Certolizumab Pegol

Class: Disease-modifying Antirheumatic Agents
Molecular Formula: C₂₁₁₅H₃₂₅₂N₅₅₆O₆₇₃S₁₆
CAS Number: 428863-50-7
Brands: Cimzia

Special Alerts:

[Posted 09/07/2011] ISSUE: FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNF) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNF blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.

Patients treated with TNF blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.

BACKGROUND: The class of TNF blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.

RECOMMENDATION: The risks and the benefits of TNF blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection. See the Drug Safety Communication for a listing of recommendations for healthcare professionals and patients, as well as a data summary. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for certolizumab pegol to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of certolizumab pegol and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• Serious Infections


• 
  

  Serious, sometimes fatal infections including tuberculosis (frequently disseminated or extrapulmonary), bacterial and viral infections, invasive fungal infections (may be disseminated), and other opportunistic infections reported.¹ (See Infectious Complications under Cautions.)

  
  


• 
  

  Carefully consider risks and benefits prior to initiating certolizumab pegol therapy in patients with chronic or recurring infections.¹

  
  


• 
  

  Evaluate patients for latent tuberculosis infection prior to and periodically during certolizumab pegol therapy; if indicated, initiate appropriate antimycobacterial regimen prior to initiating therapy.¹

  
  


• 
  

  Closely monitor patients for infection, including active tuberculosis in those with a negative tuberculin skin test, during and after treatment.¹ Discontinue certolizumab pegol if serious infection occurs.¹ Consider empiric antifungal therapy if serious systemic illness occurs in a patient at risk for invasive fungal infections.¹

  
  

• Malignancy


• 
  

  Lymphoma and other malignancies (some fatal) reported in children and adolescents receiving TNF blocking agents.¹ (See Malignancies and Lymphoproliferative Disorders under Cautions.)

  
  

Introduction

Biologic response modifier and disease-modifying antirheumatic drug (DMARD); a recombinant humanized Fab′ fragment of a monoclonal antibody specific for tumor necrosis factor (TNF; TNF-α).^{1 2 3 7 8 14 15 16}

Uses for Certolizumab Pegol

Crohn's Disease

Used to reduce the signs and symptoms of moderately to severely active Crohn's disease and to maintain clinical response in adults who have had an inadequate response to conventional therapies.^{1 2 3}

Rheumatoid Arthritis

Management of moderately to severely active rheumatoid arthritis in adults.¹ May be used alone or in combination with methotrexate or other nonbiologic DMARDs.¹

Certolizumab Pegol Dosage and Administration

General

• 
  

  Oral corticosteroids, NSAIAs, and/or analgesics may be continued in adults with rheumatoid arthritis.^{17 18 19}

  
  

REMS Program

• 
  

  FDA has approved a REMS for certolizumab pegol.¹¹

  
  


• 
  

  The program consists of a medication guide that must be provided to patients (see Advice to Patients) and a communication plan that includes initial communications targeting selected groups of clinicians.¹¹

  
  


• 
  

  The goals are to inform patients about the serious risks associated with the drug and to inform clinicians about invasive fungal infections associated with use of TNF blocking agents (see Warnings/Precautions under Cautions).¹¹

  
  

Administration

Sub-Q Administration

Administer by sub-Q injection into the thighs or abdomen using a 23-gauge needle.¹ Rotate injection sites.¹ Do not inject into areas where the skin is tender, bruised, red, or hard.¹

Allow reconstituted solution and prefilled syringes sit at room temperature for 30 minutes prior to administration.¹

Following reconstitution, draw up each 400 mg dose into 2 syringes, each containing 200 mg, and administer by sub-Q injection into separate sites on the thighs or abdomen using 23-gauge needles.¹

Reconstituted solution intended for use under the guidance and supervision of a clinician.¹ Certolizumab pegol solution supplied in prefilled syringes may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training.¹

Reconstitution

Allow lyophilized powder kit (containing drug, diluent, syringes, needles) to reach room temperature prior to reconstitution.¹

Reconstitute vial containing 200 mg of certolizumab pegol lyophilized powder by adding 1 mL of sterile water for injection (provided by manufacturer) to provide a solution containing approximately 200 mg/mL.¹

