Enbrel 25mg/0.5ml Inj (4 Vials)
WARNING: Severe infections have happened in patients who take this drug. Some of these have led to treatment in a hospital or death. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this drug. You may also be tested for TB while you take this drug.Lymphoma and other cancers have happened in people who take this drug or drugs like it. This has been deadly in some cases. Talk with the doctor. @ COMMON USES: It is used to treat some types of arthritis.It is used to treat ankylosing spondylitis.It is used to treat plaque psoriasis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Disease-modifying antirheumatic drug (DMARD)
Pharmacologic Class
Tumor Necrosis Factor (TNF) Blocker
Pregnancy Category
Not assigned (Pregnancy Registry available)
FDA Approved
Nov 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Enbrel is a medicine that helps reduce inflammation in your body. It works by blocking a protein called TNF, which can cause swelling and damage in conditions like rheumatoid arthritis, psoriatic arthritis, and psoriasis. It's given as an injection under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically in the thigh, belly area, or upper arm. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after use, wash your hands thoroughly. To minimize discomfort, remove the medication from the refrigerator and let it sit at room temperature for at least 30 minutes before injection. Do not remove the cap or cover, heat the medication, or shake the container.
When administering the injection, rotate the injection site with each use. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Additionally, do not inject within 2 inches (5 cm) of the belly button.
Before use, inspect the solution for any visible particles or changes in color. Do not use the medication if the solution is cloudy, leaking, or contains large lumps, flakes, or other particles. If you notice any changes in the solution's appearance, do not use it.
After use, dispose of needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in a refrigerator at all times, unless otherwise directed. If needed, you may store the medication at room temperature for up to 30 days. Be sure to record the date you remove the medication from the refrigerator. If the medication is not used within 30 days of being stored at room temperature, discard it. Do not return the medication to the refrigerator after it has been stored at room temperature.
Keep the medication in its original container, protected from light.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you are unsure about what to do in the event of a missed dose, consult your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically in the thigh, belly area, or upper arm. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after use, wash your hands thoroughly. To minimize discomfort, remove the medication from the refrigerator and let it sit at room temperature for at least 30 minutes before injection. Do not remove the cap or cover, heat the medication, or shake the container.
When administering the injection, rotate the injection site with each use. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Additionally, do not inject within 2 inches (5 cm) of the belly button.
Before use, inspect the solution for any visible particles or changes in color. Do not use the medication if the solution is cloudy, leaking, or contains large lumps, flakes, or other particles. If you notice any changes in the solution's appearance, do not use it.
After use, dispose of needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in a refrigerator at all times, unless otherwise directed. If needed, you may store the medication at room temperature for up to 30 days. Be sure to record the date you remove the medication from the refrigerator. If the medication is not used within 30 days of being stored at room temperature, discard it. Do not return the medication to the refrigerator after it has been stored at room temperature.
Keep the medication in its original container, protected from light.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you are unsure about what to do in the event of a missed dose, consult your doctor.
Lifestyle & Tips
- Avoid live vaccines (e.g., measles, mumps, rubella, chickenpox) while on Enbrel and for a period after stopping, as your immune system may be weakened.
- Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
- Inform your healthcare provider that you are taking Enbrel before any surgery or dental procedures.
- Discuss any new or worsening medical conditions, especially heart problems or nervous system disorders, with your doctor.
- Store Enbrel in the refrigerator and protect from light. Do not freeze.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg once weekly (subcutaneous injection)
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA):
50 mg once weekly or 25 mg twice weekly
Psoriatic Arthritis (PsA):
50 mg once weekly or 25 mg twice weekly
Ankylosing Spondylitis (AS):
50 mg once weekly or 25 mg twice weekly
Plaque Psoriasis (PsO):
50 mg twice weekly for 3 months, then 50 mg once weekly
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA): 0.8 mg/kg (up to 50 mg) once weekly. Plaque Psoriasis (PsO) (âĨ4 years): 0.8 mg/kg (up to 50 mg) once weekly.
