Enbrel 25mg/0.5ml Inj (4 Syringes)
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
Antirheumatic, Disease-Modifying; Antipsoriatic; Immunosuppressant
Pharmacologic Class
Tumor Necrosis Factor (TNF) Blocker; Fusion Protein
Pregnancy Category
Not available
FDA Approved
Nov 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Enbrel is a medicine that helps reduce inflammation and pain in conditions like rheumatoid arthritis, psoriatic arthritis, and psoriasis. It works by blocking a natural protein in your body called TNF-alpha, which can cause inflammation. It is 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 under the skin, typically in the thigh, abdominal 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 handling the medication, wash your hands thoroughly. Do not shake the medication. Rotate the injection site with each use to avoid irritation. 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.
Inspect the solution before use; it should be clear and colorless. This product may contain small white particles, but do not use it if the solution appears cloudy, is leaking, or contains large lumps, flakes, or other particles.
To prepare the medication for use, you may need to leave it at room temperature for 30 minutes. Do not remove the cap or cover until you are ready to use it, and avoid heating the medication. If you are unsure whether your specific brand of medication requires room temperature preparation, consult your pharmacist or refer to the package insert.
Do not use the medication if it has been dropped or is damaged. Dispose of used needles and other sharp objects in a designated disposal box. Do not reuse needles or other items, and follow local regulations for disposing of the full box. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store all products in the refrigerator, but do not freeze. Keep the medication in its original container to protect it from light, and avoid exposing it to extremely hot or cold temperatures.
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 extra doses. If you are unsure about what to do in the event of a missed dose, contact 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 under the skin, typically in the thigh, abdominal 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 handling the medication, wash your hands thoroughly. Do not shake the medication. Rotate the injection site with each use to avoid irritation. 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.
Inspect the solution before use; it should be clear and colorless. This product may contain small white particles, but do not use it if the solution appears cloudy, is leaking, or contains large lumps, flakes, or other particles.
To prepare the medication for use, you may need to leave it at room temperature for 30 minutes. Do not remove the cap or cover until you are ready to use it, and avoid heating the medication. If you are unsure whether your specific brand of medication requires room temperature preparation, consult your pharmacist or refer to the package insert.
Do not use the medication if it has been dropped or is damaged. Dispose of used needles and other sharp objects in a designated disposal box. Do not reuse needles or other items, and follow local regulations for disposing of the full box. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store all products in the refrigerator, but do not freeze. Keep the medication in its original container to protect it from light, and avoid exposing it to extremely hot or cold temperatures.
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 extra doses. If you are unsure about what to do in the event of a missed dose, contact your doctor.
Lifestyle & Tips
- Avoid live vaccines while on Enbrel.
- Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
- Inform your doctor if you have a history of tuberculosis, hepatitis B, or heart failure.
- Store Enbrel in the refrigerator; do not freeze. Protect from light.
- Do not shake the syringe.
- Rotate injection sites to avoid skin reactions.
- Follow proper injection technique as instructed by your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS): 50 mg subcutaneous (SC) once weekly OR 25 mg SC twice weekly (72-96 hours apart). For Plaque Psoriasis (PsO): 50 mg SC twice weekly for 3 months, then 50 mg SC once weekly.
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
Rheumatoid Arthritis:
50 mg SC once weekly or 25 mg SC twice weekly
Psoriatic Arthritis:
50 mg SC once weekly or 25 mg SC twice weekly
Ankylosing Spondylitis:
50 mg SC once weekly or 25 mg SC twice weekly
Plaque Psoriasis:
Initial: 50 mg SC twice weekly for 3 months; Maintenance: 50 mg SC once weekly
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (approved for ages 4 and older)
Child:
For Polyarticular Juvenile Idiopathic Arthritis (JIA) (ages 4 and older): 0.8 mg/kg SC once weekly (maximum 50 mg/week). For Pediatric Plaque Psoriasis (ages 4 and older): 0.8 mg/kg SC once weekly (maximum 50 mg/week).
Adolescent:
For Polyarticular Juvenile Idiopathic Arthritis (JIA) (ages 4 and older): 0.8 mg/kg SC once weekly (maximum 50 mg/week). For Pediatric Plaque Psoriasis (ages 4 and older): 0.8 mg/kg SC once weekly (maximum 50 mg/week).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Dialysis:
No specific recommendations; Etanercept is not renally cleared.
Hepatic Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
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, preventing TNF-alpha from binding to its cell surface receptors. This inhibits TNF-alpha-mediated cellular responses, which are involved in inflammatory and immune processes.
Pharmacokinetics
Absorption:
Bioavailability:
58-63%
Tmax:
72 hours (range 48-96 hours)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 7.6 L
ProteinBinding:
Not applicable (fusion protein, not typically protein bound in the conventional sense)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 79 hours (range 70-102 hours)
Clearance:
Not precisely quantified, primarily via degradation
ExcretionRoute:
Primarily via degradation and elimination by the reticuloendothelial system
Unchanged:
Not applicable (degraded)
Pharmacodynamics
OnsetOfAction:
Clinical response typically observed within 1-2 weeks for RA, PsA, AS; 2-3 months for PsO.