Gently swirl vial to ensure all of the powder comes into contact with the diluent; do not shake.¹ Leave vial undisturbed to fully reconstitute (may take up to 30 minutes).¹

Dosage

Adults

Crohn's Disease

Sub-Q

400 mg (as two 200-mg injections at separate sites) at 0, 2, and 4 weeks (induction regimen); patients who respond may receive additional 400-mg doses every 4 weeks (maintenance regimen).¹

Rheumatoid Arthritis

Sub-Q

400 mg (as two 200-mg injections at separate sites) at 0, 2, and 4 weeks, followed by 200 mg every 2 weeks.¹ For maintenance therapy, 400 mg every 4 weeks may be considered.¹

Special Populations

Dosage adjustment based on weight not necessary.¹ (See Special Populations under Pharmacokinetics.)

Hepatic Impairment

No specific dosage recommendations at this time.¹

Renal Impairment

No specific dosage recommendations at this time for patients with moderate or severe renal impairment.^a (See Special Populations under Pharmacokinetics.)

Geriatric Patients

No specific dosage recommendations at this time.¹

Cautions for Certolizumab Pegol

Contraindications

• 
  

  Manufacturer states none known.¹

  
  

Warnings/Precautions

Warnings

Infectious Complications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Serious, sometimes fatal infections (including bacterial, mycobacterial, invasive fungal, viral, or other opportunistic infections) reported with certolizumab pegol and other TNF blocking agents, particularly in patients receiving concomitant therapy with immunosuppressive agents (e.g., methotrexate, corticosteroids).¹ The most common opportunistic infections include , histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis.¹ Infections frequently are disseminated.¹

Do not initiate certolizumab pegol in patients with active infections, including clinically important localized infections.¹ Consider potential risks and benefits of the drug prior to initiating therapy in patients with a history of chronic or recurring infections; patients with underlying conditions that may predispose them to infections; and patients who have been exposed to tuberculosis or who have resided or traveled in regions where tuberculosis or mycoses such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.¹

Closely monitor patients during and after treatment for signs or symptoms of infection (e.g., fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness including shock).^{1 6}

If new infection occurs during therapy, perform thorough diagnostic evaluation (appropriate for immunocompromised patient), initiate appropriate anti-infective therapy, and closely monitor patient.^{1 6} Discontinue certolizumab pegol if serious infection or sepsis develops.^{1 6}

Evaluate all patients for active or latent tuberculosis and for risk factors for tuberculosis prior to and periodically during therapy.¹ When indicated, initiate appropriate antimycobacterial regimen for treatment of latent tuberculosis infection prior to certolizumab pegol therapy.¹ Consider antimycobacterial therapy prior to initiating certolizumab pegol in patients with a history of latent or active tuberculosis for whom adequate antimycobacterial treatment is unconfirmed, and in patients with a negative tuberculin skin test who have risk factors for tuberculosis.¹ Consultation with a tuberculosis specialist is recommended when deciding whether to initiate antimycobacterial therapy.¹

Monitor all patients, including those with negative tuberculin skin tests, for active tuberculosis.¹ Strongly consider tuberculosis in patients who develop new infections during therapy, especially if they previously have traveled to countries where tuberculosis is highly prevalent or have been in close contact with an individual with active tuberculosis.¹

Invasive fungal infections often not recognized in patients receiving TNF blocking agents; this has led to delays in appropriate treatment.⁶

Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.^{1 6} Whenever feasible, consult specialist in fungal infections when making decisions regarding initiation and duration of antifungal therapy.^{1 6}

When deciding whether to reinitiate TNF blocking agent therapy following resolution of an invasive fungal infection, reevaluate risks and benefits, particularly in patients who reside in regions where mycoses are endemic.⁶ Whenever feasible, consult specialist in fungal infections.⁶

Increased incidence of serious infection and neutropenia observed with concomitant use of etanercept (another TNF blocking agent) and anakinra (a human interleukin-1 receptor antagonist).^{1 5} Increased incidence of infection and serious infection reported with concomitant use of a TNF blocking agent and abatacept.^{1 23} (See Specific Drugs and Laboratory Tests under Interactions.)

