Class: Disease-modifying Antirheumatic Drugs
VA Class: MS190
Chemical Name: 1-235-Tumor necrosis factor receptor (human) fusion protein with 236-467-immunoglobulin G1 (human γ1-chain Fc fragment), dimer
Molecular Formula: C2224H3472N618O701S36 (monomer)
CAS Number: 185243-69-0
- Serious Infections
Increased risk of serious infections involving various organ systems and sites that may require hospitalization or result in death; tuberculosis (frequently disseminated or extrapulmonary), invasive fungal infections (may be disseminated), bacterial (e.g., legionellosis, listeriosis) and viral infections, and other opportunistic infections reported.1 27 129 137 (See Infectious Complications under Cautions.)
Evaluate patients for latent tuberculosis infection prior to and periodically during etanercept therapy; if indicated, initiate appropriate antimycobacterial regimen prior to initiating etanercept therapy.1 137
Closely monitor patients for infection, including active tuberculosis in those with a negative tuberculin skin test, during and after treatment.1 129 137 Discontinue etanercept if serious infection or sepsis occurs.1 129 Consider empiric antifungal therapy if serious systemic illness occurs in a patient at risk for invasive fungal infections.1 129 137
Biologic response modifier and disease-modifying antirheumatic drug (DMARD); a recombinant DNA-derived human immunoglobulin G1 (IgG1) monoclonal antibody specific for human tumor necrosis factor (TNF; TNF-α).1 2 3 4 5 6 8 9 32 33
Uses for Etanercept
Rheumatoid Arthritis in Adults
Used to manage the signs and symptoms of rheumatoid arthritis, to induce a major clinical response, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis.1 2 3 4 5 6 7 8 15 17 32 33 34 70 111 112 117
Can be initiated in combination with methotrexate or alone.1
Used to manage the signs and symptoms of active arthritis, to improve physical function, and to inhibit progression of structural damage associated with the disease in patients with psoriatic arthritis.1 72 76 118
Has been investigated for the management of Wegener’s granulomatosis†34 59 (designated an orphan drug by FDA for this use).57 Use with standard immunosuppressive agents has been associated with an increased incidence of solid malignant tumors without added clinical benefit.103 110 122 Use to induce or maintain remission currently is not justified.103 110 122 Use in patients with Wegener’s granulomatosis† receiving immunosuppressive therapy is not recommended.1 (See Malignancies and Lymphoproliferative Disorders under Cautions and see Specific Drugs and Laboratory Tests under Interactions.)
Inflammatory Bowel Disease
Etanercept Dosage and Administration
Glucocorticoids, NSAIAs, and analgesics may be continued in pediatric patients with juvenile idiopathic arthritis.1
Administer sub-Q injections into the thighs, abdomen, or upper arm.132 133 134 Rotate injection sites.132 133 134 Do not inject into areas where skin is tender, bruised, red, or hard or into scars, stretch marks, or psoriatic lesions.132 133 134
Development of local reactions at the injection site does not preclude continued therapy.64
For greater patient comfort, may allow etanercept prefilled syringe to reach room temperature (about 15–30 minutes) prior to administration.1 Leave prefilled auto-injector at room temperature for ≥30 minutes prior to administration.1 Do not remove the needle cover from the prefilled syringe or prefilled auto-injector until immediately before administration.1 132 133 Solution may contain small, white, proteinaceous particulates; do not administer if discolored or cloudy, or if foreign particulate matter is present.1
Intended for use under the guidance and supervision of a clinician, but may be self-administered if the clinician determines that the patient and/or their caregiver is competent to prepare and safely administer the drug.1 55 The initial self-administered dose should be made under the supervision of a healthcare professional.1
Reconstitution (25-mg Multiple-dose Vial)
For greater patient comfort, may allow dose tray containing etanercept lyophilized powder and diluent to reach room temperature (about 15–30 minutes) prior to administration.1
Reconstitute lyophilized powder by adding 1 mL of bacteriostatic water for injection (containing 0.9% benzyl alcohol) provided by the manufacturer to a 25-mg vial to provide a solution containing 25 mg/mL.1
During reconstitution, very slowly add the diluent to the vial and gently swirl the contents to minimize foaming during dissolution; some foaming will occur.1
May use vial adapter supplied by manufacturer to facilitate reconstitution and withdrawal of dose if only one dose will be withdrawn from the vial.1 If multiple doses will be withdrawn from the vial, use a syringe with a 25-gauge needle for reconstitution and withdrawal of dose from vial.1 134 Use a 27-gauge needle to administer the dose.1
Avoid shaking and excessive or vigorous agitation of the vial to avoid excessive foaming.1
The final volume in the vial will be about 1 mL.134
Dissolution usually takes less than 10 minutes.1
Do not filter solutions during preparation or administration.1
