Patient Information Kineret (KIN-eh-ret) (anakinra) injection, for subcutaneous use

Transcription

1 Patient Infrmatin Kineret (KIN-eh-ret) (anakinra) injectin, fr subcutaneus use Read this Patient Infrmatin befre yu start using Kineret and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r yur treatment. What is Kineret? Kineret is a prescriptin medicine called an interleukin-1 receptr antagnist (IL-1ra) used t: Reduce the signs and symptms and slw the damage f mderate t severe active rheumatid arthritis (RA) in peple age 18 years and lder when 1 r mre ther drugs fr RA have nt wrked. Treat peple with a frm f Crypyrin-Assciated Peridic Syndrmes (CAPS) called Nenatal-Onset Multisystem Inflammatry Disease (NOMID) Kineret is nt fr children with Juvenile Rheumatid Arthritis Wh shuld nt use Kineret? D nt use Kineret if yu are allergic t: prteins made frm bacteria called E.Cli. Ask yur healthcare prvider if yu are nt sure. anakinra r any f the ingredients in Kineret. See the end f this leaflet fr a cmplete list f ingredients in Kineret. What shuld I tell my healthcare prvider befre using Kineret? Befre yu use Kineret, tell yur healthcare prvider if yu: have an infectin, a histry f infectins that keep cming back r ther prblems that can increase yur risk f infectins. have kidney prblems. are scheduled t receive any vaccines. Peple using Kineret shuld nt receive live vaccines. are pregnant r plan t becme pregnant. It is nt knwn if Kineret will harm yur unbrn baby. are breastfeeding r plan t breastfeed. It is nt knwn if Kineret passes int yur breast milk. Yu and yur healthcare prvider shuld decide if yu will use Kineret r breastfeed. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and ver-the-cunter medicines, vitamins, and herbal supplements. Kineret and ther medicines may affect each ther and cause serius side effects. Especially, tell yur healthcare prvider if yu take certain ther medicines that: affect yur immune system called Tumr Necrsis Factr (TNF) blckers Ask yur healthcare prvider fr a list f these medicines if yu are nt sure. Knw the medicines yu take. Keep a list f yur medicines and shw it t yur healthcare prvider and pharmacist when yu get a new prescriptin. 3

2 Hw shuld I use Kineret? Read the Instructins fr Use at the end f this Patient Infrmatin fr infrmatin abut the right way t use Kineret. Use Kineret exactly as yur healthcare prvider tells yu t. Yu may nt have t use all f the liquid medicine in the prefilled syringe. Yur healthcare prvider will shw yu hw t find the crrect dse f Kineret fr yu r yur child. Kineret is given by injectin under yur skin. Inject Kineret at abut the same time each day. If yu have a kidney prblem yur healthcare prvider may need t change hw ften yu use yur Kineret injectins. If yu miss a dse f Kineret, talk t yur healthcare prvider t find ut when yu shuld use yur next injectin. What are the pssible side effects f Kineret? Kineret may cause serius side effects, including: serius infectins. Kineret may lwer yur ability t fight infectins. During yur treatment with Kineret, call yur healthcare prvider right away if yu: get an infectin have any sign f an infectin including a fever r chills have any pen sres n yur bdy Yu may get an infectin if yu receive live vaccines while yu use Kineret. Yu shuld nt receive live vaccines while yu use Kineret. allergic reactins. Stp using Kineret and call yur healthcare prvider r get emergency help right away if yu have any f these symptms f an allergic reactin: swelling f yur face, lips, muth r tngue truble breathing wheezing severe itching skin rash, redness, r swelling utside f the injectin site area dizziness r fainting fast heartbeat r punding in yur chest (tachycardia) sweating decreased ability f yur bdy t fight infectins (immunsuppressin). It is nt knwn if treatment with medicines that cause immunsuppressin, like Kineret, affect yur risk f getting cancer. lw white bld cell cunt (neutrpenia). Kineret may cause yu t have a lwer number f certain white bld cells (neutrphils). Neutrphils are imprtant in fighting infectins. Yu shuld have bld tests befre starting treatment with Kineret, then mnthly fr 3 mnths. After the first 3 mnths yu shuld have yur bld tested every 3 mnths fr 4

