MEDICATION GUIDE PegIntron (peg-in-tron) (Peginterferon alfa-2b) for injection, for subcutaneous use

Transcription

1 MEDICATION GUIDE PegIntrn (peg-in-trn) (Peginterfern alfa-2b) fr injectin, fr subcutaneus use Read this Medicatin Guide befre yu start taking PegIntrn, 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. If yu are taking PegIntrn with REBETOL (ribavirin) with r withut an apprved hepatitis C virus (HCV) prtease inhibitr, als read the Medicatin Guides fr thse medicines. PegIntrn, by itself r in cmbinatin with ther apprved medicines, is a treatment fr sme peple wh are infected with hepatitis C virus. What is the mst imprtant infrmatin I shuld knw abut PegIntrn? PegIntrn can cause serius side effects that: may cause death, r may wrsen certain serius diseases that yu may already have. Tell yur healthcare prvider right away if yu have any f the symptms listed belw while taking PegIntrn. If symptms get wrse, r becme severe and cntinue, yur healthcare prvider may tell yu t stp taking PegIntrn permanently. In many, but nt all, peple, these symptms g away after they stp taking PegIntrn. 1. Mental health prblems and suicide. PegIntrn may cause yu t develp md r behavir prblems that may get wrse during treatment with PegIntrn r after yur last dse, including: irritability (getting upset easily) depressin (feeling lw, feeling bad abut yurself, r feeling hpeless) aggressive behavir thughts f hurting yurself r thers, r suicide frmer drug addicts may fall back int drug addictin r verdse If yu have these symptms, yur healthcare prvider shuld carefully mnitr yu during treatment with PegIntrn and fr 6 mnths after yur last dse. 2. Heart prblems. Sme peple wh take PegIntrn may get heart prblems, including: lw bld pressure fast heart rate r abnrmal heart beat truble breathing r chest pain heart attacks r heart muscle prblems (cardimypathy) 3. Strke r symptms f a strke. Symptms may include weakness, lss f crdinatin, and numbness. Strke r symptms f a strke may happen in peple wh have sme risk factrs r n knwn risk factrs fr a strke. 1

2 4. New r wrsening autimmune prblems. Sme peple taking PegIntrn develp autimmune prblems (a cnditin where the bdy's immune cells attack ther cells r rgans in the bdy), including rheumatid arthritis, systemic lupus erythematsus, and psriasis. In sme peple wh already have an autimmune prblem, it may get wrse during yur treatment with PegIntrn. 5. Infectins. Sme peple wh take PegIntrn may get an infectin. Symptms may include: fever chills bldy diarrhea burning r pain with urinatin urinating ften cughing up mucus (phlegm) that is disclred (fr example, yellw r pink) PegIntrn in cmbinatin with REBETOL (ribavirin) may cause birth defects r the death f yur unbrn baby. D nt take PegIntrn and ribavirin cmbinatin therapy if yu r yur sexual partner is pregnant r plan t be cme pregnant. D nt becme pregnant within 6 mnths after discntinuing PegIntrn and ribavirin cmbinatin therapy. Yu must use 2 frms f birth cntrl when yu take PegIntrn and ribavirin and fr the 6 mnths after treatment. Females must have a pregnancy test befre starting PegIntrn and ribavirin cmbinatin therapy, every mnth while n the cmbinatin therapy, and every mnth fr the 6 mnths after the last dse f cmbinatin therapy. If yu r yur female sexual partner becmes pregnant while taking PegIntrn and ribavirin cmbinatin therapy r within 6 mnths after yu stp taking the cmbinatin therapy, tell yur healthcare prvider right away. Yu r yur healthcare prvider shuld cntact the Ribavirin pregnancy registry by calling The Ribavirin pregnancy registry cllects infrmatin abut what happens t mthers and their babies if the mther takes ribavirin while she is pregnant. While taking PegIntrn, yu shuld see a healthcare prvider regularly fr check-ups and bld tests t make sure that yur treatment is wrking, and t check fr side effects. What is PegIntrn? PegIntrn is a prescriptin medicine that is used: with REBETOL (ribavirin) and an apprved hepatitis C virus (HCV) prtease inhibitr t treat chrnic (lasting a lng time) hepatitis C infectin in adults. with REBETOL (ribavirin) t treat chrnic (lasting a lng time) hepatitis C infectin in peple 3 years and lder with stable liver prblems. alne, smetimes t treat adults wh have chrnic (lasting a lng time) hepatitis C infectin with stable liver prblems and wh can nt take REBETOL (ribavirin). Peple with hepatitis C have the virus in their bld and in their liver. PegIntrn reduces the amunt f virus in the bdy and helps the bdy's immune system fight the virus. REBETOL (ribavirin) is a drug that helps t fight the viral infectin but des nt wrk when used by itself t treat chrnic hepatitis C. It is nt knwn if PegIntrn use fr lnger than 1 year is safe and will wrk. It is nt knwn if PegIntrn use in children yunger than 3 years ld is safe and will wrk. 2

