Instructions For

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Instructions for Use Please see page 2 Instructions for Use Please see page 3 SIMPONI® (SIM-po-nee) (golimumab) SIMPONI® (SIM-po-nee) (golimumab) SmartJect® autoinjector Prefilled Syringe

SINGLE-DOSE

Important Important If your doctor decides that you or a caregiver may be able to give your SIMPONI® injections at home, you should SIMPONI® comes as a single-dose prefilled syringe containing one 50 mg or one 100 mg dose. Each SIMPONI® prefilled receive training on the right way to prepare and inject SIMPONI® using SmartJect®. syringe can only be used one time. Throw away (dispose of) the used prefilled syringe (See Step 3) after one dose, even Do not try to inject SIMPONI® yourself until you have been shown the right way to give the injections by your doctor if there is medicine left in it. Do not reuse your SIMPONI® prefilled syringe. or nurse. If your healthcare provider decides that you or a caregiver may be able to give your injections of SIMPONI® at home, Please read this Instructions for Use before using SIMPONI® SmartJect® and each time you get a refill. There may be you should receive training on the right way to prepare and inject SIMPONI® using the prefilled syringe before new information. This leaflet does not take the place of talking with your doctor about your medical condition or attempting to inject. Do not try to inject yourself until you have been shown the right way to give the injections by your your treatment. healthcare provider. Read this Instructions for Use before using your SIMPONI® prefilled syringe and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by: Manufactured by: Janssen Biotech, Inc. Janssen Biotech, Inc. Horsham, PA 19044 Horsham, PA 19044 US License No. 1864 US License No. 1864 Approved: MaySeptember 2018 2015 Revised May 2018 © Janssen Biotech, Inc. 2020 04/20 cp-26311v4 © Janssen Biotech, Inc. 2020 04/20 cp-66815v2

If your doctor decides that you or a caregiver may be Cap able to give your SIMPONI® Do not remove the cap injections at home, you until you are ready to EXP should receive training on MM/YYYY inject (See Step 2). the right way to prepare SmartJec Instructions for Use SIMPONI® and inject SIMPONI® using Security seal SmartJect®. (on side of cap) Do not try to inject Green safety sleeve SIMPONI® yourself until you Clear cover have been shown the right Thin hidden needle security seal

t way to give the injections ®

(SIM-po-nee) (golimumab) by your doctor or nurse.

autoinjector Take out SmartJect® Inspect SmartJect® Check liquid in the Choose injection site Clean injection site Please read this Instructions Take SmartJect® out of Check the expiration date SmartJect® Select from the following Wash your hands well for Use before using SIMPONI® (‘EXP’) on the back of areas for your injection: with soap and warm water. SmartJect® and each time you Viewing window the refrigerator and After 30 minutes, check remove it from the carton. SmartJect®. get a refill. There may be new the liquid in the viewing 1. Front of thighs Wipe your chosen injection Place on a flat surface information. This leaflet does Do not use SIMPONI® window. It should be clear (recommended) site with an alcohol swab out of reach of children. to slightly yellow and not take the place of talking SmartJect® if the expiration 2.Lower abdomen and allow it to dry. with your doctor about your Raised part of button SmartJect® should sit at date has passed. Call your may contain tiny white (do not use the 2-inch Do not touch, fan or blow medical condition or your Press here only when room temperature for at doctor or pharmacist for or clear particles. area around your on the injection site after treatment. SmartJect® is pushed least 30 minutes to ensure a refill. It is also normal to see navel (belly-button)) you have cleaned it. firmly against your skin proper injection. Store in refrigerator Check the security seal on a small air bubble. 3. Back of upper arms (if 36° to 46°F (2° to 8°C). and you are ready to inject (See Step 2). Do not warm any other way. the cap. Do not inject if the liquid a caregiver is giving If needed, store SIMPONI® at you the injection) Do not inject if the seal is cloudy or discolored, room temperature, up to 77°F Do not remove the cap yet. is broken. or has large particles. Choose a dierent site This Instructions for Use (25°C) for one period of time up to has been approved by within your preferred 30 days. Do not return it to the the U.S. Food and Drug area for each injection. refrigerator. Throw away (dispose Gather supplies Administration. of) if not used within 30 days at Expiration date (on back) Do not inject into skin Manufactured by: room temperature. While SmartJect® sits at that is tender, bruised, Janssen Biotech, Inc. room temperature for Do not freeze SmartJect®. Need help? red, scaly or hard. Horsham, PA 19044 30 minutes, gather your US License No. 1864 Do not shake SmartJect®. Call your doctor to talk supplies: Do not inject into areas about any questions you with scars or stretch marks. Approved: SeptemberMay 2018 2015 Keep SIMPONI® in the original • 1 Alcohol swab carton to protect from light may have. For additional © Janssen Biotech, Inc. 2020 before use. assistance or to share your • 1 Cotton ball or gauze pad 04/20 cp-26311v4 Keep SIMPONI® and all feedback call 800-JANSSEN • 1 Sharps container medicines out of the reach of (800-526-7736). (See Step 3) children.

