Enbrel

Enbrel (Etanercept) is given by subcutaneous (under the skin) injection, usually in the front of the thigh, upper arm, or abdomen. The recommended dose depends on the condition being treated.

• For adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, the recommended dose is 50 mg once a week injected under the skin.
• For adults with plaque psoriasis, the initial recommended dose is 50 mg twice weekly (3 or 4 days apart) injected under the skin. After the first 3 months of treatment, the dose can be reduced to 50 mg once weekly.
• For children aged 4 to 17 with juvenile idiopathic arthritis or psoriatric arthritis, the dose is based on body weight and should not exceed 50 mg per week.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use Enbrel (Etanercept) exactly as prescribed by your doctor. If you miss a dose of Enbrel (Etanercept), contact your doctor to find out when to take the next dose. Do not administer a double dose to make up for a missed one.

Enbrel (Etanercept) is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparing and injecting your first dose (or first few doses). Do not attempt to prepare or inject Enbrel (Etanercept) on your own until you completely understand how to mix and inject a dose. If you are having difficulty giving yourself injections, talk to your health care provider.

Single-use prefilled syringes should be stored in the refrigerator at 2°C to 8°C, protected from light, and kept out of the reach of children. Do not freeze or shake. Remove the medication from the refrigerator and allow it to warm to room temperature before injecting it. This takes approximately 15 to 30 minutes.

Vials should be should be stored in the refrigerator at 2°C to 8°C and kept out of the reach of children. Do not freeze. Once mixed, vials should be stored in the refrigerator at 2°C to 8°C for up to 14 days.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause stomach ache; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause nausea or, rarely, vomiting; it may cause redness and swelling at the injection site; it may cause a cough. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Multiple-use Vials

Each vial contains a sterile, white, preservative-free lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection (BWFI), USP (containing 0.9% benzyl alcohol) yields a multiple-use, clear, and colourless solution with a pH of 7.4±0.3 containing 25 mg of Enbrel (Etanercept). Nonmedicinal ingredients: mannitol, sucrose, and tromethamine.

Cartons of 4 dose trays. Each dose tray contains one 25 mg vial of Enbrel (Etanercept), one diluent syringe (1 mL Sterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27-gauge needle, one vial adapter, and one plunger. Each carton contains 4 "Mixing Date:" stickers. A single-dose replacement tray is available, if needed.

Single-use Pre-filled Syringes

Each single-use pre-filled syringe contains 0.98 mL (minimum deliverable volume of 0.94 mL) of a 50 mg/mL clear and colourless, formulated at pH 6.3±0.2 solution of Enbrel (Etanercept). There may be small white particles of protein in the solution. Nonmedicinal ingredients: L-arginine hydrochloride, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and sucrose. Preservative-free.

Cartons of 4 single-dose pre-filled syringes with a 27-gauge needle. A single syringe replacement carton is available if needed. Administration of one 50 mg/mL prefilled syringe of Enbrel (Etanercept) provides a dose equivalent to two 25 mg vials of lyophilized Enbrel (Etanercept), when vials are reconstituted and administered as recommended.

Single-use Pre-filled SureClick Autoinjector

Each single-use use pre-filled SureClick autoinjector contains 0.98 mL (minimum deliverable volume of 0.94 mL) of a 50 mg/mL clear and colourless, formulated at pH 6.3±0.2 solution of Enbrel (Etanercept). There may be small white particles of protein in the solution. Nonmedicinal ingredients: L-arginine hydrochloride, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and sucrose. Preservative-free.

Cartons of 4 SureClick autoinjectors. A single autoinjector replacement carton is available if needed. Administration of one 50 mg/mL Enbrel (Etanercept) SureClick autoinjector provides a dose equivalent to two 25 mg vials of lyophilized Enbrel (Etanercept), when vials are reconstituted and administered as recommended.

Do not use Enbrel (Etanercept) if you:

• are allergic to Enbrel (Etanercept) or any ingredients of the medication
• are allergic to latex (the needle cap on the pre-filled syringe contains a derivative of latex; if you know you are allergic to latex, talk to your health care provider before using the pre-filled SureClick autoinjector)
• have or are at risk of sepsis syndrome (an infection that spreads through your body), for example if you have a weakened immune system (e.g., are receiving chemotherapy) or HIV

Do not give Enbrel (Etanercept) to children less than 4 years of age.

