How patients use the prefilled syringe at home
UCB and OXO Good Grips® have partnered to create a unique prefilled syringe designed with the needs of patients in mind.
Patients who are capable may self-inject CIMZIA using the prefilled syringe after proper training in subcutaneous injection and if a physician determines that it is appropriate.
Patients using CIMZIA prefilled syringe should be instructed to inject the full amount in the syringe, 200 mg (1 mL), according to the full injection instructions provided in the Instructions for Use booklet found in each CIMZIA prefilled syringe kit.1
Prefilled Syringe Designed With Patients in Mind4
OXO, Good Grips® and the associated logos are registered trademarks of Helen of Troy Limited and are used under license.
Preparing and administering CIMZIA using the prefilled syringe
Importance of training Patients should not give themselves a CIMZIA injection unless they have been shown how by a doctor, nurse, or someone who has been trained to help them with their injections. The following instructions describe the steps your patients need to follow to inject CIMZIA.
OXO, Good Grips® and the associated logos are registered trademarks of Helen of Troy Limited and are used under license.
Instructions for Use for Your Patients
CIMZIA® solution for subcutaneous use prefilled syringes
Patients should watch the following video and/or read the following instructions before receiving or injecting CIMZIA. Patients should reread these instructions before every self-injection of CIMZIA. These instructions do not take the place of talking with a healthcare provider about a medical condition or treatment. These instructions are for 1 injection only. Your patient may need more than 1 injection at a time depending on the prescribed dose of CIMZIA.
Please instruct your patients not to share a CIMZIA prefilled syringe with another person, as doing so may give another person an infection or give your patient an infection from someone.
Supplies your patient will need
1 CIMZIA prefilled syringe with needle attached. Your patient may need 2 CIMZIA prefilled syringes with needles attached to give higher doses
1 or 2 alcohol swabs
1 or 2 clean cotton balls or gauze pads
1 puncture-resistant sharps disposal container. See "Disposing of the Syringe" at the end of these instructions
CIMZIA comes in a tray containing 2 prefilled glass syringes. Your patient should use a new CIMZIA syringe for each injection.
Preparing to take CIMZIA
Step 1: Your patient should take the carton containing the prefilled syringes of CIMZIA out of the refrigerator. Your patient should check the expiration date on the syringe carton and label.
If the expiration date has passed, your patient must not use the syringe. Your patient should call a pharmacist if your patient has questions about the expiration date. Your patient must not use CIMZIA if the tamper evident seals are missing or broken on the top or bottom of the carton when your patient receives it. If the tamper evident seals are missing or broken, your patient should contact a pharmacist.
Step 2: Your patient should remove the prefilled syringe from the carton and let it warm to room temperature. Your patient must not warm the syringe in any other way. If your patient is not using the second syringe, the carton containing the remaining prefilled syringe should be put back in the refrigerator.
Step 3: Your patient should find a clean, flat work surface, such as a table.
Step 4: Your patient must make sure the liquid medicine in the prefilled syringe is clear and colorless to yellow and free from particles. Your patient must not inject the medicine if it is cloudy, discolored, or contains particles. Your patient should call a healthcare provider or pharmacist if your patient has any questions about the CIMZIA prefilled syringe.
Step 5: Your patient should gather all the supplies needed for injection.
Step 6: Your patient should wash hands with soap and warm water and dry with a clean towel.
Injection site preparation
Step 7: Your patient should choose an injection site(s) on the stomach or upper thighs.
Your patient should choose a new injection site each time CIMZIA is used
Each new injection should be given at least 1 inch from the site used before. If your patient chooses the stomach site, your patient should avoid the 2 inches around the belly button (navel)
Your patient must not inject into areas where skin is tender, bruised, red or hard, or where scars or stretch marks are present
Your patient should change injection sites between the stomach and upper thighs to reduce the chance of having a skin reaction
Your patient may want to write down the site used for each injection to help your patient remember to use a different site with each injection
Step 8: Your patient should clean the injection site with an alcohol swab. Let the area dry completely.
Step 9: Your patient should pick up the prefilled syringe with 1 hand and hold it with the needle pointing up. Your patient may see air bubbles. This is normal. There is no need to remove air bubbles before your patient injects. Injecting the solution with air bubbles will not harm your patient. With the other hand, your patient should remove the plastic ring needle cover by pulling straight up on the plastic ring. Your patient must not touch the needle and must not let the needle touch any surface. Your patient must not bend the needle. Your patient should place the plastic ring needle cover to the side.
Step 10: With the other hand, your patient should gently pinch a fold of skin at the cleaned injection site.
Step 11: With a quick, dart-like motion, your patient should insert the needle into the skin at about a 45-degree angle. Your patient should release the pinched skin, keeping the syringe in position. Your patient should slowly push the plunger all the way down until the syringe is empty.
Step 12: When the syringe is empty, your patient should pull the needle out of the skin while carefully keeping the needle at the same angle as inserted.
Step 13: Your patient should place a dry cotton ball or gauze pad over the injection site for several seconds.
Your patient must not rub the injection site. Your patient must not use an alcohol swab as it may cause stinging. If there is a little bleeding, your patient should cover the injection site with a small bandage.
To avoid a needle-stick injury, your patient must not try to recap the needle. Your patient must not reuse any injection supplies.