PeakEffect:
Peak clinical effect may take several weeks to months.
DurationOfAction:
Related to half-life and continued administration; effects persist as long as drug levels are maintained.
Safety & Warnings
BLACK BOX WARNING
SERIOUS INFECTIONS: 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 blastomycosis; and other bacterial, mycobacterial, and viral infections. ENBREL should be discontinued if a patient develops a serious infection or sepsis. MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including ENBREL. Postmarketing cases of leukemia have been reported in patients treated with TNF blockers. There is an increased risk of malignancies in patients with rheumatoid arthritis, a disease for which ENBREL is indicated.
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 immediately or seek 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
Liver Problems
Severe and potentially life-threatening liver problems have been associated with this medication. If you experience any of the following symptoms, contact your doctor immediately:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Nervous System Problems
Rarely, people taking this medication have experienced nervous system problems, which can be permanent. If you notice any of the following symptoms, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Heart Problems
Heart failure has been reported in people taking this medication, including those with pre-existing heart disease. If you have heart disease, inform your doctor. If you experience any of the following symptoms, contact your doctor immediately:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
New or worsening swelling in the arms or legs
Bone Marrow and Blood Problems
Rarely, this medication has been associated with bone marrow and blood problems, including a severe condition called aplastic anemia, which can be life-threatening. If you notice any of the following symptoms, contact your doctor immediately:
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 Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:
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, contact 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 immediately or seek 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
Liver Problems
Severe and potentially life-threatening liver problems have been associated with this medication. If you experience any of the following symptoms, contact your doctor immediately:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Nervous System Problems
Rarely, people taking this medication have experienced nervous system problems, which can be permanent. If you notice any of the following symptoms, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Heart Problems
Heart failure has been reported in people taking this medication, including those with pre-existing heart disease. If you have heart disease, inform your doctor. If you experience any of the following symptoms, contact your doctor immediately:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
New or worsening swelling in the arms or legs
Bone Marrow and Blood Problems
Rarely, this medication has been associated with bone marrow and blood problems, including a severe condition called aplastic anemia, which can be life-threatening. If you notice any of the following symptoms, contact your doctor immediately:
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 Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:
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, contact 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, unusual fatigue, skin sores, burning urination.
- Allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
- Heart failure: new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain.
- Neurological problems: numbness, tingling, weakness in arms/legs, vision changes, seizures.
- Blood problems: persistent fever, easy bruising or bleeding, pale skin.
- Lupus-like syndrome: new or worsening joint pain, rash on cheeks or arms, fever, fatigue.
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 symptoms you experienced.
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 with your existing health conditions and other drugs. Never start, stop, or adjust the dosage of any medication without first consulting 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 symptoms you experienced.
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 with your existing health conditions and other drugs. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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.
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, limit your exposure to sunlight, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear to shield your skin from the sun. Regular skin checks are also recommended, and you should notify your doctor immediately if you notice any changes, such as new warts, skin sores, or changes in the color or size of a mole.
If you have a history of hepatitis B or are a carrier of the virus, inform your doctor, as this medication can cause the virus to become active, leading to potentially severe and life-threatening liver problems. Your doctor will recommend hepatitis B testing, which should be done as directed.
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, planning to become pregnant, or 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.
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, limit your exposure to sunlight, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear to shield your skin from the sun. Regular skin checks are also recommended, and you should notify your doctor immediately if you notice any changes, such as new warts, skin sores, or changes in the color or size of a mole.
If you have a history of hepatitis B or are a carrier of the virus, inform your doctor, as this medication can cause the virus to become active, leading to potentially severe and life-threatening liver problems. Your doctor will recommend hepatitis B testing, which should be done as directed.
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, planning to become pregnant, or 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. The highest dose administered to patients was 60 mg/m2 intravenously, which was not associated with dose-limiting toxicities.
What to Do:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, BCG)
- Anakinra (increased risk of serious infection and neutropenia)
- Abatacept (increased risk of serious infection)
Major Interactions
- Cyclophosphamide (increased risk of malignancy, particularly non-lymphoma solid tumors)
- Other TNF blockers (increased risk of serious infection)
Moderate Interactions
- Immunosuppressants (e.g., methotrexate, corticosteroids - increased risk of infection when used concomitantly, though often used in combination for efficacy)
- Vaccines (non-live, may have reduced immune response)
Confidence Interactions
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD or IGRA)
Rationale: To rule out latent or active TB infection before initiating therapy, 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) including ALT, AST, bilirubin
Rationale: To establish baseline liver function and identify pre-existing hepatic impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, fatigue, skin lesions)
Frequency: Regularly, at each visit and patient self-monitoring
Target: Absence of new or worsening infection symptoms
Action Threshold: Prompt evaluation and potential discontinuation if serious infection develops.
