Humira


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Related to Humira: Remicade, Enbrel

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.

Humira

(hyo͞o-mâr′ə)
A trademark for the drug adalimumab.

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.

Humira

A brand name for ADALIMUMAB.
References in periodicals archive ?
As for the safety of the increased dose of Humira, the safety profile was comparable to dose observed for conventional treatment with Humira; the increased dose was also well tolerated.
This isn't the first time a rival drugmaker has claimed credit for Humira and demanded royalties.
In addition, AbbVie and Eisai will continue co-promotion for HUMIRA of indications outside of the gastrointestinal disease field (treatment of rheumatoid arthritis [including prevention of structural joint damage] and the following diseases that do not sufficiently respond to existing treatments: psoriasis vulgaris, arthropathic psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis).
The leading players operating in the Humira Market are also studied in the report to provide readers with a comprehensive overview of the competitive landscape in the market.
On a conference call announcing the deal, AbbVie Chief Executive Officer Richard Gonzalez, who will lead the combined company, said the transaction should ease concerns about future competition to Humira, adding that the drug is lucrative enough to bankroll the purchase of its eventual successor.
The approval of this additional indication is based on the data from a Japanese Phase III study(1) and overseas clinical trials.(2) In these trials, the efficacy and safety of HUMIRA were evaluated in patients with moderate to severe HS.
M2 PHARMA-December 3, 2018-AbbVie signs HUMIRA global patent license with Pfizer
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Global Banking News-December 3, 2018-AbbVie signs HUMIRA global patent license with Pfizer
19, 2018 (HealthDay News) -- A lawsuit filed Tuesday in California claims that pharmaceutical company AbbVie used cash, gifts, and services to induce doctors to overprescribe the widely used drug Humira (adalimumab), ignoring the medicine's potentially lethal side effects.