certolizumab pegol




Agencia Lei Va Hong
Concise Prescribing Info
Certolizumab pegol
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. 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 adult patients w/ severe active axial spondyloarthritis: 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.
Dosage/Direction for Use
SC Adult Loading dose: 400 mg (given as 2 SC inj of 200 mg each) at wk 0, 2 & 4. RA, axial spondyloarthritis, psoriatic arthritis Maintenance dose: 200 mg every 2 wk, or 400 mg every 4 wk once clinical response is confirmed. Suitable inj sites are thigh or abdomen.
Hypersensitivity. Active TB or other severe infections eg, sepsis or opportunistic infections; moderate to severe heart failure (NYHA classes III/IV).
Special Precautions
Active infections including chronic or localised infections; history of recurrent or opportunistic infection, or underlying conditions that may predispose patients to infections, concomitant immunosuppressive therapy, or patients who traveled/resided to regions where TB & mycosis are endemic. Monitor & evaluate for signs & symptoms of both active or in active TB. 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. COPD & patients w/ increased risk of malignancy due to heavy smoking. Mild heart failure (NYHA class I/II). Discontinue in patients who develop new or worsening symptoms of CHF. Pre-existing or recent onset CNS demyelinating disorders; confirmed significant haematologic abnormalities. Discontinue in case of severe hypersensitivity reactions. Possible to cause immunosuppression. Discontinue if symptoms of lupus-like syndrome develop. Do not administer live vaccines. Concomitant use w/ anakinra or abatacept & another TNF-antagonist, etanercept. 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. Pregnancy. Can be used during breastfeeding. Childn & adolescent <18 yr. Elderly.
Adverse Reactions
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.
Drug Interactions
Increased similar toxicities w/ anakinra or abatacept.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AB05 - certolizumab pegol ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Cimzia soln for inj 200 mg/mL
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