Dosing & Uses
Dosage Forms & Strengths
injection solution, prefilled syringe
- 25mg/0.5mL (Enbrel, Erelzi, Eticovo)
- 50mg/mL (Enbrel, Erelzi, Eticovo)
injection solution, prefilled autoinjector
- 50mg/mL (Enbrel, Erelzi)
injection, lyophilized powder for reconstitution
- 25mg/vial (Enbrel)
injection, prefilled single-dose prefilled cartridge with reusable autoinjector
- 50mg/mL (Enbrel Mini)
Biosimilars to Enbrel
- Erelzi (etanercept-szzs)
- Eticovo (etanercept-ykro)
Ankylosing Spondylitis
Enbrel, Erelzi, Eticovo
Indicated for reducing signs and symptoms of active ankylosing spondylitis
50 mg SC once weekly
Rheumatoid Arthritis
Enbrel, Erelzi, Eticovo
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
50 mg SC once weekly
Psoriatic Arthritis
Enbrel, Erelzi, Eticovo
Indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis
50 mg SC once weekly
Plaque Psoriasis
Enbrel, Eticovo
Indicated for adults (≥18 yr) with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Initial: 50 mg SC twice weekly for 3 months
Maintenance: 50 mg SC once weekly
Dosing Considerations
Rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis
- 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
Dosage Forms & Strengths
injection solution, prefilled syringe
- 25mg/0.5mL (Enbrel, Erelzi, Eticovo)
- 50mg/mL (Enbrel, Erelzi, Eticovo)
injection solution, prefilled autoinjector
- 50mg/mL (Enbrel, Erelzi)
injection, lyophilized powder for reconstitution
- 25mg/vial (Enbrel)
injection, prefilled single-dose cartridge with reusable autoinjector
- 50mg/mL (Enbrel Mini)
Biosimilars to Enbrel
- Erelzi (etanercept-szzs)
- Eticovo (etanercept-ykro)
Juvenile Rheumatoid Arthritis
Indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged ≥2 years
<2 years: Safety and efficacy not established
≥2 years (<63 kg)
-
<63 kg
-
>63 kg
- Enbrel, Erelzi, Eticovo
- 50 mg SC weekly
- Glucocorticoids, NSAIDs, or analgesics may be continued during treatment
Psoriasis
Indicated for children aged ≥4 years with chronic moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy
<4 years: Safety and efficacy not established
≥4 years
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- upadacitinib
etanercept, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Serious - Use Alternative (75)
- abatacept
abatacept, etanercept. Mechanism: pharmacodynamic synergism. Contraindicated. Increased risk of serious infection.
- adalimumab
adalimumab and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- alefacept
alefacept and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anakinra
anakinra and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
anakinra, etanercept. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Additive immunosuppression; risk of serious infection. - anthrax vaccine
etanercept decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- antithymocyte globulin equine
antithymocyte globulin equine and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- antithymocyte globulin rabbit
antithymocyte globulin rabbit and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- axicabtagene ciloleucel
etanercept, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- azathioprine
azathioprine and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- baricitinib
baricitinib, etanercept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- basiliximab
basiliximab and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
etanercept decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- brexucabtagene autoleucel
etanercept, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- canakinumab
canakinumab and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- certolizumab pegol
etanercept and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.
- ciltacabtagene autoleucel
etanercept, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cyclophosphamide
etanercept, cyclophosphamide. Mechanism: unspecified interaction mechanism. Avoid or Use Alternate Drug. The incidence of noncutaneous solid malignancies may be increased in patients receiving TNF blocking agents with cyclophosphamide. Coadministration is not recommended.
