pharmacopeia
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Boxed 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 in patients at risk for invasive fungal infections who develop severe systemic illness.

Mechanism of action

Sourced from openFDA

Certolizumab pegol binds to human TNFα with a KD of 90pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes.

Indications

Sourced from openFDA
  • CIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy ( 1.1 ) Treatment of adults with moderately to severely active rheumatoid arthritis ( 1.2 ) Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older ( 1.3 ) Treatment of adult patients with active psoriatic arthritis. ( 1.4 ) Treatment of adults with active ankylosing spondylitis ( 1.5 ) Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation ( 1.6 ) Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy ( 1.7 ) 1.1 Crohn's Disease CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.ICD-10: K50.90, L40.50, L40.9, M06.9

Contraindications

Sourced from openFDA
  • CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria [see Warnings and Precautions (5.4) ] .contraindicated

Dosage & administration

Sourced from openFDA

CIMZIA is administered by subcutaneous injection . Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard. When a 400 mg dose is needed (given as two subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen. The solution should be carefully inspected visually for particulate matter and discoloration prior to administration. The solution should be a clear to opalescent, colorless to yellow liquid, essentially free from particulates and should not be used if cloudy or if foreign particulate matter is present. CIMZIA does not contain preservatives; therefore, unused portions of drug remaining in the syringe or vial should be discarded. CIMZIA is administered by subcutaneous injection ( 2 ). Crohn's Disease ( 2.1 ) 400 mg initially and at Weeks 2 and 4.

Warnings & precautions

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Serious Infections : CIMZIA should not be initiated in patients with an active infection. Monitor for infection during and after treatment; discontinue if a serious infection develops. If invasive fungal infection develops in patients who reside or travel to regions where mycoses are endemic, consider empiric antifungal therapy. ( 5.1 ) Malignancies : Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers, including CIMZIA. ( 5.2 ) Heart Failure : Monitor patients for new onset or worsening congestive heart failure. ( 5.3 ) Hypersensitivity Reactions : Discontinue CIMZIA and institute appropriate therapy if anaphylaxis or other serious hypersensitivity reactions occur. ( 5.4 ) Hepatitis B Virus Reactivation : Test for HBV infection before starting CIMZIA. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop CIMZIA and begin anti-viral therapy ( 5.5 ) Neurologic Reactions : Exacerbation or new onset demyelinating disease may occur; use caution in patients with pre-existing or recent-onset demyelinating disorders. ( 5.6 ) Hematological Reactions (including leukopenia, pancytopenia and thrombocytopenia) : Use with caution in patients who have ongoing, or a history of, significant hematologic abnormalities. Advise patients to seek immediate medical attention if symptoms develop; consider discontinuing CIMZIA in patients with confirmed abnormalities. ( 5.7 ) Use with Anakinra, Abatacept, Rituximab and Natalizumab : Increased risk of serious infections; concomitant use is not recommended.

Adverse reactions

Sourced from openFDA

The most serious adverse reactions were: Serious Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Heart Failure [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Hepatitis B Virus Reactivation [see Warnings and Precautions (5.5) ] Neurologic Reactions [see Warnings and Precautions (5.6) ] Hematologic Reactions [see Warnings and Precautions (5.7) ] Autoimmunity [see Warnings and Precautions (5.9) ] Immunosuppression [see Warnings and Precautions (5.11) ] Most common adverse reactions (≥7%): upper respiratory tract infection, rash, and urinary tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug, and may not predict the rates observed in a broader patient population in clinical practice. In premarketing controlled trials of all adult patient populations combined the most common adverse reactions (≥ 8%) were upper respiratory infections (18%), rash (9%) and urinary tract infections (8%).

Use in specific populations

Sourced from openFDA

8.1 Pregnancy 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 an ongoing pregnancy exposure registry on use of CIMZIA in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes. However, certolizumab pegol plasma concentrations obtained from two studies of CIMZIA use during the third trimester of pregnancy demonstrated that placental transfer of certolizumab pegol was negligible in most infants at birth, and low in other infants at birth (see Data ) . There are risks to the mother and fetus associated with active rheumatoid arthritis or Crohn's disease. The theoretical risks of administration of live or live-attenuated vaccines to the infants exposed in utero to CIMZIA should be weighed against the benefits of vaccinations (see Clinical Considerations ) .

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption A total of 126 healthy subjects received doses of up to 800 mg certolizumab pegol subcutaneously (sc) and up to 10 mg/kg intravenously (IV) in four pharmacokinetic studies. Data from these studies demonstrate that single intravenous and subcutaneous doses of certolizumab pegol have predictable dose-related plasma concentrations with a linear relationship between the dose administered and the maximum plasma concentration (C max ), and the Area Under the certolizumab pegol plasma concentration versus time Curve (AUC).

Approval history

Sourced from openFDA
  • Apr 22, 2008BLABLA125160Ucb Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
114,573 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective26,77223%
  2. 2Rheumatoid Arthritis19,43617%
  3. 3Pain15,69814%
  4. 4Fatigue13,47912%
  5. 5Off Label Use11,3459.9%
  6. 6Rash10,9359.5%
  7. 7Arthralgia10,7799.4%
  8. 8Alopecia10,0798.8%
  9. 9Joint Swelling9,7288.5%
  10. 10Abdominal Discomfort9,4928.3%
  11. 11Maternal Exposure During Pregnancy9,4438.2%
  12. 12Systemic Lupus Erythematosus9,0417.9%
  13. 13Pemphigus8,6387.5%
  14. 14Drug Intolerance8,6297.5%
  15. 15Swelling8,6287.5%

Literature

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Recent PubMed references pinned to Certolizumab Pegol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 172 ClinicalTrials.gov registrations naming Certolizumab Pegol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Certolizumab Pegol work?
Certolizumab pegol binds to human TNFα with a KD of 90pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes.
What is Certolizumab Pegol used for?
According to FDA labeling, Certolizumab Pegol carries indications including: CIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy ( 1.1 ) Treatment of adults with moderately to severely active rheumatoid arthritis ( 1.2 ) Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older ( 1.3 ) Treatment of adult patients with active psoriatic arthritis. ( 1.4 ) Treatment of adults with active ankylosing spondylitis ( 1.5 ) Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation ( 1.6 ) Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy ( 1.7 ) 1.1 Crohn's Disease CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Certolizumab Pegol?
Certolizumab Pegol is classified as Tumor necrosis factor alpha (TNF-alpha) inhibitors, Tumor Necrosis Factor Blocker, Biological Response Modifiers, Tumor Necrosis Factor alpha Receptor Blocking Activity, Tumor Necrosis Factor Receptor Blocking Activity, Immunologic Activity Alteration.
What are the brand names for Certolizumab Pegol?
Certolizumab Pegol is marketed under brand names including Cimzia.
What are the contraindications for Certolizumab Pegol?
Certolizumab Pegol labeling lists contraindications including: CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria [see Warnings and Precautions (5.4) ] .. Always consult the full prescribing information and a clinician.
Note. Data for certolizumab-pegol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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