Cimzia ACR Certolizumab Pegol Injection User Guide

Cimzia ACR Certolizumab Pegol Injection

Product Information

Specifications

• Medication Strength: 200 mg/mL
• Preparations: Single-dose pre-filled syringe, Lyophilized powder in single-dose vial (for SC injection)

Product Usage Instructions

Indications and Dosing in Rheumatology

Certolizumab is indicated for the following conditions in adults:

• Moderately to severely active rheumatoid arthritis (RA)
• Active psoriatic arthritis (PsA)
• Active ankylosing spondylitis (AS)
• Non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation
• Moderately to severely active Crohn’s disease

Dosing:

Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA):

• Loading dose: Subcutaneous injection of 400 mg initially at week 0, week 2, and week 4
• Maintenance dose: Subcutaneous injection of 200 mg every 2 weeks, or 400 mg every 4 weeks

Contraindications

Hypersensitivity reaction: Do not use if there is a hypersensitivity reaction to certolizumab pegol or any excipients.

Warnings and Precautions:

• Serious Infections
• Hepatitis B reactivation
• Malignancies
• Congestive heart failure (CHF)
• Neurologic reactions
• Lupus-like syndrome
• Use with specific medications
• Hematologic cytopenia
• Live vaccination
• Hypersensitivity reaction

Adverse Reactions

Common adverse reactions include upper respiratory tract infections, rash, and urinary tract infections.

Medication Administration and Storage

• Administer at separate sites
• Do not inject into tender, bruised, red, or hard skin
• Rotate injection sites (1 inch apart)

Subcutaneous Medication Preparation of Lyophilized Powder:

1. Remove certolizumab pegol from the refrigerator and allow the vial(s) to sit at room temperature for 30 minutes before reconstituting.

FAQ – Frequently Asked Questions:

Q: Can certolizumab pegol be used in patients with a history of cytopenias?

• A: Caution should be taken in patients who have or have had significant cytopenias, including leukopenia, pancytopenia, and thrombocytopenia.

Q: What are the common adverse reactions associated with certolizumab?

• A: The most common adverse reactions include upper respiratory tract infections, rash, and urinary tract infections.

Certolizumab Pegol (Cimzia®)

• Certolizumab pegol (Cimzia®) binds to human tumor necrosis factor-alpha (TNFα), a pro-inflammatory cytokine with a central role in inflammatory processes.
• Certolizumab pegol does not contain a fragment crystallizable (Fc) region, which is normally present in a complete antibody.
• Certolizumab pegol neutralizes both soluble and transmembrane forms of TNFα, blocking the binding of TNFα to its receptors and inhibiting the biologic activity of TNFα.

Resources from Manufacturer

• Cimzia Patient Medication Guide
• Cimzia Full Prescribing Information
• Cimzia Co-pay Assistance Program
• USB Patient Assistance Foundation

Indications and Dosing in Rheumatology

Certolizumab is indicated for:

• Adults with moderately to severely active rheumatoid arthritis (RA)
• Adult patients with active psoriatic arthritis (PsA)
• Adult patients with active ankylosing spondylitis (AS)
• Adult patients with non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation
• Adult patients with moderately to severely active Crohn’s disease

Dosing:

• Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA)
• Loading dose: Subcutaneous injection of 400 mg (given as two injections of 200 mg each) initially at week 0, week 2, and week 4
• Maintenance dose: Subcutaneous injection of 200 mg every 2 weeks, or 400 mg every 4 weeks

Contraindications

• Hypersensitivity reaction to certolizumab pegol or any of the excipients.

