certolizumab pegol: clinical use

Prescribing considerations

• Initiation and supervision should be by a specialist experienced in the licensed condition.
• Assess active and latent tuberculosis and test for hepatitis B before treatment.
• Do not initiate during a clinically important active infection; reassess if a serious infection develops.
• Review vaccination status and avoid concurrent live vaccines.
• Consider infection risk in older people and patients with recurrent infection, comorbidity or additional immunosuppression.
• Record the product name and batch number for biological traceability.
• Plan surgery with the relevant specialist and monitor for postoperative infection.

Contraindications and cautions

• Hypersensitivity to certolizumab pegol or an excipient
• Active tuberculosis
• Other severe infection, including sepsis or opportunistic infection
• Moderate to severe heart failure

Monitoring

• Monitor clinically for infection, including tuberculosis, before, during and after treatment.
• For hepatitis B carriers, monitor for clinical and laboratory evidence of reactivation during treatment and afterwards.
• Assess new or worsening heart failure, neurological, haematological, autoimmune or severe hypersensitivity features.
• Consider periodic skin examination, particularly when skin-cancer risk factors are present.
• Interpret an unexpectedly prolonged activated partial thromboplastin time cautiously because certolizumab can interfere with some assays.

Clinical pharmacology

A PEGylated humanised Fab' fragment that selectively neutralises TNF-alpha and lacks an Fc region.

Formulation and product differences

• The selected presentation is a clear to opalescent, colourless-to-yellow solution in a single-use pre-filled syringe.
• A pre-filled syringe with a needle guard is restricted to healthcare-professional use.
• The removable needle cap contains a derivative of natural rubber latex, so hypersensitivity risk cannot be excluded in latex-sensitive patients.

Injection

Route: Parenteral

Strengths: 200 mg