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Enbrel 50 mg Solution For Injection In Pre-Filled Pen

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FULL PRESCRIBING INFORMATION: CONTENTS*

WARNINGS: SERIOUS INFECTIONS AND MALIGNANCIES

1 INDICATIONS AND USAGE

1.1 Rheumatoid Arthritis

1.2 Polyarticular Juvenile Idiopathic Arthritis

1.3 Psoriatic Arthritis

1.4 Ankylosing Spondylitis

1.5 Plaque Psoriasis

2 DOSAGE AND ADMINISTRATION

2.1 Adult Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Patients

2.2 Adult Plaque Psoriasis Patients

2.3 JIA Patients

2.4 Preparation of Enbrel

2.5 Monitoring to Assess Safety

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

5.2 Neurologic Events

5.3 Malignancies

5.4 Patients With Heart Failure

5.5 Hematologic Events

5.6 Hepatitis B Reactivation

5.7 Allergic Reactions

5.8 Immunizations

5.9 Autoimmunity

5.10 Immunosuppression

5.11 Use in Wegener’s Granulomatosis Patients

5.12 Use with Anakinra or Abatacept

5.13 Use in Patients with Moderate to Severe Alcoholic Hepatitis

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Vaccines

7.2 Immune-Modulating Biologic Products

7.3 Cyclophosphamide

7.4 Sulfasalazine

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Use in Diabetics

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Adult Rheumatoid Arthritis

14.2 Polyarticular Juvenile Idiopathic Arthritis (JIA)

14.3 Psoriatic Arthritis

14.4 Ankylosing Spondylitis

14.5 Plaque Psoriasis

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 Enbrel Single-use Prefilled Syringe and Enbrel Single-use Prefilled SureClick Autoinjector

16.2 Enbrel Multiple-use Vial (Recommended for Weight-based Dosing)

17 PATIENT COUNSELING INFORMATION

See Medication Guide

17.1 Patient Counseling

17.2 Administration of Enbrel

*Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

WARNINGS: SERIOUS INFECTIONS AND MALIGNANCIES

SERIOUS INFECTIONS

Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Enbrel should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Enbrel use and during therapy. Treatment for latent infection should be initiated prior to Enbrel use.
  • 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 anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
  • 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 with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel.

1 INDICATIONS AND USAGE

1.1 Rheumatoid Arthritis

Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone.

1.2 Polyarticular Juvenile Idiopathic Arthritis

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

1.3 Psoriatic Arthritis

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 (PsA). Enbrel can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone.

1.4 Ankylosing Spondylitis

Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

1.5 Plaque Psoriasis

Enbrel is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

2 DOSAGE AND ADMINISTRATION

Table 1. Dosing and Administration for Adult Patients

 Patient Population

Recommended Dosage Strength and Frequency

 Adult RA, AS, and PsA Patients

50 mg weekly

 Adult PsO Patients

Starting Dose: 50 mg twice weekly for 3 months

Maintenance Dose: 50 mg once weekly

See the Enbrel (etanercept) “Instructions for Use” insert for detailed information on injection site selection and dose administration.

2.1 Adult Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Patients

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

Based on a study of 50 mg Enbrel twice weekly in patients with RA that suggested higher incidence of adverse reactions but similar American College of Rheumatology (ACR) response rates, doses higher than 50 mg per week are not recommended.

2.2 Adult Plaque Psoriasis Patients

In addition to the 50 mg twice weekly recommended starting dose, starting doses of 25 mg or 50 mg per week were shown to be efficacious. The proportion of responders was related to Enbrel dosage [see Clinical Studies (14.5)].

2.3 JIA Patients

Table 2. Dosing and Administration for Juvenile Idiopathic Arthritis

  Pediatric Patients Weight

  Recommended Dose

  63 kg (138 pounds) or more

  50 mg weekly

  Less than 63 kg (138 pounds)

  0.8 mg/kg weekly

In JIA patients, glucocorticoids, NSAIDs, or analgesics may be continued during treatment with Enbrel. Higher doses of Enbrel have not been studied in pediatric patients.

2.4 Preparation of Enbrel

Enbrel is intended for use under the guidance and supervision of a physician. Patients may self-inject when deemed appropriate and if they receive medical follow-up, as necessary. Patients should not self-administer until they receive proper training in how to prepare and administer the correct dose.

The Enbrel (etanercept) “Instructions for Use” insert for each presentation contains more detailed instructions on the preparation of Enbrel.

