Medication Guide CIMZIA (CIM-zee-uh) (certolizumab pegol) lyophilized powder or solution for subcutaneous use

Transcription

1 Medicatin Guide CIMZIA (CIM-zee-uh) (certlizumab pegl) lyphilized pwder r slutin fr subcutaneus use Read the Medicatin Guide that cmes with CIMZIA befre yu start using it, and befre each injectin f CIMZIA. This Medicatin Guide des nt take the place f talking with yur healthcare prvider abut yur medical cnditin r treatment. What is the mst imprtant infrmatin I shuld knw abut CIMZIA? CIMZIA is a medicine that affects yur immune system. CIMZIA can lwer the ability f the immune system t fight infectins. Serius infectins have happened in patients taking CIMZIA. These infectins include tuberculsis (TB) and infectins caused by viruses, fungi r bacteria that have spread thrughut the bdy. Sme patients have died frm these infectins. Yur healthcare prvider shuld test yu fr TB befre starting CIMZIA. Yur healthcare prvider shuld mnitr yu clsely fr signs and symptms f TB during treatment with CIMZIA. Yu shuld nt start receiving CIMZIA if yu have any kind f infectin unless yur healthcare prvider says it is kay. Befre yu receive CIMZIA, tell yur healthcare prvider if yu: Think yu have an infectin, flu-like symptms, r have any ther symptms f an infectin such as: bld in phlegm fever, sweat, r chills weight lss muscle aches cugh shrtness f breath diarrhea r stmach pain warm, red, r painful skin r sres n yur bdy feeling very tired burning when yu urinate r urinate mre ften than nrmal

2 are being treated fr an infectin get a lt f infectins r have infectins that keep cming back have diabetes, HIV, r a weak immune system. Peple with these cnditins have a higher chance fr infectins. have tuberculsis (TB), r have been in clse cntact with smene with TB were brn in, lived in, r traveled t cuntries where there is mre risk fr getting TB. Ask yur healthcare prvider if yu are nt sure. live r have lived in certain parts f the cuntry (such as the Ohi and Mississippi River valleys) where there is an increased risk fr getting certain kinds f fungal infectins (histplasmsis, cccidiidmycsis, blastmycsis). These infectins may develp r becme mre severe if yu take CIMZIA. If yu d nt knw if yu have lived in an area where histplasmsis, cccidiidmycsis, r blastmycsis is cmmn, ask yur healthcare prvider. have r have had hepatitis B use the medicine Kineret (anakinra), Orencia (abatacept), Rituxan (rituximab), r Tysabri (natalizumab) After starting CIMZIA, if yu get an infectin, any sign f an infectin including a fever, cugh, flu-like symptms, r have pen cuts r sres n yur bdy, call yur healthcare prvider right away. CIMZIA can make yu mre likely t get infectins r make any infectin that yu may have wrse. Cancer Fr peple taking TNF-blcker medicines, including CIMZIA, the chances f getting lymphma r ther cancers may increase. There have been cases f cancers in children, teenagers, and yung adults wh received TNF-blcker medicine that d nt usually happen in peple this age. Peple with RA, especially mre serius RA, may have a higher chance fr getting a kind f cancer called lymphma.

3 Sme peple receiving TNF-blcker medicines, including CIMZIA, have develped a rare type f cancer called hepatsplenic T-cell lymphma. This type f cancer ften results in death. Mst f these peple were male teenagers and yung adult males with Crhn's disease r ulcerative clitis. Als, mst f these peple had been treated with bth a TNF-blcker medicine and anther medicine called IMURAN (azathiprine) r PURINETHOL (6- mercaptpurine, 6-MP). If yu use TNF-blcker medicine, including CIMZIA, yur chance f develping certain kinds f skin cancer may increase. Tell yur healthcare prvider if any changes in the appearance f yur skin, including grwths n yur skin, happen during r after yur treatment. What is CIMZIA? CIMZIA is a prescriptin medicine called a Tumr Necrsis Factr (TNF) blcker. CIMZIA is used in adult patients t: Lessen the signs and symptms f mderately t severely active Crhn s disease (CD) in patients wh have nt been helped enugh by usual treatments Treat mderately t severely active rheumatid arthritis (RA) Treat active psriatic arthritis Treat active ankylsing spndylitis What shuld I tell my healthcare prvider befre starting treatment with CIMZIA? CIMZIA may nt be right fr yu. Befre starting CIMZIA, tell yur healthcare prvider abut all f yur medical cnditins, including if yu: have an infectin. (See, What is the mst imprtant infrmatin I shuld knw abut CIMZIA? ) have r have had any type f cancer. have cngestive heart failure. have seizures, any numbness r tingling, r a disease that affects yur nervus system such as multiple sclersis. are scheduled t receive a vaccine. D nt receive a live vaccine while taking CIMZIA.