Disposing of the syringe
Your patient should put used syringes with needle attached in an FDA-cleared sharps disposal container right away after use.
Your patient must not throw away (dispose of) loose syringes and needles in household trash.
If your patient does not have an FDA-cleared sharps disposal container, your patient may use a household container that is:
- Made of a heavy-duty plastic
- Can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out
- Upright and stable during use
- Properly labeled to warn of hazardous waste inside the container
When your patient's sharps disposal container is almost full, your patient will need to follow local community guidelines for the right way to dispose of the sharps disposal container. There may be state or local laws about how your patient should throw away used needles and syringes. For more information about safe sharps disposal and for specific information about sharps disposal in the state that your patient lives in, your patient can visit the FDA's website at http://www.fda.gov/safesharpsdisposal .
Your patient must not dispose of used sharps disposal container in the household trash unless local community guidelines permit this. Your patient must not recycle the used sharps disposal container.
- CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis
- CIMZIA is indicated for the treatment of adults with active psoriatic arthritis
- CIMZIA is indicated for the treatment of adults with active ankylosing spondylitis
- CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adults with moderately to severely active disease who have had an inadequate response to conventional therapy
- CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy
Important Safety Information
CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylactoid reaction, 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, anaphylactoid reaction, 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 plastic derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.
hepatitis b virus reactivation
- 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.
- CIMZIA® [prescribing information], Smyrna, GA: UCB, Inc.; 2018.
- Keystone E, van der Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty‐two–week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008;58:3319-3329.
- Schwartzman S, Morgan GJ Jr. Does route of administration affect the outcome of TNF antagonist therapy? Arthritis Res Ther. 2004;6(Suppl 2):S19-S23.
- Sheikhzadeh A, Yoon J, Formosa D, et al. The effect of a new syringe design on the ability of rheumatoid arthritis patients to inject a biological medication. Appl Ergon. 2012;43:368-375.
- Data on file. UCB, Inc.; Smyrna, GA.
- Veronese FM, Mero A. The impact of PEGylation on biologic therapies. Biodrugs. 2008;22:315-329.
- Weir N, Athwal D, Brown D, et al. A new generation of high-affinity humanized PEGylated Fab' fragment anti-tumor necrosis factor-alpha monoclonal antibodies. Therapy. 2006;3:535-545.
- Chapman AP. PEGylated antibodies and antibody fragments for improved therapy: a review. Adv Drug Deliv Rev. 2002;54:531-545.
- Harris JM, Chess RB. Effect of pegylation on pharmaceuticals. Nat Rev Drug Discov. 2003;2:214-221.
- Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73:48-55.
- Landewe R, Braun J, Deodhar A, et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled phase 3 study. Ann Rheum Dis. 2014;73(1):39-47.
- Weinblatt ME, Fleischmann R, Huizinga TW, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology. 2012;51:2204-2214.
- Gladman D, Fleischmann R, Coteur G, Woltering F, Mease PJ. Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res. 2014;66(7):1085-1092.
- Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med. 2007;357:239-250.
- Schreiber S, Colombel JF, Bloomfield R, et al. Increased response and remission rates in short-duration Crohn’s disease with subcutaneous certolizumab pegol: an analysis of PRECiSE 2 randomized maintenance trial data. Am J Gastroenterol. 2010;105(7):1574-1582.
- Feagan BG, Coteur G, Tan S, Keininger DL, Schreiber S. Clinically meaningful improvement in health-related quality of life in a randomized controlled trial of certolizumab pegol maintenance therapy for Crohn’s disease. Am J Gastroenterol. 2009;104(8):1976-1983.
- Pallis AG, Mouzas IA, Vlachonikolis IG. The inflammatory bowel disease questionnaire: a review of its national validation studies. Inflamm Bowel Dis. 2004;10(3):261-269.
- Gottlieb AB, Blauvelt A, Thaçi D, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from two phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018;79(2):302-314.e6.
- Lebwohl M, Blauvelt A, Paul C, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, randomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018;79(2):266-276.e5.
- Nesbitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis. 2007;13(11):1323-1332.
- Pasut G. Pegylation of biological molecules and potential benefits: pharmacological properties of certolizumab pegol. BioDrugs. 2014;28 (suppl 1):S15-S23.
- Porter C, Armstrong-Fisher S, Kopotsha T, et al. Certolizumab pegol does not bind the neonatal Fc receptor (FcRn): consequences for FcRn-mediated in vitro transcytosis and ex vivo human placental transfer. J Reprod Immunol. 2016;116:7-12.
- Humira [prescribing information]. North Chicago, IL: Abbvie Inc.; 2018.
- Enbrel [prescribing information]. Thousand Oaks, CA: Amgen Inc.; 2017.
- Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; 2018.
- Stelara [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; 2018.
- Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2018.
- Taltz [prescribing information]. Indianapolis, IN: Eli Lilly and Company; 2017.
- Tremfya [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; 2017.
- Siliq [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2017.
- Ilumya [prescibing information]. Whitehouse Station, NJ: Merck & Co., Inc.; 2018.
- van der Heijde D, Deodhar A, FitzGerald O, et al. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018;4(1):e000582.
- Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheumatol. 1995;38(6)727-735.
- Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013;11(3):286-292.
- Mariette X, Förger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77(2):228-233.
- Clowse MEB, Förger F, Hwang C, et al. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017;76(11):1890-1896.