Cimzia

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Colorectal disorders
  • Psoriasis
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Cimzia Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Certolizumab pegol 200mg/mL soln for SC inj; or per vial (pwd for SC inj after reconstitution); preservative-free.

    Pharmacological Class

    Tumor necrosis factor (TNF) blocker.

    How Supplied

    Pack—1 (2 single-dose vials w. syringes, needles, supplies); Single-dose prefilled syringes—2 (w. supplies); Prefilled Syringe Starter Kit—6 (w. supplies)

    How Supplied

    Lyophilized Powder for Reconstitution:

    Cimzia (certolizumab pegol) for injection is supplied as a sterile white, lyophilized powder in a single-dose vial for subcutaneous use. 

    • Pack Content:

      • Type I glass vials with rubber stopper and overseals each containing 200 mg of lyophilized Cimzia for reconstitution. Qty: 2 

      • 2 mL Type I glass vials 2 mL containing 1 mL sterile Water for Injection. Qty: 2 

      • 3 mL plastic syringes. Qty: 2

      • 20 gauge needles (1 inch). Qty: 4

      • 23 gauge needles (1 inch). Qty: 2

      • Alcohol swabs. Qty: 8

    Prefilled Syringe:

    Cimzia (certolizumab pegol) injection is supplied as a sterile, clear to opalescent, colorless to pale yellow solution in a single-dose prefilled syringe for subcutaneous use. Needle shield inside the removable cap of the prefilled syringe contains a derivative of natural rubber latex.

    • Pack Content:

      • Alcohol swabs. Qty: 2

      • Single-dose prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle, each containing 200mg (1 mL) of Cimzia. Qty: 2

    Prefilled Syringe Starter Kit:

    Cimzia (certolizumab pegol) injection is supplied as a sterile, clear to opalescent, colorless to pale yellow solution in a single-dose prefilled syringe for subcutaneous use.

    • Pack Content:

      • Alcohol swabs. Qty: 6

      • Single-dose prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle, each containing 200mg (1 mL) of Cimzia. Qty: 6

    Storage

    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.

    Manufacturer

    UCB Inc.

    Generic Availability

    NO

    Cimzia Indications

    Indications

    In adults with moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), or active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

    Cimzia Dosage and Administration

    Adult

    Rotate inj site. Give by SC inj in abdomen or thigh. RA or PsA: 400mg (two 200mg inj at separate sites) on day 1, then at weeks 2 and 4, followed by 200mg every other week. Maintenance: may consider 400mg every 4 weeks. AS or nr-axSpA: 400mg (two 200mg inj at separate sites) on day 1, then at weeks 2 and 4, followed by 200mg every 2 weeks or 400mg every 4 weeks.

    Children

    Not established.

    Cimzia Contraindications

    Not Applicable

    Cimzia Boxed Warnings

    Boxed Warning

    Serious infections. Malignancy.

    Boxed Warning

    Serious Infections

    • Increased risk for developing serious infections that may lead to hospitalization or death particularly in those taking concomitant immunosuppressants (eg, methotrexate or corticosteroids).

    • Discontinue if serious infection or sepsis develops.

    • Reported infections include:

      • Active tuberculosis (TB), including reactivation of latent TB. Test for latent TB prior to and during therapy. Initiate treatment for latent TB prior to therapy.

      • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Consider empiric antifungal therapy in patients at risk.

      • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

    • Carefully consider risks/benefits of treatment with Cimzia prior to initiation in patients with chronic or recurrent infection.

    • Monitor closely for signs and symptoms of infection during and after treatment.

    Malignancy

    • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blocker. 

    • Cimzia is not indicated for use in pediatric patients.

    Cimzia Warnings/Precautions

    Warnings/Precautions

    Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB or history of, those having risk factors for TB, and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious infection, sepsis, HBV reactivation, or hematological abnormality develops. History of histoplasmosis exposure. Lymphoma and other malignancies. Perform periodic skin exams (esp. those with skin cancer risk factors). Immunosuppressed. Pre-existing or recent-onset demyelinating disorders (eg, multiple sclerosis, Guillain-Barré syndrome). CHF (monitor). Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Latex allergy (needle shield). Pregnancy. Nursing mothers.

    Warnings/Precautions

    Risk of Serious Infections

    • Increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death, particularly in patients >65yrs of age, patients with comorbid conditions, and/or patients taking concomitant immunosuppressants (eg, methotrexate or corticosteroids). 

    • Do not initiate in patients with an active infection, including clinically important localized infections.

    • Discontinue if serious infection or sepsis develops.

    • Monitor closely for signs and symptoms of infection during and after treatment.

    • Consider risks/benefits of treatment prior to initiation in patients: 

      • with chronic or recurrent infection

      • who have been exposed to tuberculosis

      • with a history of an opportunistic infection

      • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses

      • with underlying conditions that may predispose them to infection

    • Tuberculosis (TB):

      • Evaluate for TB risk factors and test for latent TB prior to initiation and periodically during therapy.

      • Prior to initiation, assess if treatment for latent TB is needed. Consider an induration of 5mm or greater a positive tuberculin skin test result.

      • Consider anti-TB therapy prior to initiation of Cimzia in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but having risk factors for TB infection.

      • Strongly consider TB in patients who develop a new infection during treatment.

    Malignancies

    • Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blockers.

    • Perform periodic skin exams for all patients especially in those with risk factors for skin cancer.

    Heart Failure

    • Cases of worsening CHF and new onset CHF may occur.

    • Exercise caution in patients with HF and monitor carefully.

    Hypersensitivity Reactions

    • Discontinue if hypersensitivity reactions occur and institute appropriate therapy.

    • Exercise caution in patients who have experienced a severe hypersensitivity reaction towards another TNF blocker.

