CIMZIA (Certolizumab Pegol)
CIMZIA (Certolizumab Pegol)
What is this medication?
CIMZIA (Certolizumab Pegol)
Antirheumatic, Disease Modifying Agent, Gastrointestinal Agent
CIMZIA (Certolizumab Pegol) is indicated for the treatment of ankylosing spondylitis, Crohn disease, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.
Patients treated with certolizumab are at an 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.
Certolizumab should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include the following:
Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before certolizumab use and during therapy. Treatment for latent infections should be initiated prior to certolizumab 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. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections caused by opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with certolizumab should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with certolizumab, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers. Certolizumab is not indicated for use in pediatric patients.
What are the ingredients in this medication?
Sodium acetate, sodium chloride, Water for Injection. Preservative-free.
How does this medication work?
CIMZIA (Certolizumab Pegol) is a pegylated humanized antibody fragment of tumor necrosis factor alpha (TNFα) monoclonal antibody. Certolizumab binds to and neutralizes endogenous TNFα activity that results in a reduction in proinflammatory mediators (i.e. interleukins), leukocyte migration, neutrophils and eosinophils activation. Due to Certolizumab not being a complete antibody (lacks Fc region), it does not induce complement activation, antibody-dependent cell-mediated cytotoxicity, or apoptosis. Pegylation of certolizumab allows for delayed elimination and therefore an extended half-life.
How should I take this medication?
SQ: Initial dose, inject 400mg subcutaneously, repeat at 2 and 4 weeks from the initial dose. Maintenance dose, inject 200mg subcutaneously every 2 weeks or 400mg every 4 weeks.
SQ: Initial dose, inject 400mg subcutaneously, repeat at 2 and 4 weeks from the initial dose. Maintenance dose, inject 400mg subcutaneously every 4 weeks.
SQ: Inject 400mg subcutaneously every other week.
SQ: Initial dose, inject 400mg subcutaneously, repeat at 2 and 4 weeks from the initial dose. Maintenance dose, inject 200mg subcutaneously every 2 weeks.
SQ: Initial inject 400mg subcutaneously, repeat at 2 and 4 weeks from the initial dose. Maintenance dose is 200mg every 2 weeks or 400mg every 4 weeks.
How to Take: Depending on if you are using the vials or prefilled syringes there are subtle differences. Inject subcutaneously at separate injection sites in the thigh or lower abdomen (avoid injecting 2 inches within the navel); rotate the injection sites. For a 400mg (2 syringe) doses, administer each 200mg at separate injection sites. Do not use if solution is discolored or contains particulate matter. Do not administer to skin which is red, tender, bruised, hard, or that has scars or stretch marks.
What should I watch for while using this medication?
CIMZIA (Certolizumab Pegol) can lower immunity predisposing you at an increased risk of experiencing a serious infections such as tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens that can lead to hospitalization or death. It is important to watch for symptoms of infection. Watch and monitor for any new signs or worsening of medical conditions such as heart disease, neurological disease, or autoimmune disorders. Advise patients to seek immediate medical attention if they experience any symptoms of severe hypersensitivity reactions. Advise latex-sensitive patients that the needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex.
What size needle does this medication use?
Prefilled syringe: 25-gauge, ½ inch needle
Autoinjector: 25-gauge, ½ inch needle
What is the difference between a prefilled syringe and an autoinjector?
Both an autoinjector device and prefilled syringe are comparable with respect to ease of use, tolerability, and efficacy. However the addition of an autoinjector to deliver a prefilled syringe can enhance patient safety.
What if I miss a dose?
If you miss an appointment for an injection, call your doctor’s office right away. The office staff can schedule a new visit and adjust the timing of future injection appointments, if necessary.
If you forget to give yourself an injection at home, take your dose as soon as you remember. Then talk with your doctor. If needed, they can help you set up a new dosing schedule.
How should I store this medication?
Refrigerate carton between 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, which is located on the drug label and carton. Protect solution from light. Unopened vials may also be stored at room temperature up to a maximum of 25°C (77°F) for 6 months, but not exceeding the original expiration date. If stored at room temperature, do not place back in refrigerator and write the new expiration date on the carton in the space provided.
What are the possible side effects of using this medication?
Upper respiratory tract infections, rash, nausea, antibody development, and urinary tract infection.
Note this is not a complete list of side effects for CIMZIA (Certolizumab Pegol), only common ones.