Preparation of Enbrel Using the Single-use Prefilled Syringe or Single-use Prefilled SureClick Autoinjector
For a more comfortable injection, leave Enbrel at room temperature for about 15 to 30 minutes before injecting.  DO NOT remove the needle cover while allowing the prefilled syringe to reach room temperature.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. There may be small white particles of protein in the solution. This is not unusual for proteinaceous solutions. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present.

When using the Enbrel single-use prefilled syringe, check to see if the amount of liquid in the prefilled syringe falls between the two purple fill level indicator lines on the syringe. If the syringe does not have the right amount of liquid, DO NOT USE THAT SYRINGE.

Preparation of Enbrel Using the Multiple-use Vial
Enbrel should be reconstituted aseptically with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol), giving a solution of 1.0 mL containing 25 mg of Enbrel.

A vial adapter is supplied for use when reconstituting the lyophilized powder.  However, the vial adapter should not be used if multiple doses are going to be withdrawn from the vial.  If the vial will be used for multiple doses, a 25‑gauge needle should be used for reconstituting and withdrawing Enbrel, and the supplied “Mixing Date:” sticker should be attached to the vial and the date of reconstitution entered.  Reconstituted solution must be refrigerated at 36°F to 46°F (2°C to 8°C) and used within 14 days.  Discard reconstituted solution after 14 days because product stability and sterility cannot be assured after 14 days. DO NOT store reconstituted Enbrel solution at room temperature.

For a more comfortable injection, leave the Enbrel dose tray at room temperature for about 15 to 30 minutes before injecting. 

If using the vial adapter, twist the vial adapter onto the diluent syringe.  Then, place the vial adapter over the Enbrel vial and insert the vial adapter into the vial stopper.  Push down on the plunger to inject the diluent into the Enbrel vial.  If using a 25‑gauge needle to reconstitute and withdraw Enbrel, the diluent should be injected very slowly into the Enbrel vial. It is normal for some foaming to occur.  Keeping the diluent syringe in place, gently swirl the contents of the Enbrel vial during dissolution.  To avoid excessive foaming, do not shake or vigorously agitate.

Generally, dissolution of Enbrel takes less than 10 minutes.  Do not use the solution if discolored or cloudy, or if particulate matter remains.

Withdraw the correct dose of reconstituted solution into the syringe.  Some foam or bubbles may remain in the vial.  Remove the syringe from the vial adapter or remove the 25‑gauge needle from the syringe.  Attach a 27‑gauge needle to inject Enbrel.

The contents of one vial of Enbrel solution should not be mixed with, or transferred into, the contents of another vial of Enbrel.  No other medications should be added to solutions containing Enbrel, and do not reconstitute Enbrel with other diluents.  Do not filter reconstituted solution during preparation or administration.

2.5 Monitoring to Assess Safety

Prior to initiating Enbrel and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection [see Warnings and Precautions (5.1)].

3 DOSAGE FORMS AND STRENGTHS

50 mg Single-use Prefilled Syringe 

0.98 mL of a 50 mg/mL solution of etanercept

50 mg Single-use Prefilled SureClick  Autoinjector

0.98 mL of a 50 mg/mL solution of etanercept

25 mg Single-use Prefilled Syringe

0.51 mL of a 50 mg/mL solution of etanercept

25 mg Multiple-use Vial

25 mg of etanercept

4 CONTRAINDICATIONS

Enbrel should not be administered to patients with sepsis.

5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

Patients treated with Enbrel are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death.

Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF blockers.  Patients have frequently presented with disseminated rather than localized disease.

Treatment with Enbrel should not be initiated in patients with an active infection, including clinically important localized infections.  Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection.  The risks and benefits of treatment should be considered prior to initiating therapy in patients:

  • With chronic or recurrent infection;
  • Who have been exposed to tuberculosis;
  • With a history of an opportunistic infection;
  • Who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or
  • With underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes [see Adverse Reactions (6.1)].

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel.

Enbrel should be discontinued if a patient develops a serious infection or sepsis.  A patient who develops a new infection during treatment with Enbrel should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.

Tuberculosis
Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving Enbrel, including patients who have previously received treatment for latent or active tuberculosis.  Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with Enbrel than with TNF-blocking monoclonal antibodies.  Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including Enbrel.  Tuberculosis has developed in patients who tested negative for latent tuberculosis prior to initiation of therapy.  Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating Enbrel and periodically during therapy.  Tests for latent tuberculosis infection may be falsely negative while on therapy with Enbrel.

