Medication Guide ABSTRAL (AB-stral) CII (fentanyl) Sublingual tablets

Transcription

1 Medicatin Guide ABSTRAL (AB-stral) CII (fentanyl) Sublingual tablets IMPORTANT: D nt use ABSTRAL unless yu are regularly using anther piid pain medicine arund-the-clck fr at least ne week r lnger fr yur cancer pain and yur bdy is used t these medicines (this means that yu are piid tlerant). Yu can ask yur healthcare prvider if yu are piid tlerant. Keep ABSTRAL in a safe place away frm children. Get emergency medical help right away if: a child takes ABSTRAL. ABSTRAL can cause an verdse and death in any child wh takes it. an adult wh has nt been prescribed ABSTRAL takes it an adult wh is nt already taking piids arund-the-clck, takes ABSTRAL These are medical emergencies that can cause death. If pssible, try t remve ABSTRAL frm the muth. ABSTRAL is: A strng prescriptin pain medicine that cntains an piid (narctic) that is used t manage breakthrugh pain in adults with cancer wh are already rutinely taking ther piid pain medicines arund-the-clck fr cancer pain. ABSTRAL is started nly after yu have been taking ther piid pain medicines and yur bdy has becme used t them (yu are piid tlerant). D nt use ABSTRAL if yu are nt piid tlerant. An piid pain medicine that can put yu at risk fr verdse and death. Even if yu take yur dse crrectly as prescribed yu are at risk fr piid addictin, abuse, and misuse that can lead t death. Imprtant infrmatin abut ABSTRAL: Get emergency help right away if yu take t much ABSTRAL (verdse). When yu first start taking ABSTRAL, when yur dse is changed, r if yu take t much (verdse), serius life-threatening breathing prblems that can lead t death may ccur. Taking ABSTRAL with ther piid medicines that may make yu sleepy, such as ther pain medicines, antidepressants, sleeping pills, anti-anxiety medicines, antihistamines, r tranquilizers, r with alchl r street drugs can cause severe drwsiness, cnfusin, breathing prblems, cma, and death. Never give anyne else yur ABSTRAL. They culd die frm taking it. Stre ABSTRAL away frm children and in a safe place t prevent stealing r abuse. Selling r giving away ABSTRAL is against the law. If yu stp taking yur arund-the-clck piid pain medicine fr yur cancer pain, yu must stp using ABSTRAL. Yu may n lnger be piid tlerant. Talk t yur healthcare prvider abut hw t treat yur pain. ABSTRAL is available nly thrugh a prgram called the Transmucsal Immediate-Release Fentanyl (TIRF) Risk Evaluatin and Mitigatin Strategy (REMS) Access prgram. T receive ABSTRAL, yu must: talk t yur healthcare prvider understand the benefits and risks f ABSTRAL agree t all f the instructins sign the Patient-Prescriber Agreement frm ABSTRAL is nly available at pharmacies that are part f the TIRF REMS Access prgram. Yur healthcare prvider will let yu knw the pharmacy clsest t yur hme where yu can have yur ABSTRAL prescriptin filled. Be very careful abut taking ther medicines that may make yu sleepy, such as ther pain medicines, antidepressant medicines, sleeping pills, anti-anxiety medicines, antihistamines, r tranquilizers. Knw the medicines yu take. Keep a list f them t shw yur healthcare prvider and pharmacist when yu get a new medicine.