3 up t 1 year. The mst cmmn side effects f Kineret include: injectin site skin reactins. The symptms f injectin site skin reactins may include: redness swelling bruising itching stinging Mst injectin site reactins are mild, happen early during treatment, and last abut 14 t 28 days. Injectin site reactins have been bserved less frequently in peple with NOMID. rheumatid arthritis (RA) gets wrse even with treatment, if yu already have RA headache nausea and vmiting diarrhea jint pain fever feeling like yu have the flu sre thrat r runny nse sinus infectin pain in yur stmach area Tell yur healthcare prvider if yu have any side effect that bthers yu r that des nt g away. These are nt all f the pssible side effects f Kineret. Fr mre infrmatin, ask yur healthcare prvider r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre Kineret? Stre Kineret in the refrigeratr between 36 F t 46 F (2 C t 8 C). D nt freeze r shake Kineret. Keep Kineret in its riginal cartn and away frm light. Keep Kineret and all medicines ut f the reach f children. General Infrmatin abut the safe and effective use f Kineret. Medicines are smetimes prescribed fr purpses ther than thse listed in a patient leaflet. D nt use Kineret fr a cnditin fr which it was nt prescribed. D nt give Kineret t ther peple, even if they have the same symptms that yu have. It may harm them. This Patient Infrmatin leaflet summarizes the mst imprtant infrmatin abut Kineret. If yu wuld like mre infrmatin abut Kineret, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut Kineret that is written fr health prfessinals. Fr mre infrmatin g t r call

4 What are the ingredients in Kineret? Active ingredients: anakinra Inactive ingredients: anhydrus citric acid, disdium EDTA, plysrbate 80, and sdium chlride in Water fr Injectin, USP 2

5 Instructins fr Use Kineret (KIN-eh-ret) (anakinra) injectin, fr subcutaneus use Read this Instructins fr Use befre yu start using Kineret and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r yur treatment. Supplies yu will need t give yur Kineret injectin: See Figure A. 1 Kineret prefilled syringe 1 alchl wipe 1 dry sterile gauze r tissue 1 puncture-resistant sharps dispsal cntainer Figure A Each Kineret dse cmes in a prefilled glass syringe. There are 7 syringes in each new Kineret bx, 1 fr each day f the week. Use a new Kineret syringe each day. Use the Kineret prefilled syringe that matches the day f the week until all 7 syringes are used. Setting up fr yur injectin: Step 1. Take the cartn cntaining the prefilled syringes f Kineret ut f the refrigeratr. Remve the prefilled syringe frm the bx that matches the day f the week. Put the cartn cntaining the remaining prefilled syringes back in the refrigeratr. Step 2. Find a clean, flat wrk surface, such as a table. Step 3. Check the expiratin date n the syringe label. See Figure B. If the expiratin date has passed, d nt use the syringe. Call yur pharmacist r call fr assistance. 3

6 Figure B Step 4. Take the Kineret prefilled syringe ut f the refrigeratr and leave it in rm temperature fr 30 minutes befre yur injectin. Make sure the liquid medicine in the prefilled syringe is clear and clrless. It is nrmal t see a small amunt f tiny particles that are white, r that yu can see thrugh. D nt inject the medicine if it is cludy r disclred, r has large r clred particles. Call yur healthcare prvider r pharmacist if yu have any questins abut yur Kineret prefilled syringe. Step 5. Gather all the supplies yu will need fr yur injectin. Step 6. Wash yur hands with sap and warm water. Preparing yur crrect dse f Kineret: PREPARING A 100 MG DOSE OF KINERET: Hld the syringe barrel and pull the cver straight ff the needle. See Figure C. D nt tuch the needle r push the plunger. Thrw away the needle cver. Figure C Yu may ntice a small air bubble in the prefilled syringe. Yu d nt have t remve the air bubble befre injecting. Injecting the slutin with the air bubble is harmless. Carefully place the barrel f the syringe n the table until yu are ready t inject. D nt let the needle tuch the table. D nt recap the needle. 4

