HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ----------------------DOSAGE FORMS AND STRENGTHS--------------------- CIMZIA® safely and effectively. See full prescribing information for For injection: 200 mg lyophilized powder in a single-dose vial (3) CIMZIA. Injection: 200 mg/mL solution in a single-dose prefilled syringe (3) CIMZIA (certolizumab pegol) for injection, for subcutaneous use ------------------------------CONTRAINDICATIONS------------------------------- CIMZIA (certolizumab pegol) injection, for subcutaneous use Serious hypersensitivity reaction to certolizumab pegol or to any of the Initial U.S. Approval: 2008 excipients. (4) ------------------------WARNINGS AND PRECAUTIONS----------------------- WARNING: SERIOUS INFECTIONS AND MALIGNANCY Serious Infections: CIMZIA should not be initiated in patients with an See full prescribing information for complete boxed warning. active infection. Monitor for infection during and after treatment; o Increased risk of serious infections leading to hospitalization or discontinue if a serious infection develops. If invasive fungal infection death including tuberculosis (TB), bacterial sepsis, invasive develops in patients who reside or travel to regions where mycoses are fungal infections (such as histoplasmosis), and infections due to endemic, consider empiric antifungal therapy. (5.1) other opportunistic pathogens (5.1). Malignancies: Cases of lymphoma and other malignancies have been o CIMZIA should be discontinued if a patient develops a serious observed among patients receiving TNF blockers, including CIMZIA. infection or sepsis (5.1). (5.2) o Perform test for latent TB; if positive, start treatment for TB Heart Failure: Monitor patients for new onset or worsening congestive prior to starting CIMZIA (5.1). heart failure. (5.3) o Monitor all patients for active TB during treatment, even if Hypersensitivity Reactions: Discontinue CIMZIA and institute appropriate initial latent TB test is negative (5.1) therapy if anaphylaxis or other serious hypersensitivity reactions occur. o Lymphoma and other malignancies, some fatal, have been (5.4) reported in children and adolescent patients treated with TNF Hepatitis B Virus Reactivation: Test for HBV infection before starting blockers, of which CIMZIA is a member (5.2). CIMZIA is not CIMZIA. Monitor HBV carriers during and several months after therapy. indicated for use in pediatric patients. (8.4) If reactivation occurs, stop CIMZIA and begin anti-viral therapy (5.5) Neurologic Reactions: Exacerbation or new onset demyelinating disease ----------------------------RECENT MAJOR CHANGES-------------------------- may occur; use caution in patients with pre-existing or recent-onset demyelinating disorders. (5.6) Indications and Usage (1.5) 03/2019 Dosage and Administration (2.5) 03/2019 Hematological Reactions (including leukopenia, pancytopenia and Dosage and Administration (2.7) 02/2019 thrombocytopenia): Use with caution in patients who have ongoing, or a Warnings and Precautions (5.4) 02/2019 history of, significant hematologic abnormalities. Advise patients to seek immediate medical attention if symptoms develop; consider discontinuing ----------------------------INDICATIONS AND USAGE--------------------------- CIMZIA in patients with confirmed abnormalities. (5.7) CIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Use with Anakinra, Abatacept, Rituximab and Natalizumab: Increased Reducing signs and symptoms of Crohn’s disease and maintaining clinical risk of serious infections; concomitant use is not recommended. (5.8, 7.1) response in adult patients with moderately to severely active disease who Autoimmunity: Discontinue CIMZIA if lupus-like syndrome develops. have had an inadequate response to conventional therapy (1.1) (5.9) Treatment of adults with moderately to severely active rheumatoid Live vaccines: Avoid use with CIMZIA (5.10, 7.2) arthritis (1.2) Treatment of adult patients with active psoriatic