Enbrel Mini 50mg/ml (4 Cartridges)
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 available
FDA Approved
Nov 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Etanercept is a medicine that helps reduce inflammation in the body. It works by blocking a natural protein called TNF-alpha, which can cause swelling and damage in conditions like rheumatoid arthritis, psoriatic arthritis, and psoriasis. 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, 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. 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 is cloudy, leaking, or contains large lumps, flakes, or other particles.
If necessary, remove the medication from the refrigerator and let it sit at room temperature for 30 minutes before use. Do not remove the cap or cover until you are ready to use it, and do not heat the medication. If you are unsure whether your specific brand of medication requires warming to room temperature, consult your pharmacist or refer to the package insert.
After administering the injection, check the window on the auto-injector to ensure the dose has been delivered correctly. If the window does not indicate that the dose has been given or if it appears that the medication is still being injected, contact your doctor immediately for guidance.
Do not use this 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. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store all products in the refrigerator at a temperature between 39°F and 46°F (4°C and 8°C). Do not freeze. Keep the medication in its original container to protect it from light and extreme 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 take extra doses. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
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, 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. 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 is cloudy, leaking, or contains large lumps, flakes, or other particles.
If necessary, remove the medication from the refrigerator and let it sit at room temperature for 30 minutes before use. Do not remove the cap or cover until you are ready to use it, and do not heat the medication. If you are unsure whether your specific brand of medication requires warming to room temperature, consult your pharmacist or refer to the package insert.
After administering the injection, check the window on the auto-injector to ensure the dose has been delivered correctly. If the window does not indicate that the dose has been given or if it appears that the medication is still being injected, contact your doctor immediately for guidance.
Do not use this 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. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store all products in the refrigerator at a temperature between 39°F and 46°F (4°C and 8°C). Do not freeze. Keep the medication in its original container to protect it from light and extreme 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 take extra doses. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
Lifestyle & Tips
- Store Enbrel in the refrigerator (2°C to 8°C or 36°F to 46°F). Do not freeze. Protect from light.
- Allow the prefilled syringe or auto-injector to reach room temperature for 15-30 minutes before injecting. Do not warm it in any other way.
- Rotate injection sites (thigh, abdomen, upper arm) to avoid irritation.
- Do not inject into skin that is tender, bruised, red, or hard.
- Avoid live vaccines while on Etanercept. Discuss all vaccinations with your doctor.
- Report any signs of infection (fever, chills, persistent cough, skin sores) immediately to your doctor.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
- Maintain good hygiene to reduce infection risk.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg subcutaneously once weekly
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA):
50 mg subcutaneously once weekly (or 25 mg twice weekly)
Psoriatic Arthritis (PsA):
50 mg subcutaneously once weekly (or 25 mg twice weekly)
Ankylosing Spondylitis (AS):
50 mg subcutaneously once weekly (or 25 mg twice weekly)
Plaque Psoriasis (PsO):
Initial: 50 mg subcutaneously twice weekly for 3 months, then 50 mg once weekly. Some patients may benefit from 25 mg twice weekly or 50 mg once weekly from the start.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older: 0.8 mg/kg (up to a maximum of 50 mg) subcutaneously once weekly.
Adolescent:
Polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older: 0.8 mg/kg (up to a maximum of 50 mg) subcutaneously once weekly. Plaque Psoriasis (PsO) in patients 4 years of age and older: 0.8 mg/kg (up to a maximum of 50 mg) subcutaneously once weekly.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; Etanercept is not dialyzable.
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
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 TNF-alpha and blocks its interaction with cell surface TNF receptors, thereby inhibiting the biological activity of TNF-alpha. 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 RA, PsA, and AS, and in psoriatic plaques. Etanercept also modulates biological responses that are induced or regulated by TNF, including the expression of adhesion molecules, chemokines, and cytokine production.
