CIMZIA® (Non-English)

If your healthcare provider prescribes the CIMZIA powder, it should be injected by a healthcare provider. Each dose of CIMZIA will be given as 1 or 2 separate injections under the skin (subcutaneous injection) in your stomach area (abdomen) or upper thighs. If your healthcare provider prescribes the CIMZIA prefilled syringe, you will be trained on how to inject CIMZIA.

• CIMZIA is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and active non-radiographic axial spondyloarthritis (nr-axSpA) with measures of inflammation.
• CIMZIA is also approved to lessen the signs and symptoms of moderately to severely active Crohn’s disease (CD) in adults who have not been helped enough by usual treatments.
• CIMZIA is also approved to treat moderate to severe plaque psoriasis (PsO) in adults who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).

CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker that can lower the ability of your immune system to fight infections. Some people who received CIMZIA have developed serious infections, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some of these serious infections have caused hospitalization and death.

CIMZIA comes as lyophilized powder or as a solution in a prefilled syringe for injection.

Preparation and Storage:

• If refrigerated, 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.
• Reconstitute the vial(s) of CIMZIA with 1 mL of Sterile Water for Injection, USP using the gauge needle provided. The sterile water for injection should be directed at the vial wall rather than directly on CIMZIA.
• 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.
• 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 clear to opalescent, colorless to pale yellow liquid essentially free from particulates.
• 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 but do not leave reconstituted CIMZIA at room temperature for more than two 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 thigh or abdomen. Where a 400 mg dose is required, two injections are required, therefore, separate sites should be used for each 200 mg injection.

Contraindications

• CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients.
• Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria [see Warnings and Precautions.

After-care

You may need more than 1 injection at a time depending on your prescribed dose of CIMZIA. If you are prescribed more than 1 injection, each injection should be given at a different site in your stomach or upper thighs and at least 1 inch from your last injection.