INDICATIONS

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. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.

ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used with or without MTX.

ENBREL is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.

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The SureClick® Autoinjector quick reference guide to parts and injection instructions. Please read all instructions in carton before use
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Side 2 of the SureClick® Autoinjector quick reference guide with continued injection instructions.
Please read all instructions in carton before use
ENBREL Single-Dose Vial

ENBREL Single-Dose Vial

Single-Dose Vial

  • Does not contain natural rubber latex for patients with sensitivities
  • Option for pediatric patients with moderate to severe plaque PsO or JIA who weigh less than 68 lb
  • Medicine is injected manually which allows control of injection speed
  • Does not need to be mixed or prepared
  • Syringes and needles are required and are not supplied with the single-dose vial
  • State laws determine if prescriptions are needed for injection materials, and therefore, HCPs are encouraged to provide a separate prescription for the recommended injection materials. See recommended materials below

See How It Works

ENBREL Single-Dose Vial ENBREL Single-Dose Vial

When using the ENBREL single-dose vial, administer the correct dose of solution using the following recommended materials:

  • A 1 mL Luer-Lock syringe
  • A withdrawal needle with Luer-Lock connection, sterile, 22-gauge, length 1 1/2 inch
  • An injection needle with Luer-Lock connection, sterile, 27-gauge, length 1/2 inch

Two vials may be required to administer the total prescribed dose. Use the same syringe for each vial. The vial does not contain preservatives; therefore discard unused portions.

See How It Works

ENBREL Single-Dose Vial ENBREL Single-Dose Vial

When using the ENBREL single-dose vial, administer the correct dose of solution using the following recommended materials:

  • A 1 mL Luer-Lock syringe
  • A withdrawal needle with Luer-Lock connection, sterile, 22-gauge, length 1 1/2 inch
  • An injection needle with Luer-Lock connection, sterile, 27-gauge, length 1/2 inch

Two vials may be required to administer the total prescribed dose. Use the same syringe for each vial. The vial does not contain preservatives; therefore discard unused portions.

Administration

AutoTouch Connect™ Autoinjector

Enbrel Mini® with AutoTouch® is still available for existing patients. Click here for more information.

  • Bluetooth® Technology—lets patients automatically track their injection when they pair with the Embark® App 1*
  • Injection Progress Confidence—audiovisual prompts help give patients confidence that they completed their ENBREL injection 1
  • One-Handed Injection—patients can inject with one hand, without the need to pinch or stretch their skin with the other hand 1
  • Speed Control—patients can choose from 1 of 3 injection speeds based on their comfort level 1
  • Hidden-Needle Design 1

See the user manual here.

The Embark® App is designed to support your patient's ENBREL experience. They will get access to ENBREL Support®, medication reminders, injection site tracking, and more. Learn more

Your patients can download the Embark® App for free on the App Store or Google Play.

* The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Amgen is under license.

See How It Works

A video of the Enbrel Mini® cartridge with AutoTouch® Autoinjector A video of the Enbrel Mini® cartridge with AutoTouch® Autoinjector
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A Rheumatologist’s Experience
A video of a rheumatologist sharing her experience with an Enbrel® (etanercept) injection device A video of a rheumatologist sharing her experience with an Enbrel® (etanercept) injection device
 
PEDIATRIC RESTRICTIONS

Not for use for children with moderate to severe plaque psoriasis (PsO) or juvenile idiopathic arthritis (JIA) who weigh less than 138 lb.

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Lower mean injection site pain

All administration options include a phosphate-free ENBREL formulation that resulted in statistically significant lower mean injection site pain vs the prior formulation. 2†

Multicenter, randomized, double-blind crossover study in 111 patients assessed injection site pain associated with a phosphate-free etanercept formulation in adult patients with moderate to severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA). Eligible patients were randomly assigned to start with the prior or phosphate-free formulation of ENBREL 50 mg weekly (QW). Randomization was stratified by disease. Subjects injected the blinded treatment and immediately recorded the associated injection site pain using the visual analog scale (VAS), from “0, No Pain At All” to “100, Worst Pain Imaginable.” Primary endpoint was change in injection site pain score (results showed reduction in mean injection site pain by a score of 4.0 mm [P=0.05] between prior and phosphate-free formulations as measured by VAS).

SureClick® Autoinjector

50 mg

SureClick® Autoinjector

  • Designed so patients do not see the needle
  • Medicine is injected automatically
  • Does not need to be mixed or prepared

See How It Works

SureClick® Autoinjector Video SureClick® Autoinjector Video
View Reference Guide play-teal
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PEDIATRIC RESTRICTIONS

Not for use for children with moderate to severe plaque PsO or JIA who weigh less than 138 lb.

