Enbrel Sureclick 50mg/ml(4 Autoinj)
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
Category B
FDA Approved
Nov 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Etanercept is a medicine that helps reduce inflammation in your body. It works by blocking a natural protein called TNF-alpha, which can cause swelling and damage in conditions like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, 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 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. 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. While small white particles may be present, do not use the medication if the solution appears cloudy, is leaking, or contains large lumps, flakes, or other particles.
In some cases, you may need to leave the medication at room temperature for 30 minutes before use. However, do not remove the cap or cover until you are ready to use it, and avoid heating the medication. If you are unsure about the specific requirements for your brand, consult your pharmacist or refer to the package insert.
After administering the injection, check the window on the auto-injector to confirm that the dose has been delivered. 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.
Disposal and Storage
Do not use this medication if it has been dropped or is damaged. 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, consult your doctor or pharmacist.
Storage
Store this medication in its original container, protected from light, and refrigerate at a temperature that avoids freezing. Avoid exposing the medication 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 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 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. 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. While small white particles may be present, do not use the medication if the solution appears cloudy, is leaking, or contains large lumps, flakes, or other particles.
In some cases, you may need to leave the medication at room temperature for 30 minutes before use. However, do not remove the cap or cover until you are ready to use it, and avoid heating the medication. If you are unsure about the specific requirements for your brand, consult your pharmacist or refer to the package insert.
After administering the injection, check the window on the auto-injector to confirm that the dose has been delivered. 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.
Disposal and Storage
Do not use this medication if it has been dropped or is damaged. 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, consult your doctor or pharmacist.
Storage
Store this medication in its original container, protected from light, and refrigerate at a temperature that avoids freezing. Avoid exposing the medication 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 for guidance.
Lifestyle & Tips
- Avoid live vaccines while taking this medication.
- Report any signs of infection (fever, chills, cough, skin sores) immediately to your doctor.
- Inform your doctor if you have a history of tuberculosis, hepatitis B, heart failure, or any nervous system disorders.
- Maintain good hygiene to reduce the risk of infection.
- Discuss any planned surgeries or dental procedures with your doctor, as etanercept may need to be temporarily stopped.
- Store the medication in the refrigerator and protect it from light. Do not freeze.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg subcutaneously once weekly
Dose Range:
50 - 50 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA):
50 mg subcutaneously once weekly
Psoriatic Arthritis (PsA):
50 mg subcutaneously once weekly
Ankylosing Spondylitis (AS):
50 mg subcutaneously once weekly
Plaque Psoriasis (PsO):
50 mg subcutaneously twice weekly for 3 months, then 50 mg subcutaneously once weekly
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (approved for 4 years and older)
Child:
Polyarticular Juvenile Idiopathic Arthritis (pJIA) (4 years and older): 0.8 mg/kg (maximum 50 mg) subcutaneously once weekly. Plaque Psoriasis (4 years and older): 0.8 mg/kg (maximum 50 mg) subcutaneously twice weekly for 3 months, then 0.8 mg/kg (maximum 50 mg) subcutaneously once weekly.
Adolescent:
Polyarticular Juvenile Idiopathic Arthritis (pJIA): 0.8 mg/kg (maximum 50 mg) subcutaneously once weekly. Plaque Psoriasis: 0.8 mg/kg (maximum 50 mg) subcutaneously twice weekly for 3 months, then 0.8 mg/kg (maximum 50 mg) subcutaneously once weekly.
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 a large protein and not expected to be removed by dialysis.
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 and blocks its interaction with cell surface TNF receptors, thereby rendering TNF biologically inactive. TNF is a naturally occurring cytokine involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with RA, PsA, and AS, and in psoriatic plaques. Etanercept modulates biological responses that are induced or regulated by TNF, including the expression of adhesion molecules, chemokines, and cytokines.
Pharmacokinetics
Absorption:
Bioavailability:
58-63%
Tmax:
72 hours (range 48-96 hours)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Not available (complex distribution for biologics)
ProteinBinding:
Not applicable (fusion protein, not typically protein bound in the same way as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
102 hours (range 76-132 hours)
Clearance:
Not precisely quantified for biologics; primarily cleared by degradation.
ExcretionRoute:
Not applicable (degraded into amino acids)
Unchanged:
Not applicable (degraded)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks for some indications (e.g., RA), full effect may take longer.
PeakEffect:
Variable, often within 3 months for full clinical response.
