How to use the lyophilized formulation in office1

CIMZIA® (certolizumab pegol) is available in lyophilized powder formulation for subcutaneous administration by a healthcare professional*

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Preparation and injection video for healthcare professionals

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Necessary Supplies (per injection)

The CIMZIA lyophilized powder for reconstitution kit contains the Instructions for Use booklet and all necessary supplies required for reconstitution and administration, including:

  • 5-mL vial with 200 mg of lyophilized powder
  • 2-mL vial with 1 mL of Sterile Water for Injection, USP
  • Alcohol swabs
  • 20-gauge reconstitution needles
  • 23-gauge dosing needle
  • 3-mL syringe

Preparation

  • Remove CIMZIA from the refrigerator and allow the vial(s) to sit at room temperature for 30 minutes before reconstituting. Do not warm the vial in any other way
  • Use appropriate aseptic technique when preparing and administering CIMZIA

Reconstitution

  1. Add 1 mL of Sterile Water for Injection, USP, per vial. Use the 20-gauge needle provided. The sterile water for injection should be directed at the vial wall rather than directly on CIMZIA
  2. Gently swirl each vial of CIMZIA for about one minute without shaking, assuring that all of the powder comes in contact with the Sterile Water for Injection. The swirling should be as gentle as possible in order to avoid creating a foaming effect
  3. Continue swirling every 5 minutes as long as non-dissolved particles are observed. Full reconstitution may take as long as 30 minutes

The final reconstituted solution contains 200 mg/mL and should be a clear to opalescent, colorless to pale yellow liquid essentially free from particles.

  • Once reconstituted, CIMZIA can be stored in the vials for up to 24 hours between 2° to 8° C (36° to 46° F) prior to injection. Do not freeze

Administration

  • Prior to injecting, reconstituted CIMZIA should be at room temperature
  • Do not leave reconstituted CIMZIA at room temperature for more than 2 hours prior to administration
  • Withdraw the reconstituted solution into a separate syringe for each vial using a new 20-gauge needle for each vial so that each syringe contains 1 mL of CIMZIA (200 mg of certolizumab pegol)
  • Replace the 20-gauge needle(s) on the syringes with a 23-gauge(s) for administration
  • Inject the full contents of the syringe(s) subcutaneously, by pinching the skin of the abdomen or thigh

Where a 400 mg dose is required, 2 injections are required; therefore, separate sites should be used for each 200 mg injection.

  • See section 2 of the full Prescribing Information for complete preparation and administration information, or see Preparation and Administration booklet found in the CIMZIA lyophilized powder for reconstitution kit.