Erelzi (Subcutaneous)

Generic name: etanercept [ ee-TAN-er-sept ]
Brand names: Enbrel, Erelzi, Eticovo
Drug classes: Antirheumatics, TNF alfa inhibitors

Medically reviewed by Drugs.com. Last updated on Apr 7, 2024.

Subcutaneous route(Solution;Powder for Solution)

Serious Infections: Patients treated with etanercept are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Etanercept should be discontinued if a patient develops a serious infection or sepsis.

Reported Infections include: (1) Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before etanercept use and during therapy. Initiate treatment for latent infection prior to etanercept use. (2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. (3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with etanercept should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with etanercept, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Malignancies: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including etanercept .

Subcutaneous route(Solution)

Patients treated with etanercept products are at increased risk for infections, some progressing to serious infections leading to hospitalization or death. These infections have included bacterial sepsis, tuberculosis, invasive fungal and other opportunistic infections, including Legionella and Listeria. Evaluate for latent tuberculosis and treat if necessary prior to initiation of therapy. Discontinue etanercept-szzs if a serious infection or sepsis occurs during treatment. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including etanercept products .

Subcutaneous route(Solution)

Serious Infections

Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.

Etanercept-ykro should be discontinued if a patient develops a serious infection or sepsis during treatment.

Perform test for latent TB; if positive, start treatment for TB prior to starting etanercept-ykro.

Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

Malignancies

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including etanercept products .

Uses for Erelzi

Etanercept injection is used alone or with other medicines (eg, methotrexate) to reduce signs and symptoms of rheumatoid arthritis or psoriatic arthritis, such as joint swelling, pain, tiredness, and duration of morning stiffness. It may also be used to treat a condition known as ankylosing spondylitis.

Etanercept injection is also used to treat juvenile idiopathic arthritis or juvenile psoriatic arthritis. It is also used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments.

This medicine is available only with your doctor's prescription.

Before using Erelzi

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of etanercept injection in children with juvenile idiopathic arthritis and active juvenile psoriatic arthritis younger than 2 years of age and in children with psoriasis younger than 4 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of etanercept injection in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving etanercept injection.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abatacept
Adenovirus Vaccine
Anakinra
Anifrolumab-fnia
Bacillus of Calmette and Guerin Vaccine, Live
Baricitinib
Cholera Vaccine, Live
Cyclophosphamide
Dengue Tetravalent Vaccine, Live
Infliximab
Influenza Virus Vaccine, Live
Measles Virus Vaccine, Live
Mumps Virus Vaccine, Live
Poliovirus Vaccine, Live
Rilonacept
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Smallpox Vaccine
Typhoid Vaccine, Live
Varicella Virus Vaccine, Live
Vedolizumab
Yellow Fever Vaccine
Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper use of Erelzi

This medicine is given as a shot under the skin of your thigh, stomach, or upper arm. Etanercept may sometimes be given at home to patients who do not need to be in the hospital. If you or your child are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand exactly how to use the medicine.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

This medicine is available in 4 forms. You may use a prefilled Enbrel Mini™ cartridge through the AutoTouch™ reusable autoinjector, a prefilled syringe, a prefilled SureClick™ autoinjector, or a vial (glass container).

The needle cover on the prefilled syringe, SureClick™ autoinjector, and Enbrel Mini™ cartridge contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you start using this medicine.

To use the autoinjector or syringe:

Wash your hands with soap and water before and after using this medicine.
Remove the carton with the syringe or autoinjector from the refrigerator and place it on a clean cloth.
Allow 15 to 30 minutes for the syringe or autoinjector to warm up to room temperature.
Do not remove the needle cover on the prefilled syringe or the autoinjector cap while allowing the medicine to reach room temperature. Remove these immediately before use.
Check the liquid in the syringe or autoinjector. It should be clear and colorless, and may have small white particles. If it is cloudy, discolored, or has large particles, do not use it.
Check that the amount of liquid in the prefilled syringe falls between the two purple fill level indicator lines on the syringe. If the syringe does not have the right amount of liquid, do not use it.
If the liquid is clear, place it on a clean, flat surface. Do not shake the medicine.
Choose an injection site on your body (eg, thigh, abdomen or stomach area, or upper arm). Clean the injection site with a fresh alcohol wipe and let it dry.
Remove the cap or needle cover when you are ready to inject.
Do not inject into skin areas where the skin is tender, bruised, red, hard, thick, scaly, has scars or stretch marks, or affected by psoriasis.
Throw away used needles in a hard, closed container (puncture-resistant) that the needles cannot poke through. Keep this container away from children and pets.

