SubcutaneousAnkylosing spondylitisAdult: In patients with active cases who are intolerant to or have had an inadequate response to NSAIDs: Initially, 400 mg (given as 2 injections of 200 mg) at weeks 0, 2, and 4. Maintenance: 200 mg every 2 weeks or 400 mg every 4 weeks. May reduce maintenance dose to 200 mg every 4 weeks after at least 1 year of treatment in patients with sustained remission.
SubcutaneousCrohn's diseaseAdult: In patients with moderate to severe cases who have had an inadequate response to conventional treatment: Initially, 400 mg (given as 2 injections of 200 mg) at weeks 0, 2, and 4. Maintenance: 400 mg every 4 weeks. Treatment recommendations may vary between countries (refer to specific product guidelines).
SubcutaneousNon-radiographic axial spondyloarthritisAdult: In patients with objective signs of inflammation: Initially, 400 mg (given as 2 injections of 200 mg) at weeks 0, 2, and 4. Maintenance: 200 mg every 2 weeks or 400 mg every 4 weeks. Dosage recommendations may vary between countries (refer to specific product guidelines).
SubcutaneousPlaque psoriasisAdult: In patients with moderate to severe cases, who are candidates for systemic treatment or phototherapy, or weighing ≤90 kg: Initially, 400 mg (given as 2 injections of 200 mg) at weeks 0, 2, and 4. Alternatively, 400 mg (given as 2 injections of 200 mg) every 2 weeks. Maintenance: 200 mg every 2 weeks, or 400 mg every 2 weeks in patients with insufficient response. Dosage recommendations may vary between countries (refer to specific product guidelines).
SubcutaneousPsoriatic arthritisAdult: As monotherapy or in combination with methotrexate: Initially, 400 mg (given as 2 injections of 200 mg) at weeks 0, 2, and 4. Maintenance: 200 mg every 2 weeks. Alternatively, 400 mg every 4 weeks.
SubcutaneousRheumatoid arthritisAdult: For moderate to severe cases: As monotherapy or in combination with methotrexate: Initially, 400 mg (given as 2 injections of 200 mg) at weeks 0, 2, and 4. Maintenance: 200 mg every 2 weeks. Alternatively, 400 mg every 4 weeks.
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Vial: Reconstitute vial with 1 mL of sterile water for inj to a concentration of 200 mg/mL. Direct sterile water for inj at the vial wall and gently swirl for approx 1 minute to avoid foaming. Continue swirling every 5 minutes until full reconstitution (may take approx 30 minutes). Do not shake. Refer to specific product guidelines.
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Hypersensitivity. Moderate to severe heart
failure (NYHA class III or IV). Active TB or other severe infections (e.g. sepsis, opportunistic infections). Concomitant
administration with anakinra, other tumour necrosis factor
(TNF) blockers such as abatacept, etanercept, or rituximab, and live vaccines.
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Patient with previous hypersensitivity reactions with other TNF blockers, history of recurring or opportunistic infections, underlying conditions predisposing to infections (e.g. concomitant use of immunosuppressive medications); history of malignancy; moderate to severe COPD or those at high risk for malignancy due to heavy smoking; mild heart failure (NYHA class I or II); underlying haematological disorders; pre-existing or recent onset of central or peripheral nervous system demyelinating. Patients who have been exposed to TB, resided, or have travelled in areas of endemic TB or endemic mycoses. Patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery. HIV-positive patients, and HBV carriers. Renal impairment. Elderly. Pregnancy and lactation.
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Significant: Immunosuppression, immunogenicity; autoimmunity (resulting in the formation of antinuclear antibodies); disseminated or extrapulmonary TB. Rarely, haematological reactions (e.g. leucopenia, pancytopenia, thrombocytopenia, aplastic anaemia); new onset or exacerbation of demyelinating CNS disorder e.g. multiple sclerosis, Guillain-Barre syndrome and other neurological disorders e.g. seizure, optic neuritis, and peripheral neuropathy.
Blood and lymphatic system disorders: Lymphadenopathy.
Cardiac disorders: Ischaemic coronary artery disorders, arrhythmias, atrial fibrillation, palpitations.
Ear and labyrinth disorders: Tinnitus, vertigo.
Eye disorders: Visual disorder (e.g. decreased vision), eye and eyelid inflammation, lacrimation disorder.
Gastrointestinal disorders: Nausea, diarrhoea, ascites, gastrointestinal ulceration and perforation, gastrointestinal tract inflammation, stomatitis, dyspepsia, abdominal distension, oropharyngeal dryness.
General disorders and administration site conditions: Pyrexia, pain, asthenia, inj site reactions, oedema (peripheral or facial), chills, influenza-like illness, altered temperature perception, night sweats.
Immune system disorders: Vasculitides, allergic disorders.
Infections and infestations: Bacterial infections (e.g. abscess), viral infections (e.g. herpes zoster, influenza, papillomavirus).