Pharmacokinetics
Absorption:
Bioavailability:
58-63%
Tmax:
48-72 hours (single dose)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 7.6 L
ProteinBinding:
Not applicable (fusion protein, not typically protein bound in the same way as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 102 hours (range 76-132 hours)
Clearance:
Approximately 0.11 L/hr
ExcretionRoute:
Primarily via protein degradation, not renal or hepatic excretion in the traditional sense
Unchanged:
Not applicable (biologic)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks for some indications (e.g., RA, PsA)
PeakEffect:
Typically within 3 months for full therapeutic effect
DurationOfAction:
Approximately 1 week (consistent with once-weekly dosing)
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 emergency 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 bumps filled with pus
Skin lumps or growths
Swollen glands
Night sweats
Shortness of breath
Unexplained weight loss
If you experience any of the following symptoms, contact your doctor right away, 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 immediately if you experience:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
This medication can also cause heart failure or worsen existing heart disease. If you have heart disease, inform your doctor. Seek medical help right away if you experience:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
New or worsening swelling in the arms or legs
In rare cases, this medication can cause bone marrow and blood problems, including a severe condition called aplastic anemia, which can be life-threatening. Contact your doctor immediately 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 experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
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, 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 emergency 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 bumps filled with pus
Skin lumps or growths
Swollen glands
Night sweats
Shortness of breath
Unexplained weight loss
If you experience any of the following symptoms, contact your doctor right away, 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 immediately if you experience:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
This medication can also cause heart failure or worsen existing heart disease. If you have heart disease, inform your doctor. Seek medical help right away if you experience:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
New or worsening swelling in the arms or legs
In rare cases, this medication can cause bone marrow and blood problems, including a severe condition called aplastic anemia, which can be life-threatening. Contact your doctor immediately 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 experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
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, 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: fever, chills, persistent cough, shortness of breath, flu-like symptoms, skin sores, unusual fatigue.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue, 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, weakness in arms/legs, vision changes, seizures.
- Signs of blood problems: persistent fever, bruising easily, unusual bleeding, pale skin.
- Signs of lupus-like syndrome: new or worsening joint pain, rash on cheeks/nose, fever, chest 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 you experienced, including any symptoms that occurred.
If you have been diagnosed with granulomatosis with polyangiitis, a condition characterized by inflammation of the blood vessels.
If you have a blood infection or any other severe infection that requires medical attention.
If you are currently taking any of the following medications:
+ Abatacept
+ Anakinra
If you are taking cyclophosphamide, a medication used to treat certain types of cancer and autoimmune disorders.
Please note that this is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication.
To guarantee your safety, always check with your doctor before:
Starting any new medication
Stopping any medication
Changing the dosage of any medication
This will help prevent any potential interactions or adverse effects, and ensure that you can take this medication safely with all of your other medications and health conditions.
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 you experienced, including any symptoms that occurred.
If you have been diagnosed with granulomatosis with polyangiitis, a condition characterized by inflammation of the blood vessels.
If you have a blood infection or any other severe infection that requires medical attention.
If you are currently taking any of the following medications:
+ Abatacept
+ Anakinra
If you are taking cyclophosphamide, a medication used to treat certain types of cancer and autoimmune disorders.
Please note that this is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication.
To guarantee your safety, always check with your doctor before:
Starting any new medication
Stopping any medication
Changing the dosage of any medication
This will help prevent any potential interactions or adverse effects, and ensure that you can take this medication safely with all of your other medications and health conditions.
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 the 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 or weakened bacteria vaccines, such as BCG 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. Furthermore, be aware that this medication may increase your risk of developing skin cancer. To minimize this risk, limit your exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear. 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 moles.
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 likely recommend hepatitis B testing, and it is essential to follow their instructions.
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 be at a higher risk of developing certain side effects. If your child is taking this medication and experiences any weight changes, consult with your doctor, as their 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. Additionally, 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 the 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 or weakened bacteria vaccines, such as BCG 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. Furthermore, be aware that this medication may increase your risk of developing skin cancer. To minimize this risk, limit your exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear. 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 moles.
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 likely recommend hepatitis B testing, and it is essential to follow their instructions.
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 be at a higher risk of developing certain side effects. If your child is taking this medication and experiences any weight changes, consult with your doctor, as their 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. Additionally, 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 approximately twice the recommended adult dose.
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).