4 are allergic t any f the ingredients in CIMZIA. See the end f this Medicatin Guide fr a list f the ingredients in CIMZIA. are pregnant r planning t becme pregnant. It is nt knwn if CIMZIA will harm yur unbrn baby. Tell yur healthcare prvider right away if yu becme pregnant while receiving CIMZIA. Pregnancy Registry: If yu becme pregnant while taking CIMZIA, talk t yur healthcare prvider abut registering in the pregnancy expsure registry fr CIMZIA. Yu can enrll in this registry by calling The purpse f this registry is t cllect infrmatin abut the safety f CIMZIA during pregnancy. are breastfeeding r plan t breastfeed. It is nt knwn if CIMZIA passes int yur breast milk. Yu and yur healthcare prvider shuld decide if yu will receive CIMZIA r breastfeed. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and ver-the-cunter medicines, vitamins and herbal supplements. Especially tell yur healthcare prvider if yu take the fllwing medicines due t a higher chance fr serius infectins: Kineret (anakinra), Orencia (abatacept), Rituxan (rituximab), r Tysabri (natalizumab). medicines called Tumr Necrsis Factr (TNF) blckers such as Remicade (infliximab), Humira (adalimumab), Enbrel (etanercept), r Simpni (glimumab). Ask yur healthcare prvider if yu are nt sure. Yu shuld nt take CIMZIA while yu take any f these medicines. Hw shuld I receive CIMZIA? CIMZIA cmes as lyphilized pwder r as a slutin in a prefilled syringe fr injectin. If yur healthcare prvider prescribes the CIMZIA pwder, yur CIMZIA shuld be injected by a healthcare prvider. Each dse f CIMZIA will be given as 1 r 2 separate injectins under the skin in yur stmach area r upper thighs. If yur healthcare prvider prescribes the CIMZIA prefilled syringe, yu will be trained n hw t inject CIMZIA. Yu will receive a CIMZIA Prefilled Syringe Kit including a cmplete Instructins fr Use bklet fr the right way t inject CIMZIA.

5 Read the detailed Instructins fr Use bklet fr instructins abut hw t prepare and inject yur dse f CIMZIA, and hw t prperly thrw away used syringes cntaining the needle. D nt give yurself an injectin f CIMZIA unless yu have been shwn by yur healthcare prvider. A family member r friend can als be trained t help yu give yur injectin. Talk t yur healthcare prvider if yu have questins. CIMZIA is given by an injectin under the skin. Yur healthcare prvider will tell yu hw much and hw ften t inject CIMZIA. D nt use mre CIMZIA r inject mre ften than prescribed. Yu may need mre than 1 injectin at a time depending n yur prescribed dse f CIMZIA. CIMZIA may be injected int yur stmach r upper thighs. If yu are prescribed mre than 1 injectin, each injectin shuld be given at a different site in yur stmach r upper thighs. Make sure the slutin in the prefilled syringe is clear and clrless t yellw and free frm particles. D nt use the CIMZIA prefilled syringe if the medicine is cludy, disclred, r cntains particles. D nt miss any dses f CIMZIA. If yu miss a dse, call yur healthcare prvider r pharmacist fr instructins. Make sure t keep all fllw-up appintments with yur healthcare prvider. What are the pssible side effects f CIMZIA? CIMZIA can cause serius side effects including: See What is the mst imprtant infrmatin I shuld knw abut CIMZIA? Heart Failure including new heart failure r wrsening f heart failure yu already have. Symptms include shrtness f breath, swelling f yur ankles r feet, r sudden weight gain. Allergic Reactins. Signs f an allergic reactin include a skin rash, swelling r itching f the face, tngue, lips, r thrat, r truble breathing. Hepatitis B virus reactivatin in patients wh carry the virus in their bld. In sme cases patients have died as a result f hepatitis B virus being reactivated. Yur healthcare prvider shuld

6 mnitr yu carefully befre and during treatment with CIMZIA t see if yu carry the hepatitis B virus in yur bld. Tell yur healthcare prvider if yu have any f the fllwing symptms: feel unwell skin r eyes lk yellw tiredness (fatigue) pr appetite r vmiting pain n the right side f yur stmach (abdmen) New r wrsening nervus system prblems, such as multiple sclersis (MS), Guillain-Barre syndrme, seizures, r inflammatin f the nerves f the eyes. Symptms may include: dizziness numbness r tingling prblems with yur visin weakness in yur arms r legs Bld Prblems. Yur bdy may nt make enugh f the bld cells that help fight infectins r help stp bleeding. Symptms include a fever that des nt g away, bruising r bleeding very easily, r lking very pale. Immune reactins including a lupus-like syndrme. Symptms include shrtness f breath, jint pain, r a rash n the cheeks r arms that wrsens with sun expsure. Call yur healthcare prvider right away if yu have any serius side effects listed abve. The mst cmmn side effects f CIMZIA include: upper respiratry infectins (flu, cld) rash urinary tract infectins (bladder infectins) Tell yur healthcare prvider abut any side effect that bthers yu r des nt g away. These are nt all f the pssible side effects f CIMZIA. Fr mre infrmatin, ask yur healthcare prvider r pharmacist.

7 Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre CIMZIA? Keep CIMZIA in the refrigeratr between 36ºF t 46ºF (2ºC t 8ºC). D nt freeze CIMZIA. Prtect CIMZIA frm light. Stre CIMZIA in the cartn it came in. D nt use CIMZIA if the medicine is expired. Check the expiratin date n the prefilled syringe r cartn. The CIMZIA prefilled syringe is made f glass. D nt drp r crush the syringe. Keep CIMZIA and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f CIMZIA. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use CIMZIA fr a cnditin fr which it was nt prescribed. D nt give CIMZIA 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 CIMZIA. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu can ask yur pharmacist r healthcare prvider fr infrmatin abut CIMZIA that is written fr health prfessinals. Fr mre infrmatin, g t r call What are the ingredients in CIMZIA? CIMZIA lyphilized pwder: Active ingredient: certlizumab pegl Inactive ingredients: lactic acid, plysrbate, sucrse CIMZIA lyphilized pwder is mixed with sterile Water fr Injectin. CIMZIA prefilled syringe: Active ingredient: certlizumab pegl Inactive ingredients: sdium acetate, sdium chlride, Water fr Injectin CIMZIA has n preservatives.

8 This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Prduct manufactured by: UCB, Inc Lake Park Drive Smyrna, GA US License N Revised: April 2016