- cyclosporine
cyclosporine and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- diphtheria & tetanus toxoids
etanercept decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- diphtheria & tetanus toxoids/ acellular pertussis vaccine
etanercept decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine
etanercept decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- everolimus
etanercept and everolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- glatiramer
etanercept and glatiramer both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- golimumab
etanercept and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hepatitis A vaccine inactivated
etanercept decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis a/b vaccine
etanercept decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis a/typhoid vaccine
etanercept decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis b vaccine
etanercept decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- human papillomavirus vaccine, nonavalent
etanercept decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
- human papillomavirus vaccine, quadrivalent
etanercept decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
- hydroxychloroquine sulfate
etanercept and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
etanercept, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- infliximab
etanercept and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent
etanercept decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine quadrivalent, adjuvanted
etanercept decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine quadrivalent, cell-cultured
etanercept decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine quadrivalent, intranasal
etanercept decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine trivalent
etanercept decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine trivalent, adjuvanted
etanercept decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- Japanese encephalitis virus vaccine
etanercept decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- leflunomide
etanercept and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
etanercept, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles (rubeola) vaccine
etanercept decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- measles mumps and rubella vaccine, live
etanercept decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- measles, mumps, rubella and varicella vaccine, live
etanercept decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- meningococcal A C Y and W-135 polysaccharide vaccine combined
etanercept decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- muromonab CD3
etanercept and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mycophenolate
etanercept and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pneumococcal vaccine 13-valent
etanercept decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pneumococcal vaccine heptavalent
etanercept decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pneumococcal vaccine polyvalent
etanercept decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rabies vaccine
etanercept decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.
- rabies vaccine chick embryo cell derived
etanercept decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rilonacept
etanercept and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rotavirus oral vaccine, live
etanercept decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rubella vaccine
etanercept decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- selinexor
selinexor, etanercept. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- sirolimus
etanercept and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- smallpox (vaccinia) vaccine, live
etanercept decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tacrolimus
etanercept and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- temsirolimus
etanercept and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tetanus toxoid adsorbed or fluid
etanercept decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tick-borne encephalitis vaccine
etanercept decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tisagenlecleucel
etanercept, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tocilizumab
tocilizumab and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
tocilizumab, etanercept. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Additive immunosuppression; risk of serious infection. - tofacitinib
etanercept, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tongkat ali
etanercept and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- travelers diarrhea and cholera vaccine inactivated
etanercept decreases effects of travelers diarrhea and cholera vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- typhoid polysaccharide vaccine
etanercept decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- typhoid vaccine live
etanercept decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- ustekinumab
etanercept and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- varicella virus vaccine live
etanercept decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- vedolizumab
vedolizumab and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections
- yellow fever vaccine
etanercept decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- zoster vaccine live
etanercept decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
Monitor Closely (29)
- astragalus
etanercept increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- cholera vaccine
etanercept decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
etanercept decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
etanercept, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- echinacea
etanercept increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- fingolimod
etanercept increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- haemophilus influenzae type b vaccine
etanercept decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored.
- hydroxyurea
hydroxyurea, etanercept. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- ifosfamide
ifosfamide, etanercept. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor.
- influenza virus vaccine quadrivalent, recombinant
etanercept decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.
- influenza virus vaccine trivalent, recombinant
etanercept decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.
- isavuconazonium sulfate
etanercept and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
lomustine and etanercept both increase pharmacodynamic antagonism. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- maitake
etanercept increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- meningococcal group B vaccine
etanercept decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- mercaptopurine
etanercept and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ofatumumab SC
ofatumumab SC, etanercept. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
etanercept and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- oxaliplatin
oxaliplatin and etanercept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.
- ozanimod
ozanimod, etanercept. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.
- poliovirus vaccine inactivated
etanercept decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .
- ponesimod
ponesimod and etanercept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- procarbazine
procarbazine, etanercept. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- siponimod
siponimod and etanercept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
etanercept decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- trastuzumab
trastuzumab, etanercept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, etanercept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- ublituximab
ublituximab and etanercept both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- zoster vaccine recombinant
etanercept decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (1)
- cat's claw
cat's claw, etanercept. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Possible additive immunosuppr'n.
