certolizumab pegol (Rx)

Brand and Other Names:Cimzia
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • 200mg/vial
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Moderate-to-Severe Crohn Disease

Initial: 400 mg SC as 2 injections of 200 mg each, repeat at 2 and 4 weeks

Maintenance: 400 mg SC q4Weeks

Moderate-to-Severe Rheumatoid Arthritis

Initial: 400 mg SC as 2 injections of 200 mg, repeat at 2 and 4 weeks

Maintenance: 200 mg SC q2Weeks OR 400 mg SC q4Weeks

Active Psoriatic Arthritis

Initial: 400 mg SC as 2 injections of 200 mg, repeat at 2 and 4 weeks

Maintenance: 200 mg SC q2Weeks OR 400 mg SC q4Weeks

Active Ankylosing Spondylitis

Initial: 400 mg SC as 2 injections of 200 mg; repeat at 2 and 4 weeks

Maintenance: 200 mg SC q2Weeks OR 400 mg SC q4weeks

Safety and efficacy not established

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Interactions

Interaction Checker

and certolizumab pegol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            URI (20%)

            Headache (7-18%)

            Nasopharyngitis (4-13%)

            Nausea (11%)

            1-10%

            UTI (7%)

            Arthralgia (6%)

            Serious infections (3%)

            Frequency Not Defined

            Opportunistic infections (eg, TB)

            Lupus-like syndrome

            Malignancies

            Immunogenicity

            Hypersensitivity

            Blood/ lymphatic system disorder

            Cardiac disorder

            Ocular disorder

            Psychiatric disorder (anxiety, bipolar d/o, suicide attempt)

            Renal/urinary disorder

            Menstrual disorder

            Skin and subcutaneous disorder

            Postmarketing Reports

            Vascular disorder: Systemic vasculitis

            Skin: Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and new or worsening psoriasis (all sub-types including pustular and palmoplantar)

            Immune System Disorders: Sarcoidosis

            Lagophthalmos

            Neoplasms benign, malignant and unspecified (including cysts and polyps)

            Melanoma, Merkel cell carcinoma (neuroendocrine carcinoma of the skin)

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            Warnings

            Black Box Warnings

            Serious infection risk

            • Increased risk for developing serious infections resulting in hospitalization or death; most patients were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
            • Patients older than 65 years may be at greater risk
            • Discontinue if patient develops serious infection or sepsis
            • Reported infections include:
            • 1) Active TB, including reactivation of latent TB (frequently present with disseminated or extrapulmonary disease); test for latent TB before use and during therapy; treat latent infection prior to use
            • 2) Invasive fungal infections (eg, histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis); may present with disseminated, rather than localized, disease; antigen/antibody testing for histoplasmosis may be negative in some patients with active infection; initiate empiric antifungal therapy if severe systemic illness develops
            • 3) Other bacterial (eg, Legionella, Listeria), mycobacterial (eg, tuberculosis), and viral (eg, hepatitis B) opportunistic pathogens

            Malignancy

            • Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers
            • Cases of acute and chronic leukemia have been reported in association with post-marketing TNF-blocker use in rheumatoid arthritis (RA) and other indications; patients with RA may be at a higher risk (approximately 2-fold) than the general population for leukemia
            • Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer
            • Manufacturer required to report all malignancies to FDA in order for complete and consistent analysis

            Contraindications

            Concomitant live vaccines

            Active serious infections

            Cautions

            Hypersensitivity including anaphylaxis and serious reactions

            New-onset psoriasis reported with TNF blockers

            Enhanced safety surveillance requirements to capture malignancy data: (see Black Box Warnings)

            May interfere with aPPT tests

            Risk of exacerbation of, or new onset demyelinating disease

            Cytopenias reported; consider discontinuing drug if occurs

            Exacerbation or, or new onset CHF

            Melanoma and Merkel cell carcinoma reported; periodic skin examinations recommended for all patients, particularly those with risk factors for skin cancer

