Etanercept-szzs (Subcutaneous route)
ee-TAN-er-sept - szzs
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 .
Uses of This Medicine:
Etanercept-szzs injection is used 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 plaque psoriasis or a condition known as ankylosing spondylitis.
Etanercept-szzs is also used in children 2 years of age and older for polyarticular juvenile idiopathic arthritis.
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:
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.
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. Safety and efficacy have not been established for children younger than 2 years of age.
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.
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.
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.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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
- Infections (eg, hepatitis B, bacteria, fungus, virus), active or history of or
- Tuberculosis, active or history of or
- Weak immune system (eg, HIV/AIDS) or
- Wegener's granulomatosis (inflammation of the blood vessels that affects the lungs, kidneys, or other organs)—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 your skin. Etanercept-szzs may be given at home. 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 2 forms. You may use a prefilled syringe and a prefilled Sensoready® pen.
The needle cap on the prefilled syringe and the internal needle cover within the cap of 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.
- 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 immediately 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, do not use it.
- Choose an injection site on your body (eg, thigh, lower abdomen 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 that are red, bruised, tender, or hard.
- 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.
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 or Sensoready® pen):
- 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—Use and dose 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 two 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—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.
- For juvenile idiopathic arthritis:
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.
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.
You may store the prefilled syringe or pen at room temperature, for up to 28 days. 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. Do not freeze. Do not store the medicine in extreme heat or cold such as in your vehicle's glove box or trunk.
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 any of the following symptoms while using this medicine: a 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 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.
A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer (eg, leukemia, 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.
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 more than one of these symptoms: shortness of breath, 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. Anaphylaxis 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.
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:
- More common
- Body aches or pain
- cough or hoarseness
- difficulty with breathing
- ear congestion
- fever or chills
- loss of voice
- lower back or side pain
- nasal congestion
- painful or difficult urination
- runny nose
- sore throat
- unusual tiredness or weakness
- Less common or rare
- Difficulty with swallowing
- fast heartbeat
- hives, itching, or rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tightness in the chest
- Back pain, sudden and severe
- black, tarry stools
- 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 fatigue
- eye pain
- feeling sad or depressed
- general feeling of illness
- high fever
- inability to move the arms and legs
- irregular breathing
- irregular heartbeat
- muscle aches or cramps
- muscle weakness, sudden and progressing
- numbness or tingling in your arms, fingers, legs, feet, or face
- pale skin
- 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
- general tiredness and weakness
- joint or muscle pain
- light-colored stools
- mole that leaks fluid or bleeds
- nausea and vomiting
- new mole
- red skin lesions, often with a purple center
- red, irritated eyes
- sore throat
- troubled breathing with exertion
- upper right abdominal or stomach pain
- 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
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:
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:
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.
Last Updated: 9/4/2017