Formulary
Certolizumab pegol: Indications, Dosing, Side Effects and Interactions
Certolizumab pegol clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 4 min read
Certolizumab pegol: Indications, Dosing, Side Effects and Interactions
Certolizumab pegol clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Moderate to severe active rheumatoid arthritis when response to disease-modifying antirheumatic drugs [including methotrexate] has been inadequate [as monotherapy or in combination with methotrexate] (initiated by a specialist),Severe, active and progressive rheumatoid arthritis in patients not previously treated with methotrexate or other disease-modifying antirheumatic drugs [in combination with methotrexate] (initiated by a specialist),Active psoriatic arthritis when response to disease-modifying antirheumatic drugs has been inadequate [as monotherapy or in combination with methotrexate] (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Loading dose 400 mg every 2 weeks for 3 doses, then maintenance 200 mg every 2 weeks, once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered, review treatment if no response within 12 weeks.
**Severe active ankylosing spondylitis in patients who have had an inadequate response to, or are intolerant of NSAIDs (initiated by a specialist),Severe active axial spondyloarthritis, without radiographic evidence of ankylosing spondylitis but with objective signs of inflammation, in patients who have had an inadequate response to, or are intolerant of NSAIDs (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Loading dose 400 mg every 2 weeks for 3 doses, then maintenance 200 mg every 2 weeks, alternatively maintenance 400 mg every 4 weeks, review treatment if no response within 12 weeks, after at least 1 year of treatment, an alternative maintenance dosing of 200 mg every 4 weeks can be considered in patients with sustained remission.
**Moderate to severe plaque psoriasis (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Loading dose 400 mg every 2 weeks for 3 doses, then maintenance 200 mg every 2 weeks, an alternative maintenance dosing of 400 mg every 2 weeks can be considered in patients with insufficient response, review treatment if no response within 16 weeks.
Cautions
Chronic obstructive pulmonary disease (risk of malignancy); demyelinating CNS disorders (risk of exacerbation); do not initiate until active infections are controlled (discontinue if new serious infection develops and until infection controlled); elderly (risk of infections); hepatitis B virus (monitor for active infection); history or development of malignancy; mild heart failure (discontinue if symptoms develop or worsen); predisposition to infection Cautions, further information Tuberculosis Active tuberculosis should be treated with standard treatment for at least 2 months before starting certolizumab pegol. Patients who have previously received adequate treatment for tuberculosis can start certolizumab pegol but should be monitored every 3 months for possible recurrence. In patients without active tuberculosis but who were previously not treated adequately, chemoprophylaxis should ideally be completed before starting certolizumab pegol. In patients at high risk of tuberculosis who cannot be assessed by tuberculin skin test, chemoprophylaxis can be given concurrently with certolizumab pegol.
Contraindications
Moderate to severe heart failure; severe active infection
Side effects
Common or very common Abscess; asthenia; decreased leucocytes; eosinophilic disorders; fever; headaches; hepatic disorders; hypertension; increased risk of infection; nausea; neutropenia; pain; sensory disorder; skin reactions Uncommon Alopecia; anaemia; anxiety; appetite disorder; arrhythmias; ascites; asthma; breast disorder; cardiomyopathy; chills; coronary artery disease; cough; cyst; dizziness; dyslipidaemia; electrolyte imbalance; embolism and thrombosis; eye inflammation; flushing; gastrointestinal discomfort; gastrointestinal disorders; haemorrhage; healing impaired; heart failure; hypercoagulation; hypersensitivity; influenza like illness; lacrimation disorder; lupus erythematosus; lymphadenopathy; menstrual cycle irregularities; mood disorder; multi organ failure; muscle disorder; nail disorder; neoplasms; nerve disorders; oedema; oral disorders; oropharyngeal dryness; palpitations; photosensitivity reaction; renal impairment; respiratory disorders; sepsis; skin ulcer; solid organ neoplasm; sweat changes; syncope; temperature perception abnormal; thrombocytopenia; thrombocytosis; tinnitus; tremor; urinary tract disorder; vasculitides; vertigo; vision disorders; weight change Rare or very rare Angioedema; atherosclerosis; atrioventricular block; cholelithiasis; cognitive impairment; delirium; dermatomyositis exacerbated; fistula; haemosiderosis; hair texture abnormal; interstitial lung disease; movement disorders; nephritis; nephropathy; odynophagia; pancytopenia; panniculitis; pericarditis; polycythaemia; Raynaud's phenomenon; sarcoidosis; seizure; sexual dysfunction; splenomegaly; Stevens-Johnson syndrome; stroke; suicide attempt; telangiectasia; thyroid disorder Frequency not known Azoospermia; hepatitis B reactivation; multiple sclerosis Side-effects, further information Associated with infections, sometimes severe, including tuberculosis, septicaemia, and hepatitis B reactivation.
Interactions
**Severe interactions:**
- Co-administration of Cimzia with methotrexate had no significant effect on the pharmacokinetics of methotrexate.
**Other interactions (2):**
- Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics showed no effect on the pharmacokinetics of certolizumab pegol based on a...
- The combination of certolizumab pegol and anakinra or abatacept is not recommended (see section 4.4).
Pregnancy
Manufacturer advises use only if potential benefit outweighs risk-limited information available.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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