Simponi Patient Counseling Information

Instructions for Injecting SIMPONI Using a Single-Use SmartJect Autoinjector: If you would like to self-inject SIMPONI, you must be trained by a healthcare professional to prepare an injection and give it to yourself. If you have not been trained, please contact your healthcare professional to schedule a training session.
Step 1: Preparing to Use the SmartJect Autoinjector.
Do not shake the autoinjector at any time.
Do not remove the autoinjector cap until instructed to do so.
Check Expiration Date: Check the expiration date (indicated as "EXP") on the autoinjector. You can also check the expiration date printed on the carton. If the expiration date has passed, do not use the autoinjector. Please contact your doctor or pharmacist for assistance.
Check Security Seal: Check the security seal around the cap of the autoinjector. If the security seal is broken, do not use the autoinjector and please contact your doctor or pharmacist for assistance.
Wait 30 Minutes: To ensure proper injection, allow the autoinjector to sit at room temperature outside the carton for 30 minutes out of the reach of children.
Do not warm the autoinjector in any other way (for example, do not warm it in a microwave or in hot water).
Do not remove the autoinjector cap while allowing it to reach room temperature.
Assemble Additional Supplies: Assemble additional supplies you will need for your injection. These include an alcohol swab, a cotton ball or gauze, and a sharps container.
Check the Liquid in the SmartJect Autoinjector: Look through the viewing window to make sure that the liquid in the autoinjector is clear to slightly opalescent and colourless to slightly yellow. You may also notice an air bubble - this is normal.
Do not use if the liquid is discoloured, cloudy or contains particles. If this is the case, please contact your doctor or pharmacist for assistance.
Step 2: Choosing and Preparing the Injection Site.
Choose the Injection Site: The recommended injection site is the front of the middle thighs. You can also use the lower abdomen below the belly button, except for the two-inch area directly underneath the belly button. If a caregiver is giving you the injection, the caregiver can also use the outer area of the upper arms. Injection sites should be rotated. At the time of dosing, if multiple injections are required, the injections should be administered at different sites on the body.
Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.
Preparing the Injection Site: Thoroughly wash your hands with soap and warm water. Wipe the injection site with an alcohol swab.
Do not touch this area again before giving the injection. Allow the skin to dry before injecting.
Do not fan or blow on the clean area.
Step 3: Injecting SIMPONI Using the Single-Use SmartJect Autoinjector.
Remove the Cap: The cap should not be removed until you are ready to inject the medication. The medication should be injected within 5 minutes after the cap has been removed. When you are ready to inject, twist the cap slightly to break the security seal. Pull the cap off and immediately place the cap into the trash.
Do not put the cap back on because it may damage the needle inside the autoinjector.
Note: Do not use the autoinjector if it is dropped without the cap in place. If you drop the autoinjector without the cap in place, please contact your doctor, pharmacist for assistance.
Push the SmartJect Autoinjector Against the Skin: Hold the autoinjector comfortably in your hand. Do not press the button at this time. Push the open end of the autoinjector firmly against the skin at a 90-degree angle so that the Safety Sleeve slides up into the clear cover. Do not press the button until after the autoinjector is pushed firmly against the skin and the Safety Sleeve slides fully into the Clear Cover. Injecting without pinching the skin is recommended. However, if you prefer, you may pinch the skin to create a firmer surface for your injection.
Press Button to Inject: Continue to hold the autoinjector firmly against the skin, and press the front raised part of the button with your fingers or thumb. You will not be able to press in the button unless the autoinjector is pushed firmly against your skin and the Safety Sleeve slides into the Clear Cover. Once the button is pressed, it will remain pressed in so you do not need to keep pressure on it. You will hear a loud 'click' sound - don't be alarmed. The first loud 'click' indicates that the needle has been inserted and the injection has started. You may or may not feel a needle prick at this time.
Do not lift the autoinjector away from your skin. If you pull the autoinjector away from the skin, you may not get your full dose of medicine.
Wait for Second 'Click': Continue to hold the autoinjector against the skin until you hear the second 'click' (it usually takes about 3-6 seconds, but may take up to 15 seconds for you to hear the second 'click' sound). The second click indicates that the injection is finished and the needle has retracted into the autoinjector. Lift the autoinjector from the injection site.
Note: If you have hearing impairment, count 15 seconds from the time you press the button and then lift the autoinjector from the injection site.
Step 4: After the Injection.
Check the Viewing Window: After injecting, check the viewing window to make sure that the yellow indicator is visible. This indicates that the autoinjector has worked properly. The yellow indicator may not fill the entire viewing window. This is normal. If you do not think you received your injection, check the yellow indicator again to confirm that the dose was delivered. If the yellow indicator is not visible in the viewing window, please contact your doctor or pharmacist for assistance. Do not administer a second dose without speaking to your doctor.
Disposing of the SmartJect Autoinjector: Immediately dispose of the autoinjector in the sharps container. Dispose of the sharps container according to your local regulations.
Use Cotton Ball or Gauze: There may be a small amount of blood or liquid at the injection site, which is normal. You can press a cotton ball or gauze over the injection site for 10 seconds.
Do not rub the injection site.
You may cover the injection site with a small adhesive bandage, if necessary.