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  • Enbrel
    (etanercept)

    BOXED WARNING

    Increased risk for developing serious infections (eg, active TB, latent TB reactivation, invasive fungal infections, bacterial/viral infections, opportunistic infections) leading to hospitalization or death, mostly w/ concomitant use w/ immunosuppressants (eg, methotrexate [MTX], corticosteroids). D/C if serious infection or sepsis develops. Active/latent reactivation of TB may present w/ 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 (-) 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

    Plaque Psoriasis

    Initial: 50mg twice weekly for 3 months
    Maint: 50mg once weekly

    Rheumatoid Arthritis

    50mg weekly
    Max: 50mg/week

    May continue MTX, glucocorticoids, salicylates, NSAIDs, or analgesics during treatment

    Psoriatic Arthritis

    50mg weekly
    Max: 50mg/week

    May continue MTX, glucocorticoids, salicylates, NSAIDs, or analgesics during treatment

    Ankylosing Spondylitis

    50mg weekly
    Max: 50mg/week

    May continue MTX, glucocorticoids, salicylates, NSAIDs, or analgesics during treatment

    PEDIATRIC DOSAGE

    Juvenile Idiopathic Arthritis

    Moderately to Severely Active:
    ≥2 Years:

    <63kg: 0.8mg/kg weekly
    ≥63kg: 50mg weekly

    May continue glucocorticoids, NSAIDs, or analgesics during treatment

    ADMINISTRATION

    SQ route

    Leave at room temperature for about 15-30 min before injecting
    Do not mix contents of one vial of Enbrel sol w/ the contents of another vial of Enbrel
    Do not add any other medications to sol containing Enbrel
    Do not reconstitute Enbrel w/ other diluents
    Do not filter reconstituted solution during preparation or administration

    Preparation Using the Single-use Prefilled Syringe/SureClick Autoinjector
    Check to see if the amount of liquid in the prefilled syringe falls between the 2 purple fill level indicator lines; do not use if the syringe does not have the right amount of liquid

    Preparation Using the Multiple-Use Vial
    Reconstitute w/ 1mL of Sterile Bacteriostatic Water for Inj (0.9% benzyl alcohol)
    Do not use vial adaptor if multiple doses are to be withdrawn from the vial; use a 25-gauge needle if the vial will be used for multiple doses

    If Using Vial Adapter:
    1. Twist adapter onto the diluents syringe
    2. Place vial adapter over Enbrel vial and inter vial adapter into vial stopper
    3. Push down on plunger to inject diluents into Enbrel vial
    4. Keeping the diluent syringe in place, gently swirl the contents of the Enbrel vial during dissolution
    5. Withdraw the correct dose of reconstituted sol into the syringe
    6. Remove the syringe from the vial adapter or remove the 25-gauge needle from the syringe
    7. Attach a 27-gauge needle to inject Enbrel

    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 w/ an active infection. Increased risk of infection in patients >65 yrs of age and in patients w/ comorbid conditions. New onset or exacerbation of CNS and peripheral nervous system demyelinating disorders, acute and chronic leukemia, new onset and worsening of 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 w/ 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 w/ 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 w/in 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 w/ all immunizations in agreement w/ 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 w/ moderate to severe alcoholic hepatitis and in the elderly. Patients w/ a significant exposure to varicella virus should temporarily d/c therapy and be considered for prophylactic treatment w/ varicella zoster immune globulin.

    ADVERSE REACTIONS

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

    DRUG INTERACTIONS

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

    PREGNANCY AND LACTATION

    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 w/in the needle cap of the autoinjector contain dry natural rubber (a derivative of latex), which 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.

    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, w/ 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 w/in 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.