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certolizumab pegol

General

Pronunciation:
ser-toe-liz-u-mab pey-gol


Trade Name(s)

  • Cimzia

Pregnancy Category
Category B

Ther. Class.
gastrointestinal anti-inflammatories
antirheumatics

Pharm. Class.
tumor necrosis factor blockers
dmards
monoclonal antibodies

Indications

  • Moderately-to-severely active Crohn's disease when response to conventional therapy has been inadequate.
  • Moderately-to-severely active rheumatoid arthritis.
  • Active psoriatic arthritis
  • Active ankylosing spondylitis

Action

Neutralizes tumor necrosis factor (TNF), a prime mediator of inflammation; pegylation provides a long duration of action.

Therapeutic Effect(s):

  • Decreased signs/symptoms of Crohn's disease.
  • Decreased pain and swelling, decreased rate of joint destruction and improved physical function in rheumatoid arthritis.
  • Decreased joint swelling and pain in psoriatic arthritis
  • Decreased spinal pain and inflammation in ankylosing spondylitis

Pharmacokinetics

Absorption: 80% absorbed following SC administration.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: 14 days.

TIME/ACTION PROFILE (blood levels)

ROUTEONSETPEAKDURATION
Subcutunknown50–120 hr2–4 wk

Contraindication/Precautions

Contraindicated in:

  • Active infection (including localized);
  • Concurrent use of anakinra.

Use Cautiously in:

  • History of chronic or recurrent infection or underlying illness/treatment predisposing to infection;
  • History of exposure to tuberculosis;
  • History of opportunistic infection;
  • Patients residing, or who have resided, where tuberculosis, histoplasmosis, coccidioidomycoses, or blastomycosis is endemic;
  • History of demyelinating disorders (may exacerbate);
  • History of heart failure;
  • Geri: May ↑ risk of infections;
  • OB: Use in pregnancy only if clearly needed; avoid breast feeding;
  • Pedi: Safety not established; ↑ risk of lymphoma (including hepatosplenic T-cell lymphoma [HSTCL] in patients with Crohn's disease), leukemia, and other malignancies.

Adverse Reactions/Side Effects

Derm: psoriasis, skin reactions (rarely severe)

Hemat: hematologic reactions

MS: arthralgia

Misc: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS AND ANGIOEDEMA, INFECTIONS (INCLUDING REACTIVATION TUBERCULOSIS, HEPATITIS B REACTIVATION, AND OTHER OPPORTUNISTIC INFECTIONS DUE TO BACTERIAL, INVASIVE FUNGAL, VIRAL, MYCOBACTERIAL, AND PARASITIC PATHOGENS), MALIGNANCY (INCLUDING LYMPHOMA, HSTCL, LEUKEMIA, AND SKIN CANCER), lupus-like syndrome

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

  • Concurrent use with anakinra ↑ risk of serious infections (contraindicated).
  • Concurrent use with azathioprine and/or methotrexate may ↑ risk of HSTCL.
  • May ↓ antibody response to or ↑ risk of adverse reactions to live vaccines (contraindicated).

Route/Dosage

Crohn's Disease

SC: (Adults) 400 mg initially, repeat 2 and 4 wk later; may be followed by maintenance dose of 400 mg every 4 wk.

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

SC: (Adults) 400 mg initially, repeat 2 and 4 wk later; then maintenance dose of 200 mg every 2 wk (400 mg every 4 wk may be used alternatively).

Availability

Lyophilized powder for subcutaneous injection (requires reconstitution): 200 mg/vial

Prefilled syringe: 200 mg/mL

Assessment

  • Crohn's Disease: Assess abdominal pain and frequency, quantity, and consistency of stools at beginning and during therapy.
  • Arthritis/Ankylosing Spondylitis: Assess pain and range of motion before and periodically during therapy.
  • Assess for signs of infection (fever, sore throat, dyspnea, WBC) prior to and during therapy. Monitor all patients for active TB during therapy, even if initial test was negative. Do not begin certolizumab during an active infection, including chronic or localized infections. If infection develops, monitor closely and discontinue certolizumab if infection becomes serious.
  • Evaluate patients at risk for hepatitis B virus (HBV) infection for prior evidence of HBV infection before initiating therapy. Monitor carriers of HBV closely for clinical and lab signs of active HBV infection during and for several months following discontinuation of therapy. If HBV reactivation occurs, discontinue certolizumab and initiate antiviral therapy.
  • Monitor for signs of hypersensitivity reactions (angioedema, dyspnea, hypotension, rash, serum sickness, urticaria). If reactions occur, discontinue certolizumab and treat symptomatically.
  • Assess for signs and symptoms of systemic fungal infections (fever, malaise, weight loss, sweats, cough, dypsnea, pulmonary infiltrates, serious systemic illness with or without concomitant shock). Ascertain if patient lives in or has traveled to areas of endemic mycoses. Consider empiric antifungal treatment for patients at risk of histoplasmosis and other invasive fungal infections until the pathogens are identified. Consult with an infectious diseases specialist. Consider stopping certolizumab until the infection has been diagnosed and adequately treated.