Adolescent:
Juvenile Idiopathic Arthritis (JIA): 0.8 mg/kg (up to 50 mg) once weekly. Plaque Psoriasis (PsO) (âĨ4 years): 0.8 mg/kg (up to 50 mg) once weekly.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; not renally cleared
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended; use with caution due to limited data
Pharmacology
Mechanism of Action
Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. It binds specifically to tumor necrosis factor (TNF)-alpha and blocks its interaction with cell surface TNF receptors, thereby inhibiting TNF-alpha activity. TNF-alpha is a naturally occurring cytokine involved in normal inflammatory and immune responses. Elevated levels of TNF-alpha are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and in psoriatic plaques. Etanercept also modulates biological responses that are induced or regulated by TNF, including the expression of adhesion molecules and the production of other cytokines.
Pharmacokinetics
Absorption:
Bioavailability:
58-63% (subcutaneous)
Tmax:
48-72 hours
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 7.6 L
ProteinBinding:
Not applicable (biologic, not typically protein bound in the same manner as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 70-102 hours (range 70-300 hours)
Clearance:
Approximately 160 mL/hr
ExcretionRoute:
Primarily via protein catabolism; not renally or hepatically excreted in the traditional sense
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks for some indications (e.g., RA), but full effect may take longer (e.g., 3 months for psoriasis).
PeakEffect:
Variable depending on indication and patient response, often within 3 months.
DurationOfAction:
Effects persist for the duration of weekly dosing due to long half-life.
Safety & Warnings
BLACK BOX WARNING
Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include: active tuberculosis (TB), including reactivation of latent TB; invasive fungal infections, including histoplasmosis, coccidioidomycosis, or pneumocystosis; and bacterial, viral, and other infections due to opportunistic pathogens. ENBREL should be discontinued if a patient develops a serious infection. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including ENBREL.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Confusion
Pale skin
Red, scaly patches or pus-filled bumps on the skin
Skin lumps or growths
Swollen glands
Night sweats
Shortness of breath
Unintentional weight loss
If you experience any of the following symptoms, contact your doctor immediately, as they may indicate severe liver problems:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Rarely, people taking this medication have experienced nervous system problems, which can be permanent. Seek medical help right away if you experience:
Abnormal burning, numbness, or tingling sensations
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
This medication can cause heart failure or worsen existing heart disease. If you have a history of heart disease, inform your doctor. Seek immediate medical attention if you experience:
Shortness of breath
Sudden weight gain
Irregular heartbeat
New or worsening swelling in the arms or legs
In rare cases, this medication can cause bone marrow and blood problems, including a potentially life-threatening condition called aplastic anemia. Contact your doctor right away if you experience:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Purple spots on the skin
Feeling extremely tired or weak
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Irritation at the injection site
Diarrhea
Headache
* Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Confusion
Pale skin
Red, scaly patches or pus-filled bumps on the skin
Skin lumps or growths
Swollen glands
Night sweats
Shortness of breath
Unintentional weight loss
If you experience any of the following symptoms, contact your doctor immediately, as they may indicate severe liver problems:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Rarely, people taking this medication have experienced nervous system problems, which can be permanent. Seek medical help right away if you experience:
Abnormal burning, numbness, or tingling sensations
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
This medication can cause heart failure or worsen existing heart disease. If you have a history of heart disease, inform your doctor. Seek immediate medical attention if you experience:
Shortness of breath
Sudden weight gain
Irregular heartbeat
New or worsening swelling in the arms or legs
In rare cases, this medication can cause bone marrow and blood problems, including a potentially life-threatening condition called aplastic anemia. Contact your doctor right away if you experience:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Purple spots on the skin
Feeling extremely tired or weak
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Irritation at the injection site
Diarrhea
Headache
* Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: persistent fever, chills, cough, shortness of breath, flu-like symptoms, warm/red/painful skin, diarrhea, unusual fatigue.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Signs of heart failure: new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain.
- Signs of nervous system problems: numbness, tingling, vision changes, weakness in arms or legs, seizures.
- Signs of blood problems: easy bruising or bleeding, persistent fever, pale skin.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have been diagnosed with granulomatosis with polyangiitis.
If you have a blood infection or any other severe infection.
If you are currently taking abatacept or anakinra.
