(1)certolizumab pegol decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Use Caution/Monitor.poliovirus vaccine inactivatedMonitor Closely (1)certolizumab pegol decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .ponesimodMonitor Closely (1)ponesimod and certolizumab pegol both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.rabies vaccineMonitor Closely (1)certolizumab pegol decreases effects of rabies vaccine by pharmacodynamic antagonism. Use Caution/Monitor.rabies vaccine chick embryo cell derivedMonitor Closely (1)certolizumab pegol decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Use Caution/Monitor.rilonaceptSerious - Use Alternative (1)rilonacept and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.rituximabSerious - Use Alternative (1)rituximab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.rituximab-hyaluronidaseSerious - Use Alternative (1)rituximab-hyaluronidase and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.rotavirus oral vaccine, liveContraindicated (1)certolizumab pegol decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.siponimodMonitor Closely (1)siponimod and certolizumab pegol both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.sipuleucel-TMonitor Closely (1)certolizumab pegol decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.smallpox (vaccinia) vaccine, liveContraindicated (1)certolizumab pegol decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.tetanus & reduced diphtheria toxoids/ acellular pertussis vaccineMonitor Closely (1)certolizumab pegol decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Use Caution/Monitor.tisagenlecleucelSerious - Use Alternative (1)certolizumab pegol, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.tocilizumabSerious - Use Alternative (1)tocilizumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.tofacitinibSerious - Use Alternative (1)certolizumab pegol, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.trastuzumabMonitor Closely (1)trastuzumab, certolizumab pegol. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .trastuzumab deruxtecanMonitor Closely (1)trastuzumab deruxtecan, certolizumab pegol. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .typhoid polysaccharide vaccineMonitor Closely (1)certolizumab pegol decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Use Caution/Monitor.typhoid vaccine liveContraindicated (1)certolizumab pegol decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.ublituximabMonitor Closely (1)ublituximab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministeredupadacitinibContraindicated (1)certolizumab pegol, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.varicella virus vaccine liveContraindicated (1)certolizumab pegol decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.vedolizumabSerious - Use Alternative (1)vedolizumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infectionsyellow fever vaccineContraindicated (1)certolizumab pegol decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.zoster vaccine liveContraindicated (1)certolizumab pegol decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.zoster vaccine recombinantMonitor Closely (1)certolizumab pegol decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant. >10% URI (20%) Headache (7-18%) Nasopharyngitis (4-13%) Nausea (11%) 1-10% UTI (7%) Arthralgia (6%) Serious infections (3%) Frequency Not Defined Opportunistic infections (eg, TB) Lupus-like syndrome Malignancies Immunogenicity Hypersensitivity Blood/ lymphatic system disorder Cardiac disorder Ocular disorder Psychiatric disorder (anxiety, bipolar d/o, suicide attempt) Renal/urinary disorder Menstrual disorder Skin and subcutaneous disorder Postmarketing Reports Vascular disorder: Systemic vasculitis Skin: Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and new or worsening psoriasis (all sub-types including pustular and palmoplantar), lichenoid skin reaction Immune System Disorders: Sarcoidosis Lagophthalmos Neoplasms benign, malignant and unspecified (including cysts and polyps) Melanoma, Merkel cell carcinoma (neuroendocrine carcinoma of the skin) Black Box Warnings Serious infection risk Increased risk for developing serious infections resulting in hospitalization or death; most patients were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids) Patients older than 65 years may be at greater risk Discontinue if patient develops serious infection or sepsis Reported infections include Active TB, including reactivation of latent TB (frequently present with disseminated or extrapulmonary disease); test for latent TB before use and during therapy; treat latent infection prior to use Invasive fungal infections (eg, histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis); may present with disseminated, rather than localized, disease; antigen/antibody testing for histoplasmosis may be negative in some patients with active infection; initiate empiric antifungal therapy if severe systemic illness develops Other bacterial (eg, Legionella, Listeria), mycobacterial (eg, tuberculosis), and viral (eg, hepatitis B) opportunistic pathogens Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers Cases of acute and chronic leukemia have been reported in association with post-marketing TNF-blocker use in rheumatoid arthritis (RA) and other indications; patients with RA may be at a higher risk (approximately 2-fold) than the general population for leukemia Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer Manufacturer required to report all malignancies to FDA in order for complete and consistent analysis Contraindications History of hypersensitivity reaction to certolizumab pegol or to any of the excipients; reactions have included angioedema, anaphylactoid reaction, serum sickness, and urticaria