Complete Blood Count (CBC) with differential
Frequency: Periodically, or as clinically indicated (e.g., if signs of cytopenia)
Target: Within normal limits
Action Threshold: Significant decrease in cell counts (e.g., neutropenia, thrombocytopenia) may warrant dose interruption or discontinuation.
Liver Function Tests (LFTs)
Frequency: Periodically, or as clinically indicated
Target: Within normal limits or stable
Action Threshold: Significant elevation (e.g., >3x ULN) may warrant dose interruption or discontinuation.
Signs and symptoms of heart failure (e.g., dyspnea, edema, rapid weight gain)
Frequency: Regularly, at each visit and patient self-monitoring
Target: Absence of new or worsening heart failure symptoms
Action Threshold: Prompt evaluation and potential discontinuation if new or worsening heart failure develops.
Signs and symptoms of demyelinating disease (e.g., numbness, tingling, vision changes, weakness)
Frequency: Regularly, at each visit and patient self-monitoring
Target: Absence of new neurological symptoms
Action Threshold: Prompt evaluation and potential discontinuation if new neurological symptoms suggestive of demyelinating disease occur.
Symptom Monitoring
- Signs of serious infection (persistent fever, chills, cough, shortness of breath, fatigue, skin lesions, diarrhea, dysuria)
- Symptoms of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Symptoms of heart failure (new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain)
- Symptoms of neurological disorders (numbness, tingling, weakness in limbs, vision changes, seizures)
- Symptoms of blood dyscrasias (persistent fever, bruising, bleeding, pallor)
- Symptoms of lupus-like syndrome (joint pain, rash, fever, fatigue)
Special Patient Groups
Pregnancy
Etanercept is not formally assigned a pregnancy category under the new FDA labeling rule. Available data from observational studies and registries have not identified a clear drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, TNF-alpha inhibitors may cross the placenta, particularly in the third trimester. Use during pregnancy should be considered only if clearly needed and the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but no clear signal of increased risk of major birth defects.
Second Trimester:
Limited data, but no clear signal of increased risk.
Third Trimester:
Increased placental transfer of IgG1 antibodies (including etanercept) occurs during the third trimester. Live vaccines should generally be deferred in infants exposed to etanercept in utero for at least 6 months after the mother's last dose.
Lactation
Etanercept is present in human milk at low levels. The effects of etanercept on the breastfed infant and on milk production are unknown. Given the large molecular weight, oral absorption by the infant is unlikely. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for etanercept and any potential adverse effects on the breastfed infant from etanercept or from the underlying maternal condition. Generally considered compatible with breastfeeding with monitoring for adverse effects.
Infant Risk:
Low risk. Monitor for signs of infection or developmental delay, though unlikely.
Pediatric Use
Approved for polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 years and older, and for pediatric plaque psoriasis in patients aged 4 years and older. Increased risk of serious infections and malignancies (lymphoma and other cancers) has been reported in children and adolescents treated with TNF blockers.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The incidence of serious infections and malignancies is generally higher in the elderly population, and caution should be exercised when treating elderly patients.
Clinical Information
Clinical Pearls
- Etanercept is a biologic agent and should be handled and administered aseptically. Patients should be trained on proper subcutaneous injection technique.
- Store Enbrel in the refrigerator (2°C to 8°C / 36°F to 46°F). Do not freeze. Protect from light. Do not shake the prefilled syringe.
- Allow the syringe to reach room temperature for 15-30 minutes before injection to reduce discomfort.
- Rotate injection sites (thigh, abdomen, upper arm) to prevent lipodystrophy or skin irritation.
- Patients should be screened for latent tuberculosis and hepatitis B before starting therapy and monitored for signs of infection throughout treatment.
- Advise patients to report any signs of infection, allergic reactions, or new neurological symptoms immediately.
- Live vaccines are contraindicated during Enbrel therapy. Non-live vaccines may be administered, but the immune response may be blunted.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., Adalimumab, Infliximab, Golimumab, Certolizumab pegol)
- Other biologics for RA/PsA/AS/PsO (e.g., Ustekinumab, Secukinumab, Ixekizumab, Guselkumab, Risankizumab, Tofacitinib, Baricitinib, Upadacitinib, Abatacept, Rituximab)
- Conventional DMARDs (e.g., Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide)
- Corticosteroids
- NSAIDs
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per 4 syringes (25mg/0.5ml)
Insurance Coverage:
Specialty Tier (Tier 4 or higher) with prior authorization and step therapy requirements common for most insurance plans.
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, which provides crucial information for patients. It is important to read this guide carefully and review it again whenever your prescription is refilled. 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.