    • The needle shield inside the removable cap of the Cimzia prefilled syringe contains a derivative of natural rubber latex.

    Hepatitis B Virus Reactivation

    • Test for HBV infection before initiating Cimzia. If positive for HBV infection, consult with a physician with expertise in hepatitis B.

    • Monitor closely during and for several months after discontinuing therapy in patients who are carriers of HBV and require treatment with Cimzia.

    • Discontinue in patients who develop HBV reactivation and initiate effective antiviral therapy with appropriate supportive treatment. Exercise caution when considering resuming Cimzia therapy and monitor closely.

    Neurologic Reactions

    • Exercise caution in considering the use of Cimzia in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders.

    Hematological Reactions

    • Rare reports of pancytopenia, including aplastic anemia, have occurred.

    • Exercise caution in patients who have ongoing, or a history of, significant hematologic abnormalities.

    • Advise to seek immediate medical attention if signs and symptoms suggestive of blood dyscrasias or infection occur (eg, persistent fever, bruising, bleeding, pallor).

    • Consider discontinuing Cimzia in patients with confirmed significant hematologic abnormalities.

    Use with Biological Disease-Modifying Antirheumatic Drugs (Biological DMARDs)

    • The use of Cimzia with other biological DMARDs: not recommended.

    Autoimmunity

    • Discontinue treatment if symptoms suggestive of a lupus-like syndrome develop.

    Immunizations

    • The safety and efficacy of Cimzia in patients with immunosuppression has not been formally evaluated.  

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Cimzia during pregnancy. For more information, healthcare providers or patients can contact: MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS). The OTIS AutoImmune Diseases Study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/  

    Risk Summary

    • Limited data from the ongoing pregnancy registry on use of Cimzia in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes.

    Clinical Considerations 

    • Disease-Associated Maternal and/or Embryo/Fetal Risk: Published data suggest that the risk of adverse pregnancy outcomes in women with rheumatoid arthritis or Crohn’s disease is correlated with maternal disease activity and that active disease increases the risk of adverse pregnancy outcomes.

    • Fetal/Neonatal Adverse Reactions:  Cimzia administered during pregnancy could affect immune responses in the in utero-exposed newborn and infant. The safety of administering live or live-attenuated vaccines in exposed infants is unknown.

    Nursing Mother Considerations

    Risk Summary  

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Cimzia and any potential adverse effects on the breastfed infant from Cimzia or from the underlying maternal condition. 

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Considerations

    • Clinical studies of Cimzia did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. 

    • Use caution in elderly patients.

    Cimzia Pharmacokinetics

    Absorption

    • Following subcutaneous administration, peak plasma concentrations of certolizumab pegol were attained between 54 and 171 hours post-injection. 

    • Certolizumab pegol has bioavailability (F) of approximately 80% (ranging from 76% to 88%) following subcutaneous administration compared to intravenous administration. 

    Distribution

    • The steady state volume of distribution (Vss) was estimated as 4.7 to 8 L.

    Metabolism

    • The metabolism of certolizumab pegol has not been studied in human subjects. Data from animals indicate that once cleaved from the Fab' fragment the PEG moiety is mainly excreted in urine without further metabolism. 

    Elimination

    • Studies in animals indicate that the major route of elimination of the PEG component is via urinary excretion.

    • The terminal elimination phase half-life (t1/2) was approximately 14 days for all doses tested.

    • The clearance following IV administration to healthy subjects ranged from 9.21 mL/h to 14.38 mL/h. 

    • The clearance following sc dosing was estimated 17 mL/h in the Crohn’s disease population PK analysis with an intersubject variability of 38% (CV) and an inter-occasion variability of 16%.

    • The clearance following sc dosing was estimated as 21.0 mL/h in the RA population PK analysis, with an inter-subject variability of 30.8% (%CV) and inter-occasion variability 22.0%. 

    • The clearance following subcutaneous dosing in patients with plaque psoriasis was 14 mL/h with an inter-subject variability of 22.2% (CV).

    Cimzia Interactions

    Interactions

    Concomitant anakinra, abatacept, rituximab, etanercept, natalizumab, live or attenuated vaccines, other biological DMARDs or TNF blockers: not recommended. Immunosuppressants increase risk of infection. May interfere with coagulation tests (eg, aPTT).

    Cimzia Adverse Reactions

    Adverse Reactions

    Upper respiratory infections, rash, UTI; TB, HBV reactivation, other infections, malignancies (eg, lymphoma; esp. children), heart failure; rare: hypersensitivity reactions, neurological disorders, lupus-like syndrome with antibody formation.

    Cimzia Clinical Trials

    Clinical Trials

    Rheumatoid Arthritis - Studies RA-I, RA-II, RA-III, and RA-IV

    • The efficacy and safety of Cimzia was based on data from 4 randomized, placebo-controlled, double-blind studies (RA-I, RA-II, RA-III, and RA-IV) in patients 18 years of age and older with moderately to severely active rheumatoid arthritis. 

    • Studies RA-I (N=592) and RA-II (N=619) included patients who had received methotrexate (MTX) for at least 6 months prior to Cimzia. Patients were randomly assigned to receive a loading dose of Cimzia 400mg at Weeks 0, 2, and 4 (both treatment arms) or placebo, followed by either 200mg or 400mg of Cimzia or placebo every other week, in combination with MTX for 52 weeks in Study RA-I and for 24 weeks in Study RA-II.

    • Study RA-III included 247 patients who had active disease despite receiving MTX for at least 6 months prior to study enrollment. Patients received Cimzia 400mg every 4 weeks for 24 weeks without a prior loading dose.

    • Study RA-IV included 220 patients who had failed at least 1 DMARD use prior to receiving Cimzia. Patients received Cimzia 400mg or placebo every 4 weeks for 24 weeks.