2 D nt take ABSTRAL if: Yu are nt piid tlerant. Opiid tlerant means that yu are already taking ther piid pain medicines arund-the-clck fr at least ne week r lnger fr yur cancer pain, and yur bdy is used t these medicines. Yu have severe asthma, truble breathing, r ther lung prblems. Yu have a bwel blckage r have narrwing f the stmach r intestines. Yu are allergic t any f the ingredients in ABSTRAL. See the end f this Medicatin Guide fr a cmplete list f ingredients in ABSTRAL. Yu have shrt-term pain that yu wuld expect t g away in a few days, such as: pain after surgery headache r migraine dental pain Befre taking ABSTRAL, tell yur healthcare prvider if yu have a histry f: Trubled breathing r lung prblems such as asthma, wheezing, r shrtness f breath head injury, seizures slw heart rate r ther heart prblems lw bld pressure mental prblems [including majr depressin, schizphrenia r hallucinatins (seeing r hearing things that are nt there)] prblems urinating liver, kidney, thyrid prblems pancreas r gallbladder prblems abuse f street r prescriptin drugs, alchl addictin, r mental health prblems Tell yur healthcare prvider if yu are: pregnant r planning t becme pregnant. Prlnged use f ABSTRAL during pregnancy can cause withdrawal symptms in yur newbrn baby that culd be life-threatening if nt recgnized and treated. breastfeeding. ABSTRAL passes int breast milk and may harm yur baby. taking prescriptin ver-the-cunter medicines, vitamins, r herbal supplements. Taking ABSTRAL with certain ther medicines can cause serius side effects that culd lead t death

3 When taking ABSTRAL: D nt change yur dse. Take ABSTRAL exactly as prescribed by yur healthcare prvider. Yur healthcare prvider will change the dse until yu and yur healthcare prvider find the right dse fr yu. See the detailed Instructins fr Use at the end f this Medicatin Guide fr infrmatin abut hw t use ABSTRAL. Use ABSTRAL tablets whle. D nt crush, split, suck, r chew ABSTRAL tablets, r swallw the tablets whle. Yu will get less relief fr yur breakthrugh cancer pain. Wait 30 minutes after using ABSTRAL. If there is any f the ABSTRAL tablet left in yur muth, yu may drink a glass f water t help yu swallw the left ver medicine. Yu must nt use mre than 2 dses f ABSTRAL fr each episde f breakthrugh cancer pain. Use 1 dse f ABSTRAL fr an episde f breakthrugh cancer pain. If yur breakthrugh cancer pain des nt get better 30 minutes after taking the first dse f ABSTRAL, yu can use nly 1 mre dse f ABSTRAL as instructed by yur healthcare prvider. If yur breakthrugh pain des nt get better after the secnd dse f ABSTRAL, call yur healthcare prvider fr instructins. D nt use anther dse f ABSTRAL at this time. Wait at least 4 hurs befre treating a new episde f breakthrugh cancer pain with ABSTRAL. If yu nly need t take 1 dse f ABSTRAL fr an episde f breakthrugh pain, yu must wait 4 hurs frm the time f that dse t take a dse f ABSTRAL fr a new episde f breakthrugh pain. If yu need t use 2 dses f ABSTRAL fr an episde f breakthrugh pain, yu must wait 4 hurs after the secnd dse t take a dse f ABSTRAL fr a new episde f breakthrugh pain. It is imprtant fr yu t keep taking yur arund-the-clck piid pain medicine while using ABSTRAL. Talk t yur healthcare prvider if yur dse f ABSTRAL des nt relieve yur breakthrugh cancer pain. Yur healthcare prvider will decide if yur dse f ABSTRAL needs t be changed. Talk t yur healthcare prvider if yu have mre than 4 episdes f breakthrugh cancer pain per day. The dse f yur arund-the-clck piid pain medicine may need t be adjusted. If yu begin t feel dizzy, sick t yur stmach, r very sleepy befre the tablet is cmpletely disslved, rinse yur muth with water and spit the remaining pieces f the tablet int a sink r tilet right away. Rinse the sink r flush the tilet t dispse f any remaining tablet pieces. D nt stp taking ABSTRAL withut talking t yur healthcare prvider. After yu stp taking, r when ABSTRAL is n lnger needed, see Hw shuld I dispse f unused ABSTRAL tablets when they are n lnger needed? fr prper dispsal f ABSTRAL. DO NOT Drive r perate heavy machinery, until yu knw hw ABSTRAL affects yu. ABSTRAL can make yu sleepy, dizzy, r lightheaded. DO NOT Drink alchl r use prescriptin r ver-the-cunter medicines that cntain alchl. Using prducts cntaining alchl during treatment with ABSTRAL may cause yu t verdse and die. DO NOT Switch frm ABSTRAL t ther medicines that cntain fentanyl withut talking with yur healthcare prvider. The amunt f fentanyl in a dse f ABSTRAL is nt the same as the amunt f fentanyl in ther medicines that cntain fentanyl. Yur healthcare prvider will prescribe a starting dse f ABSTRAL that may be different than ther fentanyl cntaining medicines yu may have been taking. Hw shuld I stre ABSTRAL? Always keep ABSTRAL in a safe place away frm children and frm anyne fr whm it has nt been prescribed. Prtect ABSTRAL frm theft. Stre ABSTRAL at rm temperature, 59 F t 86 F (15 C t 30 C) until ready t use. Keep ABSTRAL in the riginal blister unit. D nt remve ABSTRAL tablets frm their blister packaging fr strage in a temprary cntainer, such as a pillbx. Hw shuld I dispse f unpened ABSTRAL tablets when they are n lnger needed? Dispse f any unpened ABSTRAL units remaining frm a prescriptin as sn as yu n lnger need them:

