Cimzia

Certolizumab pegol

As monotherapy or in combination w/ methotrexate (MTX) for the treatment of moderate to severe, active RA in adult patients when the response to DMARDs including MTX, has been inadequate. In combination w/ methotrexate (MTX) for the treatment of severe, active & progressive RA in adults not previously treated w/ MTX or other DMARDs. Reduce the rate of progression of joint damage as measured by X-ray & to improve physical function, when given in combination w/ MTX. Treatment of severe active axial spondyloarthritis: Adults w/ severe active ankylosing spondylitis (AS) who are intolerant or w/ inadequate response to NSAIDs; severe active axial spondyloarthritis w/o radiographic evidence of AS but w/ objective signs of inflammation by elevated C-reactive protein (CRP) &/or MRI, who are intolerant or w/ inadequate response to NSAIDs. In combination w/ MTX for treatment of active psoriatic arthritis when DMARD therapy has been inadequate. Can be given as monotherapy in case of intolerance to MTX or when inappropriate. Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

SC Adult Loading dose: 400 mg (given as 2 SC inj of 200 mg each) at wk 0, 2 & 4. Suitable inj sites are thigh or abdomen. RA Maintenance dose: 200 mg every 2 wk; or 400 mg every 4 wk once clinical response is confirmed. MTX should be continued during treatment where appropriate. Axial spondyloarthritis Maintenance dose: 200 mg every 2 wk or 400 mg every 4 wk. Consider reduction to 200 mg every 4 wk after at least 1 yr of treatment in patients w/ sustained remission. Psoriatic arthritis Maintenance dose: 200 mg every 2 wk; or 400 mg every 4 wk once clinical response is confirmed. MTX should be continued during treatment where appropriate. Plaque psoriasis Maintenance dose: 200 mg every 2 wk; or 400 mg every 2 wk in patients w/ insufficient response.

Hypersensitivity. Active TB or other severe infections eg, sepsis or opportunistic infections; moderate to severe heart failure (NYHA classes III/IV).

Risk of infections. Do not initiate in patients w/ active infections, including chronic or localised infections, until infection is controlled. Caution in patients w/ history of recurrent or opportunistic infection, or underlying conditions that may predispose patients to infections, including concomitant immunosuppressive therapy. Closely monitor for infections including TB (active or inactive) before, during & after treatment. Risk of HBV reactivation in HBV carriers; test for HBV infection prior treatment. Use w/ caution in patients w/ history of malignancy or when considering continuing treatment in patients who develop malignancy. Periodically perform skin exam particularly for patients w/ risk factors for skin cancer. Risk for the development of malignancies in childn & adolescents. Caution in patients w/ COPD; increased risk of malignancy due to heavy smoking; mild heart failure (NYHA class I/II); pre-existing or recent onset CNS demyelinating disorders. Discontinue in patients who develop new or worsening symptoms of CHF. Consider discontinuation in patients w/ confirmed significant haematologic abnormalities. Discontinue in case of severe hypersensitivity reactions. Potential risk of latex hypersensitivity. Possible to cause immunosuppression. Discontinue if symptoms of lupus-like syndrome develop. Do not administer live vaccines. Concomitant use w/ anakinra or abatacept is not recommended. Surgery patients should be closely monitored for infections. Interference w/ certain coagulation assays. Minor influence on the ability to drive & use machines. Women of childbearing potential should consider adequate contraception. Pregnancy. Can be used during breastfeeding. Childn & adolescent <18 yr. Elderly.

Bacterial infections (including abscess), viral infections (including herpes zoster, papillomavirus, influenza); eosinophilic disorders, leukopaenia (including neutropaenia, lymphopaenia); headaches (including migraine), sensory abnormalities; HTN; nausea; hepatitis (including increased hepatic enzyme); rash; pyrexia, pain (any site), asthaenia, pruritus (any site), inj site reactions.

Increased similar toxicities w/ anakinra or abatacept.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AB05 - certolizumab pegol ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.

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