7 Hw t prepare a dse f Kineret less than 100 mg: Hld the syringe in 1 hand with the needle pinting straight upwards. See Figure D. Put yur thumb n the plunger rd and push slwly until yu see a tiny liquid drp at the tip f the needle. Figure D Turn the syringe s that the needle is nw pinting dwnwards. Place a sterile gauze r tissue n a flat surface and hld the syringe abve it with the needle pinting twards the gauze r tissue. See Figure E. Make sure the needle des nt tuch the gauze r tissue. Figure E Put yur thumb n the plunger rd and push slwly until yu can see that the tp f the plunger has reached the crrect number fr yur Kineret dse yur healthcare prvider has prescribed. The liquid that was pushed ut f the needle will be absrbed by the gauze r tissue. See Figure E. If yu are nt able t select the crrect dse f Kineret, thrw away the syringe and use a new ne. Carefully place the barrel f the syringe n the table until yu are ready t inject. D nt let the needle tuch the table. D nt recap the needle. 5

8 Selecting and preparing the injectin site: Step 7. Chse an injectin site. See Figure F. Recmmended injectin sites fr adults and children include: uter area f the upper arms abdmen (except the 2-inch area arund the belly buttn) frnt f the middle thighs upper uter areas f the buttcks Adult Child Chse a new site each time yu use Kineret. Chsing a new site may help avid sreness at 1 site. D nt inject Kineret int an area f skin that is tender, red, bruised, swllen, r hard. Avid areas f skin with scars r stretch marks. D nt inject Kineret clse t a vein that yu can see under the surface f yur skin. Clean yur injectin site with an alchl swab. Let the area dry cmpletely. Giving yur injectin: Figure F Step 8. Gently pinch a fld f skin at the cleaned injectin site. Step 9. With yur ther hand, hld the syringe like a pencil at a 45 degree t 90 degree angle t the skin. With a quick, dart-like mtin insert the needle int the skin. See Figure G. Figure G 6

9 Step 10. After the needle is inserted int the skin slwly push the plunger all the way dwn t inject Kineret. See Figure H. Figure H Step 11. When the syringe is empty, pull the needle ut f the skin while carefully keeping the needle at the same angle as inserted. See Figure I. Figure I Step 12. Place a dry cttn ball r gauze pad ver the injectin site and press fr several secnds. See Figure J. D nt use an alchl swab as it may cause stinging. If there is a little bleeding, yu may cver the injectin site with a small bandage. Figure J Imprtant Infrmatin abut yur Kineret prefilled syringe: Use each Kineret prefilled syringe nly 1 time. D nt use a syringe mre than 1 time. D nt recap a needle. Yu may nt have t use all f the liquid medicine in the prefilled syringe. Yur healthcare prvider will shw yu hw t find the crrect dse f Kineret fr yu r yur child. If yu ntice that sme medicine is left in the prefilled syringe, d nt inject again with the 7

10 same prefilled syringe. If yu drp a prefilled syringe, d nt use it. The glass syringe may be brken, r the needle may be bent r dirty. Thrw away the prefilled syringe and replace it with a new ne. Take a new prefilled syringe frm what wuld be the last day f the week in yur current bx. Fr example, if yu start n Wednesday, the last day f the week in yur series is Tuesday. After using all the remaining prefilled syringes in yur current bx, start yur next bx f Kineret prefilled syringes. Dispsal f yur Kineret syringes: Put yur used syringes in a FDA-cleared sharps dispsal cntainer right away after use. D nt thrw away (dispse f) lse syringes in yur husehld trash. If yu d nt have a FDA-cleared sharps dispsal cntainer, yu may use a husehld cntainer that is: made f a heavy-duty plastic can be clsed with a tight-fitting, puncture-resistant lid, withut sharps being able t cme ut upright and stable during use leak-resistant prperly labeled t warn f hazardus waste inside the cntainer When yur sharps dispsal cntainer is almst full, yu will need t fllw yur cmmunity guidelines fr the right way t dispse f yur sharps dispsal cntainer. There may be state r lcal laws abut hw yu shuld thrw away used needles and syringes. Fr mre infrmatin abut safe sharps dispsal, and fr specific infrmatin abut sharps dispsal in the state that yu live in, g t the FDA s website at: D nt dispse f yur used sharps dispsal cntainer in yur husehld trash unless yur cmmunity guidelines permit this. D nt recycle yur used sharps dispsal cntainer. Thrw away the wet gauze r tissue with yur syringe and clean the table surface with a fresh swab. This Patient Infrmatin and Instructins fr Use has been apprved by the U.S. Fd and Drug Administratin. Manufactured by: Swedish Orphan Bivitrum AB (publ) SE Stckhlm, Sweden License N Swedish Orphan Bivitrum AB (publ). All rights reserved. Revised Date: 09/2015 PP