Medication Guide AVONEX (a-vuh-necks) (interferon beta-1a) Injection for intramuscular use

Transcription

1 Medicatin Guide AVONEX (a-vuh-necks) (interfern beta-1a) Injectin fr intramuscular use Read this Medicatin Guide befre yu start using AVONEX, and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking with yur healthcare prvider abut yur medical cnditin r yur treatment. What is the mst imprtant infrmatin I shuld knw abut AVONEX? AVONEX can cause serius side effects. Tell yur healthcare prvider right away if yu have any f the symptms listed belw while taking AVONEX. 1. Behaviral health prblems including depressin, suicidal thughts r hallucinatins. Sme peple taking AVONEX may develp md r behavir prblems including: irritability (getting upset easily) depressin (feeling hpeless r feeling bad abut yurself) nervusness anxiety aggressive behavir thughts f hurting yurself r suicide hearing r seeing things that thers d nt hear r see (hallucinatins) 2. Liver prblems, r wrsening f liver prblems including liver failure and death. Symptms may include: nausea lss f appetite tiredness dark clred urine and pale stls yellwing f yur skin r the white part f yur eye bleeding mre easily than nrmal cnfusin sleepiness During yur treatment with AVONEX yu will need t see yur healthcare prvider regularly and have regular bld tests t check fr side effects. 3. Serius allergic reactins and skin reactins. Symptms may include: itching swelling f the face, eyes, lips, tngue r thrat 1

2 truble breathing anxiusness feeling faint skin rash, hives, sres in yur muth, r yur skin blisters and peels What is AVONEX? AVONEX is a frm f a prtein called beta interfern that ccurs naturally in the bdy. AVONEX is a prescriptin medicine used t treat adults with relapsing frms f multiple sclersis (MS). This includes peple wh have had their first symptms f multiple sclersis and have an MRI cnsistent with multiple sclersis. AVONEX will nt cure yur MS but may decrease the number f flare-ups f the disease and slw the ccurrence f sme f the physical disability that is cmmn in peple with MS. MS is a life-lng disease that affects yur nervus system by destrying the prtective cvering (myelin) that surrunds yur nerve fibers. The way AVONEX wrks in MS is nt knwn. It is nt knwn if AVONEX is safe and effective in children. Wh shuld nt use AVONEX? D nt take AVONEX if yu: are allergic t interfern beta, albumin (human), r any f the ingredients in AVONEX. See the end f this Medicatin Guide fr a cmplete list f ingredients in AVONEX. What shuld I tell my healthcare prvider befre using AVONEX? Befre taking AVONEX, tell yur healthcare prvider if yu: are being treated fr a mental illness r had treatment in the past fr any mental illness, including depressin and suicidal behavir have r had bleeding prblems r bld clts have r had lw bld cell cunts have r had liver prblems have r had seizures (epilepsy) have r had heart prblems have r had thyrid prblems have r had any kind f autimmune disease (where the bdy s immune system attacks the bdy s wn cells), such as psriasis, systemic lupus erythematsus, r rheumatid arthritis drink alchl 2

3 are pregnant r plan t becme pregnant. It is nt knwn if AVONEX will harm yur unbrn baby. Tell yur healthcare prvider if yu becme pregnant during yur treatment with AVONEX. are breastfeeding r plan t breastfeed. It is nt knwn if AVONEX passes int yur breast milk. Yu and yur healthcare prvider shuld decide if yu will use AVONEX r breastfeed. Yu shuld nt d bth. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal supplements. Hw shuld I use AVONEX? Yur healthcare prvider shuld shw yu hw t prepare and measure yur dse f AVONEX and hw t inject yur AVONEX befre yu use AVONEX fr the first time. Yur healthcare prvider r nurse shuld watch the first AVONEX injectin yu give yurself. AVONEX is given nce a week by injectin int the muscle (intramuscular injectin). Inject AVONEX exactly as yur healthcare prvider tells yu. Yur healthcare prvider will tell yu hw much AVONEX t inject and hw ften t inject AVONEX. D nt inject mre than yur healthcare prvider tells yu t. If yu miss a dse, yu shuld take yur next dse as sn as yu remember. Yu shuld cntinue yur regular schedule the fllwing week. D nt take AVONEX 2 days in a rw. D nt change yur dse unless yur healthcare prvider tells yu t. Change (rtate) yur injectin site yu chse with each injectin. This will help decrease the chance that yu will have an injectin site reactin. D nt inject int an area f the bdy where the skin is irritated, reddened, bruised, infected r scarred in any way. AVONEX cmes as a: Vial with freeze-dried (lyphilized) pwder Prefilled syringe (can be used with the AVOSTARTGRIP titratin kit) Single-Use Prefilled Autinjectr Pen (AVONEX PEN ) Yur healthcare prvider will decide which ne is best fr yu. See the Instructins fr Use at the end f this Medicatin Guide fr detailed instructins fr preparing and injecting yur dse f AVONEX. Always use a new, unpened AVONEX vial, prefilled syringe, r single-use prefilled autinjectr pen fr each intramuscular injectin. 3