Lab Test Considerations: May cause anemia, leukopenia, pancytopenia, and thrombocytopenia.

  • Monitor CBC with differential periodically during therapy. May cause leukopenia, neutropenia, thrombocytopenia, and pancytopenia. Discontinue certolizumab if symptoms of blood dyscrasias (persistent fever) occur.
  • May cause ↑ liver enzymes.
  • May cause erroneously ↑ aPTT.

Potential Diagnoses

Implementation

  • Perform test for latent TB. If positive, begin treatment for TB prior to starting certolizumab therapy. Monitor for TB throughout therapy, even if latent TB test is negative.
    • Bring medication to room temperature prior to reconstituting. Reconstitute 2 vials for each dose by adding 1 mL of Sterile Water for injection to each vial, using a 20-gauge needle, for a concentration of 200 mg/mL. Gently swirl so all powder comes into contact with sterile water; do not shake. Leave vials undisturbed for as long as 30 min to fully reconstitute. Solution is clear and colorless to pale yellow; do not administer solutions that are discolored or contain particulate matter. Do not leave reconstituted solution at room temperature for >2 hr prior to injection. May be refrigerated for up to 24 hr prior to injection; do not freeze.
  • SC: Bring solution to room temperature prior to injection. Using a new 20-gauge needle for each vial, withdraw reconstituted solution into 2 separate syringes each containing 1 mL (200 mg/mL) of certolizumab. Switch each 20-gauge needle to a 23-gauge needle and inject the full contents of each syringe subcut into separate sides of the abdomen or thigh.

Patient/Family Teaching

  • Advise patient of potential benefits and risks of certolizumab. Advise patient to read the Medication Guide prior to starting therapy.
  • Inform patient of risk of infection. Advise patient to notify health care professional if symptoms of infection (fever, cough, flu-like symptoms, or open cuts or sores), including TB or reactivation of HBV infection, occur.
  • Counsel patient about possible risk of lymphoma and other malignancies while receiving certolizumab.
  • Advise patient to notify health care professional if signs of hypersensitivity reactions (rash, swollen face, difficulty breathing), or new or worsening medical conditions such as heart or neurological disease or autoimmune disorders occur and to report signs of bone marrow depression (bruising, bleeding, or persistent failure).
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional prior to taking any Rx, OTC, vitamins, or herbal products.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decrease in signs and symptoms of Crohn's disease.
  • Decreased pain and swelling with decreased rate of joint destruction in patients with rheumatoid arthritis.
  • Decreased joint swelling and pain in psoriatic arthritis
  • Decreased spinal pain and inflammation in ankylosing spondylitis
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Citation

Quiring, Courtney, et al. "Certolizumab Pegol." Davis's Drug Guide, 16th ed., F.A. Davis Company, 2019. Emergency Central, emergency.unboundmedicine.com/emergency/view/Davis-Drug-Guide/110540/all/certolizumab_pegol.
Quiring C, Sanoski CA, Vallerand AH. Certolizumab pegol. Davis's Drug Guide. 16th ed. F.A. Davis Company; 2019. https://emergency.unboundmedicine.com/emergency/view/Davis-Drug-Guide/110540/all/certolizumab_pegol. Accessed April 21, 2019.
Quiring, C., Sanoski, C. A., & Vallerand, A. H. (2019). Certolizumab pegol. In Davis's Drug Guide. Available from https://emergency.unboundmedicine.com/emergency/view/Davis-Drug-Guide/110540/all/certolizumab_pegol
Quiring C, Sanoski CA, Vallerand AH. Certolizumab Pegol [Internet]. In: Davis's Drug Guide. F.A. Davis Company; 2019. [cited 2019 April 21]. Available from: https://emergency.unboundmedicine.com/emergency/view/Davis-Drug-Guide/110540/all/certolizumab_pegol.
* Article titles in AMA citation format should be in sentence-case
TY - ELEC T1 - certolizumab pegol ID - 110540 A1 - Quiring,Courtney, AU - Sanoski,Cynthia A, AU - Vallerand,April Hazard, BT - Davis's Drug Guide UR - https://emergency.unboundmedicine.com/emergency/view/Davis-Drug-Guide/110540/all/certolizumab_pegol PB - F.A. Davis Company ET - 16 DB - Emergency Central DP - Unbound Medicine ER -