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Erelzi (Generic Etanercept Injection)

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The use of etanercept injection products may impair your ability to fight infection and raise your chance of contracting a serious illness, such as widespread severe viral, bacterial, or fungal infections. These infections may require medical treatment and may result in death. If you frequently experience any form of infection or believe you are experiencing one right now, let your doctor know. This includes transient infections (like cold sores), mild infections (such open cuts or sores), and persistent, chronic illnesses. Moreover, let your doctor know if you suffer from, or have previously suffered from, diabetes, HIV, AIDS, or any other immune-related illnesses. Also, you should let your doctor know whether you currently reside in or have formerly resided in regions where severe fungal infections are more prevalent, such as the Ohio and Mississippi river valleys. If you are unsure whether these infections are widespread where you live, ask your doctor. Additionally let your doctor know if you are taking any drugs that lower immune system activity.

Throughout and soon after your treatment, your doctor will keep an eye out for any infections. Call your doctor right away if you suffer any of the following symptoms before your treatment starts, while it is being administered, or just afterward: Sweating, breathing issues, a sore throat, coughing up bloody mucus, fever, excessive fatigue, weight loss, diarrhoea, stomach discomfort, flu-like symptoms, warm, red, or painful skin, or other infections symptoms.

You might have TB (a sort of lung infection) or hepatitis B (a type of liver illness), even though you don’t exhibit any symptoms. In this situation, etanercept injection products may raise the chance of infection aggravation and symptom development. Your doctor may request blood tests to determine whether you have an inactive hepatitis B infection in addition to performing a skin test to determine whether you have a TB infection. Before you start using etanercept injection, your doctor may prescribe medication to treat this infection if it is necessary. If you have TB now or formerly had it, have lived in a nation where TB is widespread, or have been near someone with TB, let your doctor know. Call your doctor right away if you have any of the following TB symptoms, including coughing up blood, losing weight, losing muscle tone, or feeling feverish. Additionally, call your doctor right away if you experience any of the following hepatitis B symptoms or if any of them appear during or after treatment: extreme fatigue, yellowing of the skin or eyes, appetite loss, nausea, or vomiting; muscle aches; dark urine; clay-colored bowel movements; fever; chills; stomach pain; or rash.

Some young patients and adolescents treated with etanercept injectable products and comparable drugs acquired serious or life-threatening malignancies, such as lymphoma (cancer that begins in the cells that fight infection). Call your child’s doctor right away if any of the following symptoms appear while they are receiving treatment for your child: unexplained weight loss; swollen glands in the neck, underarms, or groyne; or simple bruising or bleeding. The hazards of providing your child etanercept injection products should be discussed with your child’s doctor.

The patient information leaflet (Medication Guide) from the manufacturer will be sent to you by your doctor or chemist when you start using etanercept injection products and each time you get a new prescription. If you have any questions, carefully read the information and ask your doctor or chemist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Discuss the dangers of using etanercept injection with your doctor.

Why is this medication prescribed?

A number of autoimmune illnesses (disorders in which the immune system assaults healthy portions of the body and results in pain, swelling, and destruction) can be treated with etanercept injectable products alone or in combination with other drugs, including:

  • Adult cases of rheumatoid arthritis, a condition in which the body assaults the joints, leading to pain, swelling, and function loss,
  • Those with psoriatic arthritis, which causes joint discomfort, edoema, and skin scales,
  • Children 2 years of age and older who have juvenile idiopathic arthritis (JIA), a condition in which the body attacks its own joints, might experience discomfort, swelling, loss of function, and delays in growth and development,
  • Spondylitis with ankylosing (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage),
  • Persistent plaque psoriasis in adults and children 4 years of age and older whose psoriasis is too severe to be treated by topical treatments alone (a skin condition in which red, scaly patches develop on various portions of the body).

The drug etanercept belongs to the group of drugs known as tumor-necrosis factor (TNF) inhibitors. It functions by preventing the body’s production of TNF, a chemical that causes inflammation.

How should this medicine be used?

The injection form of etanercept is available as a solution (liquid) in single-dose prefilled syringes, dosing pens, cartridges, and automatic injection devices. The powder form of etanercept is also available in multi-dose vials (contains enough medication for more than one dose), which must be mixed with a supplied liquid. Etanercept is administered subcutaneously (under the skin). Once every week is typical for injection. When etanercept injection products are used to treat persistent plaque psoriasis, they may first be administered once every week for the first three months of treatment, and then up to twice weekly after that. Ask your doctor or chemist to explain any instructions on your prescription label that you do not understand, and carefully follow their instructions. Just as instructed, use etanercept injection products. Use only as directed by your doctor, neither more nor less of it, nor more frequently.

Your initial dosage of etanercept injection products will be administered in a doctor’s office. After that, you can administer the medication yourself at home or with the help of a friend or relative. Get your doctor or chemist to demonstrate how to inject etanercept injection products to you or the person administering the injections. Before injecting the medication, carefully read the written usage instructions that are included with etanercept injection products. If you have any concerns regarding how to administer the medication through injection, be sure to see your physician or chemist.

It is recommended to put multi-dose vials of etanercept injection products in the fridge as soon as possible, but no later than 4 hours after mixing. After mixing the etanercept injection product, if there is enough medication left over to treat a full dose, you may store the vial for up to 14 days. To produce a full dose of etanercept injection products, you should not mix the contents of two or more vials. Moreover, you should not combine etanercept injection products with any other medications.

