Enbrel Prefilled Syringe

Enbrel PFS Injection is an FDA-approved recombinant human protein & TNF inhibitor medication that is used to treat various autoimmune conditions such as psoriasis, rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, and Crohn’s disease. It is available in strengths of 25 mg/0.5 ml and 50 mg/ml, which can be administered subcutaneously. It works by blocking tumor necrosis factor, which causes inflammation and causes joint and skin damage. The dosage and usage are based on the patient’s condition, age, and needs. To ensure safe and efficient use, you should consult a licensed healthcare professional before taking Enbrel PFS Injection. You can buy Enbrel PFS Injection online for autoimmune conditions at your convenience.

Enbrel PFS Injection contains etanercept, a recombinant human protein and TNF inhibitor used to treat various autoimmune conditions such as rheumatoid arthritis, psoriasis, ulcerative colitis, ankylosing spondylitis, and Crohn’s disease. This medication works by blocking tumor necrosis factor, a substance in the body that causes inflammation and leads to joint and skin damage. Enbrel reduces swelling, pain, and redness by inhibiting TNF, improving physical function. Enbrel PFS Injection is available in 25 mg/0.5 ml & 50 mg/ml strengths.

It can be administered using a pre-filled syringe, a single-dose pre-filled SureClick autoinjector, or a multiple-dose vial. The medication dosage varies depending on the treated condition and the patient’s weight. Typically, it is given as a subcutaneous injection, and patients may continue taking other medications like methotrexate, NSAIDs, and analgesics while on Enbrel. Common side effects include allergic reactions, upper respiratory tract infections, injection site reactions, itching, and rash. Serious side effects, though rare, can include severe infections, nerve disorders, and blood disorders.

Before starting Enbrel, it is crucial to inform your doctor of all medications you are taking and any preexisting health conditions. If you miss a dose, take it as soon as you remember unless it is almost time for the next dose. Store Enbrel in the refrigerator and protect it from extreme temperatures. Consult a certified healthcare practitioner for personalized guidance and advice. Follow their suggestions to ensure the safe and efficient use of Enbrel PFS Injection.

Enbrel PFS Injection is indicated for use in patients with the following conditions:

• Ankylosing spondylitis
• Rheumatoid arthritis
• Psoriasis
• Ulcerative colitis
• Crohn’s disease

What Are the Forms & Strengths of Enbrel PFS Injection?

It comes in the following forms and strengths:

• Pre-filled syringe: 25 mg/0.5 ml, 50 mg/ml
• Single-dose pre-filled SureClick autoinjector: 50 mg/ml.
• Multiple-dose vial: 25 mg (reconstitute with 1 ml diluent)

What Are the Recommended Dosages for Enbrel PFS Injection?

For Adult Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis

• You may continue taking methotrexate, salicylates, NSAIDs, glucocorticoids, or analgesics while you are receiving treatment with Enbrel PFS Injection.
• A study found that taking 50 mg of Enbrel twice a week in patients with rheumatoid arthritis (RA) showed more side effects but similar effectiveness compared to lower doses. Therefore, taking more than 50 mg per week is not recommended.

For Adult Plaque Psoriasis Patients

For adult plaque psoriasis, you can start with either 50 mg twice a week or lower doses of 25 mg or 50 mg weekly. The effectiveness depends on the dosage.

For Children with Polyarticular Juvenile Idiopathic Arthritis, Plaque Psoriasis & Juvenile Psoriatic Arthritis

• For pediatric patients with these conditions, the dosage of Enbrel is based on their weight and is given as a subcutaneous injection.
  • For children weighing 63 kg or 138 pounds or more: 50 mg per week.
  • For children weighing below 63 kg or 138 pounds: 0.8 mg per kg of body weight weekly
  • To obtain doses other than 25 mg/50 mg, use reconstituted lyophilized powder in a multiple-dose vial or Enbrel liquid solution in a single-dose vial.
• Higher doses than those mentioned have not been studied in children. Children with pJIA can continue taking other medications like glucocorticoids, NSAIDs, or pain relievers while on Enbrel.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