Malignancies and Lymphoproliferative Disorders

Lymphoma and other malignancies (some fatal) reported during postmarketing surveillance in children and adolescents receiving TNF blocking agents, particularly in those receiving other immunosuppressive agents (e.g., azathioprine, methotrexate) concomitantly.^{1 9} Malignancies included lymphomas (about 50% of the cases) (e.g., Hodgkin's disease, non-Hodgkin's lymphoma) and various other malignancies (e.g., leukemia, melanoma, solid organ cancers), including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children and adolescents (e.g., leiomyosarcoma, hepatic malignancies, renal cell carcinoma).^{1 9} Median time to occurrence was 30 months (range: 1–84 months) after the initial TNF blocking agent dose.¹ FDA has concluded that there is an increased risk of malignancy with TNF blocking agents in children and adolescents; however, the strength of the association is not fully characterized.⁹

In controlled studies, lymphoma was reported more frequently in patients receiving certolizumab pegol or other TNF blocking agents than in control patients.¹ Patients with Crohn's disease, rheumatoid arthritis, and other chronic inflammatory diseases, especially those with highly active disease and/or chronic exposure to immunosuppressive therapies, may be at increased risk of lymphoma.^{1 9}

In clinical studies of certolizumab pegol, rate of malignancies other than nonmelanoma skin cancer was 0.5 or 0.6 per 100 patient-years in patients receiving certolizumab pegol or placebo, respectively; however, the role of certolizumab pegol use in the development of malignancies not fully determined.^{1 9}

Acute and chronic leukemias (some fatal) reported during postmarketing surveillance of TNF blocking agents in adults and pediatric patients, particularly in those receiving other immunosuppressive agents concomitantly.^{1 9} Leukemia (most commonly acute myeloid leukemia, chronic lymphocytic leukemia, and chronic myeloid leukemia) generally occurred during first 2 years of therapy.⁹ FDA has concluded that there is a possible association between TNF blocking agents and development of leukemia; interpretation of findings is complicated because patients with rheumatoid arthritis may be at increased risk for leukemia independent of any treatment with TNF blocking agents.^{1 9}

Consider possibility of and monitor for occurrence of malignancies during and following treatment with TNF blocking agents.⁹

Other Warnings/Precautions

Cardiovascular Effects

Worsening CHF and new-onset CHF reported in patients receiving TNF blocking agents; certolizumab pegol not studied in patients with CHF.¹ If used in patients with CHF, caution and careful monitoring recommended.¹

Sensitivity Reactions

Angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria reported rarely.¹ If allergic reaction occur, discontinue certolizumab pegol and initiate appropriate treatment.¹

Hepatitis B Virus (HBV) Reactivation

Increased risk of reactivation of HBV infection in patients who are chronic carriers of this virus (i.e., hepatitis B surface antigen-positive [HBsAg-positive]).^{1 5} Fatalities reported.¹ Use of multiple immunosuppressive agents may contribute to HBV reactivation.¹

Screen at-risk patients prior to initiation of therapy.¹ Evaluate and monitor HBV carriers before, during, and for up to several months after therapy.¹ Safety and efficacy of antiviral therapy for prevention of HBV reactivation not established.¹ Discontinue certolizumab pegol and initiate appropriate treatment (e.g., antiviral therapy) if HBV reactivation occurs.¹ Not known whether certolizumab pegol can be readministered once control of a reactivated HBV infection is achieved; caution advised in this situation.¹

Nervous System Effects

New onset or exacerbation of CNS demyelinating disorders (e.g., multiple sclerosis) and peripheral demyelinating disorders (e.g., Guillain-Barré syndrome) reported rarely.^a Use cautiously in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.^a

Seizure disorder, optic neuritis, and peripheral neuropathy reported rarely.¹

Hematologic Effects

Pancytopenia (including aplastic anemia),¹ leukopenia, and thrombocytopenia reported rarely; causal relationship unclear.¹ Use with caution in patients with a history of substantial hematologic abnormalities.^a Consider discontinuing therapy if substantial hematologic abnormalities occur.¹