Children 2–17 years of age: 0.8 mg/kg (maximum 50 mg) per week.1
50 mg weekly.1
50 mg weekly.1
50 mg weekly.1
Maintenance dosage: 50 mg once weekly.1
Maximum 50 mg weekly.1
Maximum 50 mg weekly.1
Maximum 50 mg weekly.1
Maximum 50 mg weekly.1
Limited data indicate that dosage adjustment is not necessary in patients with renal failure.123
Cautions for Etanercept
Increased risk of serious infections involving various organ systems and sites that may require hospitalization or result in death.1 137 Opportunistic infections caused by bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic organisms (e.g., aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, tuberculosis) reported, particularly in patients receiving concomitant therapy with immunosuppressive agents (e.g., methotrexate, corticosteroids).1 27 129 137 Infections frequently are disseminated.1 (See Boxed Warning.)
Patients >65 years of age, with comorbid conditions, and/or receiving concomitant therapy with immunosuppressive agents (e.g., corticosteroids, methotrexate) may be at increased risk of infection.1 137
Do not initiate etanercept in patients with active infections, including clinically important localized infections.1 16 36 48 Consider potential risks and benefits of the drug prior to initiating therapy in patients with a history of chronic, recurring, or opportunistic infections; patients with underlying conditions that may predispose them to infections; and patients who have been exposed to tuberculosis or who have resided or traveled in regions where tuberculosis or mycoses such as histoplasmosis, coccidioidomycosis, and blastomycosis are endemic.1 137
Closely monitor patients during and after etanercept therapy for signs or symptoms of infection (e.g., fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness including shock).1 129 137
If new infection occurs during therapy, perform thorough diagnostic evaluation (appropriate for immunocompromised patient), initiate appropriate anti-infective therapy, and closely monitor patient.1 129 Discontinue etanercept if serious infection or sepsis develops.1 16 36 48 129
Evaluate all patients for active or latent tuberculosis and for risk factors for tuberculosis prior to and periodically during therapy.1 137 When indicated, initiate appropriate antimycobacterial regimen for treatment of latent tuberculosis infection prior to etanercept therapy.1 Also consider antimycobacterial therapy prior to etanercept therapy for individuals with a history of latent or active tuberculosis in whom an adequate course of antimycobacterial treatment cannot be confirmed and for individuals with a negative tuberculin skin test who have risk factors for tuberculosis.1 Consultation with a tuberculosis specialist is recommended when deciding whether to initiate antimycobacterial therapy.1
Reactivation of latent tuberculosis reported in patients receiving etanercept, although data suggest that risk is lower with etanercept than with TNF-blocking monoclonal antibodies.1
Monitor all patients, including those with negative tuberculin skin tests, for active tuberculosis.1 Strongly consider tuberculosis in patients who develop new infections while receiving etanercept, especially if they previously have traveled to countries where tuberculosis is highly prevalent or have been in close contact with an individual with active tuberculosis.1
Failure to recognize invasive fungal infections has led to delays in appropriate treatment.129 Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.1 129 137 Whenever feasible, consult specialist in fungal infections when making decisions regarding initiation and duration of antifungal therapy.1 129
When deciding whether to reinitiate TNF blocking agent therapy following resolution of an invasive fungal infection, reevaluate risks and benefits, particularly in patients who reside in regions where mycoses are endemic.129 Whenever feasible, consult specialist in fungal infections.129
Malignancies and Lymphoproliferative Disorders
Lymphoma and other malignancies (some fatal) reported during postmarketing surveillance in children and adolescents receiving TNF blocking agents, particularly in those receiving other immunosuppressive agents (e.g., azathioprine, methotrexate) concomitantly.1 128 Malignancies included lymphomas (about 50% of the cases) (e.g., Hodgkin’s disease, non-Hodgkin’s lymphoma) and various other malignancies (e.g., leukemia, melanoma, solid organ cancers), including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children and adolescents (e.g., leiomyosarcoma, hepatic malignancies, renal cell carcinoma).1 128 Median time to occurrence was 30 months (range: 1–84 months) after the initial TNF blocking agent dose.1 FDA has concluded that there is an increased risk of malignancy with TNF blocking agents in children and adolescents; however, the strength of the association is not fully characterized.128
Hepatosplenic T-cell lymphoma (a rare, aggressive, usually fatal T-cell lymphoma) reported mainly in adolescents and young adults with Crohn’s disease or ulcerative colitis receiving TNF blocking agents and/or thiopurine analogs (mercaptopurine or azathioprine).138 Most of the patients received a combination of immunosuppressive agents, including TNF blocking agents and thiopurine analogs.138
