Adalimumab

Pronunciation

(a da LIM yoo mab)

U.S. Brand Names

Humira®

Synonyms

Antitumor Necrosis Factor Apha (Human); D2E7; Human Antitumor Necrosis Factor-alpha

Generic Available

Use

Treatment of active rheumatoid arthritis (moderate to severe) in patients with inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs)

Pregnancy Risk Factor

Pregnancy Implications

Teratogenic effects were not observed in animal studies, however, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. A pregnancy registry has been established to monitor outcomes of women exposed to adalimumab during pregnancy (877-311-8972).

Lactation

Excretion in breast milk unknown/not recommended

Contraindications

Hypersensitivity to adalimumab or any component of the formulation

Warnings/Precautions

Tuberculosis (disseminated or extrapulmonary) has been reactivated while on adalimumab. Most cases have been reported within the first 8 months of treatment. Patients should be evaluated for latent tuberculosis infection with a tuberculin skin test prior to therapy. Treatment of latent tuberculosis should be initiated before adalimumab is used. Use caution with chronic infection, history of recurrent infection, or predisposition to infection. Do not give to patients with a clinically-important, active infection. Adalimumab may affect defenses against infections and malignancies; serious infections (including sepsis and fatal infections) have been reported in patients receiving TNF-blocking agents, including adalimumab. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy. Other opportunistic infections ( Histoplasma, Aspergillus, and Nocardia ) have occurred during therapy. Use caution in patients who have resided in regions where histoplasmosis is endemic. Patients who develop a new infection while undergoing treatment with adalimumab should be monitored closely. If a patient develops a serious infection or sepsis, adalimumab should be discontinued. Impact on the development and course of malignancies is not fully defined. Rare cases of lymphoma have also been reported in association with adalimumab.

May exacerbate pre-existing or recent-onset demyelinating CNS disorders. Use caution in patients with CHF. Patients should be brought up to date with all immunizations before initiating therapy. No data are available concerning the effects of adalimumab on vaccination. Live vaccines should not be given concurrently. No data are available concerning secondary transmission of live vaccines in patients receiving adalimumab. Rare cases of pancytopenia (including aplastic anemia) have been reported with TNF-blocking agents; with significant hematologic abnormalities, consider discontinuing therapy. Safety and efficacy have not been established in pediatric patients.

Adverse Reactions

>10%:

Central nervous system: Headache (12%)

Dermatologic: Rash (12%)

Local: Injection site reaction (20%; includes erythema, itching, hemorrhage, pain, swelling)

Respiratory: Upper respiratory tract infection (17%), sinusitis (11%)

5% to 10%:

Cardiovascular: Hypertension (5%)

Endocrine & metabolic: Hyperlipidemia (7%), hypercholesterolemia (6%)

Gastrointestinal: Nausea (9%), abdominal pain (7%)

Genitourinary: Urinary tract infection (8%)

Hepatic: Alkaline phosphatase increased (5%)

Local: Injection site reaction (8%)

Neuromuscular & skeletal: Back pain (6%)

Renal: Hematuria (5%)

Miscellaneous: Accidental injury (10%), flu-like syndrome (7%)

<5%:

Cardiovascular: Arrhythmia, atrial fibrillation, chest pain, CHF, coronary artery disorder, heart arrest, hypertensive encephalopathy, myocardial infarct, palpitation, pericardial effusion, pericarditis, peripheral edema, syncope, tachycardia, thrombosis (leg), vascular disorder

Central nervous system: Confusion, fever, multiple sclerosis, pain in extremity, paresthesia, subdural hematoma, tremor

Dermatologic: Cellulitis

Endocrine & metabolic: Dehydration, menstrual disorder, parathyroid disorder

Gastrointestinal: Esophagitis, gastroenteritis, gastrointestinal hemorrhage, vomiting

Genitourinary: Cystitis, pelvic pain

Hematologic: Agranulocytosis, granulocytopenia, leukopenia, pancytopenia, polycythemia

