Erelzi Subcutaneous

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:

• Body aches or pain
• cough or hoarseness
• difficulty with breathing
• ear congestion
• fever or chills
• headache
• loss of voice
• lower back or side pain
• nasal congestion
• painful or difficult urination
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Difficulty with swallowing
• dizziness
• 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
• 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 fatigue
• eye pain
• feeling sad or depressed
• general feeling of illness
• headache
• 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
• 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

• 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 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

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:

• 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.

Etanercept is a tumor necrosis factor (TNF) blocker. It works by decreasing TNF, a protein produced by the immune system to helps the body fight infections. In people with autoimmune disorders, the immune system produces too much TNF and mistakenly attacks healthy cells.

Etanercept is used to treat rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, and to prevent joint damage caused by these conditions. Etanercept is also used to treat polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.

Etanercept is also used to treat plaque psoriasis in adults and children who are at least 4 years old.

Etanercept may also be used for purposes not listed in this medication guide.

Before you start treatment with etanercept, your doctor may perform tests to make sure you do not have an infection.

Etanercept is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

You may need to mix etanercept with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

A child who weighs less than 138 pounds may not be able to use certain forms of etanercept. If a child is using this medicine, tell your doctor if the child has any changes in weight.

Your care provider will show you the best places on your body to inject etanercept. Do not inject into the same place two times in a row. Avoid injecting into skin that is bruised, tender, red, or hard.

You may have pain, redness, swelling, or warmth where the medicine was injected. Call your doctor if these symptoms continue for longer than 5 days.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

A single-use prefilled syringe or injection pen is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Do not shake this medicine. Prepare your dose only when you are ready to give an injection. Do not use the medicine if it looks cloudy or has changed colors. Call your pharmacist for new medicine.

Etanercept can weaken your immune system. Your blood may need to be tested often.

If you have ever had hepatitis B, etanercept can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

If you need surgery, tell the surgeon ahead of time that you are using etanercept.

Store etanercept in its original carton in the refrigerator. Do not freeze. Do not use after the expiration date on the label has passed. After mixing etanercept with a diluent, store in the refrigerator and use within 14 days.

If you need to store etanercept at room temperature, protect the medicine from light and from extreme hot or cold temperatures. Once the medicine has reached room temperature, you should not put it back into the refrigerator.

Throw away any Enbrel not used within 14 days. Throw away any Erelzi not used within 28 days.

Call your doctor for instructions if you miss a dose of etanercept.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

50 mg subcutaneously once a week

Comments:
-Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.
-Doses higher than 50 mg per week are not recommended.

Uses:
-Rheumatoid Arthritis: To reduce symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). This drug can be used alone or in combination with methotrexate (MTX).
-Ankylosing Spondylitis: To reduce symptoms in patients with active ankylosing spondylitis (AS).
-Psoriatic Arthritis: To reduce symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). This drug can be used alone or in combination with methotrexate (MTX).

4 years and older:
-Less than 63 kg: 0.8 mg/kg subcutaneously once a week
-Greater than or equal to 63 kg: 50 mg subcutaneously once a week
-Maximum: 50 mg subcutaneously once a week

Comments:
-Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.

Use: For the treatment of patients 4 years and older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Administration advice:
-This drug may be injected into the thigh, abdomen or upper arm, at least 3 cm from an old site and not where the skin is tender, bruised, red, or hard.
-Injection sites should be rotated.
-Patients should be instructed and assessed on self-administration techniques and the importance of proper syringe and needle disposal if they are to self-administer.
-Prefilled syringes and auto-injector should be allowed to reach room temperature prior to injection.

Storage requirements:
-Consult the manufacturer product information.

Reconstitution/preparation techniques:
-Consult the manufacturer product information.

Monitoring:
-Infections: Patients should be evaluated before, during, and after treatment.
-Full blood counts should be obtained in patients with a history of blood dyscrasias or symptoms suggestive of blood dyscrasias.
-Periodic skin examinations should be performed in all patients at an increased risk for skin cancer.
-Blood glucose levels should be monitored in diabetic patients.

General:
-Therapy should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or pediatric plaque psoriasis.
-This drug may be used in combination with methotrexate if necessary. No apparent interactions have been documented with concurrent use of glucocorticoids, nonsteroidal anti-inflammatory agents, or analgesics.
-Patients should be instructed to call their doctor immediately if they develop symptoms such as persistent fever, bruising, bleeding, or paleness.
-If possible, pediatric patients should be up to date with all immunizations prior to commencing therapy.
-Patients exposed to the varicella virus should temporarily stop therapy and be considered for prophylactic varicella zoster immune globulin therapy.