Enbrel 50mg/ml Inj (4 Syringes)

Manufacturer AMGEN Active Ingredient Etanercept Prefilled Syringes(et a NER sept) Pronunciation et a NER sept
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.
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Drug Class
Disease-modifying antirheumatic drug (DMARD)
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Pharmacologic Class
Tumor Necrosis Factor (TNF) Blocker
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Pregnancy Category
Not available
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FDA Approved
Nov 1998
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DEA Schedule
Not Controlled

Overview

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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, psoriasis, and other autoimmune diseases. It is given as an injection under the skin.
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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 dose 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, protected from light, and avoid exposing it to 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 extra doses. If you are unsure about what to do in case of a missed dose, contact your doctor.
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Lifestyle & Tips

  • Report any signs of infection (fever, cough, flu-like symptoms) to your doctor immediately.
  • Avoid live vaccines while on Etanercept. Discuss all vaccinations with your doctor.
  • Inform your doctor if you have a history of tuberculosis, hepatitis B, or heart failure.
  • Store the medication in the refrigerator and protect it from light. Do not freeze.
  • Learn proper injection technique from your healthcare provider.
  • Do not stop taking Etanercept without consulting your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 50 mg once weekly (for most indications)
Dose Range: 25 - 50 mg

Condition-Specific Dosing:

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)
Plaque Psoriasis (PsO): Initial: 50 mg SC twice weekly for 3 months, then 50 mg SC once weekly
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Juvenile Idiopathic Arthritis (JIA): 0.8 mg/kg (up to 50 mg) SC once weekly. Plaque Psoriasis (PsO) (â‰Ĩ4 years): 0.8 mg/kg (up to 50 mg) SC once weekly.
Adolescent: Juvenile Idiopathic Arthritis (JIA): 0.8 mg/kg (up to 50 mg) SC once weekly. Plaque Psoriasis (PsO) (â‰Ĩ4 years): 0.8 mg/kg (up to 50 mg) SC once weekly.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed
Moderate: No dosage adjustment needed
Severe: No dosage adjustment needed
Dialysis: No dosage adjustment needed; Etanercept is not renally cleared.

Hepatic Impairment:

Mild: No specific dosage adjustment needed
Moderate: No specific dosage adjustment needed
Severe: No specific dosage adjustment needed

Pharmacology

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Mechanism of Action

Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. It binds specifically to tumor necrosis factor (TNF)-alpha and blocks its interaction with cell surface TNF receptors, thereby inhibiting TNF-alpha activity. TNF-alpha is a naturally occurring cytokine involved in normal inflammatory and immune responses. Elevated levels of TNF-alpha are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and in psoriatic plaques.
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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 (is a protein itself)
CnssPenetration: Limited

Elimination:

HalfLife: 102 hours (range 76-132 hours)
Clearance: Not available (complex clearance for biologics)
ExcretionRoute: Primarily via catabolism; not renally or hepatically cleared in the traditional sense.
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Within 1-2 weeks for some effects (e.g., reduction in tender/swollen joints), full therapeutic effect may take longer.
PeakEffect: Typically observed within 3 months of continuous therapy.
DurationOfAction: Sustained as long as therapy is continued, due to long half-life and mechanism of action.

Safety & Warnings

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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), invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including ENBREL.
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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 medical attention immediately:

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
+ Pain while urinating
+ 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
Feeling confused
Pale skin
Red, scaly patches or bumps filled with pus
Skin lumps or growths
Swollen glands, night sweats, shortness of breath, or unexplained weight loss
Severe liver problems, which may be indicated by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Nervous system problems, including:
+ Burning, numbness, or tingling sensations
+ Changes in vision
+ Dizziness
+ Seizures
+ Weakness in the arms or legs
Heart failure or worsening heart failure, which may be indicated by:
+ Shortness of breath
+ Sudden weight gain
+ Abnormal heartbeat
+ New or worsening swelling in the arms or legs
Bone marrow and blood problems, including:
+ 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 experience few or no side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Irritation at the injection site
Diarrhea
Headache
Common cold symptoms

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of serious infection: persistent fever, chills, cough, shortness of breath, unusual fatigue, skin sores, painful urination.
  • Allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
  • Heart failure symptoms: new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain.
  • Neurological symptoms: numbness, tingling, vision changes, weakness in arms/legs.
  • Blood problems: easy bruising or bleeding, persistent fever, pale skin.
  • Liver problems: persistent nausea, vomiting, dark urine, yellowing of skin or eyes, abdominal pain.
  • New lumps or changes in moles/skin lesions.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have been diagnosed with granulomatosis with polyangiitis.
If you have a blood infection or any other severe infection.
If you are currently taking abatacept or anakinra.
* If you are taking cyclophosphamide.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction 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.
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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 prolonged 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 skin changes, such as new warts, sores, or moles, or changes in the color or size of existing 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.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Similarly, if the patient is a child, this medication should be used with caution, as the risk of certain side effects may be higher in children. If your child's weight changes while taking this medication, 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 have taken this medication during pregnancy, be sure to inform your baby's doctor.
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Overdose Information

Overdose Symptoms:

  • No specific symptoms of overdose have been identified in clinical trials. Doses up to 60 mg/m2 (approximately three times the recommended dose) have been administered to patients with rheumatoid arthritis without dose-limiting toxicity.

What to Do:

In case of overdose, it is recommended that patients be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted. Call 1-800-222-1222 (Poison Control Center) for further guidance.

