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Pharmacologic class: Biological modifier
Therapeutic class: Antirheumatic (disease-modifying), immunomodulator
Pregnancy risk category B
FDA Box Warning
• There is increased risk of serious infections with drug use (including tuberculosis [TB], bacterial sepsis, invasive fungal infections [such as histoplasmosis], and infections due to other opportunistic pathogens) leading to hospitalization or death.
• Discontinue adalimumab if a serious infection or sepsis develops during treatment.
• Perform test for latent TB; if positive, start treatment for TB before starting adalimumab.
• Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
• Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers, including adalimumab.
• Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all these patients had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or before diagnosis. It's uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
Human immunoglobulin (Ig) G1 monoclonal antibody that binds to human tumor necrosis factor (TNF), which plays a role in inflammation and immune responses. Also modulates biological responses induced or modulated by TNF.
Injection (preservative-free): 20 mg/0.4 ml in single-use prefilled glass syringe, 40 mg/0.8 ml in a single-use prefilled pen or single-use prefilled glass syringe
Indications and dosages
➣ To reduce signs and symptoms, slow disease progression, and improve physical function of moderately to severely active rheumatoid arthritis and to reduce signs and symptoms of psoriatic arthritis
Adults: 40 mg subcutaneously every other week alone or in combination with methotrexate or other disease-modifying antirheumatic drugs
➣ Moderate to severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate
Adults: Initially, 80 mg subcutaneously followed by 40 mg every other week starting 1 week after initial dose
➣ To reduce signs and symptoms of ankylosing spondylitis
Adults: 40 mg subcutaneously every other week
➣ Crohn's disease
Adults: Initially, 160 mg subcutaneously (four 40-mg injections in one day or two 40-mg injections per day for two consecutive days), followed by 80 mg subcutaneously 2 weeks later (day 15). Two weeks later (day 29), begin a maintenance dose of 40 mg subcutaneously every other week.
➣ Moderately to severely active polyarticular juvenile idiopathic arthritis as monotherapy or concomitantly with methotrexate
Children age 4 and older weighing 15 kg (33 lb) to less than 30 kg (66 lb): 20 mg subcutaneously every other week
Children age 4 and older weighing 30 kg (66 lb) or more: 40 mg subcutaneously every other week
• Hypersensitivity to drug
• Active infection, including chronic or localized infection
Use cautiously in:
• preexisting or recent onset of demyelinating disorders, immunosuppression, or lymphoma
• elderly patients
• pregnant or breastfeeding patients
• Give subcutaneously; rotate injection sites.
• Be aware that patients not receiving methotrexate concurrently may benefit from dosage increase to 40 mg weekly.
• Store in refrigerator and protect from light.
CNS: headache, demyelinating disease
CV: hypertension, arrhythmias
GI: nausea, vomiting, abdominal pain
GU: urinary tract infection, hematuria
Metabolic: hyperlipidemia, hypercholesterolemia
Musculoskeletal: back pain
Respiratory: upper respiratory tract infection
Other: accidental injury, pain and swelling at injection site, flulike symptoms, lupuslike syndrome, fungal infection, allergic reactions, tuberculosis reactivation, malignancies
Drug-drug. Immunosuppressants (including corticosteroids): serious infection
Live-virus vaccines: serious illness
Drug-diagnostic tests. Alkaline phosphatase: elevated level
☞ Monitor for signs and symptoms of infection if patient is receiving concurrent corticosteroids or other immunosuppressants (because of risk that infection may progress).
• Monitor CBC.
• Teach patient how to recognize and report signs and symptoms of allergic response and other adverse reactions.
• Inform patient that drug lowers resistance to infection. Instruct him to immediately report fever, cough, breathing problems, and other infection symptoms.
• Instruct patient to minimize GI upset by eating small, frequent servings of healthy food and drinking plenty of fluids.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.
AdalimumabA recombinant human IgG1 monoclonal antibody that reacts with human TNF, which causes rapid reduction in acute phase reactants of inflammation—C-reactive protein, erythrocyte sedimentation rate, serum cytokines (e.g., IL-6)—in patients with rheumatoid arthritis. Serum matrix metalloproteinases, MMP-1 and MMP-3—which remodel tissue and cause cartilage destruction—also reduced after Humira administration.
Adverse effects Infections—primarily URIs—including tuberculosis, UTIs; increased risk of malignancies—lymphomas, including the extremely rare hepatosplenic T-cell lymphoma; neurologic events—TNF blockers may exacerbate clinical and/or radiographic evidence of demyelination.