Frequently Asked Questions

• Improvement may be seen as early as 1 week after starting ENBREL in adults, and within 2 weeks in children with JIA and 4 weeks in children with PsO. In clinical trials, full effect was usually seen by 3 months in both adults and children and was sustained with continued treatment.
• In clinical trials with psoriatic arthritis, one quarter of patients saw improvement in their joint symptoms within 1 month, one half of patients saw improvement within 3 months, and three quarters of patients saw improvement within 9 months of treatment with ENBREL.
• During the psoriatic arthritis clinical trials, approximately 2% of patients treated with ENBREL stopped taking ENBREL due to side effects and up to 5% of ENBREL-treated patients stopped taking ENBREL due to lack of improvement.

In studies comparing ENBREL to placebo (inactive injection), side effects that occurred more frequently in patients treated with ENBREL were:

• Reactions where the injection was given. These reactions are usually mild and included redness, rash, swelling, itching or bruising. These usually go away within 3 to 5 days. If you have pain, redness or swelling around the injection site that doesn't go away or gets worse, call your doctor.
• Upper respiratory infections (sinus infections).
• Headaches.
• This is not a complete list of side effects/ For any unexpected effects while taking ENBREL, contact your doctor or pharmacist.

• You should not take ENBREL if you have ever had an allergic reaction to ENBREL or any of the ingredients of ENBREL. You should not take ENBREL if you have an infection that has spread through your body (sepsis).
• The needle cover on the prefilled syringe and the needle cover contained in the needle cap on the prefilled SureClick Autoinjector are composed of dry natural rubber, which is made from latex. If you know you are allergic to latex, talk to your healthcare provider before using ENBREL in the prefilled syringe or SureClick Autoinjector.

• It is important that you tell your doctor about any other medicines (for example, high blood pressure medicine) you are taking for other conditions before you start taking ENBREL. You should also tell your doctor about any over-the-counter drugs, herbal medicines and vitamin and mineral supplements you are taking.
• If you have diabetes and are taking medication to control your diabetes, your doctor may decide you need less anti-diabetic medicine while taking ENBREL.

• In adults, ENBREL can be used in combination with methotrexate. However, little is known of the interaction of ENBREL with methotrexate and other drugs in children with idiopathic rheumatoid arthritis.
• Taking ENBREL with Kineret® (anakinra) is not recommended because this may increase your risk of getting a serious infection.
• Taking ENBREL with Orencia® (abatacept) is not recommended because this may increase your risk for serious side effects.
• Taking ENBREL with cyclophosphamide (used to treat cancer or immune diseases) is not recommended. You may have a higher chance for getting certain cancers when taking ENBREL with cyclophosphamide.

• The safe use of ENBREL has not been established in pregnant women.
• You should tell your doctor if you are pregnant, become pregnant or are thinking about becoming pregnant. If you took ENBREL during pregnancy, talk to your doctor prior to administration of live vaccines to your infant.
• ENBREL can pass into breast milk. ENBREL has not been studied in nursing mothers, and therefore its effects on nursing babies are not known. Talk to your healthcare provider about the best way to feed your baby while taking ENBREL.
• If you are not sure or have any questions about any of this information, ask your doctor.

• Call your doctor if you accidentally inject ENBREL more frequently than instructed.
• In case of drug overdose, contact a healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you forget to use ENBREL, inject your dose as soon as you remember. Then, take your next dose at your regular(ly) scheduled time. In case you are not sure when to inject ENBREL, call your healthcare provider. A toll-free information service is also available: 1-877-9ENBREL (1-877-936-2735).

• If you use the SureClick Autoinjector or ENBREL prefilled syringe you should keep it refrigerated at 2°C to 8°C. Do NOT FREEZE ENBREL. Refrigerated ENBREL remains stable until the expiration date printed on the autoinjector or syringe.
• When needed, for example if you are travelling, ENBREL may be transferred to room temperature storage (up to 27°C). Upon removal from the refrigerator, ENBREL must be used within 60 days. Regardless of whether it is put back into the refrigerator for storage at a later point in time, you will need to use ENBREL within 60 days of initial removal. Protect from direct sunlight, sources of heat and humidity until ready to use.
• If you do transfer ENBREL to room temperature storage, we suggest that you take note of the date at which ENBREL was taken out of refrigeration and the date by when it should be used.
• ENBREL supplies you with a cooler bag of your Enliven free resource kit. We suggest that you continue to use it when storing ENBREL at room temperature; this will help protect ENBREL from direct sunlight, sources of heat and humidity

Lyophilized ENBREL

• If you use the multi-use vial of lyophilized ENBREL, the ENBREL dose tray containing sterile powder should be refrigerated at 2°C to 8°C. Do NOT FREEZE ENBREL.
• Unopened refrigerated ENBREL sterile powder remains stable until the expiration date printed on the vial. If necessary - for example when you are travelling - unopened ENBREL sterile powder may be transferred to room temperature storage (up to 27°C). Upon removal from the refrigerator, it must be used within 60 days.
• Reconstituted solutions of ENBREL prepared with the supplied Sterile Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) must be stored in the original vial for no more than 14 days at 2°C to 8°C, with overall room temperature exposure of less than 12 hours during storage and handling. Product stability and sterility cannot be assured after 14 days. Discard reconstituted solution after 14 days.
• If you do transfer the ENBREL vial to room temperature storage before you have reconstituted the powder, we suggest that you take note of the date at which ENBREL was taken out of refrigeration and the date by when it should be used. If you have reconstituted the powder into a solution, we suggest that you also take note of the time at which ENBREL was taken out of the refrigerater and what time (within 12 hours) by when it needs to be used.
• A cooler bag is supplied to you as part of your Enliven free resource kit. We suggest that you continue to use it when storing ENBREL at room temperature; this will help protect ENBREL from extreme temperatures, direct sunlight and sources of heat, humidity and cold to the point of freezing.

Choose an injection site. Three recommended injection sites for ENBREL include the upper part of your thigh, belly (except for a 2-inch area right around your belly button) and outer area of upper arm (only if someone else is giving you the injection). You should not inject into areas where the skin is tender, bruised, hard or red. Avoid areas with scars or stretch marks. If you have psoriasis, you should try not to inject directly into any raised, thick, red or scaly skin patches (psoriatic lesions).

In clinical studies comparing ENBREL to placebo (inactive injection), some people experienced reactions where the injection was given. These reactions are usually mild and include redness, swelling, itching or bruising. These usually go away within 3 to 5 days. If you have pain, redness or swelling around the injection site that doesn’t go away or gets worse, call your doctor.

If you will be travelling with your ENBREL, download this form and bring it to your doctor to complete. It will help ensure a smooth travelling experience! Click here

DOWNLOAD INSTRUCTIONS:

Adobe Acrobat Reader must be installed on your computer for you to be able to download and view any of ENBREL's PDFs. If you do not have Adobe Acrobat Reader installed, then you can download your free copy by clicking here.