    • Results from Study RA-I showed that patients in the Cimzia 200mg + MTX every 2 weeks or Cimzia 200mg + MTX then placebo + MTX treatment arms achieved higher American College of Rheumatology (ACR) response rates vs the placebo + MTX arm, respectively:

      • ACR20

        • Week 24: 59% vs 45% vs 14%

        • Week 52: 53% vs 40% vs 13%

      • ACR50

        • Week 24: 37% vs 30% vs 8%

        • Week 52: 38% vs 30% vs 8%

      • ACR70

        • Week 24: 21% vs 18% vs 3%

        • Week 52: 21% vs 18% vs 4%

      • Major Clinical Response: 13% vs 12% vs 1%

    • In Study RA-IV, patients in the Cimzia 400mg every 4 weeks or Cimzia 400mg + placebo arms achieved higher ACR response rates vs the placebo arm, respectively:

      • ACR20

        • Week 24: 46% vs 36% vs 9%

      • ACR50

        • Week 24: 23% vs 19% vs 4%

      • ACR70

        • Week 24: 6% vs 6% vs 0%

    • The results in Study RA-II were similar to the results in RA-I at Week 24. The results in Study RA-III were similar to those seen in Study RA-IV.

    • In all 4 studies, patients who received Cimzia achieved greater improvements at Week 24 (RA-II, RA-III, and RA-IV) and at Week 52 (RA-I) from baseline in physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) compared with those who received placebo.

    Psoriatic Arthritis

    • The efficacy and safety of Cimzia was assessed in the PsA001 trial which included 409 patients 18 years of age and older with active psoriatic arthritis despite DMARD therapy. 

    • Patients were randomly assigned to receive either a loading dose of Cimzia 400mg at Weeks 0, 2, and 4 (for both treatment arms) or placebo, followed by either Cimzia 200mg every other week or Cimzia 400mg every 4 weeks or placebo every other week.

    • Results showed that patients treated with either Cimzia 200mg every 2 weeks or Cimzia 400mg every 4 weeks achieved higher ACR response rates vs those treated with placebo, respectively:

      • ACR20

        • Week 12: 58% vs 52% vs 24%

        • Week 24: 64% vs 56% vs 24%

      • ACR50

        • Week 12: 36% vs 33% vs 11%

        • Week 24: 44% vs 40% vs 13%

      • ACR70

        • Week 12: 25% vs 13% vs 3%

        • Week 24: 28% vs 24% vs 4%

    • Patients who received either Cimzia 200mg every 2 weeks or Cimzia 400mg every 4 weeks achieved a reduction in enthesitis of 1.8 and 1.7, respectively, at week 12 compared with a reduction of 0.9 in patients who received placebo.

    • Patients who received either Cimzia 200mg every other week achieved greater reduction in radiographic progression compared with those who received placebo at week 24.

    • Cimzia-treated patients achieved improvement in physical function as assessed by the HAQ-DI at week 24 compared with placebo.

    Ankylosing Spondylitis

    • The efficacy and safety of Cimzia was assessed in the AS-1 trial which included 325 patients 18 years of age and older with adult-onset active axial spondyloarthritis for at least 3 months and were intolerant to or had an inadequate response to at least 1 NSAID. Active disease was defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, and spinal pain ≥4 on a 0 to 10 Numerical Rating Scale (NRS).

    • Patients were randomly assigned to receive either a loading dose of Cimzia 400mg at Weeks 0, 2, and 4 (for both treatment arms) or placebo, followed by either Cimzia 200mg every 2 weeks or 400mg every 4 weeks or placebo. Concomitant NSAIDs were received by 91% of the AS patients.

    • Results showed that patients treated with either Cimzia 200mg every 2 weeks or 400mg every 4 weeks achieved higher ASAS response rates vs those treated with placebo, respectively:

      • ASAS20

        • Week 12: 57% vs 64% vs 37%

        • Week 24: 68% vs 70% vs 33%

      • ASAS40

        • Week 12: 40% vs 50% vs 19%

        • Week 24: 48% vs 59% vs 16%

     

    Non-radiographic Axial Spondyloarthritis 

    • The efficacy and safety of Cimzia was assessed in the nr-axSpA-1 trial which included 317 patients 18 years of age and older with adult-onset active axial spondyloarthritis for at least 12 months and were intolerant to or had an inadequate response to at least 2 NSAIDs. Active disease was defined by the BASDAI ≥4, and spinal pain ≥4 on a 0 to 10 Numerical Rating Scale (NRS).

    • Patients were randomly assigned to receive either a loading dose of Cimzia 400mg at Weeks 0, 2, and 4 or placebo, followed by either Cimzia 200mg every 2 weeks or placebo. Patients were permitted to use concomitant medications (eg, NSAIDs, DMARDs, corticosteroids, opioids) at any time.

    • Results showed that a greater proportion of patients treated with Cimzia achieved Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) responses vs those treated with placebo, respectively:

      • ASDAS-MI

        • Week 52: 47% vs 7% (odds ratio, 15.2 [95% CI, 7.3-31.6])

      • ASAS-40

        • Week 12: 48% vs 11% (odds ratio, 7.4 [95% CI, 4.1-13.4])

        • Week 52: 57% vs 16% (odds ratio, 7.4 [95% CI, 4.3-12.6])

    • In the nr-asSpA-1 study, Cimzia-treated patients achieved significantly grater improvement in the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) score at week 12 compared with placebo-treated patients.

    Cimzia Note

    Not Applicable

    Cimzia Patient Counseling

    Patient Counseling

    Risk of Serious Infections

    • May lower the ability of the immune system to fight infections. Contact physician if you develop any symptoms of infection, including tuberculosis and reactivation of hepatitis B virus infections.