There may be an interaction between Enbrel (Etanercept) and any of the following:

• abatacept
• anakinra
• bacillus Calmette-Guérin (BCG)
• Belimumab
• Canakinumab
• Certolizumab Pegol
• Cyclophosphamide
• Denosumab
• echinacea
• Fingolimod
• Infliximab
• Leflunomide
• Nivolumab
• Natalizumab
• Pimecrolimus
• Roflumilast
• Sulfasalazine
• Tacrolimus
• Tocilizumab
• Tofacitinib
• Trastuzumab
• vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella, meningococcal, diphtheria)
• Vedolizumab

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Enbrel (Etanercept).

Allergic reactions: In rare cases, some people may develop an allergic reaction to Enbrel (Etanercept). Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately. The needle cover on the prefilled syringe contains dry natural rubber. Before you start injections, tell your doctor if you have an allergy to rubber or latex.

Anemia: Enbrel (Etanercept) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Bleeding: Enbrel (Etanercept) can cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, or blood or material that looks like coffee grounds in vomit, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Cancer: Very rarely, people taking Enbrel (Etanercept) and similar medications have developed Leukemia or lymphoma, types of blood cancer. In general, people with rheumatoid arthritis or psoriasis who take medications that suppress the immune system over long periods of time may also have a higher risk of developing lymphoma, even if they don't take Enbrel (Etanercept). Discuss any concerns you have with your doctor.

There may be a slightly increased risk of developing Melanoma (a type of Skin Cancer). Report any unusual growths on your skin to your doctor as soon as possible. Your doctor will monitor you for skin cancer while you are taking Enbrel (Etanercept). Talk to your doctor if you have any concerns.

Diabetes: Enbrel (Etanercept) may cause a decrease in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Enbrel (Etanercept).

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Enbrel (Etanercept) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Enbrel (Etanercept), and whether any special monitoring is needed.

Heart failure: Enbrel (Etanercept) may worsen Congestive Heart Failure. If you have heart failure, talk to your doctor about the risks and benefits of using Enbrel (Etanercept). Symptoms to watch out for include swelling of the feet and ankles and shortness of breath. If you notice these symptoms, contact your doctor immediately.

Hepatitis B: People infected with hepatitis B virus (an infection that can damage the liver) may have a relapse of their condition while taking Enbrel (Etanercept). If you are at risk for hepatitis B, your doctor may test you for this infection before starting treatment with Enbrel (Etanercept) and will follow your condition closely while you are taking the medication. If you notice symptoms of liver problems, such as abdominal pain, yellow eyes or skin, loss of appetite, fatigue, or dark urine, contact your doctor immediately.

Infections: Enbrel (Etanercept) can increase the risk of developing an infection, including serious infections such as sepsis, chicken pox, fungal infections, and Tuberculosis. Before starting Enbrel (Etanercept) treatment, your doctor may test to see if you have tuberculosis. If you notice signs of an infection such as fever, chills, pain, swelling, coughing, or pus, contact your doctor as soon as possible. Enbrel (Etanercept) should also not be started while you have an active infection. This medication should not be used in combination with Anakinra or Abatacept, as these medications can increase the risk of severe infection.

Tell your doctor if you have a history of infections that keep coming back, or other conditions that might increase your risk of infections (e.g., diabetes) or have visited or lived in areas where there is a greater risk of certain kinds of fungal infection (e.g. blastomycosis). While you are taking Enbrel (Etanercept), your doctor will monitor you for signs of infection.

Nervous system: Enbrel (Etanercept) may cause or worsen nervous system disorders. If you have a history of nervous system disorders, such as Multiple Sclerosis, discuss with your doctor how Enbrel (Etanercept) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Enbrel (Etanercept), and whether any special monitoring is needed.

If you experience numbness or tingling, weakness in your arms or legs, dizziness, or vision changes while taking Enbrel (Etanercept), contact your doctor immediately.

Vaccines: Vaccines (e.g., yellow fever, BCG, Cholera, typhoid, varicella, meningococcal, diphtheria) should not be given while you are taking Enbrel (Etanercept). Children with JIA should complete the recommended vaccination schedule before receiving their first dose of Enbrel (Etanercept).

Pregnancy: There have been no studies on the use of Enbrel (Etanercept) by pregnant women. Enbrel (Etanercept) crosses the placenta and may affect the developing baby if it is used by the mother during pregnancy. For this reason, Enbrel (Etanercept) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Enbrel (Etanercept), contact your doctor immediately.

Breast-feeding: Enbrel (Etanercept) passes into breast milk. If you are a breast-feeding mother and are taking Enbrel (Etanercept), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Enbrel (Etanercept) has not been established for children younger than 4 years old. It can be used to treat children aged 4 to 17 years who have moderate-to-severe juvenile idiopathic arthritis or chronic severe psoriatic arthritis.

Seniors: People over the age of 65 may be more at risk of side effects from Enbrel (Etanercept).

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. This medication is typically used only once a week. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this.