3 Wh shuld nt take PegIntrn? D nt take PegIntrn: if yu have had a serius allergic reactin t anther alpha interfern r t any f the ingredients in PegIntrn. See the end f this Medicatin Guide fr a cmplete list f ingredients. Ask yur healthcare prvider if yu are nt sure. if yu have certain types f hepatitis (autimmune hepatitis). if yu have certain ther liver prblems. with REBETOL (ribavirin) if yu are pregnant, planning t get pregnant, r breastfeeding. See What is the mst imprtant infrmatin I shuld knw abut PegIntrn? Talk t yur healthcare prvider befre taking PegIntrn if yu have any f these cnditins. What shuld I tell my healthcare prvider befre taking PegIntrn? Befre yu take PegIntrn, see What is the mst imprtant infrmatin I shuld knw abut PegIntrn?, and 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 ever had any prblems with yur heart, including heart attack r high bld pressure have any kind f autimmune disease (where the bdy's immune system attacks the bdy's wn cells), such as psriasis, systemic lupus erythematsus, rheumatid arthritis have r ever had bleeding prblems r a bld clt have r ever had lw bld cell cunts have ever been addicted t drugs r alchl have liver disease (ther than hepatitis C infectin) have r had lung disease such as chrnic bstructive pulmnary disease (COPD) have thyrid prblems have diabetes have clitis (inflammatin f yur intestine) have a cnditin that suppresses yur immune system, such as cancer have hepatitis B infectin have HIV infectin have kidney prblems have high bld triglyceride levels (fat in yur bld) have an rgan transplant and are taking medicine that keeps yur bdy frm rejecting yur transplant (suppresses yur immune system) have any ther medical cnditins are pregnant r plan t becme pregnant. PegIntrn may harm yur unbrn baby. Yu shuld use effective birth cntrl during treatment with PegIntrn. Talk t yur healthcare prvider abut birth cntrl chices fr yu during treatment with PegIntrn. Tell yur healthcare prvider if yu becme pregnant during treatment with PegIntrn. are breastfeeding r plan t breastfeed. It is nt knwn if PegIntrn passes int yur breast milk. Yu and yur healthcare prvider shuld decide if yu will use PegIntrn r breastfeed. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal supplements. PegIntrn and certain ther medicines may affect each ther and cause side effects. 3

4 Especially tell yur healthcare prvider if yu take the anti-hepatitis B medicine telbivudine (Tyzeka). Knw the medicines yu take. Keep a list f them and shw it t yur healthcare prvider and pharmacist when yu get a new medicine. Hw shuld I take PegIntrn? Take PegIntrn exactly as yur healthcare prvider tells yu t. Yur healthcare prvider will tell yu hw much PegIntrn t take and when t take it. D nt take mre than yur prescribed dse. Take yur prescribed dse f PegIntrn every week, n the same day f each week and at the same time. PegIntrn is given as an injectin under yur skin (subcutaneus injectin). Yur healthcare prvider shuld shw yu hw t prepare and measure yur dse f PegIntrn, and hw t inject yurself befre yu use PegIntrn fr the first time. Yu shuld nt inject PegIntrn until yur healthcare prvider has shwn yu hw t use PegIntrn the right way. PegIntrn cmes as a: pwder in a single-use vial Selectdse single-use pre-filled pen single-use REDIPEN Yur healthcare prvider will prescribe the PegIntrn that is right fr yu. See the Instructins fr Use that cmes with yur PegIntrn fr detailed instructins fr preparing and injecting a dse f PegIntrn. If yu miss a dse f PegIntrn, take the missed dse as sn as pssible during the same day r the next day, then cntinue n yur regular dsing schedule. If several days g by after yu miss a dse, check with yur healthcare prvider abut what t d. D nt inject mre than 1 dse f PegIntrn in ne week withut talking t yur healthcare prvider. If yu take t much PegIntrn, call yur healthcare prvider right away. Yur healthcare prvider may examine yu mre clsely, and d bld tests. Yur healthcare prvider shuld d regular bld tests befre yu start PegIntrn, and during treatment t see hw well the treatment is wrking and t check yu fr side effects. What are the pssible side effects f PegIntrn? PegIntrn may cause serius side effects including: See "What is the mst imprtant infrmatin I shuld knw abut PegIntrn?" Serius eye prblems. PegIntrn may cause eye prblems that may lead t visin lss r blindness. Yu shuld have an eye exam befre yu start taking PegIntrn. If yu have eye prblems r have had them in the past, yu may need eye exams while yu are taking PegIntrn. Tell yur healthcare prvider r eye dctr right away if yu have any visin changes while taking PegIntrn. 4

