Read all of this leaflet carefully before you start taking this medicine
. - Keep this leaflet. You may need to read it again.
- If you have any further questions, talk to your doctor or pharmacist.
In this leaflet:
1. What Enbrel is and what it is used for
2. What you need to know before you take Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Further information
Enbrel (etanercept) 50 mg powder and solvent for solution for injection.
Each vial of Enbrel contains 50 mg of the active substance etanercept. The other ingredients are mannitol, sucrose, and trometamol. Each prefilled syringe contains 1 ml of water for injections.
1. WHAT IS ENBREL AND WHAT IS IT USED FOR? Enbrel comes as a white powder and a solvent for solution for injection. Each pack contains 2, 4, or 12 single-dose vials, 2, 4, or 12 pre-filled syringes of water for injections, 2, 4, or 12 needles, 2, 4, or 12 vial adaptors, and 4, 8, or 24 pre-injection wipes.
Not all pack sizes may be marketed.
Enbrel is a product of biotechnology. It is made from two human proteins. Many of the symptoms of rheumatoid arthritis could be caused by another protein that causes inflammation. Enbrel works by binding to this protein and blocking its activity. This blocking action reduces the pain and inflammation associated with rheumatoid arthritis.
Enbrel is an anti-rheumatic medicine that helps reduce the pain and swelling in your joints. Enbrel is used alone or in combination with methotrexate to treat active rheumatoid arthritis in adults when the response to long-acting anti-inflammatory medicines (including methotrexate; unless you cannot take methotrexate) has been inadequate. Enbrel can also be used in adults who have not previously been treated with methotrexate and who have severe, active and progressive rheumatoid arthritis. In patients with rheumatoid arthritis, Enbrel used alone or in combination with methotrexate has been shown to slow the structural damage caused by the disease.
Enbrel is also used to treat moderate to severe plaque psoriasis in adults who do not respond to other systemic treatments including cyclosporine, methotrexate, or PUVA.
2. BEFORE YOU USE ENBRELDo not inject Enbrel:- If you are hypersensitive (allergic) to etanercept or any of the other ingredients of Enbrel. If you experience allergic reactions such as chest tightness, wheezing, dizziness, or rash, do not inject more Enbrel and contact your doctor immediately.
- If you have sepsis (blood poisoning), or are at risk of you or your child developing sepsis. If you are not sure, please talk to your doctor.
- If you have an infection, including a long-term infection or a localized infection (for example, a leg ulcer), do not start taking Enbrel. If you are not sure, please talk to
your doctor.Take special care with Enbrel:- If you are about to undergo major surgery or if you develop a new infection. Your doctor may wish to monitor your treatment.
- Tell your doctor if you have a history of recurring infections or have diabetes or other conditions that increase the risk of infection.
- There have been very rare reports of a marked decrease in red and white blood cells and in platelets (possibly due to bone marrow failure) in patients treated with Enbrel. Seek immediate medical advice if you experience symptoms such as persistent fever, sore throat, bruising, bleeding, or paleness. Such symptoms may signal potentially life-threatening blood cell disorders that may require discontinuation of Enbrel use.
- Tell your doctor if you have multiple sclerosis or optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (a type of inflammation of the spinal cord). Your doctor will determine whether Enbrel is an appropriate treatment for you.
- Tell your doctor if you have a history of congestive heart failure, as Enbrel should be used with caution in these circumstances.
- Some vaccines, such as the oral polio vaccine, should not be given while you are taking Enbrel. Please consult your doctor before receiving any vaccines.PregnancyThe effects of Enbrel on pregnant women are unknown, and therefore, its use is not recommended for pregnant women. You are advised to avoid becoming pregnant while taking Enbrel. If you do become pregnant, consult your doctor.BreastfeedingIt is unknown whether Enbrel passes into breast milk. You should not breastfeed if you are taking Enbrel.Driving and using machinesEnbrel is not expected to affect your ability to drive or operate machinery.Using Enbrel with other medicines:Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. The long-term safety of using Enbrel in combination with other medicines for the treatment of rheumatoid arthritis has not been established.
The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been evaluated.
3. HOW IS ENBREL USED?Dosage for adult patientsYour doctor will tell you how to inject Enbrel.
The usual dose for rheumatoid arthritis is 50 mg, given once a week as an injection under the skin.
The recommended dose for plaque psoriasis is 25 mg twice a week. Your doctor may prescribe 50 mg twice a week for up to 12 weeks. The dose may then be reduced to 25 mg twice a week. Your doctor will decide how long you should use Enbrel and whether further treatment is necessary based on your response. If Enbrel has no effect on your condition after 12 weeks, your doctor may advise you to stop taking this medicine. An alternative strength (Enbrel 25 mg) is available for 25 mg doses. If you think the effect of Enbrel is too strong or too weak, talk to your doctor or pharmacist.Route and method of administrationEnbrel is injected under the skin. You can give yourself the injection or someone else can, such as a family member, friend, your doctor, or their assistant. Follow the detailed instructions on the injection procedure in the enclosed leaflet. You should continue injecting Enbrel for as long as your doctor tells you to. As a reminder, write down in your calendar which days of the week you should have your injection. Enbrel must be dissolved before use. The injection must not be mixed in the same syringe or vial as any other medicine.What to do if you inject more Enbrel than you should:If you accidentally inject more Enbrel than your doctor prescribed, consult a doctor or go to the nearest hospital emergency department. Always take the carton or bottle of your medicine with you, even if it is empty.What to do if you forget to take Enbrel:If you forget to give yourself an injection, inject your next Enbrel injection as soon as you remember. After that, continue injecting as prescribed by your doctor. Do not take a double dose to make up for a missed dose.4. POSSIBLE SIDE EFFECTSLike all medicines, Enbrel can cause side effects. If any side effect worries you, or if you experience any unusual side effects, talk to your doctor or pharmacist. If you experience a severe rash, swelling of the face, or difficulty breathing while taking Enbrel, contact your doctor or seek medical attention immediately.Side effects in adultsThe most common side effect is a mild reaction at the area where the medicine was injected, including itching, tenderness, redness, bleeding, bruising, swelling, or pain around the injection site. These reactions generally become less common after the first month of treatment. If you are concerned about injection site reactions, talk to your doctor or pharmacist. Occasionally, some patients have developed a reaction at a previous injection site when injecting Enbrel.
