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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 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.
Tumor necrosis factor (TNF) blocker
Initial: 50mg twice weekly for 3 months; initial doses of 25mg or 50mg/week were also shown to be efficaciousMaint: 50mg once weekly
50mg weeklyMax: 50mg/week
May continue MTX, glucocorticoids, salicylates, NSAIDs, or analgesics during treatment
Moderately to Severely Active:≥2 Years: <63kg: 0.8mg/kg weekly≥63kg: 50mg weekly
May continue glucocorticoids, NSAIDs, or analgesics during treatment
Do not mix contents of 1 vial of Enbrel sol w/ the contents of another vial of Enbrel Do not add any other medications to sol containing EnbrelDo not reconstitute Enbrel w/ other diluentsDo not filter reconstituted sol during preparation or administration
Preparation Using the Single-Use Prefilled SyringeLeave at room temperature for about 15-30 min before injectingCheck 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 liquidPreparation Using the SureClick AutoinjectorLeave at room temperature for at least 30 min before injecting
Preparation Using the Multiple-Use VialReconstitute w/ 1mL of sterile bacteriostatic water for inj (0.9% benzyl alcohol)Do not use vial adaptor if multiple doses are to be withdrawn from the vial; use a 25-gauge needle if the vial will be used for multiple dosesReconstituted sol must be refrigerated at 36-46°F (2-8°C) and used w/in 14 days; discard reconstituted sol after 14 daysLeave at room temperature for about 15-30 min before injecting
If Using Vial Adapter:1. Twist adapter onto the diluents syringe2. Place vial adapter over Enbrel vial and insert vial adapter into vial stopper3. Push down on plunger to inject diluent into Enbrel vial; inject the diluent very slowly into the Enbrel vial if using a 25-gauge needle4. Keeping the diluent syringe in place, gently swirl the contents of the Enbrel vial during dissolution5. Withdraw the correct dose of reconstituted sol into the syringe6. Remove the syringe from the vial adapter or remove the 25-gauge needle from the syringe7. Attach a 27-gauge needle to inject Enbrel
Inj: 25mg [multiple-use vial, single-use prefilled syringe], 50mg [single-use prefilled syringe, single-use prefilled SureClick autoinjector]
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; consider discontinuation of therapy in patients w/ confirmed significant hematologic abnormalities. 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; 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.
Infections, sepsis, malignancies, inj-site reactions, diarrhea, rash, pyrexia, pruritus.
See Boxed Warning. Avoid w/ live vaccines. 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.
Category B, caution in nursing.
TNF-blocker; inhibits binding of TNF-α and TNF-β (lymphotoxin alpha [LT-α]) to cell surface TNF-receptors, rendering TNF biologically inactive.
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).
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.
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.
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.
2-8°C (36-46°F). Do not shake. Protect from light or physical damage. Storage at room temperature at 20-25°C (68-77°F) 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.