Cautions Hypersensitivity including anaphylaxis and serious reactions (see Contraindications) May interfere with aPPT tests The needle shield inside the removable cap of prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex Therapy has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barré syndrome; exercise caution in considering use in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with drug Treatment may result in formation of autoantibodies and rarely, in development of a lupus-like syndrome; if a patient develops symptoms suggestive of a lupus-like syndrome following treatment, discontinue treatment Cases of worsening congestive heart failure (CHF) and new onset CHF reported; therapy has not been formally studied in patients with CHF; however, in clinical studies in patients with CHF with another TNF blocker, worsening congestive heart failure (CHF) and increased mortality due to CHF were observed; exercise caution in patients with heart failure and monitor them carefully Hematological Reactions Pancytopenia, including aplastic anemia, reported with TNF blockers; adverse reactions of hematologic system, including medically significant cytopenia (eg, leukopenia, pancytopenia, thrombocytopenia) reported Causal relationship of these events remains unclear although no high-risk group has been identified, exercise caution in patients who have ongoing, or a history of, significant hematologic abnormalities Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever, bruising, bleeding, pallor) while on treatment Consider discontinuation of therapy in patients with confirmed significant hematologic abnormalities Increased risk of serious infections Also, see Black Box Warnings An increased risk of serious infections seen in clinical studies of other TNF-blocking agents used in combination with anakinra or abatacept, with no added benefit; no formal drug interaction studies were performed with rituximab or natalizumab; concomitant use of certolizumab pegol with anakinra, abatacept, rituximab, or natalizumab is not recommended A higher risk of serious infections also observed in combination with DMARDs; because of nature of adverse events seen with combination therapy, use in combination with other biological DMARDs not recommended Hepatitis B Virus Reactivation Use of TNF blockers, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus; patients concomitantly receiving immunosuppressives, which may also contribute to HBV reactivation Test patients for HBV infection before initiating treatment; patients who test positive for HBV infection Closely monitor patients who are carriers of HBV and require treatment for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy In patients who develop HBV reactivation, discontinue treatment and initiate effective anti-viral therapy with appropriate supportive treatment Exercise caution when considering resumption of therapy in this situation and monitor patients closely Opportunistic infections TNF blockers increase risk for opportunistic infections, (eg, TB, invasive fungal infections); for patients who develop systemic infections, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic Coadministration with anakinra increases this risk Test for latent TB prior to starting treatment and monitor; treatment of latent tuberculosis infection prior to therapy with TNF-blocking agents has been shown to reduce risk of tuberculosis reactivation during therapy; induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis needed prior to initiating therapy with certolizumab, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG); also consider anti-tuberculosis therapy in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection Discontinue if serious infection develops Malignancy risk Enhanced safety surveillance requirements to capture malignancy data: (see Black Box Warnings) In the controlled portions of clinical studies of some TNF blockers, more cases of malignancies have been observed among patients receiving TNF blockers compared to control patients Melanoma and Merkel cell carcinoma Melanoma and Merkel cell carcinoma reported with TNF-antagonists, including certolizumab pegol Periodic skin examinations recommended for all patients, particularly those with risk factors for skin cancer Hepatosplenic T-cell lymphomas (HSTCL) Rare postmarketing cases reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with TNF blockers Reports have also included a patient being treated for psoriasis and 2 patients being treated for rheumatoid arthritis HSTCL is an aggressive, rare type of T-cell lymphoma (usually fatal) Most reported cases with TNF blockers have occurred with concomitant treatment with azathioprine or 6-mercaptopurine, although there have been cases reported receiving azathioprine or mercaptopurine alone The following HSTCL cases have been identified in the FDA Adverse Event Reporting System (AERS) database, the literature, and the HSTCL Cancer Survivors' Network: infliximab (20), etanercept (1), adalimumab (2), infliximab/adalimumab (5), certolizumab (0), golimumab (0), azathioprine (12), and mercaptopurine (3) Drug interaction overview An increased risk of serious infections seen in clinical studies of other TNF-blocking agents used in combination with anakinra or abatacept, with no added benefit; no formal drug interaction studies were performed with rituximab or natalizumab; concomitant use of certolizumab pegol with anakinra, abatacept, rituximab, or natalizumab is not recommended Patients treated may receive vaccinations, except for live or live attenuated vaccines; no data available on response to live vaccinations or secondary transmission of infection by live vaccines in patients receiving therapy Pregnancy Pregnancy exposure registry monitors pregnancy