Instructions For Use - Janssen - Free Download PDF

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Instructions for UseTREMFYA (trem fye ah) (guselkumab)Prefilled SyringeImportantTREMFYA comes as a single-dose prefilledsyringe containing one 100 mg dose. EachTREMFYA prefilled syringe can only be usedone time. Throw the used prefilled syringeaway (See Step 3) after one dose, even ifthere is medicine left in it. Do not reuse yourTREMFYA prefilled syringe.Prefilled syringe partsBefore usePlungerDo not hold or pull plunger atany time.If your healthcare provider decides thatyou or a caregiver may be able to give yourinjections of TREMFYA at home, you shouldreceive training on the right way to prepareand inject TREMFYA using the prefilledsyringe before attempting to inject. Do nottry to inject yourself until you have beenshown the right way to give the injections byyour healthcare provider.Safety guardFinger flangeBodyHold syringe body belowfinger flange.Viewing windowRead this Instructions for Use before usingyour TREMFYA prefilled syringe and eachtime you get a refill. There may be newinformation. This leaflet does not takethe place of talking with your healthcareprovider about your medical condition oryour treatment.The TREMFYA prefilled syringe is intendedfor injection under the skin, not into themuscle or vein. After injection, the needlewill retract into the body of the device andlock into place.Needle coverDo not remove until you areready to inject TREMFYA(See Step 2).After usePlunger locksSafety guardactivatesStorage informationStore in refrigerator at 36 to 46 F (2 to 8 C).Do not freeze TREMFYA prefilled syringe.Keep TREMFYA prefilled syringe and allmedicines out of reach of children.Needleretractsinto thebodyDo not shake your TREMFYA prefilled syringe.Keep TREMFYA prefilled syringe in theoriginal carton to protect from light andphysical damage.1You will need these supplies: 1 TREMFYA prefilled syringeNot provided in the TREMFYAprefilled syringe carton: 1 Alcohol swab 1 Cotton ball or gauze pad 1 Adhesive bandage 1 Sharps container(See Step 3)

TREMFYA (guselkumab)1. Prepare for your injectionInspect cartonChoose injection siteClean injection siteRemove your TREMFYA prefilledsyringe carton from therefrigerator. Keep the prefilledsyringe in the carton and letit sit on a flat surface at roomtemperature for at least 30minutes before use.Select from the following areasfor your injection:Wash your hands well with soapand warm water. F ront of thighs (recommended)Wipe your chosen injection sitewith an alcohol swab and allow itto dry.Do not warm the prefilled syringeany other way.Check the expiration date (‘EXP’)on the back panel ofthe carton.Do not use your prefilled syringeif the expiration date has passed. L ower stomach area (lowerabdomen), except for a 2-incharea right around your navel(belly-button) B ack of upper arms (only ifsomeone else is giving you theinjection)Do not touch, fan, or blow onthe injection site after you havecleaned it.Do not inject into skin that istender, bruised, red, hard, thick,scaly or affected by psoriasis.Do not inject TREMFYA if theperforations on the carton arebroken. Call your healthcareprovider or pharmacist for a refill.Inspect liquidTake your TREMFYA prefilledsyringe out of the carton.Check the TREMFYA prefilledsyringe liquid in the viewingwindow. It should be clear toslightly yellow and may containtiny white or clear particles. Youmay also see one or more airbubbles. This is normal.2Do not inject if the liquid iscloudy or discolored, or has largeparticles. Call your healthcareprovider or pharmacist for a refill.