4 What are the pssible side effects f AVONEX? AVONEX can cause serius side effects including: See What is the mst imprtant infrmatin I shuld knw abut AVONEX? Heart prblems, including heart failure. While AVONEX is nt knwn t have any direct effects n the heart, a few patients wh did nt have a histry f heart prblems develped heart muscle prblems r cngestive heart failure after taking AVONEX. If yu already have heart failure, AVONEX may cause yur heart failure t get wrse. Call yur healthcare prvider right away if yu have wrsening symptms f heart failure such as shrtness f breath r swelling f yur lwer legs r feet while using AVONEX. Sme peple using AVONEX may have ther heart prblems including: lw bld pressure fast r abnrmal heart beat chest pain heart attack r a heart muscle prblem (cardimypathy) Bld prblems. AVONEX can affect yur bne marrw and cause lw red and white bld cell, and platelet cunts. In sme peple, these bld cell cunts may fall t dangerusly lw levels. If yur bld cell cunts becme very lw, yu can get infectins and prblems with bleeding and bruising. Seizures. Sme patients have had seizures while taking AVONEX, including patients wh have never had seizures befre. Infectins. Sme peple wh take AVONEX may get an infectin. Symptms f an infectin may include: fever chills pain r burning with urinatin urinating ften bldy diarrhea cughing up mucus Thyrid prblems. Sme peple taking AVONEX develp changes in their thyrid functin. Symptms f thyrid changes include: prblems cncentrating feeling cld r ht all the time weight changes (gain r lss) skin changes Tell yur healthcare prvider right away if yu have any f the symptms listed abve. 4

5 The mst cmmn side effects f AVONEX include: Flu-like symptms. Mst peple wh take AVONEX have flu-like symptms early during the curse f therapy. Usually, these symptms last fr a day after the injectin. Yu may be able t manage these flu-like symptms by taking ver-the-cunter pain and fever reducers. Fr many peple, these symptms lessen r g away ver time. Symptms may include: muscle aches fever tiredness chills Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre AVONEX? Stre AVONEX in the refrigeratr at 36 F t 46 F (2 C t 8 C). D nt freeze AVONEX. D nt use AVONEX that has been frzen. D nt stre AVONEX abve 77 F (25 C). Keep AVONEX away frm light. D nt use AVONEX past the expiratin date. If yu cannt refrigerate yur AVONEX vials, yu can stre yur AVONEX vials at 77 F (25 C) fr up t 30 days. After mixing, the AVONEX slutin shuld be used immediately, within 6 hurs when stred refrigerated at 36 F t 46 F (2 C t 8 C). If yu cannt refrigerate yur AVONEX PEN and AVONEX prefilled syringes, yu can stre yur AVONEX PEN and AVONEX prefilled syringes up t 77 F (25 C) fr up t 7 days. Keep AVONEX vials, prefilled syringes, pens and all ther medicines ut f the reach f children. General advice abut the safe and effective use f AVONEX Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use AVONEX fr a cnditin fr which it was nt prescribed. D nt give AVONEX t ther peple, even if they have the same symptms that yu have, it may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut AVONEX. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu may ask yur healthcare prvider r pharmacist fr infrmatin abut AVONEX that is written fr healthcare prfessinals. 5

6 What are the ingredients in AVONEX? Active ingredient: interfern beta-1a Inactive ingredients: Vial with freeze-dried (lyphilized) pwder: albumin (human), sdium chlride, dibasic sdium phsphate, and mnbasic sdium phsphate. Single-Use Prefilled Syringe: sdium acetate trihydrate, glacial acetic acid, arginine hydrchlride, plysrbate 20 in water fr injectin. Single-Use Prefilled Autinjectr Pen: sdium acetate trihydrate, glacial acetic acid, arginine hydrchlride, plysrbate 20 in water fr injectin. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Manufactured by: Bigen Idec Inc. 14 Cambridge Center Cambridge, MA USA Bigen Idec Inc. All rights reserved Revised: 08/2014 6