* If you are taking cyclophosphamide.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication alongside your other treatments and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have been diagnosed with granulomatosis with polyangiitis.
If you have a blood infection or any other severe infection.
If you are currently taking abatacept or anakinra.
* If you are taking cyclophosphamide.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication alongside your other treatments and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
As this medication may increase your risk of developing an infection, it is crucial to practice good hygiene by washing your hands frequently. Avoid close contact with individuals who have infections, colds, or flu to minimize your exposure.
Before receiving any vaccinations, consult with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication. Ensure you are up to date with all recommended vaccinations before starting treatment with this drug. Additionally, do not receive live vaccines, such as the BCG vaccine for bladder cancer, while taking this medication, and discuss any concerns with your doctor.
If you have diabetes, it is vital to closely monitor your blood sugar levels, as this medication may affect them.
There is an increased risk of developing skin cancer with this medication. To minimize this risk, avoid excessive sun exposure, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear to shield yourself from the sun. Regular skin checks are also recommended, and you should inform your doctor of any skin changes, such as new warts, sores, or moles, or any changes in the size or color of existing moles.
If you have a history of hepatitis B or are a carrier of the virus, discuss the potential risks with your doctor, as this medication can cause the virus to become active, leading to severe and potentially life-threatening liver problems. Your doctor will likely recommend regular hepatitis B testing.
Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects. Similarly, children should be treated with caution, as they may have a higher risk of certain side effects. If your child is taking this medication and experiences any weight changes, consult with your doctor, as the dosage may need to be adjusted.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor. If you took this medication during pregnancy, be sure to inform your baby's doctor.
As this medication may increase your risk of developing an infection, it is crucial to practice good hygiene by washing your hands frequently. Avoid close contact with individuals who have infections, colds, or flu to minimize your exposure.
Before receiving any vaccinations, consult with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication. Ensure you are up to date with all recommended vaccinations before starting treatment with this drug. Additionally, do not receive live vaccines, such as the BCG vaccine for bladder cancer, while taking this medication, and discuss any concerns with your doctor.
If you have diabetes, it is vital to closely monitor your blood sugar levels, as this medication may affect them.
There is an increased risk of developing skin cancer with this medication. To minimize this risk, avoid excessive sun exposure, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear to shield yourself from the sun. Regular skin checks are also recommended, and you should inform your doctor of any skin changes, such as new warts, sores, or moles, or any changes in the size or color of existing moles.
If you have a history of hepatitis B or are a carrier of the virus, discuss the potential risks with your doctor, as this medication can cause the virus to become active, leading to severe and potentially life-threatening liver problems. Your doctor will likely recommend regular hepatitis B testing.
Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects. Similarly, children should be treated with caution, as they may have a higher risk of certain side effects. If your child is taking this medication and experiences any weight changes, consult with your doctor, as the dosage may need to be adjusted.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor. If you took this medication during pregnancy, be sure to inform your baby's doctor.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials.
- Higher doses may theoretically increase the risk of adverse effects, particularly infections.
What to Do:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, oral polio, BCG)
- Patients with active serious infections
Major Interactions
- Anakinra (Kineret): Increased risk of serious infection and neutropenia; concomitant use not recommended.
- Abatacept (Orencia): Increased risk of serious infection; concomitant use not recommended.
- Cyclophosphamide: Increased risk of malignancy (e.g., non-melanoma skin cancer) when used concomitantly with etanercept in Wegener's granulomatosis patients (not an approved indication for etanercept).
Moderate Interactions
- Other immunosuppressants (e.g., methotrexate, corticosteroids): May increase risk of infection, but often used concomitantly in clinical practice under close monitoring.
- Vaccines (non-live): May result in a diminished immune response to vaccination.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD or IGRA)
Rationale: To rule out latent or active TB infection, as TNF blockers can reactivate latent TB.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg, anti-HBc)
Rationale: To rule out active or chronic HBV infection, as TNF blockers can reactivate HBV.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematologic parameters and identify pre-existing cytopenias.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) (ALT, AST, bilirubin)
Rationale: To establish baseline liver function.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: Continuously (patient education)
Target: Absence of fever, cough, malaise, localized pain/redness
Action Threshold: Any new or worsening signs/symptoms of infection; prompt medical evaluation required.
