adalimumab


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adalimumab

Humira

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.

Action

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.

Availability

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

Contraindications

• Hypersensitivity to drug

• Active infection, including chronic or localized infection

Precautions

Use cautiously in:

• preexisting or recent onset of demyelinating disorders, immunosuppression, or lymphoma

• elderly patients

• pregnant or breastfeeding patients

• children.

Administration

• 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.

Adverse reactions

CNS: headache, demyelinating disease

CV: hypertension, arrhythmias

EENT: sinusitis

GI: nausea, vomiting, abdominal pain

GU: urinary tract infection, hematuria

Metabolic: hyperlipidemia, hypercholesterolemia

Musculoskeletal: back pain

Respiratory: upper respiratory tract infection

Skin: rash

Other: accidental injury, pain and swelling at injection site, flulike symptoms, lupuslike syndrome, fungal infection, allergic reactions, tuberculosis reactivation, malignancies

Interactions

Drug-drug. Immunosuppressants (including corticosteroids): serious infection

Live-virus vaccines: serious illness

Drug-diagnostic tests. Alkaline phosphatase: elevated level

Patient monitoring

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.

Patient teaching

• 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.

adalimumab

(ăd′ə-lĭm′o͞o-măb′)
n.
A human monoclonal antibody that blocks the action of tumor necrosis factor and is used to treat certain autoimmune disorders, especially rheumatoid arthritis, Crohn's disease, and psoriasis.

Adalimumab

A 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.

adalimumab

A human tumour necrosis factor-alpha monoclonal antibody used to treat severe active RHEUMATOID ARTHRITIS in cases in which treatment with methotrexate fails to produce an adequate response. The antibody binds to TNF-alpha and blocks its interaction with cell surface TNF receptors. This reduces chronic inflammation and cartilage destruction. A brand name is Humira.
References in periodicals archive ?
It was not clear to examine the efficacy of the partial response of adalimumab on fistula healing in Crohn's disease.
This study aimed to validate the use of power Doppler ultrasonography (PDUS) for evaluating synovial vascularity and synovial hypertrophy for synovitis in patients with rheumatoid arthritis (RA) treated with adalimumab.
Adalimumab is a recombinant human monoclonal antibody that binds specifically to tumor necrosis factor (TNF)-alpha, blocking interaction with its cell surface receptors and thereby reducing the impact of inflammation.
Because of tenderness of multiple joints and new occurrence of rheumatoid nodules on the left knee on 16 February 2014, and erythrocyte sedimentation rate (ESR) increased to 70 mm/h and C-reactive protein (CRP) 16.3 mg/L, with a high disease activity score for 28 joints (DAS28) scored 5.44, adalimumab (40 mg subcutaneous every other week) was initiated.
Reportamos un paciente con celulitis disecante del cuero cabelludo manejado exitosamente con adalimumab.
* Detailed information on Humira (Adalimumab) including product description, safety and efficacy profiles as well as a SWOT analysis.
Tocilizumab with methotrexate was noninferior to adalimumab and methotrexate used together
Between November 2004 and January 2012, 312 pregnant women in the United States and Canada--69 women with RA exposed to adalimumab, 80 women with RA who had not taken adalimumab, and 163 healthy controls--were enrolled before 20 weeks' gestation.
The trial will test the effectiveness of giving adalimumab as an injection every two weeks, with methotrexate.
For the study, lead researcher Merete Lund Hetland, MD, PhD, Copenhagen University Department of Rheumatology, and colleagues, set out to compare adalimumab, etanercept and infliximab and the drugs' treatment response in the 2,326 patients chosen for the eight-year follow-up, with the ultimate goal being remission of disease symptoms.