Certolizumab pegol


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Moderate to severe rheumatoid arthritis; Psoriatic arthritis As monotherapy or with methotrexate: Initial: 400 mg, repeated at weeks 2 and 4. Maintenance: 200 mg every other week, or 400 mg every 4 weeks if clinical response occurs. Ankylosing spondylitis Initial: 400 mg, repeated at weeks 2 and 4. Maintenance: 200 mg every other week or 400 mg every 4 weeks. Crohn's disease Initial: 400 mg, repeated at weeks 2 and 4. Maintenance: 400 mg every 4 weeks.
Dosage Details
Subcutaneous
Rheumatoid arthritis
Adult: Moderate to severe cases: As monotherapy or in combination with methotrexate: Initially, 400 mg (given as 2 injections of 200 mg), repeated at weeks 2 and 4. Maintenance: 200 mg every other week; may consider 400 mg every 4 weeks if clinical response occurs.

Subcutaneous
Ankylosing spondylitis
Adult: Initially, 400 mg (given as 2 injections of 200 mg), repeated at weeks 2 and 4. Maintenance: 200 mg every other week or 400 mg every 4 weeks.

Subcutaneous
Psoriatic arthritis
Adult: As monotherapy or in combination with methotrexate: Initially, 400 mg (given as 2 injections of 200 mg), repeated at weeks 2 and 4. Maintenance: 200 mg every other week; may consider 400 mg every 4 weeks if clinical response occurs.

Subcutaneous
Crohn's disease
Adult: Initially, 400 mg (given as 2 injections of 200 mg), repeated at weeks 2 and 4. Maintenance: 400 mg every 4 weeks.
Reconstitution
Add 1 mL sterile water for injection to a vial containing 200 mg to prepare a 200 mg/mL solution. Direct sterile water for injection at the vial wall and swirl gently for about 1 minute. Continue swirling every 5 minutes until fully reconstituted.
Contraindications
Active infection, including chronic or localised infections (e.g. active TB), moderate or severe heart failure (NYHA class III/IV). Concurrent administration of anakinra, abatacept, and live vaccines.
Special Precautions
Patient with haematologic disorders, hypersensitivity reactions (e.g. rash, angioedema, urticaria, dyspnoea, hypotension), mild heart failure (NYHA class I/II) pre-existing or recent central or peripheral nervous system demyelinating disorders, latent TB, chronic hepatitis B virus (HBV) carriers, history of chronic, recurrent or opportunistic infections, malignancy (including history of), risk factors for skin cancer. Patients who are undergoing surgery, exposed to TB, or those who resided or have travelled in areas of endemic TB or endemic mycoses. Pregnancy and lactation.
Adverse Reactions
Significant: Antinuclear antibody formation, immunogenicity, immunosuppression. Rarely, seizure disorder, peripheral neuropathy, multiple sclerosis, Guillain-Barre syndrome, optic neuritis, pancytopenia, aplastic anaemia, leucopenia, thrombocytopenia, severe hypersensitivity, lupus-like syndrome.
Blood and lymphatic system disorders: Hypercoagulopathy.
Cardiac disorders: Atrial fibrillation, angina pectoris, cardiac arrhythmia, CVA, hypertensive heart disease, ischaemic heart disease, MI, pericarditis, pericardial effusion, TIA.
Eye disorders: Retinal haemorrhage.
Gastrointestinal disorders: Nausea.
General disorders and administration site conditions: Fatigue, fever.
Hepatobiliary disorders: Hepatitis.
Immune system disorders: Urticaria, erythema nodosum.
Infections and infestations: Bacterial (e.g. abscess) and viral (e.g. influenza) infections.
Investigations: Increased hepatic transaminases.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Anxiety, bipolar disorder, suicidal tendencies.
Renal and urinary disorders: Urinary tract infection, nephrotic syndrome, renal failure.
Reproductive system and breast disorders: Menstrual disease.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, cough, nasopharyngitis, bronchitis.
Skin and subcutaneous tissue disorders: Alopecia, dermatitis.
Vascular disorders: Hypertension, vasculitis, haemorrhage.
Potentially Fatal: Serious infections (e.g. sepsis, TB, invasive fungal, bacterial or viral infections), hepatitis B virus (HBV) reactivation (in chronic HBV virus carriers), exacerbation of or new onset CHF, malignancies (e.g. lymphoma, leukaemia, melanoma, Merkel cell carcinoma).
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor for signs and symptoms of infection during and after treatment. Evaluate all patients for active and latent TB, HBV infection prior to therapy.
Drug Interactions
Potentially Fatal: Risk of severe infections and neutropenia with anakinra and abatacept. May diminish the effect of live vaccines.
Lab Interference
May cause falsely elevated aPTT assay results. False-negative for latent tuberculosis test.
Action
Description: Certolizumab pegol is a pegylated humanised tumour necrosis factor (TNF) antibody fragment that binds specifically to TNF-α, a naturally occurring cytokine that is involved in normal inflammatory and immune responses. It 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.
Distribution: Volume of distribution: 6-8 L.
Excretion: Terminal elimination half-life: Approx 14 days.
Storage
Store between 2-8°C. Protect from light. Do not freeze.
Any unused portions should be disposed of in accordance with local requirements (standard procedures).
ATC Classification
L04AB05 - certolizumab pegol ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
References
Anon. Certolizumab Pegol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/03/2018.

Buckingham R (ed). Certolizumab Pegol. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/03/2018.

Cimzia Injection, Solution (UCB, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/03/2018.

Disclaimer: This information is independently developed by MIMS based on Certolizumab pegol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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