    • Exercise caution in prescribing Cimzia to patients with clinically important active infections.

    Malignancies

    • Counsel patients about the risk of lymphoma and other malignancies.

    Other Medical Conditions

    • Report any signs of new or worsening medical conditions (eg, heart disease, neurological disease, or autoimmune disorders). 

    • Report promptly any symptoms suggestive of a cytopenia (eg, bruising, bleeding, or persistent fever).

    Hypersensitivity Reactions

    • Seek immediate medical attention if symptoms of severe hypersensitivity reactions develop.

    • Advise latex-sensitive patients that the needle shield inside the removal cap of Cimzia prefilled syringe contains a derivative of natural rubber latex.

    Pregnancy

    • Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to Cimzia during pregnancy, patients can call 1-877-311-8972.

    Cost Savings Program

    Cimzia Savings & Support

    Cimzia Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Certolizumab pegol 200mg/mL soln for SC inj; or per vial (pwd for SC inj after reconstitution); preservative-free.

    Pharmacological Class

    Tumor necrosis factor (TNF) blocker.

    How Supplied

    Pack—1 (2 single-dose vials w. syringes, needles, supplies); Single-dose prefilled syringes—2 (w. supplies); Prefilled Syringe Starter Kit—6 (w. supplies)

    How Supplied

    Lyophilized Powder for Reconstitution:

    Cimzia (certolizumab pegol) for injection is supplied as a sterile white, lyophilized powder in a single-dose vial for subcutaneous use. 

    • Pack Content:

      • Type I glass vials with rubber stopper and overseals each containing 200 mg of lyophilized Cimzia for reconstitution. Qty: 2 

      • 2 mL Type I glass vials 2 mL containing 1 mL sterile Water for Injection. Qty: 2 

      • 3 mL plastic syringes. Qty: 2

      • 20 gauge needles (1 inch). Qty: 4

      • 23 gauge needles (1 inch). Qty: 2

      • Alcohol swabs. Qty: 8

    Prefilled Syringe:

    Cimzia (certolizumab pegol) injection is supplied as a sterile, clear to opalescent, colorless to pale yellow solution in a single-dose prefilled syringe for subcutaneous use. Needle shield inside the removable cap of the prefilled syringe contains a derivative of natural rubber latex.

    • Pack Content:

      • Alcohol swabs. Qty: 2

      • Single-dose prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle, each containing 200mg (1 mL) of Cimzia. Qty: 2

    Prefilled Syringe Starter Kit:

    Cimzia (certolizumab pegol) injection is supplied as a sterile, clear to opalescent, colorless to pale yellow solution in a single-dose prefilled syringe for subcutaneous use.

    • Pack Content:

      • Alcohol swabs. Qty: 6

      • Single-dose prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle, each containing 200mg (1 mL) of Cimzia. Qty: 6

    Storage

    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.

    Manufacturer

    UCB Inc.

    Generic Availability

    NO

    Cimzia Indications

    Indications

    In moderately-to-severely active Crohn's disease: to reduce signs and symptoms and to maintain clinical response in adult patients with inadequate response to conventional therapy.

    Cimzia Dosage and Administration

    Adult

    Rotate inj site. Give by SC inj in abdomen or thigh. 400mg (two 200mg inj at separate sites) on day 1, then at weeks 2 and 4; maintenance 400mg every 4 weeks.

    Children

    Not established.

    Cimzia Contraindications

    Not Applicable

    Cimzia Boxed Warnings

    Boxed Warning

    Serious infections. Malignancy.

    Boxed Warning

    Serious Infections

    • Increased risk for developing serious infections that may lead to hospitalization or death particularly in those taking concomitant immunosuppressants (eg, methotrexate or corticosteroids).

    • Discontinue if serious infection or sepsis develops.

    • Reported infections include:

      • Active tuberculosis (TB), including reactivation of latent TB. Test for latent TB prior to and during therapy. Initiate treatment for latent TB prior to therapy.

      • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Consider empiric antifungal therapy in patients at risk.

      • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

    • Carefully consider risks/benefits of treatment with Cimzia prior to initiation in patients with chronic or recurrent infection.

    • Monitor closely for signs and symptoms of infection during and after treatment.

    Malignancy

    • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blocker. 

    • Cimzia is not indicated for use in pediatric patients.

    Cimzia Warnings/Precautions

    Warnings/Precautions

    Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB or history of, those having risk factors for TB, and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious infection, sepsis, HBV reactivation, or hematological abnormality develops. History of histoplasmosis exposure. Lymphoma and other malignancies. Perform periodic skin exams (esp. those with skin cancer risk factors). Immunosuppressed. Pre-existing or recent-onset demyelinating disorders (eg, multiple sclerosis, Guillain-Barré syndrome). CHF (monitor). Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Latex allergy (needle shield). Pregnancy. Nursing mothers.

    Warnings/Precautions

    Risk of Serious Infections

    • Increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death, particularly in patients >65yrs of age, patients with comorbid conditions, and/or patients taking concomitant immunosuppressants (eg, methotrexate or corticosteroids). 

    • Do not initiate in patients with an active infection, including clinically important localized infections.

    • Discontinue if serious infection or sepsis develops.

    • Monitor closely for signs and symptoms of infection during and after treatment.

    • Consider risks/benefits of treatment prior to initiation in patients: 

      • with chronic or recurrent infection

      • who have been exposed to tuberculosis

      • with a history of an opportunistic infection

      • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses

      • with underlying conditions that may predispose them to infection

    • Tuberculosis (TB):

      • Evaluate for TB risk factors and test for latent TB prior to initiation and periodically during therapy.

      • Prior to initiation, assess if treatment for latent TB is needed. Consider an induration of 5mm or greater a positive tuberculin skin test result.

