Description
Etanercept 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 injection is also used to treat juvenile idiopathic arthritis or juvenile psoriatic 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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of etanercept injection in children with juvenile idiopathic arthritis and active juvenile psoriatic 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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of etanercept injection in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving etanercept injection.
Breastfeeding
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.
Drug Interactions
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
- Adalimumab
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- 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
- 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 or
- Granulomatosis polyangiitis (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
This medicine is given as a shot under the skin of your thigh, stomach, or upper arm. Etanercept 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.
This medicine is available in 4 forms. You may use a prefilled Enbrel Mini™ cartridge through the AutoTouch™ reusable autoinjector, a prefilled syringe, a prefilled SureClick™ autoinjector, or a vial (glass container).
The needle cover on the prefilled syringe, SureClick™ autoinjector, and Enbrel Mini™ cartridge contains 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 autoinjector or syringe:
- Wash your hands with soap and water before and after using this medicine.
- Remove the carton with the syringe or autoinjector 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 the autoinjector cap while allowing the medicine to reach room temperature. Remove these immediately before use.
- Check the liquid in the syringe or autoinjector. It should be clear and colorless, and may have small white particles. If it is cloudy, discolored, or has large particles, do not use it.
- Check that the amount of liquid in the prefilled syringe falls between the two purple fill level indicator lines on the syringe. If the syringe does not have the right amount of liquid, do not use it.
- If the liquid is clear, place it on a clean, flat surface. Do not shake the medicine.
- Choose an injection site on your body (eg, thigh, abdomen or stomach area, or upper arm). 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.
- 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.
To use the Enbrel Mini™ cartridge using the AutoTouch™ reusable autoinjector:
- Wash your hands with soap and water before and after using this medicine.
- Allow 30 minutes for the cartridge to warm up to room temperature. Do not shake it.
- Do not remove the purple cap from Enbrel Mini™ while allowing the medicine to reach room temperature. Do not remove the cap unless the cartridge is inside the AutoTouch™ reusable autoinjector and you are ready to inject.
- Check the liquid in the Enbrel Mini™. It should be clear and colorless, and may have small white particles. If it is cloudy, discolored, or has large particles in it, do not use it.
- Do not use the Enbrel Mini™ if it looks cracked or broken, if the purple cap is missing or not securely attached, or if it has been dropped on a hard surface.
- Push the door button on the AutoTouch™ reusable autoinjector and insert the Enbrel Mini™ cartridge. It should slide freely and completely into the door.
- 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.
- Choose an injection site on your body (eg, thigh, stomach area, or upper arm).
- Remove the needle cap when you are ready to inject. Be sure to take note of the status button on the autoinjector.
- Use an alcohol wipe to clean the bottom (injection end) of the AutoTouch™ reusable autoinjector before and after each use. Do not store the AutoTouch™ in the refrigerator with Enbrel Mini™.
To use the vial:
- Wash your hands with soap and water before and after using this medicine.
- The vial of powder must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it. Do not shake the medicine after it has been mixed.
- Do not use the mixture if it is cloudy or has particles floating in it.
- If the liquid is clear, prepare your dose by filling the syringe with the proper amount from the vial. Attach a new needle to the syringe before you inject.
- Choose an injection site on your body (eg, thigh, stomach area, or upper arm). Clean the injection site with a fresh alcohol wipe and let it dry.
- 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.
- 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.
- If you are using one vial (container) for more than one dose, use the "Mixing Date" stickers from the dose kit to write the date you mixed the medicine. Attach the sticker to the vial.
- Put the unused mixture in the refrigerator right away. Do not mix the contents of one vial with another vial.
- Throw away any unused medicine after 14 days.
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 (prefilled autoinjector, prefilled cartridge, prefilled syringe, 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 and juvenile psoriatic 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. The dose is usually 0.8 milligram (mg) per kilogram (kg) of body weight, injected under the skin once a week.
- 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 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. The dose is usually 0.8 milligram (mg) per kilogram (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.
- 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 ankylosing spondylitis:
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 14 days (vial) or 30 days (prefilled autoinjector, syringe, or cartridge). 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 14 days (vial) or 30 days (prefilled autoinjector, syringe, or cartridge). Do not store the medicine in extreme heat or cold (including keeping it inside your vehicle's glove box or trunk).
Do not refrigerate the AutoTouch™ reusable autoinjector. Keep it at room temperature.
Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check you or your child's progress 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. 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.
While you are being treated with etanercept, 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. Be sure to ask your child's doctor if you have any questions about this.
This medicine may cause serious allergic reactions including anaphylaxis. This 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.
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 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.
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.
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). Some patients also developed a rare type of cancer called 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.
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 (CHF).
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
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
- Chills
- cough
- fever
- sneezing
- sore throat
Less common
- Chest tightness
- depression
- fast heartbeat
- frequent or painful urination
- itching, pain, redness, or swelling on the skin
- joint or muscle stiffness, tightness, or rigidity
- stomach discomfort or pain
Incidence not known
- Bladder pain
- blistering, peeling, or loosening of the skin
- bloody, black, or tarry stools
- blue-yellow color blindness
- blurred vision
- chest discomfort or pain
- cloudy or bloody urine
- confusion
- dark urine
- decreased urine output
- decreased vision
- diarrhea
- difficult, irregular, troubled, or labored breathing (or difficulty with breathing gets worse)
- difficulty with moving
- dilated neck veins
- double vision
- extreme fatigue
- eye pain
- feeling sad or empty
- fruit-like breath odor
- general feeling of discomfort, illness, or weakness
- generalized pain
- heartburn
- high blood pressure
- inability to move the arms, legs, or facial muscles
- indigestion
- irregular heartbeat
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness
- loss of consciousness
- muscle tenderness
- pain or discomfort in the arms, jaw, back, or neck
- pain, redness, or swelling in the arm or leg
- problems with bowel or bladder function
- red skin lesions, often with a purple center
- red, scaling, or crusted skin
- seizures
- severe and continuing nausea
- severe numbness, especially on one side of the face or body
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the face, fingers, feet, or lower legs
- tenderness
- trouble concentrating
- trouble sleeping
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weight loss
- yellow eyes or 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
- Loss of energy or weakness
- nausea
- pain or burning in the throat
- redness or itching, pain, or swelling at the injection site (under the skin)
- runny or stuffy nose
- stomach pain
- vomiting
Less common
- Bumps below the skin
- dry eyes
- dry mouth
- hair loss or thinning
- irritation or soreness of the mouth
- itching, redness, or tearing of the eye
- skin rash
Incidence not known
- Altered sense of taste
- burning, crawling, itching, numb, prickling, “pins and needles”, or tingling feelings
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- loss of appetite
- sweating
- weight gain
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.
CON-XXXXXXXX
