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  • Enbrel
    (Etanercept) - Immunex

    BOXED WARNING

    Increased risk for developing serious infections (eg, active tuberculosis [TB], latent TB reactivation, invasive fungal infections, bacterial/viral infections, opportunistic infections) leading to hospitalization or death, mostly with concomitant use with immunosuppressants (eg, methotrexate [MTX], corticosteroids). D/C if serious infection or sepsis develops. Active/latent reactivation of TB may present with disseminated or extrapulmonary disease; test for latent TB before and during therapy and initiate treatment for latent TB prior to therapy. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Monitor for development of infection during and after treatment, including development of TB in patients who tested negative for latent TB infection prior to therapy. Lymphoma and other malignancies, some fatal, reported in children and adolescents.

    THERAPEUTIC CLASS

    TNF-blocker

    DEA CLASS

    RX

    INDICATIONS

    Reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis (RA); can be initiated in combination with MTX or used alone. Reduce signs/symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ≥2 yrs of age. Reduce signs/symptoms, inhibit progression of structural damage of active arthritis, and improve physical function in patients with psoriatic arthritis (PsA); can be used in combination with MTX in patients with inadequate response to MTX alone. Reduce signs/symptoms of active ankylosing spondylitis (AS). Treatment of adults (≥18 yrs of age) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

    ADULT DOSAGE

    Adults: RA/AS/PsA: 50mg SQ weekly. May continue MTX, glucocorticoids, salicylates, NSAIDs, or analgesics during treatment. Max: 50mg/week. PsO: Initial: 50mg SQ twice weekly for 3 months; starting doses of 25mg or 50mg per week were also shown to be efficacious. Maint: 50mg once weekly.

    PEDIATRIC DOSAGE

    Pediatrics: ≥2 Yrs: JIA: ≥63kg: 50mg SQ weekly. <63kg: 0.8mg/kg SQ weekly. May continue glucocorticoids, NSAIDs, or analgesics during treatment.

    HOW SUPPLIED

    Inj: 25mg [multiple-use vial, single-use prefilled syringe], 50mg [single-use prefilled syringe, single-use prefilled SureClick autoinjector]

    CONTRAINDICATIONS

    Sepsis.

    WARNINGS/PRECAUTIONS

    Do not initiate in patients with an active infection. Increased risk of infection in patients >65 yrs of age and in patients with comorbid conditions. New onset or exacerbation of CNS and peripheral nervous system demyelinating disorders, acute and chronic leukemia, new onset and worsening of congestive heart failure (CHF), melanoma and non-melanoma skin cancer, and Merkel cell carcinoma reported; consider periodic skin examinations for all patients at increased risk for skin cancer. Pancytopenia, including aplastic anemia, reported. Reactivation of hepatitis B in patients who were previously infected with hepatitis B virus (HBV) reported; closely monitor for signs of active HBV infection during and for several months after therapy. Consider discontinuing therapy and initiating antiviral therapy with appropriate supportive treatment if HBV reactivation develops. Allergic reactions reported; d/c immediately and initiate appropriate therapy if an anaphylactic or other serious allergic reaction occurs. Needle cover of prefilled syringe and needle cover within the needle cap of autoinjector contain dry natural rubber, which may cause allergic reactions in latex-sensitive individuals. If possible, pediatric patients should be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy. May result in the formation of autoantibodies and in the development of a lupus-like syndrome or autoimmune hepatitis; d/c and evaluate patient if a lupus-like syndrome or autoimmune hepatitis develops. Caution with moderate to severe alcoholic hepatitis and in the elderly. Patients with a significant exposure to varicella virus should temporarily d/c therapy and be considered for prophylactic treatment with varicella zoster immune globulin.

    ADVERSE REACTIONS

    Infections, sepsis, malignancies, inj-site reactions, diarrhea, rash, pyrexia, pruritus.

    DRUG INTERACTIONS

    See Boxed Warning. Avoid with live vaccines; pediatric patients should be brought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiating therapy. Not recommended with anakinra or abatacept; may increase risk of serious infections. Not recommended in patients with Wegener's granulomatosis receiving immunosuppressive agents; increased incidence of noncutaneous solid malignancies when added to standard therapy (eg, cyclophosphamide). Not recommended with cyclophosphamide. Mild decrease in mean neutrophil counts reported with sulfasalazine. Hypoglycemia reported following initiation of therapy in patients receiving antidiabetic medication; reduction in antidiabetic medication may be necessary.

    PREGNANCY

    Category B, caution in nursing.

    MECHANISM OF ACTION

    TNF-blocker; inhibits binding of TNF-α and TNF-β (lymphotoxin alpha [LT-α]) to cell surface TNF-receptors, rendering TNF biologically inactive.

    PHARMACOKINETICS

    Absorption: Cmax=2.4mcg/mL (50mg once weekly), 2.6mcg/mL (25mg twice weekly); Tmax=69 hrs (single 25mg dose). Distribution: Found in breast milk; crosses the placenta. Elimination: T1/2=102 hrs (single 25mg dose).

    ASSESSMENT

    Assess for sepsis, active/chronic/recurrent infection, history of an opportunistic infection, recent travel in areas of endemic TB or endemic mycoses, underlying conditions that may predispose to infection, central or peripheral nervous system demyelinating disorders, CHF, history of significant hematologic abnormalities, latex sensitivity, alcoholic hepatitis, risk for skin cancer, pregnancy/nursing status, and possible drug interactions. Test for latent TB infection and for HBV infection. Assess immunization history in pediatric patients.

    MONITORING

    Monitor for development of infection during and after treatment. Monitor for sepsis, central or peripheral nervous system demyelinating disorders, malignancies, new or worsening CHF, hematologic abnormalities, allergic reactions, lupus-like syndrome, autoimmune hepatitis, and other adverse reactions. Monitor for active TB and periodically test for latent TB. Monitor for HBV reactivation during therapy and for several months following termination of therapy. Consider periodic skin examinations for all patients at increased risk for skin cancer.

    PATIENT COUNSELING

    Advise of the potential risks and benefits of therapy. Inform that therapy may lower the ability of immune system to fight infections; instruct to contact physician if any symptoms of infection, TB, or HBV develop. Advise to report any signs of new/worsening medical conditions (eg, CNS demyelinating disorders, CHF, autoimmune disorders) or any symptoms suggestive of pancytopenia. Counsel about the risk of lymphoma and other malignancies. Instruct to seek immediate medical attention if any symptoms of a severe allergic reaction develop. Advise that the needle cover of prefilled syringe and the needle cover within the needle cap of the autoinjector contain dry natural rubber (a derivative of latex) that may cause allergic reactions in individuals sensitive to latex. Instruct in inj technique, as well as proper syringe and needle disposal, and caution against reuse of needles and syringes. Advise to inform physician if pregnant/breastfeeding.

    ADMINISTRATION/STORAGE

    Administration: SQ route. Refer to PI for preparation and administration instructions. Storage: 2-8°C (36-46°F). Do not shake. Protect from light or physical damage. Storage at room temperature for a max single period of 14 days is permissible, with protection from light, sources of heat, and (vial) humidity; once the product has been stored at room temperature, do not place back into the refrigerator. Discard if not used within 14 days at room temperature. Do not store in extreme heat or cold. Do not freeze. (Vial) Reconstituted Sol: Use immediately or may refrigerate for up to 14 days.