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Prepare and inject CIMZIA lyophilized powder in three steps1

Reconstitute Reconstitute



Wash your hands and follow proper aseptic technique.

Use an alcohol swab to wipe the top of the CIMZIA vial.

Use a second alcohol swab to wipe the top of the vial of sterile water, being careful not to touch the vial tops after wiping them.



Remove a new syringe and 20-gauge reconstitution safety needle from an inner carton.

Attach the safety needle to the syringe.

Withdraw 1 mL of sterile water and inject into one of the CIMZIA powder vials.



Using proper technique, cap the needle using the safety mechanism, remove from the syringe, and dispose of it in a sharps container.



Gently swirl the vial of CIMZIA for 1 minute.

Do not shake the CIMZIA vial. Swirl as gently as possible in order to avoid creating a foaming effect.

Continue swirling every 5 minutes as long as non-dissolved particles are observed.



The final reconstituted solution contains 200 mg/mL.

Solution should be a clear to opalescent, colorless to pale yellow liquid, and essentially free of particulates.

When ready to inject, make sure the vial is at room temperature, but do not leave the solution at room temperature for more than 2 hours total prior to administration.

If you are not ready to inject CIMZIA, you can refrigerate the reconstituted solution in the vials for up to 24 hours prior to injection. The solution must be stored between 2°–8°C or 36°–46°F.

Withdraw Withdraw



Using proper aseptic technique, pick up the syringe you had set aside earlier, attach a new 20-gauge safety needle provided in the kit, and remove the cap.



Draw in 3 mL of air, and inject it into the CIMZIA vial.




Withdraw all of the reconstituted solution into the syringe so that it contains 1 mL of the CIMZIA 200 mg solution.




Cap the needle using the safety mechanism, remove the needle from the syringe, and dispose of it appropriately.



Attach the 23-gauge dosing safety needle for administration to the syringe and lay it on a clean, flat surface.

Inject Inject



Use an alcohol swab to sterilize the injection area. Do not touch the area again until you’re ready to inject.



Holding the syringe in one hand, use the other hand to gently pinch a fold of skin.



Inject the full contents of the syringe subcutaneously into the previously cleaned injection site.



Initiate the safety mechanism of the needle, and dispose of the needle and syringe appropriately.



Discard all other used kit contents.



For patients requiring a second CIMZIA injection, please follow the same steps as the first injection.

CIMZIA can be injected in an area on the abdomen or thigh.
Injection sites should be rotated. Injections should not be given where the skin is tender, bruised, red, or hard.

Injections should be given as two subcutaneous injections of 200 mg each. Injections should occur at separate sites in the thigh or abdomen.

Two storage options for 
CIMZIA In-Office Injection1

  • Unopened CIMZIA vials can be stored at room temperature for to 6 months, but not exceeding the original expiration date
  • Room temperature up to a maximum of 25°C (77°F)
  • Do not place vials back in refrigerator once they have been stored at room temperature
  • Write the new expiration date in the space provided on the kit
  • CIMZIA lyophilized powder vials stored at room temperature are immediately ready to be reconstituted
  • Refrigerate kit between 2° and 8°C (36° to 46°F)
  • Note the expiration date printed on the kit
  • Remember to bring CIMZIA lyophilized powder vials to room temperature before reconstituting (may take up to 30 minutes)
  • Do not freeze
Room temperature

Questions about how to prepare, inject, and store CIMZIA? Ask a representative.

A representative can answer your questions and show you how to offer a fast and flexible in-office injection experience for your patients.

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Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.


CIMZIA is indicated for:

  • Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
  • Treatment of adults with moderately to severely active rheumatoid arthritis (RA)
  • Treatment of adult patients with active psoriatic arthritis (PsA)
  • Treatment of adult patients with active ankylosing spondylitis (AS)
  • Treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy
  • Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation



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.


Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start CIMZIA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.


Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

  • Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.
  • In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.
  • Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.
  • Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.
  • Cases of acute and chronic leukemia were reported with TNF blocker use.


  • Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.


  • Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.


  • Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Test patients for HBV infection before initiating treatment with CIMZIA.
  • Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.
  • Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.


  • TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.


  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.
  • Consider stopping CIMZIA if significant hematologic abnormalities occur.


  • Do not use CIMZIA in combination with other biological DMARDS.


  • Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.


  • Patients on CIMZIA should not receive live or live-attenuated vaccines.


  • The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).

Please see full Prescribing Information.