MEDICATION GUIDE. (Interferon alfa-2b)

Transcription

1 MEDICATION GUIDE INTRON A (In-trn-aye) (Interfern alfa-2b) Read this Medicatin Guide befre yu start taking INTRON A, 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 INTRON A with REBETOL, als read the Medicatin Guide fr REBETOL (ribavirin) Capsules and Oral Slutin. INTRON A alne is a treatment fr certain types f cancers and hepatitis B virus. INTRON A by itself r with REBETOL is a treatment fr sme peple infected with hepatitis C virus. What is the mst imprtant infrmatin I shuld knw abut INTRON A? INTRON A 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 INTRON A: 1. Heart prblems. Sme peple wh take INTRON A may develp heart prblems, including: lw bld pressure fast heart rate r abnrmal heart beats truble breathing r chest pain heart attacks r heart muscle prblems (cardimypathy) 2. 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. 3. Mental health prblems and suicide. INTRON A may cause yu t develp md r behavir prblems, 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 4. New r wrsening autimmune disease. Sme peple taking INTRON A develp autimmune diseases (a cnditin where the bdy's immune cells

2 attack ther cells r rgans in the bdy), including rheumatid arthritis, systemic lupus erythematsus, sarcidsis, and psriasis. In sme peple wh already have an autimmune disease, the disease may get wrse while n INTRON A. 5. Infectins. Sme peple wh take INTRON A 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) While taking INTRON A, yu shuld see a healthcare prvider regularly fr checkups and bld tests t make sure that yur treatment is wrking and t check fr side effects. What is INTRON A? INTRON A is a prescriptin medicine that is used: t treat adults with a bld cancer called hairy cell leukemia t treat certain adults with a type f skin cancer called malignant melanma t treat adults with sme types f Fllicular Nn-Hdgkin s Lymphma alng with certain chemtherapy medicines t treat certain adults with genital warts (cndylmata acuminate), by injecting the medicine directly int the warts. t treat certain adults with a type f cancer caused by AIDS, called AIDSrelated Kapsi s Sarcma alne t treat adults with chrnic (lasting a lng time) hepatitis C infectin with certain types f liver disease with REBETOL t treat chrnic (lasting a lng time) hepatitis C infectin in peple 3 years and lder with certain types f liver disease t treat chrnic (lasting a lng time) hepatitis B infectin in peple 1 year and lder with certain types f liver disease Wh shuld nt take INTRON A? D nt take INTRON A if yu: had a serius allergic reactin t anther alpha interfern prduct r are allergic t any f the ingredients in INTRON A. See the end f this Medicatin Guide fr a cmplete list f ingredients. Ask yur healthcare prvider if yu are nt sure. have certain types f hepatitis (autimmune hepatitis) have certain ther liver prblems

3 Talk t yur healthcare prvider befre taking INTRON A if yu have any f these cnditins. What shuld I tell my healthcare prvider befre taking INTRON A? Befre yu take INTRON A, tell yur healthcare prvider if yu: See What is the mst imprtant infrmatin I shuld knw abut INTRON A? have r ever had any prblems with yur heart, including heart attack r have high bld pressure have r ever had bleeding prblems r bld clts are being treated fr a mental illness r had treatment in the past fr any mental illness, including depressin and suicidal behavir 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 lw bld cell cunts have ever been addicted t drugs r alchl have liver prblems (ther than hepatitis B r C) have r had lung prblems, such as chrnic bstructive pulmnary disease (COPD) have diabetes have clitis (inflammatin f yur intestine) have a cnditin that suppresses yur immune system, such as cancer have hepatitis B r C infectin have HIV infectin (the virus that causes AIDS) 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. It is nt knwn if INTRON A will harm yur unbrn baby. Yu shuld use effective birth cntrl during treatment with INTRON A. Talk t yur healthcare prvider abut birth cntrl chices fr yu during treatment with INTRON A. Tell yur healthcare prvider if yu becme pregnant during treatment with INTRON A. are breast-feeding r plan t breast-feed. It is nt knwn if INTRON A passes int yur breast milk. Yu and yur healthcare prvider shuld decide if yu will use INTRON A r breast-feed. 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. INTRON A and certain ther medicines may affect each ther and cause side effects. Especially tell yur dctr if yu take: the anti-hepatitis B medicine telbivudine (Tyzeka) the anti-hiv medicine zidvudine (Retrvir)

4 thephylline (The-24, Elixphyllin, Uniphyl, Thelair). Yur healthcare prvider may need t mnitr the amunt f thephylline in yur bdy and make changes t yur thephylline dse. 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 INTRON A? INTRON A is given as an injectin under the skin (subcutaneus) r int a muscle (intramuscular), int genital lesins, r as an injectin int a vein (intravenus), depending n the cnditin that is being treated. Yur healthcare prvider will decide yur dse f INTRON A and hw ften yu will take it. If yur healthcare prvider decides that yu can inject INTRON A fr yur cnditin, inject it exactly as prescribed, under yur skin (subcutaneus injectin) r int yur muscle (intramuscular injectin). D nt change yur dse r hw yu inject INTRON A unless yur healthcare prvider tells yu t. D nt take mre than yur prescribed dse. Yur healthcare prvider shuld shw yu hw t prepare and measure yur dse f INTRON A and hw t inject yurself befre yu use INTRON A fr the first time. Yu shuld nt inject INTRON A until yur healthcare prvider has shwn yu hw t use INTRON A the right way. INTRON A cmes as: a pwder fr injectin in a vial that is used nly 1 time (single-use vial). The pwder must be mixed with water fr injectin (a diluent) befre yu inject it. a slutin fr injectin in a multi-dse vial a slutin fr injectin in a pen that is used mre than 1 time (multidse pen) See the attached Instructins fr Use fr detailed instructins fr preparing and injecting a dse f INTRON A. If yu miss a dse f INTRON A, 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 t see what t d. D nt inject mre than 1 dse r take mre than yur prescribed dse withut talking t yur healthcare prvider. If yu take t much INTRON A, call yur healthcare prvider right away. Yur healthcare prvider may examine yu mre clsely, and d bld tests.