Drug Interactions
Major Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, oral polio, BCG)
- Anakinra (Kineret)
- Abatacept (Orencia)
Moderate Interactions
- Cyclophosphamide (increased risk of malignancy with concurrent use, though not a direct interaction)
- Sulfasalazine (potential for increased risk of pancytopenia, though data are limited)
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD test 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 identify patients at risk for HBV reactivation, as TNF blockers can cause reactivation.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic status and identify pre-existing cytopenias.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To assess baseline hepatic function.
Timing: Prior to initiation of therapy
Screening for other infections (e.g., fungal, bacterial)
Rationale: To ensure patient is free of active infections before starting immunosuppressive therapy.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, malaise)
Frequency: Regularly, at each clinical visit
Target: Absence of signs/symptoms
Action Threshold: Prompt evaluation and treatment if infection suspected; consider temporary discontinuation of Etanercept.
Signs and symptoms of malignancy (e.g., unexplained weight loss, persistent fever, lymphadenopathy)
Frequency: Regularly, at each clinical visit
Target: Absence of signs/symptoms
Action Threshold: Prompt evaluation if malignancy suspected.
Complete Blood Count (CBC) with differential
Frequency: Periodically, as clinically indicated (e.g., every 3-6 months or if symptoms of cytopenia develop)
Target: Within normal limits
Action Threshold: Investigate significant or persistent abnormalities; consider discontinuation if clinically significant cytopenia occurs.
Liver Function Tests (LFTs)
Frequency: Periodically, as clinically indicated (e.g., every 3-6 months or if symptoms of liver injury develop)
Target: Within normal limits
Action Threshold: Investigate significant or persistent abnormalities; consider discontinuation if clinically significant liver injury occurs.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, fatigue, shortness of breath, persistent cough, skin lesions, diarrhea, abdominal pain, dysuria)
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Signs of heart failure (e.g., new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain)
- Signs of demyelinating disease (e.g., numbness, tingling, weakness, vision changes)
- Signs of lupus-like syndrome (e.g., new or worsening joint pain, rash on cheeks/nose, fever, chest pain)
- Signs of hematologic abnormalities (e.g., persistent fever, bruising, bleeding, pallor)
Special Patient Groups
Pregnancy
Etanercept is generally considered to have low risk during pregnancy based on available data, but human data are limited. A pregnancy exposure registry is available. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Limited data, but no clear evidence of increased risk of major birth defects.
Second Trimester:
Limited data, but no clear evidence of increased risk.
Third Trimester:
Etanercept is an IgG1 fusion protein and can cross the placenta, especially in the third trimester. Live vaccines should generally be avoided in infants exposed to Etanercept in utero for at least 6 months after birth due to potential immunosuppression.
Lactation
Etanercept is present in human milk in very low concentrations. Due to its large molecular weight, absorption by the infant is unlikely. Considered compatible with breastfeeding by some experts (L3). Monitor breastfed infant for signs of infection.
Infant Risk:
Low risk of adverse effects to the infant. Potential for altered immune response in the infant, though unlikely due to poor oral absorption.
Pediatric Use
Approved for Polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older, and Plaque Psoriasis (PsO) in patients 4 years of age and older. Increased risk of malignancy (lymphoma and other cancers) reported in children and adolescents treated with TNF blockers. Close monitoring for infections and malignancies is crucial.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (âĨ65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Higher incidence of serious infections in patients âĨ65 years of age treated with Etanercept compared to younger patients. Use with caution, monitor closely for infections.
Clinical Information
Clinical Pearls
- Etanercept is a biologic DMARD that acts as a TNF-alpha inhibitor, effective for various inflammatory conditions.
- Patients must be screened for latent TB and HBV before starting therapy due to the risk of reactivation.
- Serious infections, including opportunistic infections, are a major risk; patients should be educated on symptoms and report them immediately.
- Increased risk of malignancy, particularly lymphoma, has been observed with TNF blockers, especially in pediatric patients.
- Avoid live vaccines during Etanercept therapy and for several months after discontinuation.
- Etanercept is generally well-tolerated at the injection site, but proper injection technique and site rotation are important.
- Consider temporary discontinuation of Etanercept if a serious infection develops.
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 flares, not long-term monotherapy)
Cost & Coverage
Average Cost:
Not available Not available
Insurance Coverage:
Specialty Tier (requires prior authorization, often step therapy)
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.