DurationOfAction:
Approximately 1 week (consistent with weekly dosing interval).
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 pneumocystosis; and bacterial, viral, and other infections due to opportunistic pathogens. 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 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
+ Difficulty 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 discolored sputum
+ 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
Unexplained weight loss
Liver Problems: A Serious Side Effect
This medication can cause severe and potentially life-threatening liver problems. 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: A Rare but Serious Side Effect
In rare cases, people taking this medication have experienced nervous system problems, which can be permanent. If you notice any of the following symptoms, contact your doctor right away:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Heart Failure: A Potential Side Effect
This medication can cause heart failure or worsen existing heart failure. If you have a history of 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
Swelling in the arms or legs (new or worsening)
Bone Marrow and Blood Problems: A Rare but Serious Side Effect
This medication can cause rare but serious blood and bone marrow problems, including aplastic anemia, which can be life-threatening. If you notice any of the following symptoms, contact your doctor right away:
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. While many people experience no side effects or only mild ones, some may encounter more bothersome symptoms. If you experience any of the following side effects, contact your doctor or seek medical attention:
Irritation at the injection site
Diarrhea
Headache
* Common cold symptoms
Reporting 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 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
+ Difficulty 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 discolored sputum
+ 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
Unexplained weight loss
Liver Problems: A Serious Side Effect
This medication can cause severe and potentially life-threatening liver problems. 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: A Rare but Serious Side Effect
In rare cases, people taking this medication have experienced nervous system problems, which can be permanent. If you notice any of the following symptoms, contact your doctor right away:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Heart Failure: A Potential Side Effect
This medication can cause heart failure or worsen existing heart failure. If you have a history of 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
Swelling in the arms or legs (new or worsening)
Bone Marrow and Blood Problems: A Rare but Serious Side Effect
This medication can cause rare but serious blood and bone marrow problems, including aplastic anemia, which can be life-threatening. If you notice any of the following symptoms, contact your doctor right away:
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. While many people experience no side effects or only mild ones, some may encounter more bothersome symptoms. If you experience any of the following side effects, contact your doctor or seek medical attention:
Irritation at the injection site
Diarrhea
Headache
* Common cold symptoms
Reporting 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, flu-like symptoms, skin redness/swelling/pain, painful urination.
- 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, weakness in arms/legs, vision changes, seizures.
- Signs of blood problems: persistent fever, bruising easily, unusual bleeding, pale skin.
- Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, nausea/vomiting.
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 other medications 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 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 other medications 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 using this medication. 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 necessary, and you should inform your doctor of any skin changes, such as new warts, sores, or moles, or any changes in the color or size 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 require you to undergo hepatitis B testing 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 use this medication with caution, as the risk of certain side effects may be higher in this population. 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 used 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 using this medication. 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 necessary, and you should inform your doctor of any skin changes, such as new warts, sores, or moles, or any changes in the color or size 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 require you to undergo hepatitis B testing 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 use this medication with caution, as the risk of certain side effects may be higher in this population. 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 used 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. Doses up to 60 mg/m2 (approximately 4 times the recommended single dose) have been administered to patients with RA without dose-limiting toxicities.
What to Do:
In case of suspected overdose, contact a poison control center or emergency medical services immediately. Provide supportive care and monitor for any adverse reactions. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, BCG, oral polio, live attenuated influenza vaccine) - due to risk of infection in immunosuppressed patients.
Major Interactions
- Anakinra (Kineret) - increased risk of serious infection and neutropenia.
- Abatacept (Orencia) - increased risk of serious infection.
- Cyclophosphamide - increased risk of malignancy (specifically non-melanoma skin cancer) when used in combination with etanercept in Wegener's granulomatosis.
Moderate Interactions
- Other immunosuppressants (e.g., methotrexate, corticosteroids) - increased risk of infection, though often used in combination for therapeutic benefit 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 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 latent HBV infection, as TNF blockers can reactivate HBV.
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 (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function.
Timing: Prior to initiation of therapy
Renal function tests (SCr, BUN)
Rationale: To assess baseline renal function.
Timing: Prior to initiation of therapy
Cardiac function assessment (e.g., history of heart failure)
Rationale: TNF blockers can exacerbate or cause new-onset heart failure.
Timing: Prior to initiation of therapy
Neurological assessment (e.g., history of demyelinating disorders)
Rationale: TNF blockers have been associated with new onset or exacerbation of central nervous system demyelinating disorders.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly, at each visit and patient self-monitoring
Target: Absence of fever, chills, cough, dysuria, skin lesions, etc.
