Administration by a Healthcare Provider

The lyophilized powder should be prepared and administered by a health care professional.

CIMZIA is provided in a package that contains everything required to reconstitute and inject the drug as described below. CIMZIA should be brought to room temperature before reconstituting to facilitate dissolution.

Reconstitute each lyophilized vial of CIMZIA using appropriate aseptic technique, with 1 mL of sterile Water for Injection, USP, and a syringe with a 20 gauge needle. Gently swirl each vial of CIMZIA without shaking so that all of the lyophilized powder comes into contact with the sterile Water for Injection. Leave the vials undisturbed to fully reconstitute (this may take as long as 30 minutes). Reconstituted CIMZIA has a concentration of approximately 200 mg/mL. Once reconstituted, CIMZIA is a clear to opalescent, colorless to pale yellow liquid essentially free from particulates.

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.

Using a new 20 gauge (reconstitution) needle for each vial, withdraw the reconstituted solution into a separate syringe for each vial, so that each syringe contains 1 mL of CIMZIA (200 mg of certolizumab pegol). Switch each 20 gauge needle to a 23 gauge (dosing) needle and inject the full contents of each syringe subcutaneously into the thigh or abdomen. Where a 400 mg dose is required, separate sites should be used for each 200 mg injection.

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