To use the Enbrel Mini™ cartridge using the AutoTouch™ reusable autoinjector:

Wash your hands with soap and water before and after using this medicine.
Allow 30 minutes for the cartridge to warm up to room temperature. Do not shake it.
Do not remove the purple cap from Enbrel Mini™ while allowing the medicine to reach room temperature. Do not remove the cap unless the cartridge is inside the AutoTouch™ reusable autoinjector and you are ready to inject.
Check the liquid in the Enbrel Mini™. It should be clear and colorless, and may have small white particles. If it is cloudy, discolored, or has large particles in it, do not use it.
Do not use the Enbrel Mini™ if it looks cracked or broken, if the purple cap is missing or not securely attached, or if it has been dropped on a hard surface.
Push the door button on the AutoTouch™ reusable autoinjector and insert the Enbrel Mini™ cartridge. It should slide freely and completely into the door.
Do not inject into skin areas where the skin is tender, bruised, red, hard, thick, scaly, has scars or stretch marks, or affected by psoriasis.
Choose an injection site on your body (eg, thigh, stomach area, or upper arm).
Remove the needle cap when you are ready to inject. Be sure to take note of the status button on the autoinjector.
Use an alcohol wipe to clean the bottom (injection end) of the AutoTouch™ reusable autoinjector before and after each use. Do not store the AutoTouch™ in the refrigerator with Enbrel Mini™.

To use the vial:

Wash your hands with soap and water before and after using this medicine.
The vial of powder must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it. Do not shake the medicine after it has been mixed.
Do not use the mixture if it is cloudy or has particles floating in it.
If the liquid is clear, prepare your dose by filling the syringe with the proper amount from the vial. Attach a new needle to the syringe before you inject.
Choose an injection site on your body (eg, thigh, stomach area, or upper arm). Clean the injection site with a fresh alcohol wipe and let it dry.
Do not inject into skin areas where the skin is tender, bruised, red, hard, thick, scaly, has scars or stretch marks, or affected by psoriasis.
Throw away used needles in a hard, closed container (puncture-resistant) that the needles cannot poke through. Keep this container away from children and pets.
If you are using one vial (container) for more than one dose, use the "Mixing Date" stickers from the dose kit to write the date you mixed the medicine. Attach the sticker to the vial.
Put the unused mixture in the refrigerator right away. Do not mix the contents of one vial with another vial.
Throw away any unused medicine after 14 days.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage forms (prefilled autoinjector, prefilled cartridge, prefilled syringe, or vial):
- For ankylosing spondylitis:
  - Adults—50 milligrams (mg) injected under the skin once a week.
  - Children—Use and dose must be determined by your doctor.
- For juvenile idiopathic arthritis and juvenile psoriatic arthritis:
  - Children 2 years of age and older weighing 63 kilograms (kg) or more—50 milligrams (mg) injected under the skin once a week.
  - Children 2 years of age and older weighing less than 63 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.8 milligram (mg) per kilogram (kg) of body weight, injected under the skin once a week.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For plaque psoriasis:
  - Adults—At first, 50 milligrams (mg) injected under the skin 2 times a week for 3 months. Then, a maintenance dose of 50 mg injected under the skin once a week. Some patients may receive a starting dose of 25 or 50 mg per week.
  - Children 4 years of age and older weighing 63 kilograms (kg) or more—50 mg injected under the skin once a week.
  - Children 4 years of age and older weighing less than 63 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.8 milligram (mg) per kilogram (kg) of body weight injected under the skin once a week.
  - Children younger than 4 years of age or weighing less than 63 kg—Use and dose must be determined by your doctor.
- For rheumatoid arthritis and psoriatic arthritis:
  - Adults—50 milligrams (mg) injected under the skin once a week with or without methotrexate.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect the medicine from direct light. Keep your medicine in the original package until you are ready to use it.