4 remve the tablets frm the blister cards and flush them dwn the tilet. D nt flush the ABSTRAL blister cards, units r cartns dwn the tilet. If yu need help with dispsal f ABSTRAL, call rcall yur lcal Drug Enfrcement Agency (DEA) ffice. General infrmatin abut ABSTRAL Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. Use ABSTRAL nly fr the purpse fr which it was prescribed. D nt give ABSTRAL t ther peple, even if they have the same symptms yu have. ABSTRAL can harm ther peple and even cause death. Sharing ABSTRAL is against the law. This Medicatin Guide summarizes the mst imprtant infrmatin abut ABSTRAL. If yu wuld like mre infrmatin, talk with yur healthcare prvider r pharmacist. Yu can ask yur pharmacist r healthcare prvider fr infrmatin abut ABSTRAL that is written fr healthcare prfessinals. Fr mre infrmatin abut the TIRF REMS Access prgram, g t r call What are the ingredients inabstral? Active Ingredient: fentanyl citrate Inactive Ingredients: crscarmellse sdium, magnesium stearate, mannitl, and silicified micrcrystalline cellulse. Patient Instructins fr Use Befre yu take ABSTRAL, it is imprtant that yu read the Medicatin Guide and these Patient Instructins fr Use. Be sure that yu read, understand, and fllw these Patient Instructins fr Use s that yu take ABSTRAL the right way. Ask yur healthcare prvider r pharmacist if yu have questins abut the right way t take ABSTRAL. When yu get an episde f breakthrugh pain, take the dse prescribed by yur healthcare prvider as fllws: If yur muth is dry, take a sip f water t misten it. Spit ut r swallw the water. Dry yur hands if they are wet befre yu handle ABSTRAL tablets. ABSTRAL cmes in a blister card with 4 blister units. Each blister unit cntains an ABSTRAL tablet. It is imprtant that the tablet stays sealed in the blister unit until yu are ready t use it. When yu are ready t take an ABSTRAL tablet, pull apart 1 f the blister units frm the blister card by tearing alng the dtted lines (perfratins) until it is fully separated. (See Figures 1 and 2) When the blister unit is fully separated, peel back the fil starting at the unsealed area where indicated. Gently remve the tablet. D nt try t push ABSTRAL tablets thrugh the fil. This will damage the tablet. (See Figures 3 and 4)

5 As sn as yu remve the ABSTRAL tablet frm the blister unit: place it n the flr f yur muth, under yur tngue, as far back as yu can (See Figures 5, 6, and 7). If mre than 1 tablet is required, spread them arund the flr f yur muth under yur tngue. Let the tablet disslve cmpletely. ABSTRAL disslves under yur tngue and will be absrbed by yur bdy t help prvide relief fr yur breakthrugh cancer pain. D nt suck, chew r swallw the tablet. Yu shuld nt drink r eat anything until the tablet has cmpletely disslved under yur tngue and yu can n lnger feel it in yur muth. Manufactured by: Pharmaceutics Internatinal, Inc. Hunt Valley, MD Manufactured fr: Sentynl Therapeutics, Inc. Slana Beach, CA Issued: December 2016 This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Cpyright 2016, Sentynl Therapeutics, Inc. All rights reserved. ABSTRAL and Sentynl Therapeutics, Inc. are trademarks wned by the Sentynl Therapeutics, Inc.