Hepatic: Cholecystitis, cholelithiasis, hepatic necrosis

Neuromuscular & skeletal: Arthritis, bone fracture, bone necrosis, joint disorder, muscle cramps, myasthenia, pyogenic arthritis, synovitis, tendon disorder

Ocular: Cataract

Renal: Kidney calculus, paraproteinemia, pyelonephritis

Respiratory: Asthma, bronchospasm, dyspnea, lung function decreased, pleural effusion, pneumonia

Miscellaneous: Adenoma, allergic reactions (1%); carcinoma (including breast, gastrointestinal, skin, urogenital); erysipelas; healing abnormality; herpes zoster; ketosis, lupus erythematosus syndrome; lymphoma; melanoma; sepsis; tuberculosis (reactivation of latent infection)

Postmarketing and/or case reports: Anaphylactoid reaction, anaphylaxis, aplastic anemia, cutaneous vasculitis, cytopenia, fixed drug eruption, thrombocytopenia, urticaria

Overdosage/Toxicology

Doses of up to 10 mg/kg have been tolerated in clinical trials. In case of overdose, treatment should be symptomatic and supportive.

Drug Interactions

Anakinra: Concomitant use may increase risk of infections; not recommended.

Vaccines, live: Concomitant use has not be studied; currently recommended not to administer live vaccines during adalimumab therapy.

Stability

Store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze, protect from light

Mechanism of Action

Adalimumab is a recombinant monoclonal antibody that binds to human tumor necrosis factor alpha (TNF-alpha) receptor sites, thereby interfering with endogenous TNF-alpha activity. Elevated TNF levels in the synovial fluid are involved in the pathologic pain and joint destruction in rheumatoid arthritis. Adalimumab decreases signs and symptoms of rheumatoid arthritis and inhibits progression of structural damage.

Pharmacodynamics/Kinetics

Distribution: Vd: 4.7-6 L; Synovial fluid concentrations: 31% to 96% of serum

Bioavailability: Absolute: 64%

Half-life elimination: Terminal: ~2 weeks (range 10-20 days)

Time to peak, serum: SubQ: 131 ± 56 hours

Excretion: Clearance increased in the presence of anti-adalimumab antibodies; decreased in patients 40 to >75 years

Dosage

SubQ: Adults: Rheumatoid arthritis: 40 mg every other week; may be administered with other DMARDs; patients not taking methotrexate may increase dose to 40 mg/weekly

Administration

For SubQ injection; rotate injection sites. Do not use if solution is discolored. Do not administer to skin which is red, tender, bruised, or hard.

Monitoring Parameters

Improvement of symptoms; signs of infection; place and read PPD before initiation

Patient Education

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, allergies, history of tuberculosis, or any kind of infection you have. Do not take any new medication during therapy without consulting prescriber. If self-administered, follow directions for injection and needle/syringe disposal exactly. Do not have any vaccinations while using this medication without consulting prescriber first. May cause headache or dizziness (use caution when driving or engaged in potentially hazardous tasks); if persistent, consult prescriber for approved analgesic. Report persistent fever, respiratory tract infection, unhealed or infected wounds, urinary tract infection, or flu-like symptoms. Stop drug and report immediately persistent nausea, abdominal pain; numbness or tingling; problems with vision; weakness in legs; chest pains, respiratory difficulty; joint pain; skin rash; and redness, swelling, or pain at injection site. Pregnancy/breast-feeding precautions: Consult prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause confusion; may exacerbate pre-existing or recent-onset demyelinating CNS disorder

Mental Health: Effects on Psychiatric Treatment

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF-

-blocking agents. Medically-significant thrombocytopenia and leukopenia have been infrequently reported; use with caution in patients receiving clozapine, carbamazepine, valproic acid, and mirtazapine.

Dosage Forms

Injection, solution [preservative free]: 40 mg/0.8 mL (1 mL) [prefilled glass syringe; packaged with alcohol preps]

International Brand Names

Humira® (CH, DE, DK, ES, FR, GB, IE, SE)

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