5 Yur healthcare prvider shuld d regular bld tests befre yu start INTRON A, and during yur treatment t see hw well the treatment is wrking and t check fr side effects. What are the pssible side effects f INTRON A? INTRON A may cause serius side effects including: See "What is the mst imprtant infrmatin I shuld knw abut INTRON A?" Bld prblems. INTRON A 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 cell cunts becme very lw, yu can get infectins r have bleeding prblems. Serius eye prblems. INTRON A may cause eye prblems that may lead t visin lss r blindness. Yu shuld have an eye exam befre yu start taking INTRON A. If yu have eye prblems r have had them in the past, yu may need eye exams while taking INTRON A. Tell yur healthcare prvider r eye dctr right away if yu have any visin changes while taking INTRON A. Thyrid prblems. Sme peple develp changes in the functin f their thyrid. Symptms f thyrid prblems include: prblems cncentrating feeling cld r ht all the time changes in yur weight skin changes Bld sugar prblems. Sme peple may develp high bld sugar r diabetes. If yu have high bld sugar r diabetes befre starting INTRON A, talk t yur healthcare prvider befre yu take INTRON A. If yu develp high bld sugar r diabetes while taking INTRON A, yur healthcare prvider may tell yu t stp INTRON A and prescribe a different medicine fr yu. Symptms f high bld sugar r diabetes may include: increased thirst tiredness urinating mre ften than nrmal increased appetite weight lss yur breath smells like fruit 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.

6 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 INTRON A. 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) Serius allergic reactins and skin reactins. Symptms may include: itching chest pain swelling f yur face, feeling faint eyes, lips, tngue, r thrat skin rash, hives, sres in yur muth, r yur skin truble breathing blisters and peels anxiusness Swelling f yur pancreas (pancreatitis) and intestines (clitis). Symptms may include: severe stmach area (abdmen) pain severe back pain nausea vmiting fever New r wrsening autimmune disease. Sme patients taking INTRON A develp autimmune diseases (a cnditin where the bdy's immune cells attack ther cells r rgans in the bdy), including rheumatid arthritis, systemic lupus erythematsus, sarcidsis, and psriasis. In sme patients wh already have an autimmune disease, the disease may wrsen while n INTRON A. Nerve prblems. Peple wh take INTRON A 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. Tell yur dctr right away if yu have any f the symptms listed abve. The mst cmmn side effects f INTRON A include: Flu-like symptms. Symptms may include: headache, muscle aches, tiredness, and fever. Sme f these symptms may be decreased by injecting yur INTRON A dse in the evening. Talk t yur healthcare

7 prvider abut which ver-the-cunter medicines yu can take t help prevent r decrease sme f the symptms. Tiredness. Many peple becme very tired during treatment with INTRON A. Appetite prblems. Nausea, lss f appetite, and weight lss can happen with INTRON A. Skin reactins. Redness, swelling, and itching are cmmn at the injectin site. 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 the side effects f INTRON A. Fr mre infrmatin, ask yur healthcare prvider r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t the FDA at FDA Hw shuld I stre INTRON A? INTRON A Slutin fr Injectin and INTRON A Slutin fr Injectin in the Multidse Pens: Stre in the refrigeratr between 36 F t 46 F (2 C t 8 C). INTRON A Slutin fr Injectin in Multidse vials fr injectin and INTRON A Slutin fr Injectin in the Multidse Pens may be used t give mre than 1 injectin f medicine. D nt freeze. Thrw away any unused INTRON A Multidse Pen remaining after 4 weeks. Thrw away any unused INTRON A Slutin fr Injectin remaining in the vial after ne mnth. INTRON A Pwder fr Injectin: Befre mixing, stre in the refrigeratr between 36 F t 46 F (2 C t 8 C). After mixing the INTRON A Pwder fr Injectin, use the slutin right away r stre the slutin in the refrigeratr fr up t 24 hurs between 36 F t 46 F (2 C t 8 C). Thrw away any medicine left in the vial after yu withdraw 1 dse. D nt freeze. Keep INTRON A and all medicines ut f the reach f children. General Infrmatin abut INTRON A Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use INTRON A fr a cnditin fr which it was nt prescribed. D nt give INTRON A 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 INTRON A. If yu wuld like mre infrmatin, ask yur healthcare prvider. Yu can ask

8 yur healthcare prvider r pharmacist fr infrmatin abut INTRON A that was written fr health care prfessinals. Fr mre infrmatin, g t r call What are the ingredients in INTRON A? Active ingredient: interfern alfa-2b Inactive ingredients: Pwder fr injectin cntains: glycine, sdium phsphate dibasic, sdium phsphate mnbasic, human albumin. Sterile water fr injectin is prvided as a diluent. Slutin Multidse vials fr injectin cntain: sdium chlride, sdium phsphate dibasic, sdium phsphate mnbasic, edetate disdium, plysrbate 80, and m-cresl as a preservative. Slutin in Multidse Pens fr injectin cntain: sdium chlride, sdium phsphate dibasic, sdium phsphate mnbasic, edetate disdium, plysrbate 80, and m-cresl as a preservative. Manufactured by: Schering Crpratin, a subsidiary f Merck & C. Inc., Whitehuse Statin, NJ USA Revised February 2011 The Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Cpyright 1996, 2001, 2004, Schering Crpratin, a subsidiary f Merck & C. Inc. All rights reserved T