INSTRUCTIONS FOR USE PLEGRIDY (PLEGG-rih-dee) (peginterferon beta-1a) Injection, for Subcutaneous Use Single-Use Prefilled Pen Starter Pack

Transcription

1 INSTRUCTIONS FOR USE PLEGRIDY (PLEGG-rih-dee) (peginterfern beta-1a) Injectin, fr Subcutaneus Use Single-Use Prefilled Pen Starter Pack Read this Instructins fr Use befre yu start using Plegridy 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. Nte: Befre yu use yur Plegridy Pen fr the first time, yur healthcare prvider shuld shw yu r yur caregiver hw t prepare and inject yur Plegridy Pen the right way. If yu experience difficulty r have questins, call Plegridy Pen is fr use under the skin nly (subcutaneus). Each Plegridy Pen can be used 1 time nly. D nt share yur Plegridy Pen with anyne else. By sharing the Pen, yu may give an infectin t them r get an infectin frm them. Supplies needed fr yur Starter Pack fr Plegridy Pen injectin (See Figure A): 1 Starter Pack fr Plegridy Pen which cntains: 1 Plegridy 63 mcg Pen (range pen) 1 Plegridy 94 mcg Pen (blue pen) Figure A Additinal supplies which are nt included in the pack (See Figure B): alchl wipe gauze pad adhesive bandage 1 sharps cntainer fr thrwing away used needles and Plegridy Pens. See Dispsing f yur used Plegridy Pens at the end f these instructins.

2 a well-lit area and a clean, flat surface t wrk n, like a table Step 1: Chse yur dse Figure B Chse the right Plegridy Pen fr yur dse. The Starter Pack fr Plegridy Pen cntains yur first 2 injectins t slwly adjust yur dse. When Which Dse Chse Day 1 First Dse: Orange Pen (See Figure C) (63 mcg) 63 mcg Figure C When Which Dse Chse Day 15 (94 mcg) Secnd Dse: 94 mcg Blue Pen (See Figure D) Figure D Make sure yu use the 63 mcg range pen fr yur first dse (day 1). Make sure yu use the 94 mcg blue pen fr yur secnd dse (day 15).

3 Ask yur healthcare prvider which Plegridy Pen yu shuld use fr yur crrect dse if yu are nt sure. Parts f yur Plegridy Pen befre use (See Figure E): Figure E Parts f yur Plegridy Pen after use (See Figure F): Nte: Befre yu prepare yur injectin, take yur Plegridy Pen ut f the refrigeratr and let it cme t rm temperature fr at least 30 minutes. D nt use external heat surces such as ht water t warm yur Plegridy Pen. D nt remve the cap until yu are ready t inject. D nt use mre than 1 Plegridy Pen every 14 days. Preparing fr yur injectin:

4 Step 2: Cllect yur supplies and wash yur hands Find a well-lit area and a clean, flat surface like a table and cllect all the supplies yu will need t give yurself r t receive an injectin. Wash yur hands with sap and water. Step 3: Check yur Plegridy Pen If yu experience difficulty r have questins, call Check the expiratin date printed n yur Plegridy Pen (See Figure G). D nt use Plegridy Pen past the expiratin date. Check the injectin status windw n yur Plegridy Pen. Yu shuld see green stripes in the injectin status windw (See Figure H). D nt use Plegridy Pen if yu d nt see the green stripes in the injectin status windw. Check the medicatin windw n yur Plegridy Pen and make sure the Plegridy medicine is clear and clrless (See Figure I). D nt use Plegridy Pen if the liquid is clred, cludy, r has flating particles in it. Yu might see air bubbles in the medicatin windw. This is nrmal and will nt affect yur dse. Giving yur injectin: Step 4: Chse yur injectin site Plegridy Pen is fr use under the skin nly (subcutaneus).

5 Plegridy Pen shuld be injected int yur thigh, abdmen r the back f yur upper arm (See Figure J). D nt inject int an area f yur bdy where the skin is irritated, reddened, bruised, infected r scarred. Change (rtate) yur injectin site fr each injectin. D nt use the same injectin site fr each injectin. Chse an injectin site and wipe yur skin with an alchl wipe. Let yur injectin site dry n its wn befre injecting yur dse. D nt tuch this area again befre giving yur injectin. D nt take ff the Plegridy Pen cap until yu are ready t inject. Step 5: Remve the Plegridy Pen cap Pull the Plegridy Pen cap straight ff and set it aside (See Figure K). D nt recap yur Plegridy Pen. The needle is cvered by the needle cver and the needle will nt be seen (See Figure K). D nt tuch r push dwn n the needle cver, yu culd get a needle stick. Figure J Figure K

6 Yur Plegridy Pen is ready t inject after the cap is remved. Step 6: Place yur Plegridy Pen n yur injectin site Place yur Plegridy Pen n yur chsen injectin site. Yu shuld hld yur Plegridy Pen at a 90 angle t yur injectin site s that yu can see the green stripes in the injectin status windw (See Figure L). D nt use yur Plegridy Pen unless yu see green stripes in the injectin status windw. Figure L Step 7: Give yur Plegridy Pen injectin Firmly press and hld dwn yur Plegridy Pen n yur injectin site. This will insert the needle and start yur injectin (See Figure M). Yu will hear a clicking sund. Hld yur Plegridy Pen firmly dwn n yur injectin site until the clicking sund has stpped. D nt lift yur Plegridy Pen ff yur injectin site until the clicking sund stps and yu see green checkmarks in the injectin status windw. Figure M

7 After the clicking sund has stpped, check the injectin status windw. Yu shuld see green checkmarks in the injectin status windw (See Figure N). Step 8: Remve yur Plegridy Pen frm yur injectin site Lift yur Plegridy Pen frm yur injectin site. The needle cver will be cvering all f the needle (See Figure O). Figure N Figure O Step 9: Check t make sure yu have received yur full dse f Plegridy Check the injectin status windw. Yu shuld see green checkmarks in the injectin status windw (See Figure P). Check the medicatin windw. Yu shuld see a yellw plunger in the medicatin windw (See Figure Q). If yu see bld at yur injectin site, wipe it ff with gauze and apply an adhesive bandage. If yu experience difficulty r have questins, call

8 After yur injectin: Step 10: Dispsing f yur used Plegridy Pens Put yur used Plegridy Pens in a FDA-cleared sharps dispsal cntainer right away after use. D nt thrw away (dispse f) Plegridy Pens 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, and 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 pens. 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. Step 11: Check yur injectin site Plegridy may cmmnly cause redness, pain r swelling f yur skin at the injectin site. Call yur healthcare prvider right away if yur injectin site becmes swllen and painful r the area lks infected and des nt heal within a few days. Hw shuld I stre Plegridy? Stre Plegridy in the refrigeratr between 36 F t 46 F (2 C t 8 C). If needed, Plegridy may be stred between 36 F t 77 F (2 C t 25 C) fr up t 30 days in ttal. Keep Plegridy in the riginal cartn t prtect it frm light. D nt freeze Plegridy. Keep Plegridy Pens, needles, and all medicines ut f the reach f children. Questins? Fr prduct r service related questins, call r g t

9 This Instructins fr Use has been apprved by the U.S. Fd and Drug Administratin. Manufactured by: Bigen Inc., Cambridge, MA 02142, U.S. License # Bigen All rights reserved Issued: 07/