Other side effects that may occur during treatment with Enbrel in adults include:
infections (including tuberculosis), headache, runny nose, rash, hives, itching, painful or upset stomach, diarrhea, increased cough, weakness, pain, dizziness, sore throat, fever, increased blood pressure, inflamed or irritated sinuses, nausea, bruising, mouth ulcers, and hair loss.
Less commonly, serious infections have occurred with Enbrel use, including kidney or urinary tract infection, bronchitis, inflammation or infection of a joint, localized infections of the abdomen or legs, tissue and wound infections, abscess, bone marrow infection, pneumonia, shingles, mouth infection, skin infection, inflammation of the bowel, bursitis, inflammation of the lining of the heart (endocarditis; suspected), inflammation of the stomach and small intestine, inflammation of the gallbladder, inflammation of the abdominal cavity (peritonitis), skin ulcers, inflammation of the small blood vessels (vasculitis), viral hepatitis, ear infection, sinus infection, and blood poisoning. Rarely, patients who have other medical problems that increase the risk of infection may develop serious infections,
including fatal blood poisoning, while taking Enbrel.
Possible side effects in adults are listed below in the following categories:
Very common: > 1/10 patients
Common: > 1/100 and < 1/10 patients
Uncommon: > 1/1,000 and < 1/100 patients
Rare: > 1/10,000 and < 1/1,000 patients
Very rare: < 1/10,000 patientsInfections:Very common: Infections, including upper respiratory tract infections, bronchitis, urinary tract infections, skin infections.
Uncommon: Serious infections, including pneumonia, deep skin infections, joint infections, blood poisoning.
Rare: Tuberculosis.Disorders of the blood and lymphatic system:Uncommon: Low platelet count
Rare: Low red blood cell count, low white blood cell count, low red and white blood cell count (pancytopenia)
Very rarely: Failure of the bone marrow to produce blood cells (aplastic anemia)Immune system disorders:Common: Allergic reactions (see Skin disorders), antibodies directed against normal tissue (autoantibody formation)
Rare: Serious allergic reactions, including severe local swelling of the skin (angioedema), wheezing and difficulty breathingDisorders of the nervous system:Rare: Epileptic seizures
Disorders of the nervous system (demyelinating disorders), with signs and symptoms similar to those of multiple sclerosis or inflammation of the optic nerves (optic neuritis) or transverse myelitis (a type of inflammation of the spinal cord);Skin conditions:Common: Itching
Uncommon: Local swelling of the skin (angioedema), hives; rash
Rare: Inflammation of the blood vessels in the skinDisorders of the musculoskeletal system, connective tissue and bonesRare: Subacute cutaneous lupus erythematosus, discoid lupus (lupus of the skin), lupus-like syndromeGeneral disorders and conditions at the site of administration:Very common: Injection site reactions including bleeding, bruising, redness, itching, pain, swelling
Common: FeverHeart conditions:There have been reports of worsening congestive heart failure.Additional information:Serious side effects reported in clinical trials: The following is a list of serious events that have been reported in clinical trials in patients treated with Enbrel (the events are included in this list whether or not they were thought to be caused by Enbrel): various cancers (e.g., breast, lung, lymphatic system), heart failure, heart attack, reduced blood flow to the heart (myocardial ischemia), chest pain, fainting, stroke, high blood pressure, low blood pressure, low white blood cell counts, inflammation of the gallbladder, inflammation of the pancreas, gastrointestinal bleeding, intestinal blockage, shortness of breath, inflammation of the lungs (allergic alveoli), asthma, confusion, depression, abnormal healing, inflammation and clots in the veins, blood clot in the vessels of the lungs, liver damage, kidney disorders (membranous glomerulonephropathy), impaired kidney function, kidney stones, inflammation of the muscles (polymyositis), inflammation of the eye (scleritis), sudden swelling (angioedema), a feeling of spinning (vertigo), abnormal skin sensations (paresthesia), partial paralysis (paresia), inflammation and ulceration of the colon (ulcerative colitis), lymph node disease (lymphadenopathy), bone fractures, and bursitis (See also Take special care with Enbrel).
If you think you are experiencing any side effects of Enbrel, whether or not they are listed in this leaflet,
contact your doctor.5. HOW TO STORE ENBREL?Keep out of the reach and sight of children. Store in a refrigerator (2°C–8°C). Do not freeze. Once the Enbrel solution is reconstituted, it is recommended to use it immediately. However, it can be used up to 6 hours after reconstitution if stored in a refrigerator (2°C–8°C). The solution should be clear, colorless or pale yellow, with no lumps, flakes, or particles. Do not use the solution if you notice that it is cloudy or contains particles. Carefully discard any Enbrel solution that is not used within 6 hours of reconstitution. Do not use Enbrel if the expiry date (EXP) stated on the package has passed. |