Adverse Effects
>10%
RA
- Infection (81%)
- Upper respiratory infections (65%)
- Non-upper respiratory infections (54%)
- Injection site reactions (43%)
- Diarrhea (16%)
- Rash (13%)
PsO (Enbrel and Eticovo only)
- Infection (27%)
- Upper respiratory infections (17%)
- Injection site reactions (15%)
- Non-upper respiratory infections (12%)
1-10%
RA
- Pruritus (5%)
- Pyrexia (2%)
- Urticaria (2%)
- Hypersensitivity (1%)
PsO (Enbrel and Eticovo only)
- Diarrhea (3%)
- Rash (1%)
- Pruritus (1%)
- Urticaria (1%)
- Hypersensitivity (1%)
Postmarketing Reports
Blood and lymphatic system disorders: Pancytopenia, anemia, leukopenia, neutropenia, thrombocytopenia, lymphadenopathy, aplastic anemia
Cardiac disorders: Congestive heart failure
Gastrointestinal disorders: Inflammatory bowel disease (IBD
General disorders: Angioedema, chest pain
Hepatobiliary disorders: Autoimmune hepatitis, elevated transaminases
Immune disorders: macrophage activation syndrome, systemic vasculitis
Musculoskeletal and connective tissue disorders: Lupus-like syndrome
Neoplasms benign, malignant, and unspecified: Melanoma and non-melanoma skin cancers, Merkel cell carcinoma
Nervous system disorders: Convulsions, multiple sclerosis, demyelination, optic neuritis, transverse myelitis, paresthesias, headache
Ocular disorders: Uveitis, scleritis
Respiratory, thoracic and mediastinal disorders: Interstitial lung disease
Skin and subcutaneous tissue disorders: Cutaneous lupus erythematosus, cutaneous vasculitis (including leukocytoclastic vasculitis), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, subcutaneous nodule, new or worsening psoriasis (all sub-types including pustular and palmoplantar)
SC nodule, new or worsening psoriasis (all sub-types including pustular and palmoplantar)
Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis and Pneumocystis jiroveci pneumonia, and protozoal infections
Warnings
Black Box Warnings
Serious infection risk
- 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
-
Reported infections include the following
- 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
Malignancy
- 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
Contraindications
Sepsis
Hypersensitivity
Cautions
HBV-positive status, history of or susceptibility to recurring infections, history of blood dyscrasias
Consider empiric anti-fungal therapy for patients at risk for invasive fungal infections who develop a systemic severe illness while receiving therapy
Monitor closely for signs or symptoms of demyelinating disease (eg, confusion, numbness, vision changes); use caution in patients with preexisting or recent-onset CNS demyelinating disorders; therapy associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders; cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barre syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders reported in postmarketing experience with etanercept products therapy
Increased risk of TB; monitor for TB
Possibility of lupuslike symptoms or development of autoimmune hepatitis; discontinue if such symptoms develop
Use with caution in patients with history of significant hematologic abnormalities; consider discontinuing if hematologic disorders (eg, pancytopenia, leukopenia, thrombocytopenia, aplastic anemia) occur; consider stopping therapy
Diluent for multidose vial contains benzyl alcohol as preservative
Children should be up to date with immunizations before starting drug
Increased risk of lymphoma and other cancers reported in children and adolescents; occurrence of leukemia and new-onset psoriasis reported in patients treated with TNF blockers
Enhanced safety surveillance requirements to capture malignancy data; manufacturers required to report all malignancies to FDA for complete and consistent analysis
Worsening or new onset congestive heart failure reported with TNF blockers; Exercise caution when using in patients who have heart failure; TNFalpha inhibitors should only be considered in patients with HF if there are no other reasonable treatment options, and then only consider in patients with compensated HF
Reactivation of hepatitis B (HBV) in chronic carriers of the virus reported; fatal in patients receiving concomitant immunosuppressants; evaluate for HBV prior to initiation in all patients
Use caution in patients with moderate to severe alcoholic hepatitis; significant higher rate of mortality reported at 6 months of therapy
Use caution in patients with history of seizures, new onset or exacerbatin of seizures reported with therapy
Therapy not recommended in patients with Wegener granulomatosis receiving immunosuppressive therapy due to higher incidence of noncutaneous solid malignancies
Use in patients with granulomatosis with polyangiitis receiving immunosuppressive agents not recommended; use is associated with a higher incidence of non-cutaneous solid malignancies and not associated with improved clinical outcomes when compared with standard therapy alone
