Home Drug Guide Certolizumab Pegol

Drug Guide

Generic Name

Certolizumab Pegol

Brand Names Cimzia

Classification

Therapeutic: Immunosuppressant, Tumor Necrosis Factor (TNF) Inhibitor

Pharmacological: Monoclonal antibody (TNF inhibitor)

FDA Approved Indications

Crohn's Disease
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Uveitis

Mechanism of Action

Certolizumab Pegol binds to tumor necrosis factor-alpha (TNF-α), neutralizing its activity and thereby reducing inflammation.

Dosage and Administration

Adult: Typically 200 mg subcutaneously every 2 or 4 weeks, based on condition and response.

Pediatric: Use in pediatric patients is limited; dosing and safety should be determined by a specialist.

Geriatric: Adjust dose based on individual tolerance and response, no specific contraindication but monitor for infections.

Renal Impairment: No specific dosage adjustment needed; caution advised due to immunosuppression.

Hepatic Impairment: No specific adjustment needed.

Pharmacokinetics

Absorption: Subcutaneous absorption with a bioavailability of approximately 80%.

Distribution: Widespread distribution; primarily remains within vascular and interstitial spaces.

Metabolism: Metabolized via proteolytic pathways typical of IgG antibodies.

Excretion: Primarily via catabolism; not eliminated unchanged in urine or feces.

Half Life: Approximately 14 days.

Contraindications

Hypersensitivity to certolizumab pegol or excipients.
Active infections, including tuberculosis.

Precautions

Monitor for signs of infection.
Screen for latent TB prior to therapy.
Use with caution in patients with demyelinating diseases, heart failure, or history of cancer.

Adverse Reactions - Common

Infections (upper respiratory, urinary tract infections) (Common)
Headache (Common)
Nausea (Common)

Adverse Reactions - Serious

Serious infections (including opportunistic infections) (Less common, but serious)
Lymphoma and other malignancies (Rare)
Demyelinating disease episodes (Rare)
Liver enzyme elevations (Uncommon)

Drug-Drug Interactions

Other immunosuppressants, live vaccines, agents that increase risk of infection.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of infection, tuberculosis reactivation, and hypersensitivity reactions.

Diagnoses:

Risk for infection
Impaired skin integrity

Implementation: Administer via subcutaneous injection, monitor injection site, educate patient about infection risks.

Evaluation: Assess for effectiveness, adverse effects, and any signs of infection or adverse reactions.

Patient/Family Teaching

Instruct on importance of regular health monitoring.
Advise to report signs of infection or allergic reactions immediately.
Discuss the importance of adherence to dosing schedule.
Educate about potential side effects and when to seek medical attention.

Special Considerations

Black Box Warnings:

Increased risk of serious infections, including tuberculosis, bacterial, invasive fungal, and viral infections.
Risk of lymphoma and other malignancies.

Genetic Factors: No specific genetic factors reported affecting drug efficacy or safety.

Lab Test Interference: May cause falsely decreased tuberculin skin test responses.

Overdose Management

Signs/Symptoms: Symptoms not well established; monitor for signs of infection or immunosuppression.

Treatment: Supportive care; consider hospitalization for management of infections or adverse effects.

Storage and Handling

Storage: Store in the original container at 2°C to 8°C (36°F to 46°F). Do not freeze.

Stability: Stable until expiry date when stored properly. May be kept at room temperature up to 25°C (77°F) for a maximum of 14 days if necessary.