Immunologic Reactions and Antibody Formation

Possible formation of autoimmune antibodies.^{1 2 3} Lupus-like syndrome reported rarely.¹ Discontinue therapy if manifestations suggestive of a lupus-like syndrome occur.¹

Antibodies to certolizumab pegol may develop.¹ Incidence of antibody formation was lower in patients receiving concomitant therapy with other immunosuppressive agents (e.g., methotrexate) than in those not receiving immunosuppressive agents at baseline.¹

Antibody formation associated with lower plasma drug concentrations and reduced efficacy in patients with rheumatoid arthritis.¹ In patients with Crohn's disease, no apparent association between antibody development and efficacy or adverse events.¹

Immunization

Avoid live vaccines.¹ (See Interactions.)

Immunosuppression

May affect host defenses against infections and malignancies.^a (See Infectious Complications and also Malignancies and Lymphoproliferative Disorders, under Cautions.) Safety and efficacy in immunosuppressed patients not evaluated.¹

Psoriasis

New-onset psoriasis, including pustular and palmoplantar psoriasis, and exacerbation of existing psoriasis reported with TNF blocking agents.^{1 9} Onset of new cases observed weeks to years following initiation of drug.⁹ Some patients required hospitalization.⁹ Most patients experienced improvement following discontinuance of the TNF blocking agent.⁹ FDA has concluded that there is a possible association between use of TNF blocking agents and development of psoriasis.⁹

Consider possibility of and monitor for manifestations (e.g., new rash) of new or worsening psoriasis, particularly pustular and palmoplantar psoriasis.⁹ Consider discontinuance of certolizumab pegol if psoriasis occurs or worsens.^a

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether distributed into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established.¹

Malignancies, some fatal, reported in children and adolescents who received TNF-blocking agents.^{1 9} (See Malignancies and Lymphoproliferative Disorders under Cautions.)

Geriatric Use

No substantial differences in response relative to younger adults.¹

Possible increased incidence of infections in geriatric patients; use with caution.¹

Common Adverse Effects

Upper respiratory infection, urinary tract infection, arthralgia, rash.^{1 2 a}

No formal drug interaction studies with oral corticosteroids, NSAIAs, analgesics, or immunosuppressants to date.^{1 a}

Administered concomitantly with methotrexate, corticosteroids, NSAIAs, and/or other analgesics in patients with rheumatoid arthritis.^{1 17 18 19 a}

Administered concomitantly with aminosalicylates, corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or anti-infective agents in patients with Crohn's disease.^{2 3}

Vaccines

Avoid live vaccines.¹ No data available on secondary transmission of infection by live vaccines in certolizumab pegol-treated patients.¹

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
Abatacept	Increased incidence of infection and serious infection, without additional clinical benefit, reported with abatacept and TNF blocking agents in patients with rheumatoid arthritis1 23	Concomitant use not recommended1 23
Anakinra	Possible increased risk of serious infection and neutropenia, with no clinical benefit, reported with anakinra and etanercept (another TNF blocking agent); similar toxicities expected with certolizumab pegol and anakinra1 5	Concomitant use not recommended1
Corticosteroids, oral	Increased risk of serious infection1	Used concomitantly in clinical studies1
Methotrexate	Increased risk of serious infection1 Possible decrease in rate of development of antibodies to certolizumab pegol in patients with rheumatoid arthritis; may result in sustained therapeutic plasma certolizumab pegol concentrations1 Methotrexate pharmacokinetics not altered by certolizumab pegol in patients with rheumatoid arthritis; effect of methotrexate on certolizumab pharmacokinetics not determined1	Used concomitantly in clinical studies1
Natalizumab	Increased risk of progressive multifocal leukoencephalopathy (PML) or other serious infection1 12	Concomitant use not recommended1 12
Rituximab	Increased risk of serious infection1 13	Concomitant use not recommended1 13
Tests, coagulation	May erroneously elevate aPPT; thrombin time and PT unaffected; no evidence of effect on in vivo coagulation1