Drug Interactions

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Contraindicated Interactions

  • Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, oral polio, BCG) during Etanercept therapy due to increased risk of infection.
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Major Interactions

  • Anakinra (Kineret): Increased risk of serious infection and neutropenia. Concomitant use is not recommended.
  • Abatacept (Orencia): Increased risk of serious infection. Concomitant use is not recommended.
  • Cyclophosphamide: Increased risk of malignancy (e.g., non-melanoma skin cancer) when used concomitantly with Etanercept in Wegener's granulomatosis (off-label use).
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Moderate Interactions

  • Other immunosuppressants (e.g., methotrexate, corticosteroids): May increase risk of infection, but often used concomitantly in clinical practice under close monitoring.
  • Vaccines (non-live): May result in a diminished immune response to vaccination.

Monitoring

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Baseline Monitoring

Tuberculosis (TB) screening (e.g., 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 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 assess baseline hematologic parameters and monitor for cytopenias (e.g., neutropenia, pancytopenia).

Timing: Prior to initiation of therapy

Liver Function Tests (LFTs) (ALT, AST, bilirubin)

Rationale: To assess baseline liver function and monitor for potential liver injury.

Timing: Prior to initiation of therapy

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Routine Monitoring

Signs and symptoms of infection

Frequency: Regularly throughout therapy and after discontinuation

Target: Absence of fever, cough, malaise, skin lesions, etc.

Action Threshold: Prompt evaluation and potential discontinuation if serious infection suspected.

Complete Blood Count (CBC) with differential

Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)

Target: Within normal limits; monitor for significant decreases in cell counts.

Action Threshold: Investigate persistent cytopenias; consider discontinuation if clinically significant.

Liver Function Tests (LFTs)

Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)

Target: Within normal limits; monitor for significant elevations.

Action Threshold: Investigate persistent elevations; consider discontinuation if clinically significant.

Signs and symptoms of heart failure

Frequency: Regularly

Target: Absence of new or worsening dyspnea, edema, fatigue.

Action Threshold: Prompt evaluation if new or worsening heart failure symptoms occur.

Signs and symptoms of demyelinating disease

Frequency: Regularly

Target: Absence of new or worsening neurological symptoms (e.g., paresthesias, visual disturbances, weakness).

Action Threshold: Prompt evaluation if new neurological symptoms occur; consider discontinuation.

Skin examination for malignancy

Frequency: Periodically, especially for patients with risk factors for skin cancer.

Target: Absence of suspicious lesions.

Action Threshold: Referral to dermatology for evaluation of suspicious lesions.

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Symptom Monitoring

  • Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, fatigue, skin lesions, diarrhea, dysuria)
  • Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • New or worsening symptoms of heart failure (e.g., shortness of breath, swelling of ankles/feet, sudden weight gain)
  • New or worsening neurological symptoms (e.g., numbness, tingling, vision changes, weakness in arms/legs)
  • Signs of blood disorders (e.g., persistent fever, bruising, bleeding, pallor)
  • Signs of liver problems (e.g., persistent nausea, vomiting, dark urine, yellowing of skin/eyes, abdominal pain)
  • New or changing skin lesions (for potential malignancy)

Special Patient Groups

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Pregnancy

Etanercept is generally considered for use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Human data from registries and observational studies have not identified a drug-associated risk of major birth defects or miscarriage. However, Etanercept is an IgG1 antibody and can cross the placenta, especially during the third trimester. Live vaccines should not be administered to infants exposed to Etanercept in utero for at least 6 months after the mother's last dose.

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 of major birth defects.
Third Trimester: Increased placental transfer, potential for infant exposure and transient immunosuppression in the neonate.
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Lactation

Etanercept is present in human milk at low levels. The amount ingested by a breastfed infant is very low, and systemic absorption by the infant is unlikely due to the protein nature of the drug. Generally considered compatible with breastfeeding, but monitor the infant for signs of infection.

Infant Risk: Low risk of adverse effects to the breastfed infant. Monitor for signs of infection.
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Pediatric Use

Approved for Juvenile Idiopathic Arthritis (JIA) in patients aged 2 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 malignancies, some fatal) have been reported in children and adolescent patients treated with TNF blockers.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger patients, but the greater sensitivity of some older individuals cannot be ruled out. Elderly patients may have a higher incidence of infections, so caution is advised.

Clinical Information

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Clinical Pearls

  • Etanercept is a biologic DMARD that specifically targets TNF-alpha, a key cytokine in inflammatory processes.
  • Patients must be screened for latent tuberculosis and hepatitis B before initiating therapy due to the risk of reactivation.
  • Live vaccines are contraindicated during Etanercept therapy. Patients should be up-to-date on all recommended vaccinations prior to starting.
  • Patients should be educated on the signs and symptoms of serious infections and instructed to seek immediate medical attention if they occur.
  • Etanercept can be used as monotherapy or in combination with methotrexate for rheumatoid arthritis.
  • Injection site reactions are common but usually mild and transient.
  • Consider the risk of malignancy, particularly lymphoma and non-melanoma skin cancer, with long-term use of TNF blockers.
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Alternative Therapies

  • Other TNF blockers (e.g., Adalimumab, Infliximab, Golimumab, Certolizumab pegol)
  • Other biologic DMARDs with different mechanisms of action (e.g., Abatacept, Rituximab, Tocilizumab, Ustekinumab, Secukinumab, Tofacitinib)
  • Conventional synthetic DMARDs (e.g., Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide)
  • Corticosteroids (for acute symptom control, not long-term disease modification)
  • NSAIDs (for symptomatic relief)
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Cost & Coverage

Average Cost: High (e.g., $5,000 - $7,000+) per 4 syringes (50mg/ml)
Insurance Coverage: Specialty Tier (requires prior authorization, step therapy)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, don't hesitate 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.