TREMFYA (guselkumab)2. Inject TREMFYA using prefilled syringe45 Remove needle coverHold your prefilled syringe bythe body and pull needle coverstraight off. It is normal to see adrop of liquid.Inject TREMFYA within 5 minutesof removing the needle cover.Do not put needle cover back on,as this may damage the needle orcause a needle stick injury.Do not touch needle or let it touchany surface.Do not use a TREMFYA prefilledsyringe if it is dropped. Callyour healthcare provider orpharmacist for a refill.Position fingers andinsert needleRelease pinch andreposition handPlace your thumb, index andmiddle fingers directly under thefinger flange, as shown.Use your free hand to grasp thebody of the prefilled syringe.Do not touch plunger or areaabove finger flange as this maycause the needle safety device toactivate.Use your other hand to pinchskin at the injection site. Positionsyringe at about a 45 degreeangle to the skin.It is important to pinch enoughskin to inject under the skin andnot into the muscle.Insert needle with a quick, dartlike motion.Press plungerPlace thumb from the oppositehand on the plunger and pressthe plunger all the way downuntil it stops.Release pressure from plunger3The safety guard will cover theneedle and lock into place, removingthe needle from your skin.

TREMFYA (guselkumab)How should I dispose of the usedprefilled syringe?3. After your injectionIf you do not have an FDA-clearedsharps disposal container, you mayuse a household container that is: made of a heavy-duty plastic can be closed with a tight-fitting,puncture-resistant lid, without sharpsbeing able to come out upright and stable during use leak-resistantDispose of your prefilledsyringePut your used TREMFYA prefilledsyringe in an FDA-cleared sharpsdisposal container right awayafter use.Do not throw away (dispose of)your TREMFYA prefilled syringe inyour household trash.Do not recycle your used sharpsdisposal container.For more information, see“How should I dispose of theused prefilled syringe?”Check injection siteThere may be a small amountof blood or liquid at theinjection site. Hold pressureover your skin with a cottonball or gauze pad until anybleeding stops.Do not rub the injection site.If needed, cover injection sitewith a bandage.Need help?Call your healthcare providerto talk about any questionsyou may have. For additionalassistance or to share yourfeedback call 800-JANSSEN(800-526-7736). properly labeled to warn of hazardouswaste inside the containerWhen your sharps disposal container isalmost full, you will need to follow yourcommunity guidelines for the right wayto dispose of your sharps disposalcontainer. There may be state or locallaws about how you should throw awayused needles and syringes.For more information about safe sharpsdisposal, and for specific informationabout sharps disposal in the state thatyou live in, go to the FDA’s website at:www.fda.gov/safesharpsdisposalThis Instructions for Use has been approvedby the U.S. Food and Drug Administration.Manufactured by:Janssen Biotech, Inc.Horsham, PA 19044US License No. 1864Approved: July 20174cp-76864v1

Instructions for UseTREMFYA (trem fye ah) (guselkumab)One-Press Patient-Controlled InjectorImportantTREMFYA comes in a single-dose One-Pressinjector containing one 100 mg dose. EachOne-Press injector can only be used one time.Throw away (See Step 3) after one dose, evenif there is medicine left in it. Do not reuse yourOne-Press injector.If your healthcare provider decides that you ora caregiver may be able to give your injectionsof TREMFYA at home, you should receivetraining on the right way to prepare and injectTREMFYA using the One-Press injector. Do nottry to inject yourself until you have been trainedby your healthcare provider.SINGLE-DOSEPlease read this Instructions for Use beforeusing your One-Press injector and each timeyou get a new One-Press injector. There maybe new information. This leaflet does not takethe place of talking with your healthcareprovider about your medical condition or yourtreatment.Storage informationStore in refrigerator at 36 to 46 F (2 to 8 C).Do not freeze your One-Press injector.Keep your One-Press injector and all medicinesout of reach of children.Do not shake your One-Press injector.Keep your One-Press injector in the originalcarton to protect from light and physical damage.Need help?Call your healthcare provider to talk about anyquestions you may have. For additionalassistance or to share your feedback call800-JANSSEN (800-526-7736).5One-Press injectorpartsHandleTeal BodyWindowNeedle GuardBottom CapYou will need: 1 One-Press injectorNot provided in the carton: 1 Alcohol swab1 Cotton ball or gauze pad1 Adhesive bandage1 Sharps container(See Step 3)