Use each syringe, dosing pen, cartridge, automatic injection device, or vial only once, injecting the whole contents of the container, if your medication is supplied in a single-dose prefilled container. Do not re-use the syringe, bottle, or tool, even if there is still some solution in it. Put used needles, syringes, and equipment in a container that won’t puncture. How to get rid of the puncture-resistant container should be discussed with your doctor or chemist.

When using an etanercept injection product that has been refrigerated, lay it flat and let it reheat to room temperature for 15–30 minutes before injecting the medication. Never attempt to reheat the drug by putting it in a hot water bath, microwave, or any other device.

Do not shake an etanercept-containing syringe, dosing pen, cartridge, automatic injection device, or vial. Dosing pen, cartridge, device, syringe, or needle damage could result from dropping the device onto a hard surface.

Before injecting etanercept, always check the solution. Verify the expiration date is still valid. To find out what your etanercept injection product solution should resemble, consult the written instructions for use. Syringes, dosing pens, cartridges, autoinjectors, vials, and other delivery devices should not be used if they are cracked, damaged, or expired, or if the liquid inside them does not appear to be what is described in the written directions for use.

The front of your middle thighs are the ideal area for etanercept injections. Aside from the region 2 inches (5 cm) around your navel, you can also inject the drug in your lower stomach below your navel. The individual administering the injection to you may also administer the drug into your upper arms. For each injection, pick a different location. Never administer an injection to skin that is brittle, bruised, red, rigid, or covered in scars or stretch marks. Do not inject into red, thick, raised, or scaly skin if you have psoriasis.

Your illness won’t be cured by etanercept injection, but it might help regulate it. Even if you feel better, keep taking the etanercept injection. Without consulting your doctor, do not discontinue taking etanercept.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using etanercept injection products,

  • Inform your doctor and chemist if you have any allergies to rubber, latex, other drugs, etanercept, or any other components found in etanercept injection products. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
  • Inform your doctor and chemist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Mention any diabetes medications you may be taking. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your physician if you suffer from a neurological condition like multiple sclerosis or if you currently have or have previously had seizures (MS; loss of coordination, weakness, and numbness due to nerve damage), transverse myelitis, Guillain-Barré syndrome, optic neuritis (inflammation of the nerve that transmits messages from the eye to the brain), transverse myelitis (inflammation of the spinal cord that may result in abnormal sensations, loss of sensation, or loss of ability to move the lower body), or bleeding issues, liver disease, heart failure, or heart failure.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you get pregnant while using etanercept injectable products. Be sure to discuss your use of etanercept injection products with your baby’s doctor after delivery if you did so throughout your pregnancy. Some immunisations may need to be given to your baby later than usual.
  • Inform your doctor or dentist that you are using etanercept injection products if you are scheduled for surgery, including dental surgery.
  • Without consulting your doctor, avoid getting any vaccinations while using etanercept injection products. Consult your kid’s doctor on any recommended vaccines prior to the commencement of therapy if your child will be receiving etanercept injectable products. Before starting treatment, your child should, if at all feasible, receive all the immunisations recommended for kids his or her age.
  • When using etanercept injection products, call your doctor right away if you are exposed to the chickenpox.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, administer it as soon as you remember. Skip the missed dose if the next dose is soon due and carry on with your regular dosing plan. To make up for a missing dose, do not provide a second injection.

What side effects can this medication cause?

Side effects are possible with etanercept injectable medications. If any of these symptoms are severe or do not go away, consult your doctor:

  • At the injection site, look for redness, itching, discomfort, swelling, bleeding, or bruising.

Some adverse effects may be severe. Get emergency medical assistance or call your doctor right away if you suffer any of the following side effects or those listed in the IMPORTANT WARNING SECTION:

  • Seizures
  • Problems with vision
  • Bruising
  • Bleeding
  • Light skin
  • Trouble breathing or swallowing, a rash, hives, itching, or swelling of the eyes, face, lips, tongue, or throat.
  • Breathing difficulty
  • Edoema in the lower legs, ankles, or foot
  • A sun-exacerbated rash on the arms and face
  • Feeling numb or tingly
  • Vision issues
  • Weakened back or legs
  • Dizziness
  • Pus-filled lumps or red, scaly spots on the skin

People who use etanercept injection products may be more likely than adults who don’t to develop cancers such as skin cancer, lymphoma, leukaemia (a cancer that starts in the white blood cells), and other cancers. Discuss the dangers of receiving etanercept injectable products with your doctor.

Further negative effects could be brought on by etanercept injectable products. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Do not freeze etanercept injectable products; instead, store them in the refrigerator. Products for injecting etanercept may be kept at room temperature if necessary. Find out how long your etanercept injection product can be kept at room temperature by speaking to your doctor or chemist. To protect them from light, keep etanercept injectable items in their original boxes. You can keep the etanercept solution, which you made by combining a vial of the powder with the supplied liquid, in the fridge for up to 14 days.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how well your body is responding to etanercept injectable products, your doctor may request specific lab tests.

Inform the lab staff and your doctor that you are using etanercept injectable products before to any laboratory test.

Do not share your medication with anybody else. Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Enbrel® (etanercept)
  • Erelzi® (etanercept-szzs)
  • Eticovo® (etanercep-ykro)
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