Pronunciation:

ee-TAN-er-sept - szzs

Brand Names:

• Erelzi

Warnings:

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 .

Classifications:

Pharmacologic—

Etanercept

Uses of This Medicine:

Etanercept-szzs 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-szzs injection is also used to treat polyarticular juvenile idiopathic 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 This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of etanercept-szzs injection in children with juvenile idiopathic 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.

Older adults—

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

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.

Other 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

Other interactions—

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.

Other medical problems—

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

• Alcoholic hepatitis, moderate to severe or
• Blood or bone marrow problems (eg, aplastic anemia, low white blood cells), history of or
• Congestive heart failure, history of or
• Nervous system problems (eg, 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 (eg, hepatitis B, bacteria, fungus, virus), active or history of or
• Tuberculosis, active or history of or
• Weak immune system (eg, HIV/AIDS)—Patients with these conditions may have an increased chance for side effects.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child 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-szzs. 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.

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

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). 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 or your child's skin has red, scaly patches, or raised bumps that are filled with pus.

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.

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.

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

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.

While you are being treated with etanercept-szzs, 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-szzs. Be sure to ask your child's doctor if you have any questions about this.

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 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 yellow eyes and skin.

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 This Medicine:

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

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. 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

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.