      • Consider anti-TB therapy prior to initiation of Cimzia in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but having risk factors for TB infection.

      • Strongly consider TB in patients who develop a new infection during treatment.

    Malignancies

    • Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blockers.

    • Perform periodic skin exams for all patients especially in those with risk factors for skin cancer.

    Heart Failure

    • Cases of worsening CHF and new onset CHF may occur.

    • Exercise caution in patients with HF and monitor carefully.

    Hypersensitivity Reactions

    • Discontinue if hypersensitivity reactions occur and institute appropriate therapy.

    • Exercise caution in patients who have experienced a severe hypersensitivity reaction towards another TNF blocker.

    • The needle shield inside the removable cap of the Cimzia prefilled syringe contains a derivative of natural rubber latex.

    Hepatitis B Virus Reactivation

    • Test for HBV infection before initiating Cimzia. If positive for HBV infection, consult with a physician with expertise in hepatitis B.

    • Monitor closely during and for several months after discontinuing therapy in patients who are carriers of HBV and require treatment with Cimzia.

    • Discontinue in patients who develop HBV reactivation and initiate effective antiviral therapy with appropriate supportive treatment. Exercise caution when considering resuming Cimzia therapy and monitor closely.

    Neurologic Reactions

    • Exercise caution in considering the use of Cimzia in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders.

    Hematological Reactions

    • Rare reports of pancytopenia, including aplastic anemia, have occurred.

    • Exercise caution in patients who have ongoing, or a history of, significant hematologic abnormalities.

    • Advise to seek immediate medical attention if signs and symptoms suggestive of blood dyscrasias or infection occur (eg, persistent fever, bruising, bleeding, pallor).

    • Consider discontinuing Cimzia in patients with confirmed significant hematologic abnormalities.

    Use with Biological Disease-Modifying Antirheumatic Drugs (Biological DMARDs)

    • The use of Cimzia with other biological DMARDs: not recommended.

    Autoimmunity

    • Discontinue treatment if symptoms suggestive of a lupus-like syndrome develop.

    Immunizations

    • The safety and efficacy of Cimzia in patients with immunosuppression has not been formally evaluated.  

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Cimzia during pregnancy. For more information, healthcare providers or patients can contact: MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS). The OTIS AutoImmune Diseases Study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/  

    Risk Summary

    • Limited data from the ongoing pregnancy registry on use of Cimzia in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes.

    Clinical Considerations 

    • Disease-Associated Maternal and/or Embryo/Fetal Risk: Published data suggest that the risk of adverse pregnancy outcomes in women with rheumatoid arthritis or Crohn’s disease is correlated with maternal disease activity and that active disease increases the risk of adverse pregnancy outcomes.

    • Fetal/Neonatal Adverse Reactions:  Cimzia administered during pregnancy could affect immune responses in the in utero-exposed newborn and infant. The safety of administering live or live-attenuated vaccines in exposed infants is unknown.

    Nursing Mother Considerations

    Risk Summary  

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Cimzia and any potential adverse effects on the breastfed infant from Cimzia or from the underlying maternal condition. 

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Considerations

    • Clinical studies of Cimzia did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. 

    • Use caution in elderly patients.

    Cimzia Pharmacokinetics

    Absorption

    • Following subcutaneous administration, peak plasma concentrations of certolizumab pegol were attained between 54 and 171 hours post-injection. 

    • Certolizumab pegol has bioavailability (F) of approximately 80% (ranging from 76% to 88%) following subcutaneous administration compared to intravenous administration. 

    Distribution

    • The steady state volume of distribution (Vss) was estimated as 4.7 to 8 L.

    Metabolism

    • The metabolism of certolizumab pegol has not been studied in human subjects. Data from animals indicate that once cleaved from the Fab' fragment the PEG moiety is mainly excreted in urine without further metabolism. 

    Elimination

    • Studies in animals indicate that the major route of elimination of the PEG component is via urinary excretion.

    • The terminal elimination phase half-life (t1/2) was approximately 14 days for all doses tested.

    • The clearance following IV administration to healthy subjects ranged from 9.21 mL/h to 14.38 mL/h. 

    • The clearance following sc dosing was estimated 17 mL/h in the Crohn’s disease population PK analysis with an intersubject variability of 38% (CV) and an inter-occasion variability of 16%.

    • The clearance following sc dosing was estimated as 21.0 mL/h in the RA population PK analysis, with an inter-subject variability of 30.8% (%CV) and inter-occasion variability 22.0%. 

    • The clearance following subcutaneous dosing in patients with plaque psoriasis was 14 mL/h with an inter-subject variability of 22.2% (CV).

    Cimzia Interactions

    Interactions

    Concomitant anakinra, abatacept, rituximab, etanercept, natalizumab, live or attenuated vaccines, other biological DMARDs or TNF blockers: not recommended. Immunosuppressants increase risk of infection. May interfere with coagulation tests (eg, aPTT).

    Cimzia Adverse Reactions

    Adverse Reactions

    Upper respiratory infections, rash, UTI; TB, HBV reactivation, other infections, malignancies (eg, lymphoma; esp. children), heart failure; rare: hypersensitivity reactions, neurological disorders, lupus-like syndrome with antibody formation.

    Cimzia Clinical Trials

    Clinical Trials

    Crohn Disease - Study CD1

    • The double-bind, randomized, placebo-controlled study included 662 patients 18 years of age and older with moderately to severely active Crohn disease. Patients were randomly assigned to receive either Cimzia or placebo at Weeks 0, 2, and 4, then every 4 weeks until Week 24.

    • Clinical response was defined as at least a 100-point reduction in Crohn Disease Activity Index (CDAI) score compared to baseline, and clinical remission was defined as an absolute CDAI score of 150 points or lower.

