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";s:4:"text";s:17032:"Remove one prefilled syringe and place it on your work surface. The skin lesions of psoriasis were also improved with Enbrel, relative to placebo, as measured by percentages of patients achieving improvements in the Psoriasis Area and Severity Index (PASI). Immunex Corporation Two JIA patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae. Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate to severe alcoholic hepatitis. For Subcutaneous Use Only infections. disease severity) may have impacted the occurrence of birth defects (see Data). The proportion of responders was related to Enbrel dosage [see Clinical Studies (14.5)]. Similar responses were seen in patients with each of the subtypes of PsA, although few patients were enrolled with the arthritis mutilans and ankylosing spondylitis-like subtypes. Hold the syringe at eye level and slowly pull the plunger down to the unit markings on the side of the syringe that correspond with your/your child’s dose. The needle cover within the purple cap of the Enbrel Mini single-dose prefilled cartridge contains dry natural rubber (a derivative of latex). On a clean, well-lit work surface, place the: D  Prepare and clean your injection site. May continue with methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics during treatment, Based on a study of 50 mg twice weekly in patients with RA that suggested higher incidence of adverse reactions but similar American College of Rheumatology response rates, doses higher than 50 mg/week are not recommended, 0.8 mg/kg SC weekly; not to exceed 50 mg weekly, Glucocorticoids, NSAIDs, or analgesics may be continued during treatment, Increased risk of 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, Active tuberculosis (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 before use, 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, Infections caused by other bacterial (eg, Legionella, Listeria), mycobacterial (eg, Mycobacterium tuberculosis), and viral (eg, hepatitis B virus) opportunistic pathogens, Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers, Cases of acute and chronic leukemia have been reported in association with postmarketing TNF-blocker use in rheumatoid arthritis (RA) and other indications; patients with RA may be at higher (approximately 2-fold greater) risk for leukemia than general population, Manufacturer required to report all malignancies to FDA for complete and consistent analysis, Rare postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL; an aggressive, rare, and usually fatal type of T-cell lymphoma) have been reported, primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with TNF blockers but also in 1 patient being treated for psoriasis and 2 patients being treated for rheumatoid arthritis, Most reported cases with TNF blockers have occurred with concomitant treatment with azathioprine or 6-mercaptopurine (6-MP), though some cases have been reported with azathioprine or 6-MP alone, No data are available on the secondary transmission of infection by live vaccines in patients receiving etanercept, Patients with a significant exposure to varicella virus should temporarily discontinue etanercept and be considered for prophylactic treatment with varicella zoster immune globulin, Use of etanercept with cyclophosphamide therapy is not recommended, Patients in a clinical study who were on established therapy with sulfasalazine, to which etanercept was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either etanercept or sulfasalazine alone, Clinical significance of this observation is unknown, Reconstituted vial powder with 1 mL of the supplied sterile bacteriostatic water for injection, Dissolution generally takes <10 minutes; resulting concentration is 25 mg/mL, Do not use if discolored or cloudy, or if particulate matter remains, Withdraw correct dose of reconstituted solution into the syringe, some foam or bubbles may remain in the vial, Remove syringe from the vial adapter or remove the 25-gauge needle from the syringe; attach a 27-gauge needle for SC injection, Vial contents should not be mixed with, or transferred into, the contents of another vial of etanercept, No other medications should be added to solutions containing etanercept, and do not reconstitute with other diluents, Do not filter reconstituted solution during preparation or administration. Learn how to set up your needle, vial, and adapter. These antibodies were all non-neutralizing. For each additional dose, you will need two new needles (one 25-gauge needle to withdraw the solution and one 27-gauge needle for injection) and one new empty syringe (1 mL). likely to get lymphoma. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider. Throw away any Enbrel SureClick autoinjector that has been stored at room temperature after 14 days. MODERATE TO SEVERE This is normal. No formal pharmacokinetic studies have been conducted to examine the effects of renal or hepatic impairment on etanercept disposition. It plays an important role in the inflammatory processes of RA, polyarticular JIA, PsA, and AS and the resulting joint pathology. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. E Pull white cap straight off, only when you are ready to inject. 25 mg/vial In the MTX treatment group, 55% of patients experienced no radiographic progression (TSS change ≤ 0.0) at 12 months compared to 63% and 76% in the Enbrel alone and the Enbrel/MTX combination treatment groups, respectively. When using the Enbrel single-dose vial, administer the correct dose of solution using the following recommended materials: A withdrawal needle with Luer-Lock connection, sterile, 22-gauge, length 1 1/2 inch. After removing the autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means the patient has not received a full dose. The Enbrel solution must be used within 14 days of the mixing date. When feasible, the decision to administer empiric anti-fungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of anti-fungal therapy. NDC 58406-445-04 A  Remove one Enbrel SureClick autoinjector from the package. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient. ENBREL should be discontinued if a patient develops a serious infection or sepsis. E-selectin, and to a lesser extent, intercellular adhesion molecule-1 [ICAM-1]), serum levels of cytokines (e.g. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. Last updated on Apr 22, 2020. Refrigerate at 2°C to 8°C (36° to 46°F). The needle cover inside the purple cap on the Enbrel Mini cartridge contains dry natural rubber, which is made from latex. ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Contains 4 Single-Dose Prefilled Syringes Then, you can push the purple start button again. chronic moderate to severe plaque psoriasis. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops. If you have any questions about the autoinjector, its storage, or about your injection, contact your healthcare provider or visit www.Enbrel.com or call 1-888-4Enbrel (1-888-436-2735) for help. etanercept Gently pinch skin. In global postmarketing adult and pediatric use, lymphoma and other malignancies have been reported. Do not remove the needle cover from the syringe until you are ready to inject. Keep AutoTouch and Enbrel Mini out of the reach of children. At Enbrel.com, you can find out more about ongoing assistance through ENBREL Support®, which can help with out-of-pocket costs* and connect you with registered nurses and ENBREL Nurse Partners™. 2. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders. Please see Prescribing Information and Medication Guide. Single-Dose Prefilled Syringe If you are 65 or older, use Enbrel (etanercept vials) with care. Manufactured by Immunex Corporation, Thousand Oaks, CA 91320, PRINCIPAL DISPLAY PANEL ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older. allergic reactions; autoimmune reactions, including a lupus-like syndrome and autoimmune Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. IMPORTANT: Do NOT touch the gray stopper with your hands. Leave Enbrel Mini single-dose prefilled cartridge at room temperature for at least 30 minutes before injecting. insert with attached Medication Guide) are intended to be Enbrel has not been studied in children < 2 years of age with JIA and < 4 years of age with PsO. Etanercept is a dimeric soluble form of the p75 TNF receptor that can bind TNF molecules. 50 mg/mL (•) is medium The status button will start to flash green. In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients. AMGEN® Your healthcare provider will tell you how often you should use Enbrel. If you have any questions about storage, contact your healthcare provider or call 1-888-4Enbrel (1-888-436-2735) for further instructions. Place the needle cover (open side up) in the round space marked “N” in the Enbrel dose tray. No other medications should be added to solutions containing Enbrel, and do not reconstitute Enbrel with other diluents. Melanoma and non-melanoma skin cancer has been reported in patients treated with TNF antagonists including etanercept. With the other hand, hold the syringe (like a pencil) at a 45-degree angle to the skin. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known preexisting cardiovascular disease. 3. Controlled studies in pregnant women show no evidence of fetal risk. 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