arthritis. (1.3) ------------------------------ADVERSE REACTIONS------------------------------ Most common adverse reactions (≥7%): upper respiratory tract infection, rash, Treatment of adults with active ankylosing spondylitis (1.4) and urinary tract infection (6.1) Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation (1.5) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at Treatment of adults with moderate-to-severe plaque psoriasis who are 1-866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. candidates for systemic therapy or phototherapy (1.6) ------------------------------DRUG INTERACTIONS------------------------------ -----------------------DOSAGE AND ADMINISTRATION----------------------- Laboratory Tests: May cause erroneously elevated aPTT results. (7.3) CIMZIA is administered by subcutaneous injection. The recommended initial dose of CIMZIA is 400 mg (given as two subcutaneous injections of 200 mg) See 17 for PATIENT COUNSELING INFORMATION and Medication (2). Guide. Crohn’s Disease (2.1) Revised: 09/2019 400 mg initially and at Weeks 2 and 4. If response occurs, follow with 400 mg every four weeks Rheumatoid Arthritis (2.2) 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered Psoriatic Arthritis (2.3) 400 mg initially and at week 2 and 4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered. Ankylosing Spondylitis (2.4) 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every other week or 400 mg every 4 weeks. Non-radiographic Axial Spondyloarthritis (2.5) 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every other week or 400 mg every 4 weeks. Plaque Psoriasis (2.6, 14.6) 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week. For some patients (with body weight ≤ 90 kg), a dose of 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other week may be considered. 1 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SERIOUS INFECTIONS AND MALIGNANCY 1 INDICATIONS AND USAGE 5.11 Immunosuppression 1.1 Crohn’s Disease 6 ADVERSE REACTIONS 1.2 Rheumatoid Arthritis 6.1 Clinical Trials Experience 1.3 Psoriatic Arthritis 6.2 Immunogenicity 1.4 Ankylosing Spondylitis 6.3 Postmarketing Experience 1.5 Non-radiographic Axial Spondyloarthritis 7 DRUG INTERACTIONS 1.6 Plaque Psoriasis 7.1 Use with Anakinra, Abatacept, Rituximab and 2 DOSAGE AND ADMINISTRATION Natalizumab 2.1 Crohn’s Disease 7.2 Live Vaccines 2.2 Rheumatoid Arthritis 7.3 Laboratory Tests 2.3 Psoriatic Arthritis 8 USE IN SPECIFIC POPULATIONS 2.4 Ankylosing Spondylitis 8.1 Pregnancy 2.5 Non-radiographic Axial Spondyloarthritis 8.2 Lactation 2.6 Plaque Psoriasis 8.4 Pediatric Use 2.7 Preparation and Administration of CIMZIA Using 8.5 Geriatric Use the Lyophilized Powder for Injection 10 OVERDOSAGE 2.8 Preparation and Administration of CIMZIA Using 11 DESCRIPTION the Prefilled Syringe 12 CLINICAL PHARMACOLOGY 2.9 Monitoring to Assess Safety 12.1 Mechanism of Action 2.10 Concomitant Medications 12.2 Pharmacodynamics 3 DOSAGE FORMS AND STRENGTHS 12.3 Pharmacokinetics 4 CONTRAINDICATIONS 13 NONCLINICAL TOXICOLOGY 5 WARNINGS AND PRECAUTIONS 13.1 Carcinogenesis, Mutagenesis, and Impairment of 5.1 Risk of Serious Infections Fertility 5.2 Malignancies 14 CLINICAL STUDIES 5.3 Heart Failure 14.1 Crohn’s Disease 5.4 Hypersensitivity Reactions 14.2 Rheumatoid Arthritis 5.5 Hepatitis B Virus Reactivation 14.3 Psoriatic Arthritis 5.6 Neurologic Reactions 14.4 Ankylosing Spondylitis 5.7 Hematological Reactions 14.5 Non-radiographic Axial Spondyloarthritis 5.8 Use with Biological Disease-Modifying 14.6 Plaque Psoriasis Antirheumatic Drugs (Biological DMARDs) 15 REFERENCES 5.9 Autoimmunity 16 HOW SUPPLIED/STORAGE AND HANDLING 5.10 Immunizations 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. ______________________________________________________________________________ 2 FULL PRESCRIBING INFORMATION WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated 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. Empiric anti-fungal therapy should be considered