Erelzi (Subcutaneous)

Etanercept-szzs injection is used by itself or with other medicines (like methotrexate) to lessen signs and symptoms of rheumatoid arthritis or psoriatic arthritis, including joint swelling, pain, tiredness, and how long morning stiffness lasts. It may also be used to treat a condition called ankylosing spondylitis.

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

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

It is very important for your doctor to check how you or your child are doing at regular visits to ensure that this medicine is effective. You may need blood tests to look for side effects.

While being treated with etanercept-szzs, your body's ability to fight infections may be weakened. It is crucial that you contact your doctor at the first signs of an infection. Call your doctor immediately 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.

Before starting this medicine, you or your child will need a skin test for tuberculosis. Inform your doctor if you or anyone in your household has ever had a positive reaction to a tuberculosis skin test.

A small number of individuals (including children and teenagers) who have used this medicine have developed certain types of cancer (e.g., leukemia, lymphoma, skin cancer). Speak with your doctor if you or your child experience unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, contact your doctor immediately if you or your child's skin has red, scaly patches, or raised bumps filled with pus.

Serious nervous system issues, such as Guillain-Barré syndrome, multiple sclerosis, demyelinating disease, and seizures have occurred rarely in people taking this medicine. Discuss any concerns you have with your doctor.

Contact your doctor immediately if you have difficulty breathing, swelling of the face, fingers, feet, or lower legs, or sudden weight gain. These could be signs of a heart condition called congestive heart failure.

This medicine can cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child experience a rash, itching, swelling of the face, tongue, and throat, trouble breathing or swallowing, or chest pain after receiving the medicine.

Serious skin reactions can happen while using this medicine. Contact your doctor immediately 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.

While being treated with etanercept-szzs, do not get any immunizations (vaccines) without your doctor's approval. Your child's vaccines must be up to date before starting etanercept-szzs. Ask your child's doctor if you have any questions about this.

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

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

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it might provide. Here are some important things to consider for this medicine:

Allergies

Let your doctor know if you have ever had any strange or allergic reactions to this medicine or any other medicines. Also, inform your health care professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. If you are using non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies on how etanercept-szzs injection affects children with juvenile idiopathic arthritis younger than 2 years old and children with psoriasis younger than 4 years old. Safety and effectiveness for these age groups have not been established.

Geriatric

Studies so far have not found any specific problems in elderly patients that would limit the use of etanercept-szzs injection. However, older patients are more likely to have infections, which may require caution when using etanercept-szzs.

Breast Feeding

There are not enough studies to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before taking this medication while nursing.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been chosen based on their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both 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 around the time of eating food or certain types of food because interactions may occur. Drinking alcohol or using tobacco with some medicines can also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Alcoholic hepatitis, moderate to severe or
• Blood or bone marrow problems (e.g., aplastic anemia, low white blood cells), history of or
• Congestive heart failure, history of or
• Nervous system problems (e.g., Guillain-Barré syndrome, multiple sclerosis, demyelinating disease) or
• Optic neuritis (inflammation of the eye nerve) or
• Psoriasis (skin disease) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Cancer, history of or
• Diabetes or
• Granulomatosis with polyangiitis (inflammation of the blood vessels that affects the lungs, kidneys, or other organs) or
• Infections (e.g., hepatitis B, bacteria, fungus, virus), active or history of or
• Tuberculosis, active or history of or
• Weak immune system (e.g., HIV/AIDS)—Patients with these conditions may have a higher chance of side effects.