Certolizumab Pegol Pharmacokinetics

Absorption

Bioavailability

Bioavailability is approximately 80% following sub-Q administration.¹ Peak serum concentrations achieved in 54–171 hours.¹

Elimination

Metabolism

Not studied.¹

Elimination Route

Not studied.^a Polyethylene glycol moiety excreted principally in urine.¹

Half-life

Approximately 14 days.^a

Special Populations

Pharmacokinetics of certolizumab pegol not formally studied in patients with renal impairment.^a However, pharmacokinetics of polyethylene glycol moiety dependent on renal function.^a

Among adults, age does not appear to influence pharmacokinetics.^a

Clearance of certolizumab pegol is higher with increasing body weight; however, no clinically important weight-related differences observed.^a

In patients with certolizumab pegol antibodies, clearance of certolizumab is higher.^a

No gender-related pharmacokinetic differences apparent. ^a

Stability

Storage

Sub-Q

Injection in Prefilled Syringes

2–8°C.^a Do not freeze.^a Protect from light; store in original carton until administration.^a

Powder for Injection Kit

2–8°C.^a Do not freeze.^a Protect from light; store in original carton until administration.^a

Store reconstituted solution for up to 2 hours at room temperature or up to 24 hours (in vials) at 2–8°C.^a Do not freeze.^a

Actions

• 
  

  Recombinant humanized Fab′ fragment of an anti-TNF monoclonal antibody conjugated to an approximately 40-kilodalton polyethylene glycol (PEG2MAL40K) in order to prolong the half-life.^{1 2 3 7 8}

  
  


• 
  

  Binds with high affinity to TNF-α, a cytokine involved in the regulation of immune response.^{1 2 3 7 8}

  
  


• 
  

  Does not contain a fragment crystallizable (Fc) region or induce complement activation, antibody-dependent cellular cytotoxicity, apoptosis, or neutrophil degranulation in vitro.^{1 2 3 7 8}

  
  

Advice to Patients

• 
  

  A copy of the manufacturer's patient information (medication guide) for certolizumab pegol must be provided to all patients with each prescription of the drug. (See REMS Program under Dosage and Administration.)^{1 11 a} Importance of advising patients about potential benefits and risks of certolizumab pegol.^{a 9} Importance of patients reading the medication guide prior to initiation of therapy and each time the prescription is refilled.¹

  
  


• 
  

  Importance of instructing patient and/or caregiver regarding proper dosage and administration of certolizumab pegol, including the use of aseptic technique, and proper disposal of needles and syringes if it is determined that the patient and/or caregiver is competent to safely administer the drug.^a

  
  


• 
  

  Risk of increased susceptibility to infection.¹ Importance of informing clinician promptly if any signs or symptoms of infection (e.g., persistent fever, sweating, cough, dyspnea, fatigue) occur.^{1 6}

  
  


• 
  

  Risk of lymphoma, leukemia, and other malignancies.^{1 9} Importance of informing patients and families about the increased risk of cancer development in children and adolescents, taking into account the clinical utility of TNF blocking agents, the benefits and risks of other immunosuppressive drugs, and the risks associated with untreated disease.⁹ Importance of promptly informing clinicians if signs and symptoms of cancer occur (e.g., unexplained weight loss; fatigue; swollen lymph nodes in the neck, underarm, or groin; easy bruising or bleeding).⁹

  
  


• 
  

  Risk of new-onset psoriasis or worsening of existing psoriasis with TNF blocking agents.^{1 9} Importance of informing clinicians of any manifestations of new or worsening psoriasis (e.g., new rash).^{1 9}

  
  


• 
  

  Importance of seeking immediate medical attention for symptoms of severe allergic reactions.¹

  
  


• 
  

  Importance of informing clinician of any new or worsening medical conditions (e.g., CHF, neurologic disease, autoimmune disorders, cytopenias).¹

  
  


• 
  

  Importance of promptly informing clinician if symptoms suggestive of blood dyscrasias (e.g., bruising, bleeding, pallor, persistent fever) develop.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or history of tuberculosis, hepatitis B virus infection, or recurrent infections.^{1 6}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)¹

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Certolizumab Pegol

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for subcutaneous use	2 vials (200 mg each)	Cimzia (available as kit with sterile water for injection diluent, needles, syringes, and alcohol swabs)	UCB
		2 syringes (200 mg/mL each)	Cimzia (available as disposable prefilled syringes)	UCB

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. UCB, Inc. Cimzia (certolizumab pegol) for subcutaneous injection prescribing information. Smyrna, GA; 2009 Nov.

