These are medical emergencies that can cause death. If possible, remove OTFC from the mouth.

Transcription

1 MEDICATION GUIDE Oral Transmucsal Fentanyl Citrate (OTFC) CII (fentanyl citrate) ral transmucsal lzenge 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, 1600 mcg IMPORTANT: D nt use Oral Transmucsal Fentanyl Citrate (OTFC) 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 OTFC in a safe place away frm children. Get emergency medical help right away if: a child takes OTFC. OTFC can cause an verdse and death in any child wh uses it. an adult wh has nt been prescribed OTFC uses it. an adult wh is nt already taking piids arund-the-clck, uses OTFC. These are medical emergencies that can cause death. If pssible, remve OTFC frm the muth. Read this Medicatin Guide cmpletelybefre yu start using OTFC and each time yu get a new prescriptin. There may be new infrmatin. This Medicatin Guide des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r yur treatment. Share this imprtant infrmatin with members f yur husehld and ther caregivers. What is the mst imprtant infrmatin I shuld knw abut Oral Transmucsal Fentanyl Citrate (OTFC)? OTFC can cause life-threatening breathing prblems which can lead t death: D nt use OTFC if yu are nt piid tlerant. If yu stp taking yur arund-the-clck piid pain medicine fr yur cancer pain, yu must stp using OTFC. Yu may n lnger be piid tlerant. Talk t yur healthcare prvider abut hw t treat yur pain. Use OTFC exactly as prescribed by yur healthcare prvider. Yu must nt use mre than 1 unit f OTFC at a time and n mre than 2 units f OTFC during each episde f breakthrugh cancer pain. Yu must wait at least 4 hurs befre treating a new episde f breakthrugh pain. See the Medicatin Guide sectin Hw shuld I use Oral Transmucsal Fentanyl Citrate (OTFC)? and the Patient Instructins fr Use at the end f this Medicatin Guide abut hw t use OTFC the right way. D nt switch frm OTFC t ther medicines that cntain fentanyl withut talking with yur healthcare prvider. The amunt f fentanyl in a dse f OTFC is nt the same as the amunt f fentanyl in ther medicines that cntain fentanyl. Yur healthcare prvider will prescribe a starting dse f OTFC that may be different than ther fentanyl cntaining medicines yu may have been taking. D nt use OTFC fr shrt-term pain that yu wuld expect t g away in a few days, such as: pain after surgery headache r migraine dental pain

2 6. Never give OTFC t anyne else, even if they have the same symptms yu have. It may harm them r even cause death. 7. What is Oral Transmucsal Fentanyl Citrate (OTFC)? OTFC is a federally cntrlled substance (CII) because it is a strng piid (narctic) pain medicine that can be misused by peple wh abuse prescriptin medicines r street drugs. Prevent theft, misuse r abuse. Keep OTFC in a safe place t prtect it frm being stlen. OTFC can be a target fr peple wh abuse piid (narctic) medicines r street drugs. Selling r giving away this medicine is against the law. OTFC is available nly thrugh a prgram called the Transmucsal Immediate Release Fentanyl (TIRF) Risk Evaluatin and Mitigatin Strategy (REMS) Access prgram. T receive OTFC, yu must: talk t yur healthcare prvider understand the benefits and risks f OTFC agree t all f the instructins sign the Patient-Prescriber Agreement frm OTFC is a prescriptin medicine that cntains the medicine fentanyl. OTFC is used t manage breakthrugh pain in adults (16 years f age and lder) with cancer wh are already rutinely taking ther piid pain medicines arund-the-clck fr cancer pain. OTFC 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 OTFC if yu are nt piid tlerant. OTFC is a lzenge (attached t a handle) that yu place between yur cheek and lwer gum and suck n t disslve. Yu must stay under yur healthcare prvider s care while using OTFC. OTFC is nly: available thrugh the TIRF REMS Access prgram given t peple wh are piid tlerant It is nt knwn if OTFC is safe and effective in children under 16 years f age. Wh shuld nt use Oral Transmucsal Fentanyl Citrate (OTFC)? D nt use OTFC: 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. fr shrt-term pain that yu wuld expect t g away in a few days, such as: pain after surgery headache r migraine dental pain if yu are allergic t any f the ingredients in OTFC. See the end f this Medicatin Guide fr a cmplete list f ingredients in OTFC. What shuld I tell my healthcare prvider befre using Oral Transmucsal Fentanyl Citrate (OTFC)? Befre using OTFC, tell yur healthcare prvider if yu:

3 have truble breathing r lung prblems such as asthma, wheezing, r shrtness f breath have r had a head injury r brain prblem have liver r kidney prblems have seizures have a slw heart rate r ther heart prblems have lw bld pressure have mental prblems including majr depressin, schizphrenia r hallucinatins (seeing r hearing things that are nt there) have a past r present drinking prblem (alchlism), r a family histry f drinking prblems have a past r present drug abuse r addictin prblem, r a family histry f a drug abuse prblem r addictin prblem have diabetes. Each OTFC unit cntains abut ½ teaspn (2 grams) f sugar. have any ther medical cnditins are pregnant r plan t becme pregnant. OTFC may cause serius harm t yur unbrn baby. are breastfeeding r plan t breastfeed. OTFC passes int yur breast milk. It can cause serius harm t yur baby. Yu shuld nt use OTFC while breastfeeding. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal supplements. Sme medicines may cause serius r life-threatening side effects when taken with OTFC. Smetimes, the dses f certain medicines and OTFC may need t be changed if used tgether. D nt take any medicine while using OTFC until yu have talked t yur healthcare prvider. Yur healthcare prvider will tell yu if it is safe t take ther medicines while yu are using OTFC. Be very careful abut taking ther medicines that may make yu sleepy, such as ther pain medicines, anti-depressants, 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. Hw shuld I use Oral Transmucsal Fentanyl Citrate (OTFC)? Befre yu can begin t use OTFC: Yur healthcare prvider will explain the TIRF REMS Access prgram t yu. Yu will sign the TIRF REMS Access prgram Patient-Prescriber Agreement frm. OTFC 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 OTFC prescriptin filled. Using OTFC: Use OTFC exactly as prescribed. D nt use OTFC mre ften than prescribed. Yur healthcare prvider will change the dse until yu and yur healthcare prvider find the right dse fr yu. See the detailed Patient Instructins fr Use at the end f this Medicatin Guide fr infrmatin abut hw t use OTFC the right way. Finish the OTFC unit cmpletely in 15 minutes t get the mst relief. If yu finish OTFC t quickly, yu will swallw mre f the medicine and get less relief. D nt bite r chew OTFC. Yu will get less relief fr yur breakthrugh cancer pain.

4 Yu may drink sme water befre using OTFC but yu shuld nt drink r eat anything while using OTFC. Yu must nt use mre than 2 units f OTFC during each episde f breakthrugh cancer pain: Use 1 unit fr an episde f breakthrugh cancer pain. Finish the unit ver 15 minutes. If yur breakthrugh cancer pain is nt relieved 15 minutes after yu finished the OTFC unit, use nly 1 mre unit f OTFC at this time. If yur breakthrugh pain des nt get better after the secnd unit f OTFC, call yur healthcare prvider fr instructins. D nt use anther unit f OTFC at this time. Wait at least 4 hurs befre treating a new episde f breakthrugh cancer pain with OTFC. It is imprtant fr yu t keep taking yur arund-the-clck piid pain medicine while using OTFC. Talk t yur healthcare prvider if yur dse f OTFC des nt relieve yur breakthrugh cancer pain. Yur healthcare prvider will decide if yur dse f OTFC 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 OTFC is cmpletely disslved, remve OTFC frm yur muth. If yu use t much OTFC r verdse, yu r yur caregiver shuld call fr emergency medical help r have smene take yu t the nearest hspital emergency rm right away. What shuld I avid while using Oral Transmucsal Fentanyl Citrate (OTFC)? D nt drive, perate heavy machinery, r d ther dangerus activities until yu knw hw OTFC affects yu. OTFC can make yu sleepy. Ask yur healthcare prvider when it is kay t d these activities. D nt drink alchl while using OTFC. It can increase yur chance f getting dangerus side effects. What are the pssible side effects f Oral Transmucsal Fentanyl Citrate (OTFC)? OTFC can cause serius side effects, including: Breathing prblems that can becme life-threatening. See What is the mst imprtant infrmatin I shuld knw abut Oral Transmucsal Fentanyl Citrate (OTFC)? Call yur healthcare prvider r get emergency medical help right away if yu: have truble breathing have drwsiness with slwed breathing have slw shallw breathing (little chest mvement with breathing) feel faint, very dizzy, cnfused, r have ther unusual symptms These symptms can be a sign that yu have used t much OTFC r the dse is t high fr yu. These symptms may lead t serius prblems r death if nt treated right away. If yu have any f these symptms, d nt use any mre OTFC until yu have talked t yur healthcare prvider. Decreased bld pressure. This can make yu feel dizzy r lightheaded if yu get up t fast frm sitting r lying dwn. Physical dependence. D nt stp taking OTFC r any ther piid, withut talking t yur healthcare prvider. Yu culd becme sick with uncmfrtable withdrawal symptms because yur bdy has becme used t these medicines. Physical dependency is nt the same as drug addictin. A chance f abuse r addictin. This chance is higher if yu are r have ever been addicted t r abused ther medicines, street drugs, r alchl, r if yu have a histry f mental health prblems.