Children with significant exposure to varicella virus should temporarely discontinue therapy; consider administering varicella zoster immune globulin
Hepatosplenic T-cell lymphoma
- 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
Drug interaction overview
-
Vaccines
- Avoid coadministration of live vaccines
- 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
-
Cyclophosphamide
- Use of etanercept with cyclophosphamide therapy is not recommended
-
Sulfasalazine
- 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
Pregnancy & Lactation
Pregnancy
Available studies during pregnancy do not reliably support an association between therapy and major birth defects; clinical data are available from the Organization of Teratology Information Specialists (OTIS) Enbrel Pregnancy Registry in women with rheumatic diseases or psoriasis and a Scandinavian study in pregnant women with chronic inflammatory disease; Both studies showed the proportion of liveborn infants with major birth defects was higher for women exposed to etanercept compared to diseased etanercept unexposed women; however, the lack of pattern of major birth defects is reassuring and differences between exposure groups (e.g. disease severity) may have impacted the occurrence of birth defects
The risk of fetal/neonatal adverse reactions with in utero exposure to therapy is unknown; risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to drug in utero
Lactation
Limited data from published literature show that etanercept is present in low levels in human milk and minimally absorbed by a breastfed infant; no data are available on effects of therapy on breastfed child or on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Binds and inactivates TNF, thereby preventing synovial inflammation
Absorption
Bioavailability: 60%
Onset: 1-2 weeks
Peak plasma time (single 25-mg dose): 69 ± 34 hr
Peak plasma concentration (single 25-mg dose): 1.1 ± 0.6 mcg/mL
Distribution
Vd: 12 L
Elimination
Half-life: ~5 days
Clearance: 160 mL/hr (varies)
Administration
SC Preparation
For a more comfortable injection, leave prefilled syringe/autoinjector/reconstituted vial at room temperature for ~15-30 minutes before injecting
Do not remove the needle cover while allowing to reach room temperature
Reconstitution of vial
- 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
SC Administration
Rotate injection sites
Clean injection site area with alcohol wipe and let skin dry
Inject SC in top of thighs, abdomen (avoid 2-inch area around navel), or outer area of upper arm
Do not inject areas of skin that are tender, bruised, red, or hard
Avoid injecting area with scars or stretch marks
For psoriasis, avoid injecting directly into raised, thick, red, or scaly skin patch or lesion
Storage
Refrigerate at 36-46ºF (2-8ºC)
Do not shake
Store in the original carton to protect from light or physical damage
For convenience, storage of individual syringes, autoinjectors, or vials at room temperature for a maximum single period of 14 days is permissible, with protection from light and sources of heat
Once stored at room temperature, do not place back in the refrigerator
Discard if not used within 14 days at room temperature
Once a vial has been reconstituted, the solution must be used immediately or may be refrigerated for up to 14 days
Do not store in extreme heat or cold
Do not freeze
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Enbrel subcutaneous - | 25 mg/0.5 mL (0.5) solution |  | |
| Enbrel subcutaneous - | 50 mg/mL (1 mL) solution |  | |
| Enbrel subcutaneous - | 25 mg/0.5 mL vial |  | |
| Enbrel subcutaneous - | 25 mg (1 mL) vial |  | |
| Enbrel subcutaneous - | 50 mg/mL (1 mL) solution |  | |
| Enbrel subcutaneous - | 50 mg/mL (1 mL) solution |  | |
| Enbrel subcutaneous - | 25 mg/0.5 mL vial |  | |
| Enbrel SureClick subcutaneous - | 50 mg/mL (1 mL) injection |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
etanercept subcutaneous
ETANERCEPT - INJECTION
(ee-TAN-er-sept)
COMMON BRAND NAME(S): Enbrel
WARNING: Because etanercept works by blocking the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection (such as fungal infections, bacterial infections including tuberculosis) or make any infection you have worse. Tell your doctor your medical history, especially of past/recent/current infections. Also, tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. You should be tested for tuberculosis (TB skin test or chest X-ray) before and during treatment with etanercept. See Side Effects section for symptoms of infections to watch out for, and get medical help right away if you develop any of these symptoms.The immune system is also important in preventing and controlling cancer. Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as fever that doesn't go away, unusual lumps/growths, swollen or painful abdomen, unexplained weight loss, or night sweats.