• Sepsis (serious infection in the blood)—Should not be used in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

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

More common

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• hoarseness
• loss of voice
• lower back or side pain
• painful or difficult urination
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Chest tightness
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Rare

• Back pain, sudden and severe
• black, tarry stools
• blindness
• bloody, black, or tarry stools
• blue-yellow color blindness
• blurred vision
• chest pain
• decreased urine output
• decreased vision
• difficulty controlling your bladder or bowels
• difficulty with walking
• dilated neck veins
• extreme tiredness or weakness
• eye pain
• feeling sad or depressed
• general feeling of illness
• high fever
• inability to move the arms and legs
• irregular breathing or heartbeat
• muscle aches or cramps
• muscle weakness, sudden and progressing
• numbness or tingling in your arms, fingers, legs, feet, or face
• pale skin
• seizures
• slurred speech
• sores, ulcers, or white spots on the lips or in the mouth
• sudden numbness and weakness in the arms and legs
• swelling of the face, fingers, feet, or lower legs
• swollen or painful glands
• unusual bleeding or bruising
• weight gain or loss
• yellow skin and eyes

Incidence not known

• Blistering, peeling, or loosening of the skin
• bone pain
• change in size, shape, or color of existing mole
• dark urine
• diarrhea
• general tiredness and weakness
• joint or muscle pain
• light-colored stools
• mole that leaks fluid or bleeds
• nausea
• new mole
• red, irritated eyes
• red skin lesions, often with a purple center
• sore throat
• trouble breathing
• upper right abdominal or stomach pain
• vomiting

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. 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

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.

In the U.S.

• Erelzi

Pharmacologic Class: Etanercept

Find detailed information on biosimilars for this medication.

This medicine is given as a shot under the skin of your thigh, stomach, or upper arm. Etanercept-szzs 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 the 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 3 forms. You may use a prefilled syringe, prefilled Sensoready® pen, or a vial.

The needle cap on the prefilled syringe and the internal needle cover within the cap of the Sensoready® pen contain 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 prefilled syringe or pen:

• Wash your hands with soap and water before and after using this medicine.
• Remove the carton with the syringe or pen 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 pen while allowing the medicine to reach room temperature. Remove this just before use. Do not shake the medicine.
• Check the liquid in the syringe or pen. It should be clear and colorless to slightly yellow, and may have small white particles. If it is cloudy, discolored, or has large particles in it, do not use it.
• Choose an injection site on your body (eg, thigh, upper arms, or stomach area). 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.
• When using the Sensoready® Pen, the window in the pen turns green when the injection is complete. After removing the Sensoready® Pen, if the window has not turned green, or if it looks like the medicine is still injecting, it means you have not received a full dose. Call your doctor right away if this happens.

To use the vial:

• Use free-hand method for children who are using one vial for more than one dose.
• Wash your hands with soap and water before and after using this medicine.
• Remove the pink plastic cap from the vial. Do not remove the gray stopper or silver metal ring. Write the mixing date.
• Attach the plunger into the gray rubber stopper in the syringe by turning it clockwise.
• Turn the twist-off cap counter-clockwise. Do not touch the plunger and syringe tip.
• Push the plunger down slowly until all the liquid from the syringe is in the vial. Do not add the liquid too fast as it will cause foaming.
• Gently swirl the vial in a circular motion to dissolve the powder. Do not shake. Wait until all the powder is completely dissolved (usually less than 10 minutes).
• Check the liquid in the vial. It should be clear and colorless. All powder must be fully dissolved. Do not use the medicine if the liquid is discolored, or has lumps, flakes, or particles in it.
• Use a new needle and syringe each time you inject your medicine.

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 form (prefilled syringe, Sensoready® pen, 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: 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. 0.8 milligram per kilogram (mg/kg) of body weight injected under the skin once a week. Children younger than 2 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. For plaque psoriasis: Adults—At first, 50 milligrams (mg) injected under the skin two 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. 0.8 milligram per kilogram (mg/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.

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 28 days (prefilled syringe or pen) or 31 days (vial). 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 28 days (prefilled syringe or pen) or 31 days (vial). Do not store the medicine in extreme heat or cold (including keeping it inside your vehicle's glove box or trunk).

Vial: You may use the mixed liquid right away or keep it in the refrigerator for up to 14 days.

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

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