• Before starting treatment with Enbrel PFS Injection, your doctor may ask you to take certain tests to ensure you do not have an infection.
• Enbrel is taken as a subcutaneous injection. A licensed healthcare professional may teach you how to administer this medication yourself.
• Before using the Enbrel PFS Injection, and each time you get a refill, you should carefully read and follow the instructions for use that came with this prescription.
• Ask your pharmacist or physician if you do not understand any part of the patient information leaflet.
• You should not shake the contents of this product. Prepare the injection only when you are ready to use it. Do not use the injection if there is any visual change in the appearance of the medication. Dispose of the injection and ask your pharmacist for a new one if the injectable solution looks cloudy, has particles in it, or if it is discolored.
• You may need to mix or dilute this medication with a liquid. If you are self-administering this injection, ensure that you know how to prepare, properly mix, and store the medication.
• In pediatric patients, the dosage of Enbrel is based on their weight. If your child gains or loses weight while receiving treatment with this medication, they may require a dosage adjustment.
• If you are planning to have surgery, you should tell your doctor ahead of time that you are using Enbrel. You should also tell them about all the prescription, non-prescription, and over-the-counter drugs and herbal supplements you are currently taking or planning to take.
• This medication may affect your immune system, which may cause you to get infections more easily. Severe or life-threatening infections are also possible. While you are receiving treatment with this medication, your doctor will examine you regularly.
• If you have a history of hepatitis B, using this medication can cause the virus of the infection to get worse or become active. While using this medication and after several months of stopping it, you may require frequent liver tests to look for unwanted side effects.
• If you feel that the effect of this medication is too strong or too weak, tell your doctor or pharmacist.
• You can keep Enbrel PFS Injection in the refrigerator till its expiration date, or if needed, you may also store it at room temperature for up to 14 days. Discard it after this period, even if there is medication left in it.
• Do not keep this medication in extreme temperatures, such as in the freezer or your car’s dashboard or trunk.
• The cartridge, pre-filled syringe, and injection pen are for one-time use only. Even if medication is left inside, you should discard it after a single use.
• You should use a needle and syringe only once and then keep it in a puncture-proof, FDA-approved sharps disposal container.
• If you discontinue the use of Enbrel PFS Injection, your symptoms may return or worsen.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

Enbrel works by interfering with a protein called tumor necrosis factor (TNF). People with psoriatic arthritis (PsA) generally have higher levels of TNF in their joints, which can lead to joint and skin damage caused by PsA. Enbrel blocks TNF’s activity in the body, reducing inflammation, joint pain, and skin symptoms associated with PsA. It acts as a decoy p75 TNF receptor, binding both TNF-alpha and TNF-beta instead of cell surface TNF receptors, rendering TNF inactive.

Like every other medication, Enbrel PFS Injection can cause side effects in some people. These side effects usually do not require medical attention and disappear within a few days. However, if they still persist or if they become bothersome, you should consult a licensed healthcare professional. The common side effects caused by Enbrel PFS Injection are as follows:

• Infections such as colds, bronchitis, urinary tract infections, sinusitis, and skin infections
• Headache
• Injection site reactions, including bleeding, bruising, itching, redness, pain and swelling
• Allergic reactions include rash, fever, itching, and antibody formation.

It is noteworthy to mention that this is not the complete list of side effects caused by this medication. You should talk to your healthcare provider to discuss all the potential side effects and how to monitor and manage them. Enbrel may also cause rare but serious side effects. In some cases, these side effects may be life-threatening. If you experience any of the following side effects, you should discontinue using the medication and call your doctor. If you experience severe symptoms, you may also head to the nearest emergency room. Severe side effects caused by Enbrel PFS Injection are as follows:

• Signs of severe infections, including high fever accompanied by shortness of breath, cough, chills, weakness, or a hot, tender, red, and sore area on the skin or joints.
• Signs of nerve disorders include tingling or numbness, vision changes, eye pain, or the onset of weakness in hands, arms, or legs.
• Signs of blood disorder such as bruising, bleeding, or paleness.
• Signs of heart failure or worsening heart conditions include shortness of breath, unusual tiredness, swelling in the ankles, a feeling of fullness in the abdomen or neck, bluish nails and lips, and nighttime shortness of breath or coughing.
• Signs of autoimmune reactions where antibodies are formed that may harm normal tissues of the body. Its symptoms may include itching, pain, weakness, abnormal vision, thinking, breathing, or sensation.
• Signs of cancer, such as fever, weight loss, swelling with or without pain, presence of lumps, or skin growth. Cancer may affect any part of the body, such as skin and blood, and the possible signs will be based on the type and location of the cancer.
• Signs of lupus or lupus-like syndrome, like persistent rash, weight changes, fever, muscle or joint pain, or unusual tiredness.
• Signs of blood vessel inflammation, such as fever, pain, itching, redness or warmth of the skin.

[Note: This list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Are There Any Warnings for Enbrel PFS Injection?