USES: This medication is used alone or in combination with an immunosuppressant (such as methotrexate) to treat certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, and ankylosing spondylitis). Some brands of this medication are also used to treat a skin condition called psoriasis. These conditions are caused by an overactive immune system (autoimmune disease). The immune system attacks the body's own healthy cells, causing inflammation in the joints and skin.Etanercept controls your body's defensive response by blocking the action of a certain natural substance (TNF) that is used by the immune system. Treatment decreases redness, itching and scaly patches in psoriasis as well as the pain, swelling and stiffness of joints in arthritis. This medication can stop the progression of disease and joint damage, resulting in improved daily functioning and quality of life.This medication treats but does not cure autoimmune diseases. Symptoms usually return within 1 month of stopping the medication.
HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Inject this medication under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once or twice a week.The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight. Do not change your dose without consulting your doctor.Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day(s) each week.If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Your doctor may give your first injection in the medical office.If your medication has been refrigerated, leave it at room temperature for at least 15 to 30 minutes before injecting. Do not warm up this medication any other way. For example, do not heat it in the microwave or place it in hot water. Do not shake this medication. Before using, check this product visually for particles, cloudiness, or discoloration. The prefilled syringe, cartridge, or pen injector may have small white particles in the liquid. This is normal. If you see other particles, cloudiness, or discoloration, do not use the liquid.Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into areas that are sore, bruised, red, or hard.Learn how to store and discard medical supplies safely.You may notice improvement in your condition after 1 to 2 weeks, but it may take a few months to get the full benefit of this medication. Tell your doctor if your condition does not get better or if it gets worse.
SIDE EFFECTS: See also Warning section.Redness, itching, pain, or swelling at the injection site may occur. This usually starts 1-2 days after the injection and clears up in 3-5 days. Injection site reactions usually lessen after the first month. Headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you develop signs of infection while using this drug, such as: sore throat that doesn't go away, cough that doesn't go away, fever, chills, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, a rash on nose and cheeks (butterfly rash), dizziness, extreme fatigue, looking pale, hair loss, swelling of the arms/legs, unusual bruising/bleeding, severe headache, mental/mood changes, seizures, unexplained muscle weakness, numbness/tingling of the hands/feet, unsteadiness, vision changes, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using etanercept, tell your doctor or pharmacist if you are allergic to it; or to latex or natural dry rubber (found in some forms of etanercept); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: active or recurrent infection (such as hepatitis B, HIV, tuberculosis), blood disorders (such as leukemia, anemia), weakened bone marrow, history of cancer (such as lymphoma), diabetes, heart failure, seizures, nervous system problems (such as multiple sclerosis), a certain liver problem (alcoholic hepatitis), blood vessel disorders (such as vasculitis).Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine. Consult your doctor about risks of exposure to chickenpox and other infections.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be at greater risk for infections while using this drug.It is recommended that children be up to date on all their childhood vaccinations before starting etanercept.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: abatacept, interleukin-1 blockers (such as anakinra, canakinumab, rilonacept), live vaccines (such as measles, mumps, polio, rubella, typhoid, varicella, yellow fever), other medications for autoimmune disease (such as azathioprine, cyclophosphamide).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, liver function, TB test) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.This medication may interfere with certain lab tests. Be sure to tell the lab personnel that you are on this medication.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store unopened medication in the refrigerator away from light. Do not freeze. Some dosage forms may also be stored at room temperature for a certain time (for example, up to 14 or 30 days). Consult your pharmacist or the manufacturer's package for details. If stored at room temperature, do not place this medication back in the refrigerator. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised January 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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