CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Recommended Dosing

The recommended initial adult dose of CIMZIA is 400 mg (given as two subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks.

Preparation Instructions

CIMZIA should be prepared 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 two 200 mg vials of CIMZIA for each dose. Using appropriate aseptic technique, reconstitute each lyophilized vial of CIMZIA with 1 mL of sterile Water for Injection, USP, using 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.

Do not leave reconstituted CIMZIA at room temperature for more than 2 hours prior to administration. 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.

Administration Instructions

CIMZIA should be administered by a health care professional.

Once reconstituted, CIMZIA is a clear to opalescent, colorless to pale yellow liquid with no visible particulates or gels in solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstituted CIMZIA with obvious particulate matter or discoloration should be discarded.

Prior to injecting, reconstituted CIMZIA should be at room temperature. Using a new 20 gauge needle for each vial, withdraw the reconstituted solution into a separate syringe for each vial, resulting in two syringes each containing 1 mL of CIMZIA (200 mg). Switch each 20 gauge needle to a 23 gauge needle and inject the full contents of each syringe subcutaneously into separate sites on the abdomen or thigh.

Dosage Forms And Strengths

CIMZIA is supplied as a sterile, white, lyophilized powder for reconstitution and then subcutaneous administration. Each single-use vial provides approximately 200 mg certolizumab pegol.

• Pack Content

NDC 50474-700-62

• Storage and Stability

Refrigerate intact carton at 2 to 8 ° C (36 to 46 ° F). Do not freeze. Do not separate contents of carton prior to use. Do not use beyond expiration date on container.

Product developed and manufactured for: UCB, Inc. 1950 Lake Park Drive Smyrna, GA 30080. Revised April 2008. FDA revision date: 4/22/2008

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