2. Inject SIMPONI® using SmartJect® 3. After your injection Helpful tips Additional disposal information: If you are having If you do not have an FDA-cleared sharps disposal container, you Make sure the cap may use a household is removed. container that is: Make sure SmartJect® • made of a heavy-duty is pushed firmly plastic 1st 2nd against your skin. • can be closed with a CLICK! tight-fitting, puncture- CLICK! Make sure you are pressing the raised resistant lid, without green safety part of button. sharps being able to sleeve come out Remove cap Position Push fi rmly Press button and wait Listen for 2nd ‘click’ Check the viewing Dispose of your Check injection site Try pressing the • upright and stable Twist the cap to break the Hold SmartJect® comfortably Push SmartJect® firmly Keep holding SmartJect® Keep holding SmartJect® window SmartJect® There may be a small button a little harder. during use security seal, then pull it and position it straight onto against your skin so the firmly against your skin. firmly against your skin until After lifting SmartJect® Put your used SmartJect® amount of blood or liquid Try a dierent • leak-resistant straight o. Dispose of the your skin, as shown. green safety sleeve slides Use your other hand to you hear the 2nd ‘click’ from your skin, look for in an FDA-cleared sharps at the injection site. injection site. • properly labeled to warn cap right away. into the clear cover. press the raised part of (3–15 seconds). Make sure the green safety the yellow indicator in the disposal container right Hold pressure over your of hazardous waste the button to start It is important to inject sleeve is flat against your Do not touch or press The 2nd ‘click’ means the viewing window to confirm away after use. skin with a cotton ball inside the container your injection. SmartJect® worked within 5 minutes of skin and that your injection the button while pushing injection is complete and Do not throw away or gauze pad until any If you are pinching When your sharps disposal properly. The yellow removing the cap. site is as flat as possible. SmartJect® against your skin. You will hear a loud 1st you can lift SmartJect® (dispose of) loose needles bleeding stops. the skin to inject: container is almost full, you ‘click’ as you press the from your skin. indicator will fill about half Do not put the cap back Do not touch or press the and syringes in your Do not rub the injection will need to follow your button. This is normal, of the viewing window. Use 1 hand to both on, this may damage the button while positioning the If you have trouble hearing household trash. site. community guidelines for The green safety the medication is just If you do not see the yellow position SmartJect® the right way to dispose of hidden needle. SmartJect® onto your skin. the ‘clicks’, count to 15 Do not recycle your used sleeve helps prevent beginning to be delivered. indicator, call 800-JANSSEN If needed, cover injection against the skin and your sharps disposal after pressing the button, sharps disposal container. Do not inject if SmartJect® You may or may not feel site with a bandage. Your press the button. accidental injections. then lift the SmartJect® o (800-526-7736). container. There may be is dropped without the a needle prick. For more information, injection is now complete! state or local laws about You will not be able to your skin. Do not administer a cap on. see “Helpful tips”. how you should throw away press the button to start Do not lift SmartJect® second dose without used needles and syringes. your injection until up yet! This may result in speaking to your doctor. SmartJect® is pushed loss of medication. For more information about firmly enough against After 1 press of the button, safe sharps disposal, and your skin for the green you do not need to keep for specific information safety sleeve to slide into pressure on the button. about sharps disposal in the clear cover. the state that you live in, Wait for the 2nd ‘click’ go to the FDA’s website at: which means your www.fda.gov/ injection is complete. safesharpsdisposal

cp-26311v2_808812_v2b.indd Custom V 2 7/25/18 8:55 AM Important Preﬁ lled syringe parts 1. Prepare for your injection

SIMPONI® comes as a The SIMPONI® prefilled Before use After use single-dose prefilled syringe syringe is intended for Plunger Plunger containing one 50 mg or injection under the skin, not locks one 100 mg dose. Each into the muscle or vein. Do not hold or pull plunger at any time. SIMPONI® prefilled syringe After injection, the needle Safety Prefilled Syringe SIMPONI® Instructions for Use can only be used one time. will retract into the body of guard Throw away (dispose of) the the device and lock into activates used prefilled syringe (See place. Step 3) after one dose, even if there is medicine left in it. Do not reuse your Storage Information SIMPONI® prefilled syringe. Store SIMPONI® in the Safety guard (SIM-po-nee) (golimumab) If your healthcare provider refrigerator at 36° to Inspect carton Choose injection site Clean injection site Inspect liquid decides that you or a 46°F (2° to 8°C). Remove your SIMPONI® Select from the following Wash your hands well Check the SIMPONI® caregiver may be able to If needed, store SIMPONI® at prefilled syringe carton areas for your injection: with soap and warm water. give your injections of Finger fl ange prefilled syringe liquid in room temperature, up to 77° from the refrigerator. SIMPONI® at home, you •Front of thighs the viewing window. It F (25°C) for one period of Needle Wipe your chosen injection Body Remove the prefilled should be clear to slightly should receive training on time up to 30 days. Do not retracts (recommended) site with an alcohol swab Hold syringe body yellow and may contain the right way to prepare and return it to the refrigerator. into the syringe from the carton • Lower stomach area and allow it to dry. below fi nger fl ange. tiny white or clear inject SIMPONI® using the Throw away if not used body and let it sit on a flat (lower abdomen), except Do not touch, fan or blow particles. You may also see prefilled syringe before within 30 days at room surface at room for a 2-inch area right attempting to inject. Do not temperature for at least on the injection site after temperature. around your navel (belly- one or more air bubbles. try to inject yourself until 30 minutes before use. you have cleaned it. Do not freeze SIMPONI® Viewing window button) This is normal. you have been shown the prefilled syringe. Do not warm the prefilled right way to give the • Back of upper arms (only Do not inject if the liquid is Do not shake SIMPONI® Needle cover syringe any other way. if someone else is giving cloudy or discolored, or

