Etanercept-ykro (Subcutaneous)

Etanercept-ykro injection is used by itself or with other medicines (like methotrexate) to help reduce signs and symptoms of active arthritis, rheumatoid arthritis, or psoriatic arthritis. This includes issues like joint swelling, pain, tiredness, and morning stiffness. This medicine may also help slow down the damage caused by active arthritis or rheumatoid arthritis. It can also be used to treat a condition called ankylosing spondylitis.

Etanercept-ykro is also used in children 2 years and older for juvenile idiopathic arthritis. It is used to treat moderate to severe plaque psoriasis in patients 4 years and older who may benefit from receiving 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 you or your child's progress during regular visits to ensure 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 lowered while you are being treated with etanercept-ykro. It is very important that you call your doctor at the first signs of any infection. Contact your doctor immediately 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 get any immunizations (vaccines) without your doctor's approval. Your child's vaccines need to be up to date before he or she starts 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. Contact your doctor immediately if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the medicine.

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.

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

This medicine may increase the risk for cancer (e.g., 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, contact your doctor right away if your skin has red, scaly patches, or raised bumps filled with pus.

Contact your doctor immediately 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 developing a lupus-like syndrome or autoimmune hepatitis. Contact 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 yellowing of the eyes and skin.

Serious skin reactions can occur during treatment with this medicine. Contact your doctor immediately 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 these medicines together 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 may provide. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any strange or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been adequate studies on how etanercept-ykro injection affects children with juvenile idiopathic arthritis who are younger than 2 years old and children with psoriasis who are younger than 4 years old. Safety and effectiveness have not been confirmed for these age groups.

Geriatric

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

Breast Feeding

There are no sufficient studies in women to determine the risk to infants using this medication while breastfeeding. Consider the potential benefits and risks before using this medication if you are breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in some cases, two different medicines may be used at the same time even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. It is especially 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 for their importance and may not include all possible interactions.

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, your doctor may change the dose or how often you take 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

Some medicines should not be taken around the time of eating food or certain types of food as interactions may occur. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, 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 worsen these conditions.

• Cancer, history of or
• Diabetes or
• Granulomatosis with polyangiitis (inflammation of the blood vessels affecting the lungs, kidneys, or other organs) or
• Immune system disease, history of or
• Infections (e.g., hepatitis B, bacteria, fungus, virus), active or history of or
• Tuberculosis, active or history of—Patients with these conditions may have a higher risk of 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.

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

Contact your doctor right away if any of the following side effects happen:

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. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Eticovo

Pharmacologic Class: Etanercept

Find detailed information on biosimilars for this medication.

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.

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