Certolizumab pegol parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection formulation of certolizumab pegol.
Drugs List
Therapeutic Indications
Uses
Active psoriatic arthritis
Moderate to severe plaque psoriasis
Rheumatoid arthritis (unresp to DMARD/TNF inhib.) in comb with methotrexate
Rheumatoid arthritis when inadequate response to DMARDs incl. methotrexate
Severe active axial spondyloarthritis
Severe active rheumatoid arthritis
Rheumatoid arthritis
In combination with methotrexate:
Treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs).
Certolizumab pegol can be given as monotherapy in case of intolerance to methotrexate or where continued treatment with methotrexate in inappropriate.
Treatment of severe, active and progressive rheumatoid arthritis in patients not previously treated with methotrexate or other DMARDs.
Certolizumab pegol has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Axial spondyloarthritis
Treatment of adult patients with severe active axial spondyloarthritis, comprising:
Ankylosing spondylitis (AS)
Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to non steroidal anti-inflammatory drugs (NSAIDs).
Axial spondyloarthritis without radiographic evidence of AS
Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to NSAIDs.
Psoriatic arthritis
In combination with methotrexate:
Treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.
Certolizumab pegol can be given as monotherapy in case of intolerance to methotrexate or where continued treatment with methotrexate in inappropriate.
Plaque psoriasis
Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Dosage
Adults
Loading dose
The recommended starting dose is 400mg (as 2 injections of 200mg each on one day) at weeks 0, 2 and 4.
Rheumatoid arthritis
After the starting dose, the recommended maintenance dose of certolizumab pegol is 200mg every 2 weeks. Once clinical response is confirmed, an alternative maintenance dosing of 400mg every 4 weeks can be considered.
Methotrexate should be continued during treatment with certolizumab pegol where appropriate.
Axial spondyloarthritis
After the starting dose, the recommended maintenance dose of certolizumab pegol is 200mg every 2 weeks or 400mg every 4 weeks.
After 1 year of treatment with certolizumab pegol, in patients with sustained remission, a reduced maintenance dose of 200mg every 4 weeks may be considered.
Psoriatic arthritis
After the starting dose, the recommended maintenance dose of certolizumab pegol for adult patients is 200mg every 2 weeks. Once clinical response is confirmed, an alternative maintenance dosing of 400mg every 4 weeks can be considered.
Methotrexate should be continued during treatment with certolizumab pegol where appropriate.
Plaque psoriasis
After the starting dose, the recommended maintenance dose of certolizumab pegol for adult patients is 200mg every 2 weeks. A dose of 400mg every 2 weeks can be considered in patients with an insufficient response.
Additional Dosage Information
Patients who miss a dose should be advised to inject the next dose of certolizumab pegol as soon as they remember and then continue injecting subsequent doses every 2 weeks as originally instructed.
For rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis, continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment. For plaque psoriasis reconsider treatment in patients who show no evidence of therapeutic benefit within the first 16 weeks of treatment.
Administration
For subcutaneous administration into the thigh or abdomen.
After proper training, patients may self-inject if their physician determines that it is appropriate and with medical follow-up as necessary.
Contraindications
Children under 18 years
Severe infection
New York Heart Association class III failure
Tuberculosis
Precautions and Warnings
Elderly
Females of childbearing potential
History of recurrent infection
Immunosuppression
Surgery
Central nervous system demyelinating disorder
Chronic obstructive pulmonary disease
History of malignant melanoma
Latent or healed tuberculosis
New York Heart Association class I failure
Pregnancy
Administration of live vaccines is not recommended
Latex allergy may predispose patient to severe allergic reaction
Advise ability to drive/operate machinery may be affected by side effects
Before initiating screen at risk patients for hepatitis B infection
Consider prophylactic anti-tuberculosis therapy if appropriate
Prior to starting therapy rule out active tuberculosis
Prior to starting therapy screen for latent tuberculosis
Treat and control infections prior to commencing therapy
Treatment to be initiated and supervised by a specialist
May cause activation / exacerbation of latent / intercurrent infections
Monitor closely any patient who develops new infection while on treatment
Monitor for infection for 5 months after treatment
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor patient constantly for signs of new infection
Review if an adequate response not obtained within 3 months
Advise patient to monitor for and report any skin changes
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Discontinue if a serious infection develops
Discontinue if hepatitis develops
Immunosuppressive drugs may increase risk of malignancy
Reactivation of hepatitis B may occur in chronic carriers
Risk of developing opportunistic infections
False negative tuberculin test results in immunosupp./severely ill patients
May affect results of some laboratory tests
Discontinue and investigate if symptoms of lupus-like syndrome develop
Discontinue at the first signs of cardiac failure
Discontinue if blood dyscrasia develops
Discontinue if severe hypersensitivity reactions occur
Female: Contraception required during & for at least 5 months after therapy
Remind patient of importance of carrying Alert Card with them at all times
Caution should be exercised when treating patients with a history of recurring infection or with underlying conditions which may predispose a patient to infections.
