremity, parathyroid disorder, pelvic pain, reactivated tuberculosis (TB), sepsis, surgery, thorax pain (less than 5%).
Patients are at increased risk of developing serious infections that may lead to hospitalization or death. Most patients were taking concomitant immunosuppressive agents (eg, corticosteroids, methotrexate). Infections include active TB, invasive fungal infections, bacterial, viral or other infections caused by opportunistic pathogens. Discontinue treatment in patients who develop serious infection or sepsis.
Closely monitor patient with new-onset or worsening heart failure during therapy with adalimumab. Instruct patient to inform health care provider immediately if worsening of heart failure is noted or suspected. Monitor patient for signs and symptoms of infection. Evaluate patient for presence of latent TB using a TB skin test prior to starting therapy. If latent infection is identified, ensure patient is started on appropriate prophylaxis before adalimumab therapy begins. Monitor patients for signs and symptoms of active TB during therapy, including patients testing negative for latent TB. Closely monitor patients who are carriers of hepatitis B virus (HBV) and require treatment with TNF-blocking agents for clinical and laboratory signs of active HBV infection throughout therapy and for several months following treatment.
Category B .
Safety and efficacy not established in children younger than 4 yr of age, and there are limited data in treating children who weigh less than 15 kg (7 lb).Other indications
Safety and efficacy not established.
Because of higher incidence of infections and malignancies in elderly patients, use with caution.
Anaphylaxis and angioedema have been reported rarely.
Worsening of CHF and new-onset CHF have occurred.
Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF-blocking agents.
Risk of reactivation of HBV may be increased in chronic carriers of this virus. Use with caution in known HBV carriers. In patients who develop HBV reactivation, stop treatment with this drug and initiate effective antiviral therapy.
If possible, bring juvenile idiopathic arthritis patients up to date with all immunizations prior to initiating therapy.
May result in formation of autoantibodies and, rarely, in the development of a lupus-like syndrome.
May affect host defenses against infection and malignancies.
Serious, fatal infections and sepsis have occurred. Do not initiate treatment in patients with active infections, including chronic or local infections.
The needle cover of the syringe contains dry rubber (latex).
Lymphoma and nonmelanoma skin cancer have occurred. Patients with highly active RA are at high risk for developing lymphoma.
Rare cases of exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease have occurred.
Doses of up to 10 mg/kg have been administered without evidence of toxicity.
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