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INCOMPATIBILITIES: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING: Golimumab (Simponi) is supplied in a single use pre‑filled pen/autoinjector (SmartJect) called SmartJect.
Each Golimumab (Simponi) pack is provided with instructions for use that fully describe the use of the pen/autoinjector (SmartJect). After removing the pre‑filled pen/autoinjector (SmartJect) from the refrigerator it should be allowed to reach room temperature by waiting for 30 minutes, before injecting Golimumab (Simponi). The pen/autoinjector (SmartJect) should not be shaken.
The solution is clear to slightly opalescent, colorless to light yellow and may contain a few small translucent or white particles of protein. This appearance is not unusual for solutions containing protein. Golimumab (Simponi) should not be used if the solution is discolored, cloudy or containing visible foreign particles.
Comprehensive instructions for the preparation and administration of Golimumab (Simponi) in a pre‑filled pen/autoinjector (SmartJect) are given as follows.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
INSTRUCTIONS FOR INJECTING GOLIMUMAB (SIMPONI) USING A SINGLE-USE AUTOINJECTOR/PRE-FILLED PEN/AUTOINJECTOR (SMARTJECT): If the patient would like to self‑inject Golimumab (Simponi), he/she must be trained by a healthcare professional to prepare an injection and give it to themselves. If the patient have not been trained, please contact a healthcare professional to schedule a training session.
STEP 1: PREPARING TO USE THE AUTOINJECTOR: DO NOT shake the autoinjector at any time.
DO NOT remove the autoinjector cap from the pen/autoinjector (SmartJect) until immediately before the injection.
Check Expiration Date: Check the expiration date (indicated as "EXP") on the autoinjector.
The patient can also check the expiration date printed on the carton.
If the expiration date has passed, DO NOT use the autoinjector and please contact a doctor, pharmacist, or local distributor of this medicine 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 a doctor, pharmacist, or local distributor of this medicine 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 that will be needed for the injection. These include an alcohol swab, a cotton ball or gauze, and a sharps container.
Check the Liquid in the Autoinjector: Look through the viewing window to make sure that the liquid in the autoinjector is clear to slightly opalescent and colorless to slightly yellow.
The patient may also notice an air bubble - this is normal.
DO NOT use if the liquid is discolored, cloudy or contains particles. If this is the case, please contact a doctor, pharmacist, or local distributor of this medicine 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.
The patient 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 the injection, the caregiver can also use the outer area of the upper arms.
If multiple injections are required for a single administration, 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 Injection Site: Thoroughly wash 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 THE MEDICINE: Remove the Cap: The cap should NOT be removed until the patient are ready to inject the medication. The medication should be injected within 5 minutes after the cap has been removed.
When 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 autoinjector if it is dropped without the cap in place. If the patient drops the autoinjector without the cap in place, contact a doctor, pharmacist, or local distributor of this medicine for assistance.
Push the Autoinjector Against the Skin: Hold the autoinjector comfortably in the 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.
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 the patient prefers, he/she may pinch the skin to create a firmer surface for the injection.
Press Button to Inject: Continue to hold the autoinjector firmly against the skin, and press the front raised part of the button with the fingers or thumb. The patient will not be able to press in the button unless the autoinjector is pushed firmly against the skin and the Safety Sleeve slides into the Clear Cover.
Once the button is pressed, it will remain pressed in so the patient do not need to keep pressure on it.
The patient 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. The patient may or may not feel a needle prick at this time.
DO NOT lift the autoinjector away from the skin. If the patient pull the autoinjector away from the skin, he/she may not get the full dose of medicine.
Wait for Second 'Click': Continue to hold the autoinjector against the skin until the patient hears the second 'click' (it usually takes about 3 to 6 seconds, but may take up to 15 seconds for the patient to hear the second 'click' sound).
The second 'click' indicates that the injection is finished and the needle has retracted into the autoinjector. Note: If the patient has a hearing problem and do not hear the second 'click', count 15 seconds from the time the patient first presses the button and then lift the autoinjector from the injection site.
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.
The yellow indicator may not fill the entire viewing window. This is normal.
This indicates that the autoinjector has worked properly.
If the patient does not think he/she received the injection, check the yellow indicator again to confirm that the dose was delivered.
If the yellow indicator is not visible in the viewing window, call a doctor, pharmacist, or local distributor of this medicine for assistance. DO NOT administer a second dose without speaking to a doctor.
Disposing of the Autoinjector: Immediately dispose of the autoinjector in the sharps container.
Dispose of the sharps container according to the local regulations when the container is full.
Use Cotton Ball or Gauze: There may be a small amount of blood or liquid at the injection site, which is normal.
The patient can press a cotton ball or gauze over the injection site for 10 seconds. DO NOT rub the injection site.
The patient may cover the injection site with a small adhesive bandage, if necessary.