            Lupus-like syndrome reported; discontinue if syndrome develops

            Opportunistic infections

            • TNF blockers increase risk for opportunistic infections, (eg, TB, invasive fungal infections); for patients who develop systemic infections, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic
            • Coadministration with anakinra increases this risk
            • Test for latent TB prior to starting treatment and monitor; treatment of latent tuberculosis infection prior to therapy with TNF-blocking agents has been shown to reduce risk of tuberculosis reactivation during therapy; induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis needed prior to initiating therapy with certolizumab, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG); also consider anti-tuberculosis therapy in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection
            • Risk of hepatitis B virus reactivation (discontinue if this occurs)
            • Discontinue if serious infetion develops

            Hepatosplenic T-cell lymphomas (HSTCL)

            • Rare postmarketing cases reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with TNF blockers
            • Reports have also included a patient being treated for psoriasis and 2 patients being treated for rheumatoid arthritis
            • HSTCL is an aggressive, rare type of T-cell lymphoma (usually fatal)
            • Most reported cases with TNF blockers have occurred with concomitant treatment with azathioprine or 6-mercaptopurine, although there have been cases reported receiving azathioprine or mercaptopurine alone
            • The following HSTCL cases have been identified in the FDA Adverse Event Reporting System (AERS) database, the literature, and the HSTCL Cancer Survivors' Network: infliximab (20), etanercept (1), adalimumab (2), infliximab/adalimumab (5), certolizumab (0), golimumab (0), azathioprine (12), and mercaptopurine (3)
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            Pregnancy & Lactation

            Pregnancy

            There is pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the drug 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/

            Limited data from ongoing pregnancy registry on use of drug in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes; drug may be eliminated at slower rate in exposed infants than in adult patients; there are risks to mother and fetus associated with active rheumatoid arthritis or Crohn’s disease; theoretical risks of administration of live or live-attenuated vaccines to infants exposed in utero to drug should be weighed against benefits of vaccinations

            Lactation

            No data are available regarding presence of certolizumab pegol in human milk, effects on the breast fed infant, or effects on milk production; published data suggest that systemic exposure to a breastfed infant is expected to be low because certolizumab pegol is a large molecule and is degraded in the gastrointestinal tract; if certolizumab pegol is transferred into human milk, effects of local exposure in gastrointestinal tract are unknown; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant humanized antihuman TNF-alpha neutralizing antibody

            Pharmacokinetics

            Bioavailability: 80%

            Peak Plasma Time: 54-171 hr

            Vd: 6.4 L

            Half-Life: 14 days

            Clearance: 17 mL/hr

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            Administration

            SC Preparation

            Remove from refrigerator and allow the vial(s) to sit at room temperature for 30 min before reconstituting; do not warm vial in any other way

            Reconstitute 200 mg vial(s) with 1 mL of sterile water for injection, using the 20-gauge needle provided; water should be directed at vial wall rather than directly to contents

            Gently swirl each vial for about one min without shaking, assuring that all of powder comes in contact with sterile water; avoid creating a foaming effect

            Continue swirling every 5 min as long as non-dissolved particles observed; full reconstitution may take as long as 30 min; final reconstituted solution contains 200 mg/mL and should be clear to opalescent, colorless to pale yellow liquid essentially free from particulates

            Reconstitute each 200 mg vial with 1 mL sterile water for injection, swirl to dissolve; leave vials undisturbed for up to 30 minutes to fully reconstitute

            SC Administration

            Inject full contents of each syringe SC into separate sites on abdomen or thigh

            Storage

            Unopened vial

            • Refrigerate intact carton between 2-8°C (36-46°F)
            • Do not freeze
            • Do not separate contents of carton prior to use
            • Protect solution from light

            Reconstituted vial

            • Do not leave reconstituted solution at room temperature >2 hr
            • May be stored for up to 24 hr at 2-8°C (36-46°F) prior to injection
            • Do not freeze
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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