In controlled studies, lymphoma was reported more frequently in patients receiving etanercept or other TNF blocking agents than in control patients.1 99 Patients with Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis, especially those with highly active disease, may be at increased risk of lymphoma;1 138 may be difficult to measure added risk of TNF-blocking agents, azathioprine, and/or mercaptopurine.138
Acute and chronic leukemias (some fatal) reported during postmarketing surveillance of TNF blocking agents in adults and pediatric patients, particularly in those receiving other immunosuppressive agents concomitantly.1 128 Leukemia (most commonly acute myeloid leukemia, chronic lymphocytic leukemia, and chronic myeloid leukemia) generally occurred during first 2 years of therapy.128 FDA has concluded that there is a possible association between TNF blocking agents and development of leukemia; interpretation of findings is complicated because patients with rheumatoid arthritis may be at increased risk for leukemia independent of any treatment with TNF blocking agents.1 128
Melanoma and nonmelanoma skin cancer reported in patients receiving TNF blocking agents, including etanercept.1 Merkel cell carcinoma reported infrequently in patients who received etanercept.1 Consider periodic dermatologic examinations in all patients at increased risk.1
For malignancies other than lymphoma and nonmelanoma skin cancer, no differences in exposure-adjusted occurrence rates observed between etanercept-treated patients and control patients.1
Solid noncutaneous malignant tumors reported in patients with Wegener’s granulomatosis receiving etanercept and cyclophosphamide; malignancies not reported in control patients receiving standard immunosuppressive therapy (corticosteroids plus cyclophosphamide or methotrexate) for Wegener’s granulomatosis.1 122 (See Specific Drugs and Laboratory Tests under Interactions.)
In controlled studies of other TNF blocking agents in adults at increased risk of malignancies (e.g., patients with COPD and a history of heavy smoking), a greater proportion of malignancies occurred in patients receiving the TNF blocking agent compared with control patients.142
Some immune-related diseases (e.g., Crohn’s disease) have been shown to increase risk of cancer independent of treatment with TNF blocking agents, while for others (e.g., juvenile idiopathic arthritis) it is unknown whether there is an increased risk of cancer.128
Carefully consider risks and benefits of TNF blocking agents, especially in adolescents and young adults and especially in the treatment of Crohn’s disease or ulcerative colitis;138 etanercept is not effective in the management of inflammatory bowel disease.1
Other Warnings and Precautions
Nervous System Effects
New onset or exacerbation of CNS demyelinating disorders (some presenting with mental status changes and some associated with permanent disability) and peripheral nervous system demyelinating disorders reported rarely with etanercept or other TNF blocking agents.1 TNF blockers associated with increased disease activity in patients with multiple sclerosis.71 73 74
Multiple sclerosis,1 88 transverse myelitis,1 optic neuritis,1 Guillain-Barré syndrome,1 peripheral demyelinating neuropathies,1 and new onset or exacerbation of seizure disorders1 reported in patients receiving etanercept.1
Worsening CHF (with and without identifiable precipitating factors) and, rarely, new-onset CHF (including in patients without known cardiovascular disease) reported, sometimes in patients <50 years of age.1 Use with caution and monitor carefully in patients with heart failure.1
One study evaluating etanercept for treatment of CHF suggested higher mortality rate in etanercept-treated patients versus placebo recipients.1
Possible pancytopenia including aplastic anemia, sometimes with fatal outcome.1 Use with caution in patients with a history of substantial hematologic abnormalities.1 Consider discontinuance in patients with confirmed hematologic abnormalities.1
Reactivation of HBV infection reported in patients previously infected with the virus.1 Death reported in a few individuals.1 Use of multiple immunosuppressive agents may contribute to HBV reactivation.1
Screen at-risk patients prior to initiation of therapy.1 Evaluate and monitor patients with prior HBV infection before, during, and for up to several months after therapy.1 Safety and efficacy of concomitant antiviral therapy for prevention of HBV reactivation not established.1
Discontinue etanercept and initiate appropriate treatment (e.g., antiviral therapy) if HBV reactivation occurs.1 Not known whether etanercept can be readministered once control of a reactivated HBV infection is achieved; caution advised in this situation.1
Patients may receive inactivated vaccines.1 Avoid live vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, poliovirus vaccine live oral, typhoid vaccine live oral, varicella virus vaccine live, yellow fever vaccine).1 (See Interactions.)