See How It Works

SureClick® Autoinjector Video SureClick® Autoinjector Video SureClick® Autoinjector Video
View Reference Guide play-teal View free-hand method play-teal eou-green

PEDIATRIC RESTRICTIONS

Not for use for children with moderate to severe plaque PsO or JIA who weigh less than 138 lb.

​ ​
Prefilled syringe containing ENBREL Prefilled syringe containing ENBREL

Prefilled syringe containing ENBREL Prefilled syringe containing ENBREL

Prefilled Syringe

  • Medicine is injected manually which allows control of injection speed
  • Does not need to be mixed or prepared

See How It Works

A video on how to use a prefilled syringe containing ENBREL A video on how to use a prefilled syringe containing ENBREL
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PEDIATRIC RESTRICTIONS

The 25 mg syringe is not for use for children with moderate to severe plaque PsO or JIA who weigh less than 68 lb.

The 50 mg syringe is not for use for children with moderate to severe plaque PsO or JIA who weigh less than 138 lb.

See How It Works

A video on how to use a prefilled syringe containing ENBREL A video on how to use a prefilled syringe containing ENBREL
eou-green

PEDIATRIC RESTRICTIONS

The 25 mg syringe is not for use for children with moderate to severe plaque PsO or JIA who weigh less than 68 lb.

The 50 mg syringe is not for use for children with moderate to severe plaque PsO or JIA who weigh less than 138 lb.

​ ​
ENBREL Single-Dose Vial

ENBREL Single-Dose Vial

Single-Dose Vial

  • Does not contain natural rubber latex for patients with sensitivities
  • Option for pediatric patients with moderate to severe plaque PsO or JIA who weigh less than 68 lb
  • Medicine is injected manually which allows control of injection speed
  • Does not need to be mixed or prepared
  • Syringes and needles are required and are not supplied with the single-dose vial
  • State laws determine if prescriptions are needed for injection materials, and therefore, HCPs are encouraged to provide a separate prescription for the recommended injection materials. See recommended materials below

See How It Works

ENBREL Single-Dose Vial ENBREL Single-Dose Vial

When using the ENBREL single-dose vial, administer the correct dose of solution using the following recommended materials:

  • A 1 mL Luer-Lock syringe
  • A withdrawal needle with Luer-Lock connection, sterile, 22-gauge, length 1 1/2 inch
  • An injection needle with Luer-Lock connection, sterile, 27-gauge, length 1/2 inch

Two vials may be required to administer the total prescribed dose. Use the same syringe for each vial. The vial does not contain preservatives; therefore discard unused portions.

See How It Works

ENBREL Single-Dose Vial ENBREL Single-Dose Vial

When using the ENBREL single-dose vial, administer the correct dose of solution using the following recommended materials:

  • A 1 mL Luer-Lock syringe
  • A withdrawal needle with Luer-Lock connection, sterile, 22-gauge, length 1 1/2 inch
  • An injection needle with Luer-Lock connection, sterile, 27-gauge, length 1/2 inch

Two vials may be required to administer the total prescribed dose. Use the same syringe for each vial. The vial does not contain preservatives; therefore discard unused portions.

In clinical trials, all injection site reactions were described as mild to moderate (erythema, itching, pain, swelling, bleeding, bruising) and generally did not necessitate drug discontinuation. The mean duration of injection site reactions was 3 to 5 days. 3

Dosing

Moderate to Severe Rheumatoid Arthritis

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For adult patients, the recommended dose of ENBREL is 50 mg weekly: 3*

* MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL.

Psoriatic Arthritis

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For adult patients, the recommended dose of ENBREL is 50 mg weekly: 3*

* MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL.

Moderate to Severe Plaque Psoriasis

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For adult patients, step-down dosing is recommended: 3

  • Starting Dose: ENBREL 50 mg twice weekly for 3 months *
  • Maintenance Dose: ENBREL 50 mg once weekly after 3 months
  • Starting doses of ENBREL 25 mg or 50 mg per week were also shown to be efficacious

For pediatric patients ages 4-17, the recommended dosing is weight-based: 3†

  • 138 lb or more: 50 mg once weekly
  • Less than 138 lb: 0.8 mg/kg once weekly

* MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL.

Higher doses of ENBREL have not been studied in pediatric patients.

Ankylosing Spondylitis

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For adult patients, the recommended dose of ENBREL is 50 mg weekly: 3*

* MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL.

Moderate to Severe Polyarticular Juvenile Idiopathic Arthritis

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For JIA patients ages 2 and older, the recommended dosing is weight-based: 3*

  • 138 lb or more: 50 mg once weekly
  • Less than 138 lb: 0.8 mg/kg once weekly

* Higher doses of ENBREL have not been studied in pediatric patients.

Glucocorticoids, NSAIDs, or analgesics may be continued during treatment with ENBREL.