    • Results showed that a significantly greater proportion of Cimzia-treated patients achieved clinical response and clinical remission compared with placebo, respectively:

      • Week 6 – Clinical Response: 35% (95% CI, 30-40) vs 27% (95% CI, 22-32) (P <.05)

      • Week 6 – Clinical Remission: 22% (95% CI, 17-26) vs 17% (95% CI, 13-22)

      • Week 26 – Clinical Response: 37% (95% CI, 32-42) vs 27% (95% CI, 22-31) (P <.05)

      • Week 26 – Clinical Remission: 29% (95% CI, 25-34) vs 18% (95% CI, 14-22) (P <.05)

      • Both Weeks 6 & 26 – Clinical Response: 23% (95% CI, 18-28) vs 16% (95% CI, 12-20) (P <.05)

    Crohn Disease - Study CD2

    • The randomized treatment-withdrawal study included patients 18 years of age and older with moderately to severely active Crohn disease. All patients received an initial dose of Cimzia 400mg at Weeks 0, 2, and 4 then assessed for clinical response at Week 6. Clinical response was defined as at least a 100-point reduction in CDAI score, and clinical remission was defined as CDAI less than or equal to 150 points.

    • At Week 6, there were 428 clinical responders who were randomly assigned to receive either Cimzia 400mg or placebo every 4 weeks starting at Week 8 through Week 24.

    • Results showed that 63% of Cimzia-treated patients achieved clinical response at Week 26 compared with 36% of placebo-treated patients (P <.05). Moreover, 48% of Cimzia-treated patients achieved clinical remission at Week 26 compared with 29% of placebo-treated patients (P <.05).

    Cimzia Note

    Not Applicable

    Cimzia Patient Counseling

    Patient Counseling

    Risk of Serious Infections

    • May lower the ability of the immune system to fight infections. Contact physician if you develop any symptoms of infection, including tuberculosis and reactivation of hepatitis B virus infections.

    • Exercise caution in prescribing Cimzia to patients with clinically important active infections.

    Malignancies

    • Counsel patients about the risk of lymphoma and other malignancies.

    Other Medical Conditions

    • Report any signs of new or worsening medical conditions (eg, heart disease, neurological disease, or autoimmune disorders). 

    • Report promptly any symptoms suggestive of a cytopenia (eg, bruising, bleeding, or persistent fever).

    Hypersensitivity Reactions

    • Seek immediate medical attention if symptoms of severe hypersensitivity reactions develop.

    • Advise latex-sensitive patients that the needle shield inside the removal cap of Cimzia prefilled syringe contains a derivative of natural rubber latex.

    Pregnancy

    • Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to Cimzia during pregnancy, patients can call 1-877-311-8972.

    Cost Savings Program

    Cimzia Savings & Support

    Cimzia Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Certolizumab pegol 200mg/mL soln for SC inj; or per vial (pwd for SC inj after reconstitution); preservative-free.

    Pharmacological Class

    Tumor necrosis factor (TNF) blocker.

    How Supplied

    Pack—1 (2 single-dose vials w. syringes, needles, supplies); Single-dose prefilled syringes—2 (w. supplies); Prefilled Syringe Starter Kit—6 (w. supplies)

    How Supplied

    Lyophilized Powder for Reconstitution:

    Cimzia (certolizumab pegol) for injection is supplied as a sterile white, lyophilized powder in a single-dose vial for subcutaneous use. 

    • Pack Content:

      • Type I glass vials with rubber stopper and overseals each containing 200 mg of lyophilized Cimzia for reconstitution. Qty: 2 

      • 2 mL Type I glass vials 2 mL containing 1 mL sterile Water for Injection. Qty: 2 

      • 3 mL plastic syringes. Qty: 2

      • 20 gauge needles (1 inch). Qty: 4

      • 23 gauge needles (1 inch). Qty: 2

      • Alcohol swabs. Qty: 8

    Prefilled Syringe:

    Cimzia (certolizumab pegol) injection is supplied as a sterile, clear to opalescent, colorless to pale yellow solution in a single-dose prefilled syringe for subcutaneous use. Needle shield inside the removable cap of the prefilled syringe contains a derivative of natural rubber latex.

    • Pack Content:

      • Alcohol swabs. Qty: 2

      • Single-dose prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle, each containing 200mg (1 mL) of Cimzia. Qty: 2

    Prefilled Syringe Starter Kit:

    Cimzia (certolizumab pegol) injection is supplied as a sterile, clear to opalescent, colorless to pale yellow solution in a single-dose prefilled syringe for subcutaneous use.

    • Pack Content:

      • Alcohol swabs. Qty: 6

      • Single-dose prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle, each containing 200mg (1 mL) of Cimzia. Qty: 6

    Storage

    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.

    Manufacturer

    UCB Inc.

    Generic Availability

    NO

    Cimzia Indications

    Indications

    Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

    Cimzia Dosage and Administration

    Adult

    Rotate inj site. Give by SC inj in abdomen or thigh. 400mg (two 200mg inj at separate sites) every other week. If ≤90kg: may consider 400mg on day 1, then at weeks 2 and 4, followed by 200mg every other week.

    Children

    Not established.

    Cimzia Contraindications

    Not Applicable

    Cimzia Boxed Warnings

    Boxed Warning

    Serious infections. Malignancy.

    Boxed Warning

    Serious Infections

    • Increased risk for developing serious infections that may lead to hospitalization or death particularly in those taking concomitant immunosuppressants (eg, methotrexate or corticosteroids).

    • Discontinue if serious infection or sepsis develops.

    • Reported infections include:

      • Active tuberculosis (TB), including reactivation of latent TB. Test for latent TB prior to and during therapy. Initiate treatment for latent TB prior to therapy.

      • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Consider empiric antifungal therapy in patients at risk.

      • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

    • Carefully consider risks/benefits of treatment with Cimzia prior to initiation in patients with chronic or recurrent infection.

    • Monitor closely for signs and symptoms of infection during and after treatment.

    Malignancy

    • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blocker. 

    • Cimzia is not indicated for use in pediatric patients.

    Cimzia Warnings/Precautions

    Warnings/Precautions

    Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB or history of, those having risk factors for TB, and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious infection, sepsis, HBV reactivation, or hematological abnormality develops. History of histoplasmosis exposure. Lymphoma and other malignancies. Perform periodic skin exams (esp. those with skin cancer risk factors). Immunosuppressed. Pre-existing or recent-onset demyelinating disorders (eg, multiple sclerosis, Guillain-Barré syndrome). CHF (monitor). Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Latex allergy (needle shield). Pregnancy. Nursing mothers.

    Warnings/Precautions

    Risk of Serious Infections

    • Increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death, particularly in patients >65yrs of age, patients with comorbid conditions, and/or patients taking concomitant immunosuppressants (eg, methotrexate or corticosteroids). 

    • Do not initiate in patients with an active infection, including clinically important localized infections.

    • Discontinue if serious infection or sepsis develops.

    • Monitor closely for signs and symptoms of infection during and after treatment.

    • Consider risks/benefits of treatment prior to initiation in patients: 

      • with chronic or recurrent infection

      • who have been exposed to tuberculosis

      • with a history of an opportunistic infection

      • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses

      • with underlying conditions that may predispose them to infection

    • Tuberculosis (TB):

      • Evaluate for TB risk factors and test for latent TB prior to initiation and periodically during therapy.

      • Prior to initiation, assess if treatment for latent TB is needed. Consider an induration of 5mm or greater a positive tuberculin skin test result.

      • Consider anti-TB therapy prior to initiation of Cimzia in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but having risk factors for TB infection.

      • Strongly consider TB in patients who develop a new infection during treatment.

    Malignancies

    • Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blockers.

    • Perform periodic skin exams for all patients especially in those with risk factors for skin cancer.

    Heart Failure

    • Cases of worsening CHF and new onset CHF may occur.

    • Exercise caution in patients with HF and monitor carefully.

    Hypersensitivity Reactions

    • Discontinue if hypersensitivity reactions occur and institute appropriate therapy.

    • Exercise caution in patients who have experienced a severe hypersensitivity reaction towards another TNF blocker.

    • The needle shield inside the removable cap of the Cimzia prefilled syringe contains a derivative of natural rubber latex.

    Hepatitis B Virus Reactivation

    • Test for HBV infection before initiating Cimzia. If positive for HBV infection, consult with a physician with expertise in hepatitis B.

    • Monitor closely during and for several months after discontinuing therapy in patients who are carriers of HBV and require treatment with Cimzia.

    • Discontinue in patients who develop HBV reactivation and initiate effective antiviral therapy with appropriate supportive treatment. Exercise caution when considering resuming Cimzia therapy and monitor closely.

    Neurologic Reactions

    • Exercise caution in considering the use of Cimzia in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders.

    Hematological Reactions

    • Rare reports of pancytopenia, including aplastic anemia, have occurred.

    • Exercise caution in patients who have ongoing, or a history of, significant hematologic abnormalities.

    • Advise to seek immediate medical attention if signs and symptoms suggestive of blood dyscrasias or infection occur (eg, persistent fever, bruising, bleeding, pallor).

    • Consider discontinuing Cimzia in patients with confirmed significant hematologic abnormalities.

    Use with Biological Disease-Modifying Antirheumatic Drugs (Biological DMARDs)

    • The use of Cimzia with other biological DMARDs: not recommended.

    Autoimmunity

    • Discontinue treatment if symptoms suggestive of a lupus-like syndrome develop.

    Immunizations

    • The safety and efficacy of Cimzia in patients with immunosuppression has not been formally evaluated.  

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Cimzia during pregnancy. For more information, healthcare providers or patients can contact: MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS). The OTIS AutoImmune Diseases Study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/  

    Risk Summary

    • Limited data from the ongoing pregnancy registry on use of Cimzia in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes.

    Clinical Considerations 

    • Disease-Associated Maternal and/or Embryo/Fetal Risk: Published data suggest that the risk of adverse pregnancy outcomes in women with rheumatoid arthritis or Crohn’s disease is correlated with maternal disease activity and that active disease increases the risk of adverse pregnancy outcomes.

    • Fetal/Neonatal Adverse Reactions:  Cimzia administered during pregnancy could affect immune responses in the in utero-exposed newborn and infant. The safety of administering live or live-attenuated vaccines in exposed infants is unknown.

    Nursing Mother Considerations

    Risk Summary  

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Cimzia and any potential adverse effects on the breastfed infant from Cimzia or from the underlying maternal condition. 

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Considerations

    • Clinical studies of Cimzia did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. 

    • Use caution in elderly patients.

    Cimzia Pharmacokinetics

    Absorption

    • Following subcutaneous administration, peak plasma concentrations of certolizumab pegol were attained between 54 and 171 hours post-injection. 

    • Certolizumab pegol has bioavailability (F) of approximately 80% (ranging from 76% to 88%) following subcutaneous administration compared to intravenous administration. 

    Distribution

    • The steady state volume of distribution (Vss) was estimated as 4.7 to 8 L.

    Metabolism

    • The metabolism of certolizumab pegol has not been studied in human subjects. Data from animals indicate that once cleaved from the Fab' fragment the PEG moiety is mainly excreted in urine without further metabolism. 

    Elimination

    • Studies in animals indicate that the major route of elimination of the PEG component is via urinary excretion.

    • The terminal elimination phase half-life (t1/2) was approximately 14 days for all doses tested.

