There may be small white particles of protein in the solution. Inspect visually for particulate matter and discoloration prior to administration.
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DO NOT remove the vial cap while allowing the vial to reach room temperature. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.įor a more comfortable injection, leave Enbrel vial(s) at room temperature for at least 30 minutes before injecting. The risks and benefits of treatment with Enbrel should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.Treatment for latent infection should be initiated prior to Enbrel use. Patients should be tested for latent tuberculosis before Enbrel use and during therapy. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Active tuberculosis, including reactivation of latent tuberculosis.Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Įnbrel should be discontinued if a patient develops a serious infection or sepsis. Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death.
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( 5.9)įULL PRESCRIBING INFORMATION: CONTENTS * WARNING: SERIOUS INFECTIONS and MALIGNANCIES 1 INDICATIONS AND USAGE 1.1 Rheumatoid Arthritis 1.2 Polyarticular Juvenile Idiopathic Arthritis 1.3 Psoriatic Arthritis 1.4Ěnkylosing Spondylitis 1.5 Plaque Psoriasis 2 DOSAGE AND ADMINISTRATION 2.1Ědult Patients 2.2 Pediatric Patients 2.3 Preparation of Enbrel 2.4 Monitoring to Assess Safety 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Serious Infections 5.2 Neurologic Reactions 5.3 Malignancies 5.4 Patients with Heart Failure 5.5 Hematologic Reactions 5.6 Hepatitis B Reactivation 5.7Ěllergic Reactions 5.8 Immunizations 5.9Ěutoimmunity 5.10 Immunosuppression 5.11 Use in Granulomatosis with Polyangiitis Patients 5.12 Use with Anakinra or Abatacept 5.13 Use in Patients with Moderate to Severe Alcoholic Hepatitis 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity 6.3 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Vaccines 7.2 Immune-Modulating Biologic Products 7.3Ĝyclophosphamide 7.4 Sulfasalazine 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Use in Diabetics 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1Ědult Rheumatoid Arthritis 14.2 Polyarticular Juvenile Idiopathic Arthritis (JIA) 14.3 Psoriatic Arthritis 14.4Ěnkylosing Spondylitis 14.5Ědult Plaque Psoriasis 14.6 Pediatric Plaque Psoriasis 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.