Pronunciation:

ee-TAN-er-sept - ykro

Brand Names:

• Eticovo

Warnings:

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

Classifications:

Pharmacologic—

Etanercept

Uses of This Medicine:

Etanercept-ykro injection is used alone or together with other medicines (eg, methotrexate) to reduce signs and symptoms of active arthritis, rheumatoid arthritis, or psoriatic arthritis, such as joint swelling, pain, tiredness, and duration of morning stiffness. This medicine may also slow the progression of damage to the body from active arthritis or rheumatoid arthritis. It may also be used to treat a condition known as ankylosing spondylitis.

Etanercept-ykro is also used in children 2 years of age and older for juvenile idiopathic arthritis. It is also used to treat moderate to severe plaque psoriasis in patients 4 years of age and older 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-ykro 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 in these age groups.

Older adults—

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

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
• Disease of the immune system, history of or
• Infections (eg, hepatitis B, bacteria, fungus, virus), active or history of or
• Tuberculosis, active or history of—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.

• Varicella zoster (chickenpox) infection—Should be treated first before using this medicine.

Proper Use of This Medicine:

This medicine is given as a shot under the skin of your thighs, stomach, or upper arms. Etanercept-ykro 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. Do not inject into skin areas that are red, hard, bruised, tender, thick, or scaly, in areas with scars or stretch marks, or in areas affected by psoriasis.

Allow the medicine to come to room temperature for at least 30 minutes before you use it. Do not warm it in any other way.

Check the liquid in the prefilled syringe. It should be colorless or slightly yellow and may contain small, white or almost clear particles. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it that are not small, white or almost clear. Do not shake.

Do not remove the needle cap from the prefilled syringe until you are ready to use it.

Use a new needle and syringe each time you inject your medicine.

You might not use all of the medicine in each prefilled syringe. Use each prefilled syringe only one time. Do not save an open syringe.

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 (solution):
  • 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.
    • 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 per week, given 3 or 4 days apart, for 3 months. Then, your dose will be reduced to 50 mg once a week.
    • Children 4 years of age and older weighing 63 kilograms (kg) or more—50 milligrams (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.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
  • For rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis:
    • Adults—50 milligrams (mg) injected under the skin once a week.
    • 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.

You may also store the medicine at room temperature, away from heat and light for 14 days. Do not return it back to the refrigerator once kept at room temperature. Throw away any unused medicine after 14 days. Do not store the prefilled syringe in extreme heat or cold, including keeping it in your vehicle's glove box or trunk.

Throw away used needles in a hard, closed container that 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 you or your child's progress at regular visitsto 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-ykro. 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 any of the following symptoms while using this medicine: 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-ykro, 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-ykro. Be sure to ask your child's doctor if you have any questions about this.

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, 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.

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.

This medicine may increase the risk for cancer (eg, leukemia, lymphoma, melanoma). 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 more than one of these symptoms: 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).

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 any of the following symptoms while using this medicine: 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.

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 in breathing

ear congestion

fever

headache

loss of voice

sneezing

sore throat

stuffy or runny nose

unusual tiredness or weakness

Less common

Accumulation of pus

chest pain

confusion

cough producing mucus

diarrhea

dizziness

fainting

fast heartbeat

frequent or painful urination

hives or welts, itching, skin rash

hoarseness

increase in bone pain

irritation

itching, pain, redness, swelling, tenderness, or warmth on the skin

joint pain, stiffness, or swelling

lightheadedness

loss of appetite

nausea

rapid, shallow breathing

redness of the skin

stomach pain

swelling of the eyelids, face, lips, hands, or feet

swollen, red, or tender area of infection

tightness in the chest

trouble with swallowing

Rare

Rectal bleeding

severe diarrhea

severe stomach pain

Incidence not known

Back pain, sudden and severe

being forgetful

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

blue-yellow color

blindness

blurred vision or other change in vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in size, shape, or color of existing mole

dark urine

decreased urine output

difficulty controlling your bladder or bowels

difficulty walking

dilated neck veins

extreme tiredness or weakness

eye pain, redness, or tenderness

feeling sad or depressed

general feeling of discomfort, illness, or weakness

high fever

increased tearing

irregular breathing

irregular heartbeat

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

light-colored stools

mole that leaks fluid or bleeds

muscle cramps or pain

muscle weakness, sudden and progressing

new mole

painful blisters on the trunk of the body

pale skin

pinpoint red spots on the skin

red skin lesions, often with a purple center

red, irritated eyes

seizures

sensitivity of the eye or skin to light

severe eye pain

slurred speech

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

swollen, painful, or tender lymph glands in the neck, armpit, or groin

troubled breathing with exertion

unexplained bleeding or bruising

upper right abdominal pain

vomiting

weight gain

yellow eyes and 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

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.