    • The clearance following IV administration to healthy subjects ranged from 9.21 mL/h to 14.38 mL/h. 

    • The clearance following sc dosing was estimated 17 mL/h in the Crohn’s disease population PK analysis with an intersubject variability of 38% (CV) and an inter-occasion variability of 16%.

    • The clearance following sc dosing was estimated as 21.0 mL/h in the RA population PK analysis, with an inter-subject variability of 30.8% (%CV) and inter-occasion variability 22.0%. 

    • The clearance following subcutaneous dosing in patients with plaque psoriasis was 14 mL/h with an inter-subject variability of 22.2% (CV).

    Cimzia Interactions

    Interactions

    Concomitant anakinra, abatacept, rituximab, etanercept, natalizumab, live or attenuated vaccines, other biological DMARDs or TNF blockers: not recommended. Immunosuppressants increase risk of infection. May interfere with coagulation tests (eg, aPTT).

    Cimzia Adverse Reactions

    Adverse Reactions

    Upper respiratory infections, rash, UTI; TB, HBV reactivation, other infections, malignancies (eg, lymphoma; esp. children), heart failure; rare: hypersensitivity reactions, neurological disorders, lupus-like syndrome with antibody formation.

    Cimzia Clinical Trials

    Clinical Trials

    Plaque Psoriasis

    • The efficacy and safety of Cimzia was assessed in 3 studies (Study PS-1, PS-2, and PS-3) which included patients 18 years of age and older with moderate to severe plaque psoriasis who were eligible for systemic therapy or phototherapy.

    • In Studies PS-1 (N=234) and PS-2 (N=227), patients were randomly assigned to receive either Cimzia 200mg every other week (following a loading dose of Cimzia 400mg at Weeks 0, 2, and 4), or Cimzia 400mg every other week, or placebo. The coprimary endpoints was the proportion of patients who achieved a PASI 75 and PGA of “clear” or “almost clear” with at least a 2-point improvement at week 16.

    • In Study PS-3 (N=559), patients were randomly assigned to receive either Cimzia 200mg every other week (following a loading dose of Cimzia 400mg at Weeks 0, 2, and 4), or Cimzia 400mg every other week up to Week 16, or a biologic comparator (up to Week 12). The primary endpoint was the proportion of patients who achieved PASI 75 at week 12.

    • Findings from Study PS-1 showed that patients treated with Cimzia 200mg or 400mg achieved the following efficacy results at week 16 compared with those treated with placebo, respectively:

      • PGA of 0 or 1: 45% vs 55% vs 4%

      • PASI 75: 65% vs 75% vs 7%

      • PASI 90: 36% vs 44% vs 0%

    • In Study PS-2, patients treated with Cimzia 200mg or 400mg achieved the following efficacy results at week 16 compared with those treated with placebo, respectively:

      • PGA of 0 or 1: 61% vs 65% vs 3%

      • PASI 75: 81% vs 82% vs 13%

      • PASI 90: 50% vs 52% vs 5%

    • In Study PS-3, patients treated with Cimzia 200mg or 400mg achieved the following efficacy results at week 16 compared with those treated with placebo, respectively:

      • PGA of 0 or 1: 52% vs 62% vs 4%

      • PASI 75: 69% vs 75% vs 4%

      • PASI 90: 40% vs 49% vs 0%

    • Maintenance of Response

      • In PS-1 and PS-2, among subjects who were PASI 75 responders at Week 16 and received Cimzia 400 mg every other week, the PASI 75 response rates at Week 48 were 94% and 81%, respectively. In subjects who were PASI 75 responders at Week 16 and received Cimzia 200 mg every other week, the PASI 75 response rates at Week 48 were 81% and 74%, respectively. 

      • In PS-1 and PS-2, among subjects who were PGA clear or almost clear responders at Week 16 and received Cimzia 400 mg every other week, the PGA response rates at Week 48 were 79% and 73%, respectively. In subjects who were PGA clear or almost clear responders at Week 16 and received Cimzia 200 mg every other week, the PGA response rates at Week 48 were 79% and 76%, respectively. 

      • In PS-3, subjects who achieved a PASI 75 response at Week 16 were re-randomized to either continue treatment with Cimzia or be withdrawn from therapy (i.e., receive placebo). At Week 48, 98% of subjects who continued on Cimzia 400 mg every other week were PASI 75 responders as compared to 36% of subjects who were re-randomized to placebo. Among PASI 75 responders at Week 16 who received Cimzia 200 mg every other week and were re-randomized to either Cimzia 200 mg every other week or placebo, there was also a higher percentage of PASI 75 responders at Week 48 in the Cimzia group as compared to placebo (80% and 46%, respectively). 

    Cimzia Note

    Not Applicable

    Cimzia Patient Counseling

    Patient Counseling

    Risk of Serious Infections

    • May lower the ability of the immune system to fight infections. Contact physician if you develop any symptoms of infection, including tuberculosis and reactivation of hepatitis B virus infections.

    • Exercise caution in prescribing Cimzia to patients with clinically important active infections.

    Malignancies

    • Counsel patients about the risk of lymphoma and other malignancies.

    Other Medical Conditions

    • Report any signs of new or worsening medical conditions (eg, heart disease, neurological disease, or autoimmune disorders). 

    • Report promptly any symptoms suggestive of a cytopenia (eg, bruising, bleeding, or persistent fever).

    Hypersensitivity Reactions

    • Seek immediate medical attention if symptoms of severe hypersensitivity reactions develop.

    • Advise latex-sensitive patients that the needle shield inside the removal cap of Cimzia prefilled syringe contains a derivative of natural rubber latex.

    Pregnancy

    • Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to Cimzia during pregnancy, patients can call 1-877-311-8972.

    Cost Savings Program

    Cimzia Savings & Support

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