Keep this medicine in its original container. You may also store the medicine at room temperature for up to 14 days (vial) or 30 days (prefilled autoinjector, syringe, or cartridge). Do not put it back in the refrigerator once it has reached room temperature. Throw away any unused medicine that has been stored at room temperature after 14 days (vial) or 30 days (prefilled autoinjector, syringe, or cartridge). Do not store the medicine in extreme heat or cold (including keeping it inside your vehicle's glove box or trunk).

Do not refrigerate the AutoTouch™ reusable autoinjector. Keep it at room temperature.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions while using Erelzi

It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Your body's ability to fight infection may be reduced while you are being treated with etanercept. It is very important that you call your doctor at the first signs of any infection. Check with your doctor right away if you or your child have fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.

While you are being treated with etanercept, do not have any immunizations (vaccines) without your doctor's approval. Your child's vaccines need to be current before he or she begins using etanercept. Be sure to ask your child's doctor if you have any questions about this.

This medicine may cause serious allergic reactions including anaphylaxis. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

You or your child will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

This medicine may increase your risk of having a lupus-like syndrome or autoimmune hepatitis. Check with your doctor right away if you or your child have a fever or chills, a general feeling of discomfort, illness, or weakness, light-colored stools, nausea, vomiting, upper right-sided abdominal or stomach pain, or yellow eyes and skin.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in your mouth or lips, or unusual tiredness or weakness.

Serious nervous system problems, including Guillain-Barré syndrome, multiple sclerosis, demyelinating disease, and seizures have occurred rarely in people using this medicine. Talk with your doctor if you have concerns about this.

A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer (eg, leukemia, lymphoma, skin cancer). Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you or your child have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

Check with your doctor right away if you have trouble breathing, swelling of the face, fingers, feet, or lower legs, or sudden weight gain. These may be signs of a heart condition called congestive heart failure (CHF).

Do not take other medicines unless they have been discussed with your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), or cyclophosphamide (Cytoxan®). Using any of them together with this medicine may increase your risk of having serious side effects.

Side Effects of Erelzi

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chills
cough
fever
sneezing
sore throat

Less common

Chest tightness
depression
fast heartbeat
frequent or painful urination
itching, pain, redness, or swelling on the skin
joint or muscle stiffness, tightness, or rigidity
stomach discomfort or pain

Incidence not known

Bladder pain
blistering, peeling, or loosening of the skin
bloody, black, or tarry stools
blue-yellow color blindness
blurred vision
chest discomfort or pain
cloudy or bloody urine
confusion
dark urine
decreased urine output
decreased vision
diarrhea
difficult, irregular, troubled, or labored breathing (or difficulty with breathing gets worse)
difficulty with moving
dilated neck veins
double vision
extreme fatigue
eye pain
feeling sad or empty
fruit-like breath odor
general feeling of discomfort, illness, or weakness
generalized pain
heartburn
high blood pressure
inability to move the arms, legs, or facial muscles
indigestion
irregular heartbeat
joint or muscle pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lightheadedness
loss of consciousness
muscle tenderness
pain or discomfort in the arms, jaw, back, or neck
pain, redness, or swelling in the arm or leg
problems with bowel or bladder function
red skin lesions, often with a purple center
red, scaling, or crusted skin
seizures
severe and continuing nausea
severe numbness, especially on one side of the face or body
sores, ulcers, or white spots on the lips or in the mouth
swelling of the face, fingers, feet, or lower legs
tenderness
trouble concentrating
trouble sleeping
unexplained weight loss
unusual bleeding or bruising
unusual tiredness or weakness
vomiting of blood or material that looks like coffee grounds
weight loss
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Loss of energy or weakness
nausea
pain or burning in the throat
redness or itching, pain, or swelling at the injection site (under the skin)
runny or stuffy nose
stomach pain
vomiting

Less common

Bumps below the skin
dry eyes
dry mouth
hair loss or thinning
irritation or soreness of the mouth
itching, redness, or tearing of the eye
skin rash

Incidence not known

Altered sense of taste
burning, crawling, itching, numb, prickling, “pins and needles”, or tingling feelings
feeling faint, dizzy, or lightheaded
feeling of warmth or heat
flushing or redness of the skin, especially on the face and neck
loss of appetite
sweating
weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.