TREMFYA (guselkumab)1. Prepare for your injectionInspect cartonChoose injection siteWash handsRemove your One-Press injectorcarton from the refrigerator.Select from the following areasfor your injection:Wash your hands well with soap andwarm water.Keep your One-Press injector inthe carton and let it sit on a flatsurface at room temperature forat least 30 minutes before use. Front of thighs(recommended) Lower stomach area(lower abdomen), except fora 2-inch area right aroundyour navel (belly-button) Back of upper arms(only if someone else isgiving you the injection)Clean injection siteDo not warm your One-Pressinjector any other way.Check the expiration date (‘EXP’)on the carton.Do not use your One-Pressinjector if the expiration date haspassed.Do not inject TREMFYA if theperforations on the carton arebroken. Call your healthcareprovider or pharmacist for a newOne-Press injector.Wipe your chosen injection site withan alcohol swab and allow it to dry.Do not touch, fan, or blow on theinjection site after you have cleaned it.Do not inject into skin thatis tender, bruised, red, hard,thick, scaly, or affected bypsoriasis.Inspect liquid in windowTake your One-Press injector out ofthe carton.Check the liquid in the window. Itshould be clear to slightly yellowand may contain tiny white or clearparticles. You may also see one ormore air bubbles. This is normal.Do not inject if the liquid is cloudyor discolored, or has large particles.Call your healthcare provider orpharmacist for a new One-Pressinjector.6

TREMFYA (guselkumab)2. Inject TREMFYA using the One-Press injectorTwist and pull offbottom capKeep hands away from theneedle guard after the capis removed.Place on skinPush handle straight downPosition the One-Pressinjector straight onto theskin (about 90 degreesrelative to injection site).Medication injects as you push. Do thisat a speed that is comfortable for you.Inject TREMFYA within5 minutes of removing the cap.Do not lift the One-Press injector duringthe injection. The needle guard will lockand the full dose will not be delivered.Do not put the cap back on, thiscould damage the needle.Do not use a One-Press injectorif it is dropped after removingthe cap. Call your healthcareprovider or pharmacist for anew One-Press injector.Complete injectionInjection is complete when the handle ispushed all the way down, you hear a click,and the teal body is no longer visible.Lift straight upThe yellow band indicates that theneedle guard is locked.7

TREMFYA (guselkumab)How should I dispose of the usedOne-Press injector?3. After your injectionIf you do not have an FDA-clearedsharps disposal container, you mayuse a household container that is: made of a heavy-duty plastic can be closed with a tight-fitting,puncture-resistant lid, without sharpsbeing able to come out upright and stable during use leak-resistant properly labeled to warn of hazardouswaste inside the containerDispose of yourOne-Press injectorPut your used One-Press injectorin an FDA-cleared sharps disposalcontainer right away after use.Do not throw away (dispose of)your One-Press injector in yourhousehold trash.Do not recycle your used sharpsdisposal container.Check injection siteThere may be a small amount ofblood or liquid at the injectionsite. Hold pressure over yourskin with a cotton ball or gauzepad until any bleeding stops.Do not rub the injection site.If needed, cover injectionsite with a bandage.For more information, see “Howshould I dispose of the usedOne-Press injector?”.When your sharps disposal container isalmost full, you will need to follow yourcommunity guidelines for the right wayto dispose of your sharps disposalcontainer. There may be state or locallaws about how you should throw awayused needles and syringes.For more information about safe sharpsdisposal, and for specific informationabout sharps disposal in the state thatyou live in, go to the FDA’s website at:www.fda.gov/safesharpsdisposalThis Instructions for Use has been approvedby the U.S. Food and Drug Administration.Manufactured by:Janssen Biotech, Inc.Horsham, PA 19044US License No. 1864Approved: January 20198cp-76864v1

Read this Instructions for Use before using your TREMFYA 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. The TREMFYA prefilled syringe is intended for injection under the skin, not into the