• Using this medication may increase the risk of developing certain cancers, such as a rare type of lymphoma. Speak with a medical expert to learn more about your specific risk. This condition has occurred mainly in teenage and young adult patients using Enbrel or similar drugs used to treat ulcerative colitis/ Crohn’s disease. You should call your doctor at once if you experience any of the following symptoms, such as night sweats, feeling full after eating only a small amount of food, fever, fatigue, loss of appetite, weight loss, nausea, itching, pain in your upper abdomen that can spread to your shoulder, easy bleeding or bruising, light-headedness, pale skin, shortness of breath, dark urine, clay-colored stool, rapid heart rate, or yellowing of the eyes or skin.
• This medication may weaken your immune system, which can cause frequent or serious infections. Its symptoms may include chills, cough, fever, sweating, skin sores or redness, body aches, diarrhea, burning while urinating, shortness of breath, or unusual tiredness.

What Are the FDA Boxed Warning for Enbrel PFS Injection?

Enbrel PFS Injection has a boxed warning for the risk of severe infections and malignancies.

• Serious infections
  • Patients receiving treatment with Enbrel are at an increased risk of severe infections, including bacterial sepsis, tuberculosis, invasive fungal infections, and infections due to other opportunistic pathogens leading to hospitalization or death.
  • During treatment, patients should discontinue taking the medication if they develop sepsis or severe infection.
  • Before starting treatment with Enbrel, your doctor may ask you to undergo tests for latent TB; if found positive, you should start treatment for TB.
  • Careful monitoring of all patients for active TB is crucial during treatment with Enbrel, even if the initial latent TB test is negative.
• Malignancies
  • Lymphoma and other malignancies, some life-threatening, have been reported in children, teenagers, and young adult patients treated with TNF blockers, including Enbrel. These cases have had a very aggressive disease course and have been life-threatening.

• Do not use this medication if you have an allergy to Enbrel or etanercept or a severe infection, such as sepsis.
• Before using Enbrel PFS Injection, share your complete medical history with your doctor, especially if you have the following conditions:
  • A weakened immune system, HIV/AIDS, tuberculosis, or any type of severe or recurring infection
  • Symptoms of infection such as flue symptoms, fever, diarrhea, or painful urination
  • A history of nerve disorders such as myelitis, multiple sclerosis, or optic neuritis
  • Congestive heart failure
  • Diabetes
  • Asthma or other breathing disorder
  • Epilepsy or other seizure disorder
  • History of hepatitis B
  • An open cut or skin sores
  • Allergy to latex rubber
  • If you are scheduled for vaccination or if you have been recently vaccinated with Bacille Calmette-Guerin
• Let your doctor know if you have ever had tuberculosis or were exposed to this disease indicated by a positive PPD test, if someone in your family has tuberculosis, or if you have recently traveled to certain places such as the Ohio River Valley, Mississippi River Valley, and the Southwest, where infections are common.
• Using this medication may increase your risk of developing cancer, such as a fast-growing lymphoma that can be life-threatening. This rare lymphoma has occurred in male adolescents and young adult men using a combination of immunosuppressant medicines to treat Crohn’s disease or ulcerative colitis. However, people with autoimmune disorders such as rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, and psoriasis may have a higher risk of lymphoma. Talk to your doctor about your risk.
• Let your doctor know if you are pregnant, suspect a pregnancy, or plan to become pregnant while using Enbrel PFS Injection. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the pregnancy’s outcome and evaluate any Enbrel effects on the baby.
• Enbrel may pass into your breast milk and cause harm to the nursing infant. You should not breastfeed a baby while you are receiving treatment with Enbrel PFS Injection.

Enbrel PFS Injection is contraindicated for use in patients who have:

• Sepsis
• Known hypersensitivity to etanercept or its components

• If you missed a dose of Enbrel PFS Injection, you should inject as soon as you remember unless it’s almost time for the next dose.
• Don’t take double or extra doses of the same medication.
• You should talk to your pharmacist, healthcare provider, or physician if you are still determining when to take your missed dose.
• You should try setting a reminder on your phone to prevent missing your doses.

[Note: If you have missed a medication dose and are unsure when to take the next one, immediately consult your doctor or pharmacist.]

You should not take Enbrel in large quantities, more frequently, or more than the prescribed dose. If someone has taken more than the prescribed dose, they may experience adverse reactions such as severe infections or allergic reactions. If someone has the given symptoms, they should seek immediate medical assistance. You should call your doctor or poison control helpline. You can also head to the nearest emergency room.