Injury, poisoning, and procedural complications: Skin injuries, impaired healing.
Investigations: Increased blood bilirubin, hepatic enzyme, blood alkaline phosphatase, blood creatinine phosphokinase, and serum transaminases, prolonged coagulation time, weight change.
Metabolism and nutrition disorders: Electrolyte imbalance, dyslipidaemia, appetite disorders.
Musculoskeletal and connective tissue disorders: Muscle disorders, arthralgia.
Neoplasms benign, malignant, and unspecified: Non-melanoma skin cancers, precancerous lesions (e.g. oral leukoplakia, melanocytic nevus), solid organ tumours, benign tumours, cysts (e.g. skin papilloma).
Nervous system disorders: Headaches (including migraine), sensory abnormalities, dizziness, tremor.
Psychiatric disorders: Anxiety, mood disorders.
Renal and urinary disorders: Renal impairment, blood in urine, bladder and urethral symptoms, UTI.
Reproductive system and breast disorders: Menstrual cycle, uterine bleeding disorders (including amenorrhea), and breast disorders.
Respiratory, thoracic, and mediastinal disorders: Cough, asthma, pleural effusion, respiratory tract congestion and inflammation, URTI.
Skin and subcutaneous tissue disorders: Rash, pruritus, alopecia, new onset or worsening of psoriasis (including palmoplantar pustular psoriasis), dermatitis, eczema, sweat gland disorder, skin ulcer, photosensitivity, acne, skin discolouration, dry skin, nail, or nail bed disorders.
Vascular disorders: Hypertension, haemorrhage or bleeding (any site), hypercoagulation (e.g. thrombophlebitis, pulmonary embolism), syncope, ecchymoses (e.g. haematoma, petechiae), flushing.
Potentially Fatal: Serious or fatal infections (e.g. sepsis, active TB [including reactivation of latent TB], invasive fungal infections such as aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, pneumocystosis, and other bacterial or viral infections caused by opportunistic pathogens including legionellosis, listeriosis); HBV reactivation; new onset or exacerbation of CHF; malignancies (e.g. lymphoma, leukaemia, melanoma, Merkel cell carcinoma). Rarely, severe hypersensitivity reactions (e.g. anaphylaxis, angioedema).
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This drug may cause dizziness, vertigo, vision disorder and fatigue, if affected, do not drive, or operate machinery. Women of childbearing potential must use proven birth control methods during therapy and for 5 months after stopping the treatment.
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Perform TB screening before and during therapy; HBV or HCV screening prior to initiation of treatment; HBV carriers (during and for several months after therapy); HIV screening at baseline. Obtain baseline CBC with differential, complete metabolic panel. Monitor for signs and symptoms of infection, heart failure, hypersensitivity reactions (e.g. angioedema, dyspnoea, hypotension), lupus-like syndrome or malignancy (e.g. splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss). Monitor symptoms improvement and physical function assessments.
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Decreased therapeutic effect and increased risk of vaccine-associated infections with live vaccines.
Potentially Fatal: Increased risk of serious infections and neutropenia with anakinra or other TNF-blockers such as abatacept, etanercept, and rituximab.
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May cause a false-negative latent TB test. May result in falsely elevated aPTT assay results.
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Description:
Mechanism of Action: Certolizumab pegol, a biologic DMARD, is a pegylated humanised antibody Fab' fragment of tumour necrosis factor-α (TNF-α). It binds and selectively neutralises the activity of human TNF-α, a pro-inflammatory cytokine involved in the regulation of immune response such as inflammatory processes associated with Crohn's disease and in joint destruction related to rheumatoid arthritis. Certolizumab pegol also inhibits the production of lipopolysaccharide-induced TNF-α and interleukin-1β (IL-1β).
Pharmacokinetics:
Absorption: Bioavailability: Approx 80% (range: 76-88%). Time to peak plasma concentration: 54-171 hours.
Excretion: Elimination half-life: Approx 14 days.
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Intact vial/pre-filled syringe, pen, or dose-dispenser cartridge: Store between 2-8°C. Do not freeze. Protect from light. Pre-filled syringe/pen may also be stored up to 25°C for up to 10 days; discard any unused portion at the end of this period. Protect from light. Reconstituted solution: Store between 2-8°C for up to 24 hours. Do not freeze. Storage recommendations may vary among individual products or between countries (refer to specific product or local guidelines).
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L04AB05 - certolizumab pegol ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
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Anon. Certolizumab Pegol. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/08/2023. Anon. Certolizumab Pegol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/10/2023. Buckingham R (ed). Certolizumab Pegol. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/10/2023. Cimzia (UCB). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 12/10/2023. Cimzia 200 mg Solution for Injection in Dose-dispenser Cartridge (UCB Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/08/2023. Cimzia 200 mg Solution for Injection in Pre-filled Pen (UCB Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/08/2023. Cimzia Injection, Solution (UCB, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/08/2023. Joint Formulary Committee. Certolizumab Pegol. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/08/2023.
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