injections by your healthcare provider. prefilled syringe. Do not remove until Check the expiration date you the injection) has large particles. Call you are ready to your healthcare provider Read this Instructions for Keep SIMPONI® prefilled (‘EXP’) on the back panel Choose a different site inject SIMPONI® of the carton and on the or pharmacist for a refill. Use before using your syringe in the original carton • 1 SIMPONI® prefilled within your preferred area to protect from light before (See Step 2). prefilled syringe (through SIMPONI® prefilled syringe syringe for each injection. and each time you get a use. the viewing window). Not provided in the Do not inject into skin that refill. There may be new Keep SIMPONI® prefilled Do not use your prefilled Need help? SIMPONI® prefilled is tender, bruised, red, hard, information. This leaflet syringe and all medicines You will need syringe if the expiration Call your doctor to talk about syringe carton: thick or scaly. does not take the place of out of the reach of these supplies: date has passed. any questions you may have. talking with your healthcare children. • 1 Alcohol swab Do not inject SIMPONI® if Do not inject into areas with For additional assistance or provider about your medical • 1 Cotton ball or gauze the perforations on the scars or stretch marks. to share your feedback call condition or your treatment. pad SINGLE-DOSE carton are broken. Call your 800-JANSSEN • 1 Adhesive bandage healthcare provider or (800-526-7736). • 1 Sharps container pharmacist for a refill. (See Step 3)

2. Inject SIMPONI® using the prefilled syringe 3. After your injection

45° How should • upright and stable information about sharps during use disposal in the state that I dispose of • leak-resistant you live in, go to the FDA’s website at: • properly labeled to the used www.fda.gov/ warn of hazardous safesharpsdisposal prefi lled waste inside the syringe? container When your sharps disposal container is Remove needle cover Position fi ngers and Release pinch and Press plunger Release pressure Dispose of your Check injection site almost full, you will This Instructions for Use If you do not have an insert needle reposition hand from plunger prefi lled syringe need to follow your has been approved by Hold your prefilled syringe Place thumb from the There may be a small FDA-cleared sharps by the body and pull needle opposite hand on the amount of blood or liquid community guidelines for the U.S. Food and Drug Place your thumb, index Use your free hand to The safety guard will cover Put your used SIMPONI® disposal container, you cover straight off. It is plunger and press the at the injection site. the right way to dispose Administration. and middle fingers directly grasp the body of the the needle and lock into prefilled syringe in an may use a household normal to see a drop of plunger all the way down of your sharps disposal Manufactured by: under the finger flange, as prefilled syringe. place, removing the needle FDA-cleared sharps Hold pressure over your container that is: liquid. until it stops. container. There may be shown. from your skin. disposal container right skin with a cotton ball or Janssen Biotech, Inc. • made of a heavy-duty state or local laws about Inject SIMPONI® within 5 away after use. gauze pad until any Horsham, PA 19044 Do not touch plunger or plastic how you should throw minutes of removing the Do not throw away bleeding stops. US License No. 1864 area above finger flange as away used needles and needle cover. (dispose of) your • can be closed with a this may cause the needle Do not rub the injection Revised May 2018 SIMPONI® prefilled tight-fitting, puncture- syringes. Do not put needle cover safety device to activate. site. © Janssen Biotech, Inc. 2020 syringe in your resistant lid, without For more information back on, as this may 04/20 cp-66815v2 Use your other hand to household trash. If needed, cover injection sharps being able to about safe sharps damage the needle or pinch skin at the injection Do not recycle your used site with a bandage. Your come out disposal, and for specific cause a needle stick injury. site. Position syringe at sharps disposal container. injection is now complete! Do not touch needle or let about a 45 degree angle to it touch any surface. the skin. For more information, see “How should I It is important to pinch Do not use a SIMPONI® dispose of the used enough skin to inject under prefilled syringe if it is prefilled syringe?” dropped. Call your the skin and not into the healthcare provider or muscle. pharmacist for a refill. Insert needle with a quick, dart-like motion.

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