5 Bld prblems. PegIntrn can affect yur bne marrw and cause lw white bld cell and platelet cunts. In sme peple, these bld cunts may fall t dangerusly lw levels. If yur bld cunts becme very lw, yu can get infectins, and prblems with bleeding and bruising. Swelling f yur pancreas (pancreatitis) r intestines (clitis). Symptms may include: severe stmach area (abdmen) pain severe back pain nausea and vmiting bldy diarrhea fever Lung prblems including: truble breathing pneumnia inflammatin f lung tissue new r wrse high bld pressure f the lungs (pulmnary hypertensin). This can be severe and may lead t death. Yu may need t have a chest X-ray r ther tests if yu develp fever, cugh, shrtness f breath r ther symptms f a lung prblem during treatment with PegIntrn. Severe liver prblems, r wrsening f liver prblems, including liver failure and death. Symptms may include: nausea lss f appetite tiredness diarrhea yellwing f yur skin r the white part f yur eyes bleeding mre easily than nrmal swelling f yur stmach area (abdmen) cnfusin sleepiness yu cannt be awakened (cma) Thyrid prblems. Sme peple develp changes in their thyrid functin. Symptms f thyrid changes include: prblems cncentrating feeling cld r ht all f the time weight changes skin changes Bld sugar prblems. Sme peple may develp high bld sugar r diabetes. If yu have high bld sugar r diabetes that is nt cntrlled befre starting PegIntrn, talk t yur healthcare prvider befre yu take PegIntrn. If yu develp high bld sugar r diabetes while taking PegIntrn, yur healthcare prvider may tell yu t stp PegIntrn and prescribe a different medicine fr yu. Symptms f high bld sugar r diabetes may include: increased thirst tiredness 5

6 urinating mre ften than nrmal increased appetite weight lss yur breath smells like fruit Serius allergic reactins and skin reactins. Symptms may include: itching swelling f the face, eyes, lips, tngue, r thrat truble breathing anxiusness chest pain feeling faint skin rash, hives, sres in yur muth, r yur skin blisters and peels Grwth prblems in children. Weight lss and slwed grwth are cmmn in children during cmbinatin treatment with PegIntrn and REBETOL. Mst children will g thrugh a grwth spurt and gain weight after treatment stps. Sme children may nt reach the height that they were expected t have befre treatment. Talk t yur healthcare prvider if yu are cncerned abut yur child s grwth during treatment with PegIntrn and REBETOL. Nerve prblems. Peple wh take PegIntrn r ther alpha interfern prducts with telbivudine (Tyzeka) can develp nerve prblems such as cntinuing numbness, tingling, r burning sensatin in the arms r legs (peripheral neurpathy). Call yur healthcare prvider if yu have any f these symptms. Dental and gum prblems. Tell yur healthcare prvider right away if yu have any f the symptms listed abve. The mst cmmn side effects f PegIntrn include: Flu-like symptms. Symptms may include: headache, muscle aches, tiredness, and fever. Sme f these symptms may be decreased by injecting yur PegIntrn dse at bedtime. Talk t yur healthcare prvider abut which ver-the-cunter medicines yu can take t help prevent r decrease sme f these symptms. Tiredness. Many peple becme very tired during treatment with PegIntrn. Appetite prblems. Nausea, lss f appetite, and weight lss can happen with PegIntrn. Skin reactins. Redness, swelling, and itching are cmmn at the site f injectin. Hair thinning. Tell yur healthcare prvider if yu have any side effect that bthers yu r that des nt g away. These are nt all f the pssible side effects f PegIntrn. 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 PegIntrn? 6

7 Befre mixing, stre PegIntrn Selectdse single-use pre-filled pen r single-use REDIPEN in the refrigeratr between 36 F t 46 F (2 C t 8 C). Befre mixing, stre PegIntrn vials at rm temperature between 68 F t 77 F (20 C t 25 C). Keep PegIntrn away frm heat. After mixing, use PegIntrn right away r stre it in the refrigeratr fr up t 24 hurs between 36 F t 46 F (2 C t 8 C). D nt freeze PegIntrn. Keep PegIntrn and all medicines ut f the reach f children. General Infrmatin abut PegIntrn Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use PegIntrn fr a cnditin fr which it was nt prescribed. D nt give PegIntrn 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 PegIntrn. If yu wuld like mre infrmatin, ask yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut PegIntrn that was written fr healthcare prfessinals. Fr mre infrmatin, g t r call What are the ingredients in PegIntrn? Active ingredients: peginterfern alfa-2b Inactive ingredients: dibasic sdium phsphate anhydrus, mnbasic sdium phsphate dihydrate, sucrse, plysrbate 80. Sterile water fr injectin is supplied as a diluent. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Revised: 12/2013 Fr patent infrmatin: Cpyright 2001, 2013 Schering Crpratin, a subsidiary f Merck & C., Inc. All rights reserved. usmg-mk4031-mtl-xxxxrxxx 7