Treatment of latent tuberculosis infection prior to therapy with TNF-blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy.  Induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis is needed prior to initiating Enbrel, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).

Anti-tuberculosis therapy should also be considered prior to initiation of Enbrel in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection.  Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient.

Tuberculosis should be strongly considered in patients who develop a new infection during Enbrel treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.

Invasive Fungal Infections
Cases of serious and sometimes fatal fungal infections, including histoplasmosis, have been reported with TNF blockers, including Enbrel.  For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness.  Appropriate empiric anti-fungal therapy should be considered while a diagnostic workup is being performed.  Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.  When feasible, the decision to administer empiric anti-fungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of anti-fungal therapy.  In 38 Enbrel clinical trials and 4 cohort studies in all approved indications representing 27,169 patient-years of exposure (17,696 patients) from the United States and Canada, no histoplasmosis infections were reported among patients treated with Enbrel.

5.2 Neurologic Events

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 [see Adverse Reactions (6.2)].

5.3 Malignancies

Lymphomas
In the controlled portions of clinical trials of TNF‑blocking agents, more cases of lymphoma have been observed among patients receiving a TNF blocker compared to control patients.  During the controlled portions of Enbrel trials in adult patients with RA, AS, and PsA, 2 lymphomas were observed among 3306 Enbrel‑treated patients versus 0 among 1521 control patients (duration of controlled treatment ranged from 3 to 36 months).

Among 6543 adult rheumatology (RA, PsA, AS) patients treated with Enbrel in controlled and uncontrolled portions of clinical trials, representing approximately 12,845 patient‑years of therapy, the observed rate of lymphoma was 0.10 cases per 100 patient‑years.  This was 3‑fold higher than the rate of lymphoma expected in the general U.S. population based on the Surveillance, Epidemiology, and End Results (SEER) Database.  An increased rate of lymphoma up to several-fold has been reported in the RA patient population, and may be further increased in patients with more severe disease activity.

Among 4410 adult PsO patients treated with Enbrel in clinical trials up to 36 months, representing approximately 4278 patient‑years of therapy, the observed rate of lymphoma was 0.05 cases per 100 patient‑years, which is comparable to the rate in the general population.  No cases were observed in Enbrel- or placebo-treated patients during the controlled portions of these trials.

Leukemia
Cases of acute and chronic leukemia have been reported in association with postmarketing TNF-blocker use in rheumatoid arthritis and other indications.  Even in the absence of TNF-blocker therapy, patients with rheumatoid arthritis may be at higher risk (approximately 2-fold) than the general population for the development of leukemia.

During the controlled portions of Enbrel trials, 2 cases of leukemia were observed among 5445 (0.06 cases per 100 patient-years) Enbrel-treated patients versus 0 among 2890 (0%) control patients (duration of controlled treatment ranged from 3 to 48 months).

Among 15,401 patients treated with Enbrel in controlled and open portions of clinical trials representing approximately 23,325 patient-years of therapy, the observed rate of leukemia was 0.03 cases per 100 patient-years.

Other Malignancies
Information is available from 10,953 adult patients with 17,123 patient-years and 696 pediatric patients with 1282 patient-years of experience across 45 Enbrel clinical studies.

For malignancies other than lymphoma and non-melanoma skin cancer, there was no difference in exposure-adjusted rates between the Enbrel and control arms in the controlled portions of clinical studies for all indications.  Analysis of the malignancy rate in combined controlled and uncontrolled portions of studies has demonstrated that types and rates are similar to what is expected in the general U.S. population based on the SEER database and suggests no increase in rates over time. Whether treatment with Enbrel might influence the development and course of malignancies in adults is unknown.

Melanoma and Non-melanoma skin cancer (NMSC)
Melanoma and non-melanoma skin cancer has been reported in patients treated with TNF antagonists including etanercept. 

Among 15,401 patients treated with Enbrel in controlled and open portions of clinical trials representing approximately 23,325 patient-years of therapy, the observed rate of melanoma was 0.043 cases per 100 patient-years.

Among 3306 adult rheumatology (RA, PsA, AS) patients treated with Enbrel in controlled clinical trials representing approximately 2669 patient‑years of therapy, the observed rate of NMSC was 0.41 cases per 100 patient‑years vs 0.37 cases per 100 patient-years among 1521 control-treated patients representing 1077 patient-years.  Among 1245 adult psoriasis patients treated with Enbrel in controlled clinical trials, representing approximately 283 patient‑years of therapy, the observed rate of NMSC was 3.54 cases per 100 patient-years vs 1.28 cases per 100 patient-years among 720 control-treated patients representing 156 patient-years. 

Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel.

Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Pediatric Patients
Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy at ≤ 18 years of age), including Enbrel.  Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma.  The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents.  The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months).  Most of the patients were receiving concomitant immunosuppressants.  These cases were reported postmarketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports.

In clinical trials of 1140 pediatric patients representing 1927.2 patient-years of therapy, no malignancies, including lymphoma or NMSC, have been reported.

Postmarketing Use
In global postmarketing adult and pediatric use, lymphoma and other malignancies have been reported.

5.4 Patients With Heart Failure

Two clinical trials evaluating the use of Enbrel in the treatment of heart failure were terminated early due to lack of efficacy. One of these studies suggested higher mortality in Enbrel-treated patients compared to placebo [see Adverse Reactions (6.2)]. There have been postmarketing reports of worsening of congestive heart failure (CHF), with and without identifiable precipitating factors, in patients taking Enbrel. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known preexisting cardiovascular disease. Some of these patients have been under 50 years of age. Physicians should exercise caution when using Enbrel in patients who also have heart failure, and monitor patients carefully.

5.5 Hematologic Events

Rare (< 0.1%) reports of pancytopenia, including very rare (< 0.01%) reports of aplastic anemia, some with a fatal outcome, have been reported in patients treated with Enbrel. The causal relationship to Enbrel therapy remains unclear. Although no high-risk group has been identified, caution should be exercised in patients being treated with Enbrel who have a previous history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever, bruising, bleeding, pallor) while on Enbrel. Discontinuation of Enbrel therapy should be considered in patients with confirmed significant hematologic abnormalities.

Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 x 109/L). While neutropenic, one patient developed cellulitis that resolved with antibiotic therapy.

5.6 Hepatitis B Reactivation

Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-blocking agents, including very rare cases (< 0.01%) with Enbrel, has been reported.  In some instances, hepatitis B reactivation occurring in conjunction with TNF-blocker therapy has been fatal.  The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to hepatitis B reactivation.  Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF-blocker therapy.  Prescribers should exercise caution in prescribing TNF blockers in patients previously infected with HBV.  Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-blocker therapy to prevent HBV reactivation.  Patients previously infected with HBV and require treatment with Enbrel should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.  In patients who develop HBV reactivation, consideration should be given to stopping Enbrel and initiating anti-viral therapy with appropriate supportive treatment.  The safety of resuming Enbrel therapy after HBV reactivation is controlled is not known.  Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy in this situation.

5.7 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.

Caution: The following components contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex: the needle cover of the prefilled syringe and the needle cover within the needle cap of the SureClick autoinjector.

5.8 Immunizations

Live vaccines should not be given concurrently with Enbrel. It is recommended that pediatric patients, if possible, be brought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiating Enbrel therapy [see Drug Interactions (7.1)].

5.9 Autoimmunity

Treatment with Enbrel may result in the formation of autoantibodies [see Adverse Reactions (6.1)] and, rarely (< 0.1%), in the development of a lupus-like syndrome or autoimmune hepatitis[see Adverse Reactions (6.2)], which may resolve following withdrawal of Enbrel. If a patient develops symptoms and findings suggestive of a lupus-like syndrome or autoimmune hepatitis following treatment with Enbrel, treatment should be discontinued and the patient should be carefully evaluated.

5.10 Immunosuppression

TNF mediates inflammation and modulates cellular immune responses.  TNF-blocking agents, including Enbrel, affect host defenses against infections.  The effect of TNF inhibition on the development and course of malignancies is not fully understood.  In a study of 49 patients with RA treated with Enbrel, there was no evidence of depression of delayed‑type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations [see Warnings and Precautions (5.1, 5.3) and Adverse Reactions (6.1)].

5.11 Use in Wegener’s Granulomatosis Patients

The use of Enbrel in patients with Wegener’s granulomatosis receiving immunosuppressive agents is not recommended. In a study of patients with Wegener’s granulomatosis, the addition of Enbrel to standard therapy (including cyclophosphamide) was associated with a higher incidence of non-cut

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Enbrel 50 mg Solution For Injection In Pre-Filled Pen

  • Brand: Pfizer
  • Product Code: 8699572950022
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  • $891.00

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