Complete Blood Count (CBC) with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant cytopenias (e.g., persistent neutropenia, thrombocytopenia, pancytopenia) may require dose interruption or discontinuation.
Liver Function Tests (LFTs)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant elevations (e.g., >3x ULN) may require dose interruption or discontinuation.
Signs and symptoms of heart failure
Frequency: Continuously (patient education)
Target: Absence of dyspnea, edema, rapid weight gain
Action Threshold: New or worsening heart failure symptoms; prompt medical evaluation required.
Signs and symptoms of demyelinating disease
Frequency: Continuously (patient education)
Target: Absence of numbness, tingling, vision changes, weakness
Action Threshold: New onset or worsening neurological symptoms suggestive of demyelinating disease; prompt medical evaluation required.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, skin lesions, diarrhea, fatigue)
- Signs of malignancy (e.g., unexplained weight loss, persistent lymphadenopathy, new skin lesions)
- Signs of heart failure (e.g., worsening shortness of breath, swelling of ankles/feet, sudden weight gain)
- Signs of demyelinating disease (e.g., numbness, tingling, vision changes, weakness in limbs)
- Signs of allergic reactions (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Signs of hematologic abnormalities (e.g., easy bruising, bleeding, persistent fever, pallor)
Special Patient Groups
Pregnancy
Etanercept is not assigned a traditional FDA pregnancy category. A pregnancy exposure registry is available. Limited data from the registry and postmarketing reports suggest no increased risk of major birth defects or miscarriage. However, due to its mechanism of action, etanercept may cross the placenta, particularly in the third trimester. Consider the potential risks and benefits.
Trimester-Specific Risks:
First Trimester:
Limited data, no clear evidence of increased risk of major birth defects.
Second Trimester:
Limited data, no clear evidence of increased risk.
Third Trimester:
Increased placental transfer in the third trimester. Infants exposed to etanercept in utero may have an increased risk of infection, particularly if live vaccines are administered. Live vaccines should be deferred for at least 6 months after birth.
Lactation
Etanercept is present in human milk at low concentrations. The amount absorbed by a breastfed infant is expected to be very low due to its large molecular weight and susceptibility to degradation in the infant's gastrointestinal tract. Clinical data suggest that adverse effects in breastfed infants are unlikely. Breastfeeding is generally considered compatible with etanercept use, but caution is advised.
Infant Risk:
L3 (Moderately Safe - Limited controlled studies show no adverse effects, or risk is minimal)
Pediatric Use
Approved for Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years and older, and for Plaque Psoriasis in patients aged 4 years and older. Increased risk of serious infections and malignancies (lymphoma and other malignancies) has been reported in children and adolescents treated with TNF blockers, including Enbrel. Close monitoring is essential.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. The incidence of serious infections was higher in patients 65 years of age and older. Use with caution and monitor closely for infections.
Clinical Information
Clinical Pearls
- Etanercept is a biologic agent and should not be considered interchangeable with biosimilars without careful consideration and prescriber approval.
- Patients should be thoroughly screened for latent tuberculosis and hepatitis B before initiating therapy and monitored during treatment.
- Educate patients on proper injection technique and storage, emphasizing refrigeration and protection from light.
- Stress the importance of reporting any signs of infection immediately, as serious infections can occur.
- Live vaccines are contraindicated during Enbrel therapy and for a period after discontinuation. Non-live vaccines may have a diminished response.
- Consider the risk of malignancy, particularly in pediatric patients, and discuss with patients/parents.
- Etanercept has a relatively long half-life, allowing for once-weekly dosing for most indications, which can improve adherence.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., Adalimumab, Infliximab, Golimumab, Certolizumab pegol)
- Other biologic DMARDs with different mechanisms of action (e.g., Abatacept, Rituximab, Tocilizumab, Ustekinumab, Secukinumab, Ixekizumab, Tofacitinib, Baricitinib, Upadacitinib)
- Conventional synthetic DMARDs (e.g., Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide)
- Corticosteroids (for acute symptom control)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per 4 vials (25mg/0.5ml)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.