Patient Information TECFIDERA™ (tek” fi de’ rah) (dimethyl fumarate) delayed-release capsules
What is TECFIDERA? ɒ 7(&),'(5$ LV D SUHVFULSWLRQ PHGLFLQH XVHG WR WUHDW SHRSOH ZLWK UHODSVLQJ IRUPV RI PXOWLSOH VFOHURVLV 06 ɒ ,W LV QRW NQRZQ LI 7(&),'(5$ LV VDIH DQG HIIHFWLYH LQ FKLOGUHQ XQGHU
\HDUV RI DJH
Before taking and while you take TECFIDERA, tell your doctor if you have or have had: ɒ ORZ ZKLWH EORRG FHOO FRXQWV RU DQ LQIHFWLRQ ɒ DQ\ RWKHU PHGLFDO FRQGLWLRQV
Tell your doctor if you are: ɒ SUHJQDQW RU SODQ WR EHFRPH SUHJQDQW ,W LV QRW NQRZQ LI 7(&),'(5$ ZLOO KDUP \RXU XQERUQ EDE\ ɒ ,I \RX EHFRPH SUHJQDQW ZKLOH WDNLQJ 7(&),'(5$ WDON WR \RXU GRFWRU DERXW HQUROOLQJ LQ WKH 7(&),'(5$ 3UHJQDQF\ 5HJLVWU\ <RX FDQ HQUROO LQ WKLV UHJLVWU\ E\ FDOOLQJ LV WR PRQLWRU WKH KHDOWK RI \RX DQG \RXU EDE\
ɒ WDNLQJ SUHVFULSWLRQ RU RYHU WKH FRXQWHU PHGLFLQHV YLWDPLQV RU KHUEDO VXSSOHPHQWV
How should I take TECFIDERA? ɒ 7DNH 7(&),'(5$ H[DFWO\ DV \RXU GRFWRU WHOOV \RX WR WDNH LW ɒ 7KH UHFRPPHQGHG VWDUWLQJ GRVH LV RQH ɒ 7KH UHFRPPHQGHG GRVH DIWHU
GD\V LV RQH GD\V
PJ FDSVXOH WDNHQ E\ PRXWK PJ FDSVXOH WDNHQ E\ PRXWK
WLPHV D GD\ IRU WLPHV D GD\
GD\V
ɒ 7(&),'(5$ FDQ EH WDNHQ ZLWK RU ZLWKRXW IRRG ɒ 6ZDOORZ 7(&),'(5$ ZKROH 'R QRW FUXVK FKHZ RU VSULQNOH FDSVXOH FRQWHQWV RQ IRRG ɒ 3URWHFW 7(&),'(5$ IURP OLJKW <RX FDQ GR WKLV E\ VWRULQJ WKH FDSVXOHV LQ WKHLU RULJLQDO FRQWDLQHU 7KURZ DZD\ RSHQHG 7(&),'(5$ DIWHU
What are the possible side effects of TECFIDERA?
TECFIDERA may cause serious side effects including: ɒ decreases in your white blood cell count
The most common side effects of TECFIDERA include: ɒ IOXVKLQJ UHGQHVV LWFKLQJ RU UDVK ɒ QDXVHD YRPLWLQJ GLDUUKHD VWRPDFK SDLQ RU LQGLJHVWLRQ
)OXVKLQJ DQG VWRPDFK SUREOHPV DUH WKH PRVW FRPPRQ UHDFWLRQV HVSHFLDOO\ DW WKH VWDUW RI WKHUDS\ DQG PD\ GHFUHDVH RYHU WLPH &DOO \RXU GRFWRU LI \RX KDYH DQ\ RI WKHVH V\PSWRPV DQG WKH\ ERWKHU \RX RU GR QRW JR DZD\ 7KHVH DUH QRW DOO WKH SRVVLEOH VLGH HIIHFWV RI 7(&),'(5$ &DOO \RXU GRFWRU IRU PHGLFDO DGYLFH DERXW VLGH HIIHFWV <RX PD\ UHSRUW VLGH HIIHFWV WR )'$ DW
)'$ For more information go to
dailymed.nlm.nih.gov.
General Information about the safe and effective use of TECFIDERA ɒ 0HGLFLQHV DUH VRPHWLPHV SUHVFULEHG IRU SXUSRVHV RWKHU WKDQ WKRVH OLVWHG LQ WKLV 3DWLHQW ,QIRUPDWLRQ 'R QRW XVH 7(&),'(5$ IRU D FRQGLWLRQ IRU ZKLFK LW ZDV QRW SUHVFULEHG 'R QRW JLYH 7(&),'(5$ WR RWKHU SHRSOH HYHQ LI WKH\ KDYH WKH VDPH V\PSWRPV WKDW \RX KDYH ,W PD\ KDUP WKHP
ɒ ,I \RX ZRXOG OLNH PRUH LQIRUPDWLRQ WDON WR \RXU GRFWRU RU SKDUPDFLVW <RX FDQ DVN \RXU GRFWRU RU SKDUPDFLVW IRU LQIRUPDWLRQ DERXW 7(&),'(5$ WKDW LV ZULWWHQ IRU KHDOWKFDUH SURIHVVLRQDOV
What are the ingredients in TECFIDERA? Active ingredient: GLPHWK\O IXPDUDWH Inactive ingredients: PLFURFU\VWDOOLQH FHOOXORVH VLOLFLILHG PLFURFU\VWDOOLQH FHOOXORVH FURVFDUPHOORVH VRGLXP WDOF VLOLFD FROORLGDO VLOLFRQ GLR[LGH PDJQHVLXP VWHDUDWH WULHWK\O FLWUDWH PHWKDFU\OLF DFLG FRSRO\PHU PHWKDFU\OLF DFLG FRSRO\PHU GLVSHUVLRQ VLPHWKLFRQH Capsule Shell: JHODWLQ WLWDQLXP GLR[LGH )' & EOXH
HPXOVLRQ 0DQXIDFWXUHG E\ %LRJHQ ,GHF ,QF &DPEULGJH 0$ 7KLV 3DWLHQW ,QIRUPDWLRQ KDV EHHQ DSSURYHG E\ WKH 8 6 )RRG DQG 'UXJ $GPLQLVWUDWLRQ ZZZ 7(&),'(5$ FRP RU FDOO ,VVXHG © PARADE Publications 2014. All rights reserved
7KH SXUSRVH RI WKLV UHJLVWU\
ɒ EUHDVWIHHGLQJ RU SODQ WR EUHDVWIHHG ,W LV QRW NQRZQ LI 7(&),'(5$ SDVVHV LQWR \RXU EUHDVW PLON <RX DQG \RXU GRFWRU VKRXOG GHFLGH LI \RX ZLOO WDNH 7(&),'(5$ RU EUHDVWIHHG
7\SH $ VRGLXP ODXU\O VXOSKDWH DQG SRO\VRUEDWH EULOOLDQW EOXH )&) \HOORZ LURQ R[LGH DQG EODFN LURQ R[LGH
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20