2. Sandborn WJ, Feagan BG, Stoinov S et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007; 357:228-38. [PubMed 17634458]

3. Schreiber S, Khaliq-Kareemi M, Lawrance IC et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007; 357:239-50. [PubMed 17634459]

4. Best WR, Becktel JM, Singleton JW et al. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976; 70:439-44. [PubMed 1248701]

5. Amgen/Wyeth Corporation. Enbrel (etanercept) for subcutaneous injection prescribing information. Thousand Oaks, CA: 2008 Jun.

6. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professionals Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). Rockville MD: Food and Drug Administration; 2008 Sep 4. Available from FDA website. Accessed 2008 Sep 25.

7. Bourne T, Fossati G, Nesbitt A. A PEGylated Fab' fragment against tumor necrosis factor for the treatment of Crohn disease: exploring a new mechanism of action. BioDrug. 2008; 22:331-7.

8. Nesbitt A, Fossati G, Bergin M et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor α agents. In flamm Bowel Dis. 2007; 13:1323-32.

9. Food and Drug Administration, Center for Drug Evaluation and Research. Information for healthcare professionals: Tumor necrosis factor (TNF) blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). FDA alert, Rockville, MD; 2009 Aug 4. Available from FDA website. Accessed 2009 Nov 3.

10. UCB, Smyrna, GA: Personal communication.

11. Cimzia (certolizumab pegol) risk evaluation and mitigation strategy (REMS). From FDA website. Accessed 2010 Jul 28.

12. Biogen Idec Inc. Tysabri (natalizumab) injection prescribing information. Cambridge, MA; 2010 Jul.

13. Centocor Ortho Biotech Inc. Simponi (golimumab) injection prescribing information. Horsham, PA; 2009 Nov.

14. Sebba A. Tocilizumab: the first interleukin-6-receptor inhibitor. Am J Health Syst Pharm. 2008; 65:1413-8. [PubMed 18653811]

15. McCluggage LK, Scholtz JM. Golimumab: a tumor necrosis factor alpha inhibitor for the treatment of rheumatoid arthritis. Ann Pharmacother. 2010; 44:135-44. [PubMed 20118145]

16. . Drugs for rheumatoid arthritis. Treat Guidel Med Lett. 2009; 7:37-46; quiz 47-8. [PubMed 19390497]

17. Keystone E, Heijde D, Mason D 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; 58:3319-29. [PubMed 18975346]

18. Smolen J, Landewé RB, Mease P et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009; 68:797-804. [PubMed 19015207]

19. Fleischmann R, Vencovsky J, van Vollenhoven RF et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009; 68:805-11. [PubMed 19015206]

20. Felson DT, Anderson JJ, Boers M et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995; 38:727-35. [PubMed 7779114]

21. Felson DT, Anderson JJ, Boers M et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum. 1993; 36:729-40. [PubMed 8507213]

22. Felson DT, Anderson JJ, Lange MLM et al. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent. Arthritis Rheum. 1998; 41:1564-70. [IDIS 411264] [PubMed 9751088]

23. Bristol-Myers Squibb. Orencia (abatacept) lyophilized powder for intravenous infusion prescribing information. Princeton, NJ; 2009 Aug.

a. UCB, Inc. Cimzia (certolizumab pegol) powder for sub-Q injection prescribing information. Smyrna, GA; 2010 Dec..

b. AHFS Drug Information. McEvoy GK, ed. Certolizumab Pegol. Bethesda, MD: American Society of Health-System Pharmacists; 2011.

More Certolizumab Pegol resources

• Certolizumab Pegol Side Effects (in more detail)
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• Certolizumab Pegol Drug Interactions
• Certolizumab Pegol Support Group
• 6 Reviews for Certolizumab Pegol - Add your own review/rating

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