No routine laboratory monitoring for ENBREL required 3

Concomitant medications or comorbidities may require laboratory monitoring.
See Important Safety Information for additional treatment considerations. 3

Storage Guidelines for ENBREL

Enbrel Mini® Cartridge with AutoTouch Connect™ Autoinjector

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Temperature
  • Store Enbrel Mini®, the prefilled cartridge which contains ENBREL, in the refrigerator between 36°F to 46°F (2°C to 8°C)
  • If needed, Enbrel Mini® cartridge may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days
    • Discard Enbrel Mini® cartridge that has been stored at room temperature for more than 14 days
  • Enbrel Mini® cartridge should not be returned to the refrigerator after it has reached room temperature
  • Do not store Enbrel Mini® cartridge in extreme heat or cold. Do not freeze
  • Do not store AutoTouch Connect™ Autoinjector in the refrigerator
Exposure to Light
  • Store Enbrel Mini® cartridge in the original carton to protect from light or damage
Shaking
  • Do not shake ENBREL

SureClick® Autoinjector

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Temperature
  • Store SureClick® autoinjector in the refrigerator at 36°F to 46°F (2°C to 8°C)
  • If needed, SureClick® autoinjector may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days
    • Discard SureClick® autoinjector that has been stored at room temperature for more than 14 days
  • SureClick® autoinjector should not be returned to the refrigerator after it has reached room temperature
  • Do not store the SureClick® autoinjector in extreme heat or cold. Do not freeze
Exposure to Light
  • Store SureClick® autoinjector in the original carton to protect from light or physical damage
Shaking
  • Do not shake ENBREL

Prefilled Syringe

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Temperature
  • Store ENBREL prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C)
  • If needed, ENBREL prefilled syringe may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days
    • Discard ENBREL prefilled syringe that has been stored at room temperature for more than 14 days
  • ENBREL prefilled syringe should not be returned to the refrigerator after it has reached room temperature
  • Do not store the ENBREL prefilled syringe in extreme heat or cold. Do not freeze
Exposure to Light
  • Store ENBREL prefilled syringe in the original carton to protect from light or physical damage
Shaking
  • Do not shake ENBREL

Single-Dose Vial

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Temperature
  • Store the ENBREL single-dose vial in the refrigerator between 36°F to 46°F (2°C to 8°C)
  • If needed, ENBREL single-dose vial may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days
    • Discard ENBREL single-dose vial that has been stored at room temperature after 14 days
  • Do not store the ENBREL single-dose vial in extreme heat or cold. Do not freeze
Exposure to Light
  • Store ENBREL single-dose vial in the original carton to protect from light or physical damage
Shaking
  • Do not shake ENBREL

Prescription Enbrel® (etanercept) is administered by injection.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

SERIOUS INFECTIONS

Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. 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. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. 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 TB in patients who tested negative for latent TB prior to initiating therapy.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL.

In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA patients. The role of TNF blocker therapy in the development of malignancies is unknown.

Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population.

Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Pediatric Patients

In patients who initiated therapy at ≤18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin's and non-Hodgkin's lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

NEUROLOGIC REACTIONS

Treatment with TNF-blocking agents, including ENBREL, has been 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-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

CONGESTIVE HEART FAILURE

Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored.

HEMATOLOGIC REACTIONS

Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed.

HEPATITIS B REACTIVATION

Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ENBREL. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation. Exercise caution when considering ENBREL in these patients.

ALLERGIC REACTIONS

Allergic reactions associated with administration of ENBREL during clinical trials have been reported in <2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated.

IMMUNIZATIONS

Live vaccines should not be administered to patients on ENBREL. Pediatric patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, temporarily discontinue ENBREL and consider prophylactic treatment with Varicella Zoster Immune Globulin.

AUTOIMMUNITY

Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops.

USE IN GRANULOMATOSIS WITH POLYANGIITIS PATIENTS

The use of ENBREL in patients with granulomatosis with polyangiitis receiving immunosuppressive agents (eg, cyclophosphamide) is not recommended.

MODERATE TO SEVERE ALCOHOLIC HEPATITIS

Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate to severe alcoholic hepatitis.

ADVERSE REACTIONS

The most commonly reported adverse reactions in RA clinical trials were injection site reaction and infection. In clinical trials of all other adult indications, adverse reactions were similar to those reported in RA clinical trials.

In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population.

DRUG INTERACTIONS

The use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrent therapy with ENBREL and anakinra is not recommended. Hypoglycemia has been reported following initiation of ENBREL therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.

Please see Prescribing Information and Medication Guide.

INDICATIONS

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. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.

ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used with or without MTX.

ENBREL is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.

IMPORTANT SAFETY INFORMATION AND INDICATIONS: SERIOUS INFECTIONS

Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. 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. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy.