Drug information of Adalimumab

Adalimumab


Adalimumab is a human monoclonal antibody against TNF-alpha. It is produced by recombinant DNA technology using a mammalian cell expression system. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.

Mechanism of effect

Recombinant human anti-TNF-α IgG1 monoclonal antibody; blocks inflammatory activity of TNF-α; specifically binds to TNF-α and blocks its interaction with p55 and p75 cell surface TNF receptors; also modulates biologic responses responsible for leukocyte migration.

Pharmacodynamic

Used in the treatment of immune system mediated diseases, adalimumab binds specifically to TNF-alpha and blocks its general cytokine effects, thereby reducing TNF-induced inflammation and halting tissue destruction.

Pharmacokinetics

Absorption

Bioavailability: 64%

Distribution

Vd: 4.7-6 L

Elimination

Half-life: 10-20 days

Dosage

Injection, prefilled glass syringe

10mg/0.1mL

10mg/0.2mL

20mg/0.2mL

20mg/0.4mL

40mg/0.4mL

40mg/0.8mL

80mg/0.8mL 

Injection, prefilled syringe/pen

20mg/0.4mL

40mg/0.4mL

40mg/0.8mL

80mg/0.8mL 

Injection, vial

40mg/0.8mL

Rheumatoid Arthritis

Indicated for reduction of signs and symptoms, induction of major clinical response, inhibition of progression of structural damage, and improvement of physical function in adults with moderate-to-severe active rheumatoid arthritis

40 mg SC q2wk

Dosing considerations

May be administered as monotherapy or combined with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs)

If not taken with concomitant methotrexate, additional benefit may be derived from increasing adalimumab dosing frequency to once weekly

Psoriatic Arthritis

Indicated for reduction of signs and symptoms, inhibition of progression of structural damage, and improvement of physical function in adults with active psoriatic arthritis

40 mg SC q2wk

Dosing considerations

May be administered as monotherapy or combined with methotrexate or other nonbiologic DMARDs

If not taken with concomitant methotrexate, additional benefit may be derived from increasing adalimumab dosing frequency to once weekly

Ankylosing Spondylitis

Indicated for reduction of signs and symptoms of active ankylosing spondylitis

40 mg SC q2wk

Dosing considerations

May be administered as monotherapy or combined with methotrexate or other nonbiologic DMARDs

If not taken with concomitant methotrexate, additional benefit may be derived from increasing adalimumab dosing frequency to once weekly

Plaque Psoriasis

Indicated for treatment of moderate-to-severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy and for whom other systemic therapies are inappropriate

80 mg SC once, then, after 1 week, 40 mg SC q2wk

Crohn Disease

Indicated for reduction of signs and symptoms and induction and maintenance of clinical remission in adults with moderately to severely active Crohn disease who have had inadequate response to conventional therapy; may be used in patients who have lost response to or are intolerant of infliximab

Induction: 160 mg SC either as 4 injections of 40 mg on day 1 or as 2 injections of 40 mg daily on 2 consecutive days, then 80 mg SC 2 weeks later

Maintenance (beginning Week 4 [Day 29]): 40 mg SC q2wk

Dosing considerations

Some patients may require weekly 40-mg dose for

Ulcerative Colitis

Indicated for treatment of ulcerative colitis unresponsive to immunosuppressants (eg, corticosteroids, azathioprine, 6-mercaptopurine [6-MP])

Induction: 160 mg SC either as 4 injections of 40 mg on day 1 or as 2 injections of 40 mg daily on 2 consecutive days, then 80 mg SC 2 weeks later (day 15)

Maintenance (beginning Week 4 [Day 29]): 40 mg SC q2wk

Continue maintenance dose only if evidence of clinical remission is apparent by 8 weeks of therapy 

Hidradenitis Suppurativa

Indicated for treatment of moderate-to-severe hidradenitis suppurativa

Induction: 160 mg SC either as 4 injections of 40 mg on day 1 or as 2 injections of 40 mg daily on 2 consecutive days, then 80 mg SC 2 weeks later (day 15)

Maintenance (beginning Week 4 [Day 29]): 40 mg SC qwk

Uveitis

Indicated for treatment of noninfectious intermediate, posterior, and panuveitis in adults

80 mg SC once, then, after 1 week, 40 mg SC q2wk

Alerts

Concerns related to adverse effects:

Heart failure: Worsening and new-onset heart failure (HF) has been reported with adalimumab and other TNF blockers. Use with caution in patients with HF or decreased left ventricular function.

Infections:  Patients receiving adalimumab are at increased risk for serious infections which may result in hospitalization and/or fatality; infections usually developed in patients receiving concomitant immunosuppressive agents (eg, methotrexate, corticosteroids) and may present as disseminated disease.

Active tuberculosis (including reactivation of latent tuberculosis), invasive fungal (including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, and pneumocystosis) and bacterial, viral or other opportunistic infections (including legionellosis and listeriosis) have been reported. Monitor closely for signs/symptoms of infection during and after treatment. Discontinue for serious infection. Consider risks versus benefits prior to initiating therapy in patients with chronic or recurrent infection.

Malignancy:  Lymphoma and other malignancies (some fatal) have been reported in children and adolescents receiving TNF-blocking agents, including adalimumab. Half of the malignancies reported in children and adolescents were lymphomas (Hodgkin and non-Hodgkin). Most patients were receiving concomitant immunosuppressants. 

Special populations:

Elderly: Infection and malignancy has been reported at a higher incidence; use caution in elderly patients.

Points of recommendation

This medicine affects patients immune system. Patient may get infections more easily, even serious or fatal infections.

Before or during treatment with adalimumab, patients should tell their doctor if they have signs of infection such as fever, chills, aches, tiredness, cough, diarrhea, or burning when urinate.


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