Warnings and Precautions

• Serious Infections—Do not initiate certolizumab pegol during an active infection.
• If a serious infection develops, discontinue certolizumab pegol until the infection is controlled.
• Hepatitis B reactivation— Monitor HBV carriers during and several months after therapy.
• If reactivation occurs, stop certolizumab pegol and begin anti-viral therapy.
• Malignancies—Patients with highly active forms of rheumatoid arthritis and other chronic inflammatory diseases who are exposed to immunosuppressant therapy may be at a higher risk for developing lymphomas than the general population.
• The risks and benefits of treatment should be evaluated in patients with a known malignancy.
• Congestive heart failure (CHF) —Closely monitor patients with CHF who are initiated on certolizumab pegol. Discontinue therapy if new or worsening signs of CHF appear.
• Neurologic reactions— New onset or exacerbation of demyelinating disorders may occur; use caution in patients with pre-existing or recent onset demyelinating disorders.
• Lupus-like syndrome— Discontinue if symptoms occur.
• Use with abatacept, anakinra, natalizumab, and rituximab —Not recommended due to increased risk of serious infections.
• Hematologic cytopenia —Caution should be taken in patients who have or have had significant cytopenias, including leukopenia, pancytopenia, and thrombocytopenia.
• Live vaccination —Avoid use with certolizumab pegol
• Hypersensitivity reaction— Discontinue certolizumab pegol if anaphylaxis or other serious allergic reaction occurs

Adverse Reactions

Most common adverse reactions (≥ 7%):

• Upper respiratory tract infections
• Rash
• Urinary tract infection

Medication Strength and Preparations

• Single-dose pre-filled syringe: 200 mg/mL
• Lyophilized powder in single-dose vial (for SC injection): 200 mg

Medication Administration and Storage

• Store in original carton to protect from light
• Store in refrigerator at 2°C to 8°C (36°F to 46°F) – do not freeze
• The needle cover of the pre-filled syringe contains latex

Subcutaneous Administration

• Before administration, allow the syringe to warm to room temperature for 30 – 90 minutes
• Inject subcutaneously into the front of the thigh or lower abdomen (avoid injecting within 2 inches of the navel)
• When a 400 mg dose is needed (given as two separate injections of 200 mg), injections should occur at separate sites
• Do not administer to tender, bruised, red, or hard skin
• Rotate injection sites (≥ 1 inch apart)

Subcutaneous Medication Preparation of Lyophilized Powder

1. Unopened certolizumab pegol vials may be stored at room temperature (up to 25°C, or 77°F) for 6 months, but not exceeding the original expiration date.
   • If stored at room temperature, do not place it back in the refrigerator and write the new expiration date on the carton.
2. Remove certolizumab pegol from the refrigerator and allow the vial(s) to sit at room temperature for 30 minutes before reconstituting.
3. Reconstitute the vial(s) with 1 mL of Sterile Water for Injection, USP using the 20-gauge needle provided, with the sterile water directed at the vial wall rather than the powder.
4. Gently swirl each vial as gently as possible and without shaking to avoid creating a foaming effect for about one minute.
5. Continue swirling every 5 minutes as long as non-dissolved particles are observed. Full reconstitution may take as long as 30 minutes.
6. The final reconstituted solution contains 200 mg/mL and should be clear to opalescent, colorless to pale yellow, and free from particulates.
   • Subcutaneous Medication Administration of Reconstituted Lyophilized Powder
7. Once reconstituted, certolizumab pegol can be stored in the vials for up to 24 hours before injection.
8. Before injection, ensure a reconstituted solution is at room temperature, but not more than 2 hours before administration.
9. Withdraw the reconstituted solution into a 1 mL syringe. Replace the needle on the syringe with a 23-gauge needle for subcutaneous administration into the thigh or abdomen.
10. When a 400 mg dose is needed, 2 injections of 200 mg each are required with administration into separate sites.

Updated June 2023—ARP Practice Committee

DISCLAIMER: The information contained in this biological reference guide is published by the American College of Rheumatology (“ACR”) for informational purposes only, in furtherance of its educational mission. It is not a substitute for the user’s independent medical discretion or decision-making, nor a replacement for the manufacturer’s complete prescribing and labeling information, as in effect at the time of use. The information contained herein reflects the conclusions of the individual companies who manufacture the products and not those of the ACR. ACR does not endorse or make any statement regarding the efficacy or safety of any of the listed companies or any of their drugs or other products. ACR specifically disclaims all responsibility or liability for the accuracy or completeness of the contents of this reference guide, the use of such information by anyone, and/or for the performance of any of the drugs listed in this biological reference guide (including without limitation, any adverse effects).

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