Action Threshold: Any new or worsening signs/symptoms of infection require immediate medical evaluation and potential interruption of therapy.
Complete Blood Count (CBC) with differential
Frequency: Periodically, as clinically indicated (e.g., every 3-6 months or if symptoms suggest hematologic abnormalities)
Target: Within normal limits for WBC, RBC, platelets
Action Threshold: Significant or persistent cytopenias (e.g., neutropenia, thrombocytopenia, pancytopenia) may require dose reduction or discontinuation.
Signs and symptoms of malignancy
Frequency: Regularly, at each visit and patient self-monitoring
Target: Absence of unexplained weight loss, persistent fever, night sweats, lymphadenopathy, new skin lesions.
Action Threshold: Suspicion of malignancy requires prompt investigation.
Signs and symptoms of heart failure
Frequency: Regularly, at each visit and patient self-monitoring
Target: Absence of dyspnea, edema, rapid weight gain.
Action Threshold: New or worsening heart failure symptoms require immediate evaluation and consideration of discontinuation.
Signs and symptoms of demyelinating disorders
Frequency: Regularly, at each visit and patient self-monitoring
Target: Absence of new or worsening numbness, tingling, weakness, vision changes.
Action Threshold: New neurological symptoms require immediate evaluation.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Shortness of breath
- Unusual fatigue
- Skin rash or lesions
- Painful urination
- Swelling in ankles/feet
- Unexplained weight loss
- Night sweats
- Persistent sore throat
- Easy bruising or bleeding
- Numbness or tingling
- Weakness in limbs
- Vision changes
Special Patient Groups
Pregnancy
Etanercept is classified as Pregnancy Category B. Available data from clinical trials and postmarketing surveillance suggest that etanercept use during pregnancy does not appear to increase the risk of major birth defects. However, etanercept is an IgG1 fusion protein and is known to cross the placenta, particularly during the third trimester. Therefore, infants exposed to etanercept in utero may be at increased risk of infection for several months after birth. Live vaccines should generally be withheld from these infants for at least 6 months after the last maternal dose of etanercept.
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 of major birth defects.
Third Trimester:
Placental transfer increases significantly in the third trimester, potentially leading to infant immunosuppression and increased risk of infection post-birth. Live vaccines should be deferred in exposed infants.
Lactation
Etanercept is present in human milk at low levels. The developmental and health benefits of breastfeeding should be considered 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. Due to its large molecular weight, absorption by the infant is unlikely. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk. Monitor breastfed infants for signs of infection.
Pediatric Use
Approved for Polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 4 years of age and older, and for pediatric plaque psoriasis in patients 4 years of age and older. Dosing is weight-based (0.8 mg/kg up to a maximum of 50 mg). Pediatric patients treated with TNF blockers have an increased risk of malignancy, including lymphoma and other malignancies, some fatal.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (≥65 years) and younger patients, but a higher incidence of infections has been observed in the elderly population. Use with caution and monitor closely for infections.
Clinical Information
Clinical Pearls
- Etanercept is a biologic DMARD that specifically targets TNF-alpha, offering a different mechanism of action than traditional DMARDs.
- Patients should be thoroughly screened for latent TB and HBV before starting therapy, and monitored for signs of infection throughout treatment.
- The Black Box Warning for serious infections and malignancy is critical and must be discussed with patients.
- Self-injection technique should be carefully taught and reinforced to patients using the SureClick autoinjector.
- Patients should be advised to avoid live vaccines during treatment and for a period after discontinuation.
- Etanercept has a relatively long half-life, allowing for once-weekly dosing for most indications.
- While generally well-tolerated, injection site reactions are common but usually mild and transient.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., Adalimumab, Infliximab, Golimumab, Certolizumab pegol)
- Other biologic DMARDs with different mechanisms (e.g., Rituximab, Abatacept, Tocilizumab, Ustekinumab, Secukinumab, Tofacitinib, Baricitinib, Upadacitinib)
- Conventional synthetic DMARDs (e.g., Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide)
- Non-steroidal anti-inflammatory drugs (NSAIDs) for symptomatic relief
- Corticosteroids for acute flares
Cost & Coverage
Average Cost:
Highly variable, typically >$5,000 - $7,000 per 4 autoinjectors (1 month supply)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and often high co-pays/coinsurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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. 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, we encourage you to discuss them with 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 amount consumed, and the time it occurred.