Use of anti-tuberculosis therapy should also be considered before treating patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and in patients who have significant risk factors for tuberculosis despite a negative test for latent tuberculosis. Biological tests for tuberculosis screening should be considered before starting treatment if there is any potential latent tuberculosis infection, regardless of BCG vaccination.
Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating therapy. Carriers of HBV who require treatment with TNF antagonists should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.
In patients with pre-existing or recent onset demyelinating disorders, the benefits and risks of TNF antagonist treatment should be carefully considered before initiating therapy.
Tumour necrosis factor (TNF) mediates inflammation and modulates cellular immune responses, the possibility exists for TNF antagonists, including certolizumab, to cause immunosuppression, affecting host defences against infections and malignancies.
The 14-day half-life of certolizumab pegol should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on treatment should be closely monitored for infections.
Pregnancy and Lactation
Pregnancy
Certolizumab pegol should be used with caution during pregnancy.
Data collected does not indicate a malformative effect of certolizumab pegol, however experience is too limited from use in pregnant women to exclude risk. Due to its inhibition of TNF-alpha, certolizumab pegol administered during pregnancy could affect normal immune response in the newborn. Women of childbearing potential should use adequate contraception and continue its use for at least 5 months following the cessation of treatment.
The manufacturer states that animal studies have not revealed any harm to the foetus.
Certolizumab pegol should only be used during pregnancy if clinically needed.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Certolizumab pegol can be used during breastfeeding.
Certolizumab pegol is minimally excreted into breast milk and absorption is unlikely because it is degraded in the infant's gastrointestinal tract.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abnormal leukocytes
Allergic reaction
Altered temperature sensation
Anaemia
Angioneurotic oedema
Anxiety
Arrhythmias
Arteriosclerosis
Ascites
Asthenia
Atrioventricular block
Autoantibody positive
Bacterial infection
Benign tumours
Breast changes
Cardiomyopathy
Cerebrovascular accident
Coronary artery disorder
Creatine phosphokinase increased
Cysts
Delirium
Depression (with risk of suicide)
Disturbances of appetite
Dizziness
Dyslipidaemia
Ecchymosis
Electrolyte disturbances
Eosinophilia
Eye disorder
Flushing
Fungal infection
Gastrointestinal disorder
Haemorrhage
Haemosiderosis
Headache
Hepatobiliary disorders
Hypercoagulability of the blood
Hypersensitivity reactions
Hypertension
Impaired co-ordination
Impaired healing
Impairment of mental skills
Increase in alkaline phosphatase
Increased coagulation time
Increased susceptibility to development of lymphoma and other malignancies
Increased uric acid level
Influenza-like symptoms
Injection site reactions
Interstitial lung disease
Leukopenia
Livedo reticularis
Local pain (injection site)
Lupus erythematosus
Lymphadenopathy
Malignant melanoma
Menstrual disturbances
Mood changes
Multiorgan failure
Multiple sclerosis
Muscle disorders
Nausea
Neuralgia
Night sweats
Non melanoma skin cancer
Oedema
Palpitations
Pancytopenia
Panniculitis
Pericarditis
Peripheral neuropathy
Polycythaemia
Pre-cancerous lesions
Pruritus
Pyrexia
Raynaud's phenomenon
Renal disorders
Respiratory disorders
Sarcoidosis
Sensory disturbances
Sepsis
Septic shock
Serum sickness
Sexual dysfunction
Skin disorder
Solid organ tumours
Splenomegaly
Syncope
Telangiectasia
Thrombocytopenia
Thrombocytosis
Thyroid abnormalities
Tinnitus
Tremor
Tuberculosis
Vasculitis
Vertigo
Viral infection
Visual disturbances
Weight changes
Effects on Laboratory Tests
Certolizumab pegol may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.
Careful attention should be given to interpretation of abnormal coagulation results in patients receiving certolizumab therapy.
Risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: March 2018
Reference Sources
Summary of Product Characteristics: Cimzia 200mg solution for injection in pre-filled pen. UCB Pharma Limited. Revised July 2020.
Summary of Product Characteristics: Cimzia 200mg solution for injection in pre-filled syringe. UCB Pharma Limited. Revised July 2020.
Summary of Product Characteristics: Cimzia 200mg solution for injection in dose-dispenser cartridge. UCB Pharma Limited. Revised July 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 March 2018
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Certolizumab pegol Last revised: 2 June, 2016
Last accessed: 11 October, 2016
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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