[Note: If you consumed more than the recommended dose, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

• Refrigerate Enbrel PFS Injection at 36°F-46°F (2°C-8°C).
• Do not allow the medication to freeze. Do not use it if it is frozen.
• Enbrel PFS Injection may be stored for up to 14 days at a controlled room temperature of up to 77°F/25°C.
• Keep it in a dark and dry place in its original container, away from direct light, moisture, and excess heat.
• After the product has reached 25°C, it should not be returned to refrigerated storage.
• After removing the Enbrel PFS Injection from the refrigerator, wait for approximately 15 to 30 minutes before using the medication. Do not warm the injection using any other method, such as microwaving or putting it in hot water.
• Before using this medication, check for any change in visual appearance. Do not use it if it is discolored, has particles, or is cloudy.
• Keep all medications, including Enbrel PFS Injection, in a safe place, away from the sight and reach of children.
• Do not use medications that have passed their expiration date, the last date of the month mentioned in the medication carton, or a pre-filled syringe.
• Do not keep medications that are outdated or no longer needed. Discard them safely.
• To discard unwanted medications safely, you should use an FDA-approved sharps disposal container. If you do not have a sharps container, you can use a container made of hard plastic with a tightly fitting lid.
• Dispose of the unwanted medications in such a way that children, pets, and others cannot consume them.
• With that being said, don’t throw it in your household garbage bin, flush it down the toilet or pour it in the drain.
• Learn how to properly eliminate unwanted medications by contacting your pharmacist, healthcare provider, or local waste management company. This will help in protecting the environment.

[Note: Discuss with your healthcare professional the proper disposal of unused medicine and any questions you may have regarding its storage.]

What Medications Interact with Enbrel PFS Injection?

Enbrel PFS Injection is a tumor necrosis factor inhibitor used to treat various autoimmune conditions. As with many medications, Enbrel can interact with other drugs. A list of potential interactions is given below. It’s noteworthy to mention that this list is not exhaustive, and new interactions may be discovered over time. You should consult a healthcare provider, physician, or pharmacist about potential drug interactions, especially when starting new medications or changing doses. They can provide personalized advice and guidance based on your personal and family medical history and current medication regimen.

• Other TNF inhibitors: Combining Enbrel with other TNF inhibitors like adalimumab, infliximab, or certolizumab pegol is not indicated for use due to the increased risk of infections and other side effects.
• Immunosuppressants such as Methotrexate, Cyclosporine, and Azathioprine may increase the risk of severe infections and potentially certain cancers. Methotrexate is often used in combination with Nebrel, but it requires careful monitoring.
• Biologic therapies:
  • Anakinra (IL-1 receptor antagonist): Combination increases the risk of serious infections.
  • Abatacept (T-cell inhibitor): May increase the risk of serious infections.
  • Rituximab (B-cell depleting agent): Potential for increased immunosuppression.
• Live vaccines should be avoided while receiving treatment with Enbrel due to the increased risk of infection.
• Cytochrome P450 substrate drugs: Enbrel may affect the metabolism of drugs processed by CYP450 enzymes, potentially altering their effectiveness.
• Sulfasalazine: Some studies suggest that Enbrel may reduce the blood concentration of sulfasalazine.
• Warfarin and other anticoagulants should be used cautiously, as Enbrel may affect blood clotting.
• Digoxin: Monitoring may be needed as Enbrel could potentially affect digoxin levels.
• Cyclophosphamide: The combination may increase the risk of certain cancers.
• Corticosteroids: While often used together, the combination may increase infection risk.
• NSAIDs (Non-Steroidal Anti-Inflammatory Drugs): No significant interactions, but may increase the risk of gastrointestinal side effects.
• Insulin and oral diabetes medications: Enbrel may affect blood glucose levels, requiring dose adjustments of diabetes medications.

What Are the Other Enbrel PFS Injection Interactions?

Before starting to take Enbrel PFS Injection, you should discuss with your healthcare provider about the potential drug interactions with this medication. Tell your doctor about all the medications you are currently taking or planning to take. This includes all prescription medications, non-prescription or over-the-counter medications, and supplements such as vitamins, calcium, and herbs.

[Note: This isn’t a complete list, and there could be other drugs that interact with Enbrel PFS Injection. Tell your doctor about any prescription, over-the-counter medicines, and herbal products.]

• Actemra Actpen (tocilizumab) 
• Arava (leflunomide)
• Cimzia (certolizumab) 
• Otrexup (methotrexate)
• Orencia Clickject (abatacept) 
• Rituxan (rituximab) 
• Xeljanz (tofacitinib)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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