Immunologic Reactions and Antibody Formation
Possible formation of autoimmune antibodies.1 15 32 33 Lupus-like syndrome or autoimmune hepatitis reported rarely;1 87 may resolve upon discontinuance of the drug.1 If manifestations suggestive of lupus-like syndrome or autoimmune hepatitis develop, discontinue etanercept and carefully evaluate patient.1 36 48 56
New-onset psoriasis, including pustular and palmoplantar psoriasis, and exacerbation of existing psoriasis reported with TNF blocking agents, including etanercept.1 128 Most patients experienced improvement following discontinuance of the TNF blocking agent.128
Consider possibility of and monitor for manifestations (e.g., new rash) of new or worsening psoriasis, particularly pustular and palmoplantar psoriasis.128
Patients with Alcoholic Hepatitis
Use in patients with moderate to severe alcoholic hepatitis associated with higher mortality rate following 6 months of use; use with caution in such patients.1
Patients with Diabetes Mellitus
Limited data suggest etanercept crosses the placenta in small amounts; in 3 neonates, cord blood concentrations at the time of delivery were 3–32% of maternal serum concentrations.1 Clinical implications of in utero exposure are unknown.1 (See Pediatric Use under Cautions.)
Pregnancy registry at 800-772-6436 (for patients and clinicians).1
Limited data indicate etanercept is distributed into human milk in low concentrations and is minimally absorbed by breast-fed infants.1 Caution when used in nursing women.1 Consider benefits of breast-feeding, importance of etanercept to the woman, and potential adverse effects on the breast-fed child from the drug or underlying maternal condition.1
Women who choose to continue etanercept therapy while nursing are encouraged to enroll in the manufacturer's lactation surveillance program at 800-772-6436 (for patients and clinicians).1
Used for treatment of polyarticular course juvenile idiopathic arthritis in children ≥2 years of age.1 Not studied in children <2 years of age with juvenile idiopathic arthritis.1 Safety and efficacy not established in children with plaque psoriasis.1
Consider risks and benefits of administering live vaccines to infants who were exposed to etanercept in utero; safety of live vaccines in these infants is unknown.1 (See Pregnancy under Cautions.)