5 The mst cmmn side effects f OTFCare: nausea vmiting dizziness sleepiness weakness headache anxiety cnfusin depressin rash truble sleeping Cnstipatin (nt ften enugh r hard bwel mvements) is a very cmmn side effect f pain medicines (piids) including OTFC and is unlikely t g away withut treatment. Talk t yur healthcare prvider abut dietary changes, and the use f laxatives (medicines t treat cnstipatin) and stl sfteners t prevent r treat cnstipatin while taking OTFC. OTFC cntains sugar. Cavities and tth decay can happen in peple taking OTFC. When taking OTFC, yu shuld talk t yur dentist abut prper care f yur teeth. Tell yur healthcare prvider if yu have any side effect that bthers yu r that des nt g away. These are nt all the pssible side effects f OTFC. 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 Oral Transmucsal Fentanyl Citrate (OTFC)? Always keep OTFC in a safe place away frm children and frm anyne fr whm it has nt been prescribed. Prtect OTFC frm theft. Yu can use the OTFC Child Safety Kit t help yu stre OTFC and yur ther medicines ut f the reach f children. It is very imprtant that yu use the items in the OTFC Child Safety Kit t help prtect the children in yur hme r visiting yur hme. If yu were nt ffered a Child Safety Kit when yu received yur medicine, call Cephaln, Inc., at t request ne. The OTFC Child Safety Kit cntains imprtant infrmatin n the safe strage and handling f OTFC. The Child Safety Kit includes: A child-resistant lck that yu use t secure the strage space where yu keep OTFC (See Figure 1).

6 Figure 1 A prtable lcking puch fr yu t keep a small supply f OTFC nearby. The rest f yur OTFC must be kept in a lcked strage space. Keep this puch secured with its lck and keep it ut f the reach and sight f children (See Figure 2). Figure 2 A child-resistant temprary strage bttle (See Figure 3). Figure 3 Stre OTFC at rm temperature, 59 F t 86 F (15 C t 30 C) until ready t use. D nt freeze OTFC. Keep OTFC in the riginal sealed child-resistant blister package. D nt pen the blister package until yu are ready t use OTFC. Keep OTFC dry. Hw shuld I dispse f Oral Transmucsal Fentanyl Citrate (OTFC) units when they are n lnger needed? Dispsing f OTFC units after use:

7 Partially used OTFC units may cntain enugh medicine t be harmful r fatal t a child r ther adults wh have nt been prescribed OTFC. Yu must prperly dispse f the OTFChandle right away after use even if there is little r n medicine left n it. After yu have finished the OTFC unit and the medicine is ttally gne, thrw the handle away in a place that is ut f the reach f children. If any medicine remains n the used OTFC unit after yu have finished: Place the used OTFC unit under ht running water until the medicine is gne, and then thrw the handle away ut f the reach f children and pets (See Figure 4). Figure 4 Temprary Strage f Used OTFC Units: If yu did nt finish the entire OTFC unit and yu cannt disslve the medicine under ht running water right away, put the used OTFC unit in the temprary strage bttle that yu received in the OTFC Child Safety Kit. Push the used OTFC unit int the pening n the tp until it falls cmpletely int the bttle. Never leave unused r partially used OTFC units where children r pets can get t them (See Figure 5). Figure 5 Dispsing f Used OTFC Units frm the Temprary Strage Bttle:

8 Yu must dispse f all used OTFC units in the temprary strage bttle at least ne time each day, as fllws: 1. T pen the temprary strage bttle, push dwn n the cap until yu are able t twist the cap t the left t remve it (See Figure 6). Figure Remve ne OTFC unit frm the temprary strage bttle. Hld the OTFC by its handle ver the tilet bwl. Using wire-cutting pliers, cut the medicine end ff s that it falls int the tilet. Thrw the handle away in a place that is ut f the reach f children. Repeat these 3 steps fr each OTFC handle that is in the strage bttle. There shuld nt be mre than 4 handles in the temprary strage bttle fr 1 day. Flush the tilet twice. D nt flush entire unused OTFC units, OTFC handles, r blister packages dwn the tilet. Dispsing f unpened OTFC units: Dispse f any unpened OTFC units remaining frm a prescriptin as sn as they are n lnger needed, as fllws: 1. Remve all OTFC frm the lcked strage space (See Figure 7). Figure 7 2.