Varicella infection associated with aseptic meningitis reported.1 If a varicella-susceptible child has a clinically important exposure to varicella while receiving etanercept, discontinue the drug temporarily and consider use of varicella-zoster immune globulin.1
Frequencies and types of adverse effects reported in pediatric patients similar to those in adults.1 Adverse effects reported in children 2–4 years of age similar to those reported in older children.1
Inflammatory bowel disease reported rarely in patients with juvenile idiopathic arthritis receiving etanercept; the drug is not effective in the management of inflammatory bowel disease.1
No substantial differences in safety or efficacy relative to younger adults;1 34 61 however, insufficient experience in geriatric patients with psoriasis to determine whether they respond differently than younger adults.1
Possible increased incidence of infections in geriatric patients; use with caution.1
Common Adverse Effects
Injection site reactions, infections (including respiratory tract and other infections).1
Interactions for Etanercept
Administered concomitantly with methotrexate, glucocorticoids, salicylates, NSAIAs, and/or analgesics in clinical studies.1
Biologic Antirheumatic Agents
Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase the risk of infection.142
Patients may receive inactivated vaccines.1
Specific Drugs and Laboratory Tests
Drug or Test
Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection142
Concomitant use not recommended1
Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection142
Concomitant use not recommended1
Pharmacokinetic interaction unlikely1
Concomitant use not associated with additive toxicity7
Pneumococcal polysaccharide vaccine
B-cell immune response adequate in etanercept-treated psoriatic arthritis patients, although titers moderately lower and twofold increases less common than in controls1
Clinical importance of observed differences not known1
Increased risk of serious infection reported in patients who received rituximab and subsequently received a TNF blocking agent142
Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection142
Decrease in neutrophil counts reported1
Clinical importance unknown1
Test for troponin
False-positive troponin determinations using murine monoclonal antibody-based assay (i.e., AxSym Troponin, Abbott)65
Concomitant use not studied; possibility of increased immunosuppression and increased risk of infection139
Avoid concomitant use139
Limited data suggest etanercept crosses the placenta in small amounts.1
Limited data indicate etanercept distributes into human milk in low concentrations.1
Powder for Injection
May store individual dose trays containing etanercept powder for injection and diluent at 20–25°C for a maximum single period of 14 days, with protection from light, heat, and humidity.1 Following storage at room temperature, do not return to refrigerator; discard if not used within 14 days.1
Prefilled Syringe and Prefilled Auto-injector
May store individual prefilled syringes or auto-injectors at 20–25°C for a maximum single period of 14 days, with protection from light and heat.1 Following storage at room temperature, do not return to refrigerator; discard if not used within 14 days.1
High binding affinity for TNF and lymphotoxin-α (TNF-β);1 2 3 4 5 6 8 9 13 33 35 37 each molecule can bind to 2 TNF molecules.33 Prevents the binding of TNF to cell surface TNF receptors, thereby blocking the biologic activity of TNF.1 2 3 4 5 6 7 8 9 33 37
Produced by recombinant DNA technology in a mammalian cell expression system.1
Advice to Patients
A copy of the manufacturer’s patient information (medication guide) for etanercept should be provided to all patients with each prescription of the drug.1 128 Importance of advising patients about potential benefits and risks of etanercept.1 128 137 138 Importance of patients reading the medication guide prior to initiation of therapy and each time the prescription is refilled.128 136 137 138
If the patient or caregiver is to administer etanercept, provide careful instructions regarding proper dosage and administration of etanercept, including proper aseptic technique, and proper disposal of needles and syringes.1
Increased susceptibility to infection.1 136 137 Importance of seeking immediate medical attention if signs and symptoms suggestive of infection (e.g., fever, chills, flu-like symptoms, cough, burning or pain on urination) develop.1 136
Risk of lymphoma, including hepatosplenic T-cell lymphoma, leukemia, or other malignancies with TNF blocking agents.1 128 138 Importance of informing patients and caregivers about the increased risk of cancer development in children, adolescents, and young adults, taking into account the clinical utility of TNF blocking agents, the relative risks and benefits of these and other immunosuppressive drugs, and the risks associated with untreated disease.1 128 138 Importance of promptly informing clinicians if signs and symptoms of malignancies (e.g., unexplained weight loss; fatigue; abdominal pain; persistent fever; night sweats; easy bruising or bleeding; swollen lymph nodes in the neck, underarm, or groin; easy bruising or bleeding; hepatomegaly or splenomegaly) occur.128 138
Importance of informing clinician of any new or worsening medical conditions (e.g., neurologic conditions [e.g., demyelinating disorders], heart failure, autoimmune disorders [e.g., lupus-like syndrome, autoimmune hepatitis], psoriasis, cytopenias).1 128 136
Importance of alerting clinician if allergy to latex exists.1
Importance of promptly contacting a clinician if manifestations of an allergic reaction (e.g., rash, facial swelling, difficulty breathing) occur.136
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or any history of cancer, tuberculosis, HBV infection, or other chronic or recurring infections.1 129 137
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
For injection, for subcutaneous use
Enbrel (with prefilled syringe containing 1 mL bacteriostatic water for injection [with benzyl alcohol 0.9%] diluent, plunger, and vial adapter)
Injection, for subcutaneous use
25 mg/0.5 mL
Enbrel (available as disposable prefilled syringes)
Enbrel (available as disposable prefilled syringes and prefilled auto-injectors [SureClick])
AHFS DI Essentials. © Copyright 2017, Selected Revisions December 11, 2015. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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- Other brands: Enbrel