9 Remve ne OTFC unit frm its blister package by using scissrs t cut ff the marked end and then peel back the blister backing (See Figures 8A and 8B). 3. Figure 8A Figure 8B Hld OTFC by its handle ver the tilet bwl. Use wire-cutting pliers t cut the medicine end ff s that it falls int the tilet (See Figures 9A and 9B). 4. Figure 9A Figure 9B Thrw the handle away in a place that is ut f the reach f children (See Figure 10). Figure Repeat steps 1 thrugh 4 fr each OTFC unit. Flush the tilet twice after the medicine ends frm 5 OTFC units have been cut ff (See Figure 11). D nt flush mre than 5 OTFC units at a time.

10 Figure 11 D nt flush entire unused OTFC units, OTFC handles, r blister packages dwn the tilet. If yu need help with dispsal f OTFC, call Cephaln, Inc., at , r call yur lcal Drug Enfrcement Agency (DEA) ffice. General infrmatin abut Oral Transmucsal Fentanyl Citrate (OTFC) Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. Use OTFC nly fr the purpse fr which it was prescribed.d nt give OTFC t ther peple, even if they have the same symptms yu have.otfc can harm ther peple and even cause death. Sharing OTFC is against the law. This Medicatin Guide summarizes the mst imprtant infrmatin abut OTFC. If yu wuld like mre infrmatin, talk with yur healthcare prvider r pharmacist. Yu can ask yur pharmacist r healthcare prvider fr infrmatin abut OTFC that is written fr healthcare prfessinals. Fr mre infrmatin abut the TIRF REMS Access prgram, g t r call What are the ingredients f Oral Transmucsal Fentanyl Citrate (OTFC)? Active Ingredient: fentanyl citrate Inactive Ingredients: sugar, citric acid, dibasic sdium phsphate, artificial berry flavr, magnesium stearate, mdified fd starch and cnfectiner s sugar. Patient Instructins fr Use Befre yu use OTFC, 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 use OTFC the right way. Ask yur healthcare prvider r pharmacist if yu have any questins abut the right way t use OTFC. When yu get an episde f breakthrugh cancer pain, use the dse f OTFC prescribed by yur healthcare prvider as fllws: Yu may drink sme water befre using OTFC but yu shuld nt drink r eat anything while using OTFC. Each unit f OTFC is sealed in its wn blister package (See Figure 12). D nt pen the blister package until yu are ready t use OTFC.

11 Figure 12 When yu are ready t use OTFC, cut pen the package using scissrs. Peel back the blister backing, and remve the OTFC unit (See Figures 13A and 13B). The end f the unit printed with FENTANYL and the strength number f the unit ( 200, 400, 600, 800, 1200, r 1600 ) is the medicine end that is t be placed in yur muth. Hld the OTFC unit by the handle (See Figure 14). Figure 13A Figure 13B Figure Place the medicine end f the OTFC unit in yur muth between yur cheeks and gums and actively suck n the medicine. Mve the medicine end f the OTFC unit arund in yur muth, especially alng the inside f yur cheeks (See Figure 15).

12 Figure Twirl the handle ften. Finish the OTFC unit cmpletely ver 15 minutes t get the mst relief. If yu finish OTFC t quickly, yu will swallw mre f the medicine and get less relief. D nt bite r chew OTFC. Yu will get less relief fr yur breakthrugh cancer pain. If yu cannt finish all f the medicine n the OTFC unit and cannt disslve the medicine under ht tap water right away, immediately put the OTFC unit in the temprary strage bttle fr safe keeping (See Figure 16). Push the OTFC unit int the pening n the tp until it falls cmpletely int the bttle. Yu must prperly dispse f the OTFC unit as sn as yu can. Figure 16 See Hw shuld I dispse f OTFC units when they are n lnger needed? fr prper dispsal f OTFC. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Distributed by: TEVA PHARMACEUTICALS USA, Inc. Nrth Wales, PA Revised January 2015 OTF-012 OTFMG Cephaln, Inc. All rights reserved. Printed in USA