MEDICATION GUIDE LEMTRADA (lem-tra-da) (alemtuzumab) Injection for intravenous infusion

Transcription

1 MEDICATION GUIDE LEMTRADA (lem-tra-da) (alemtuzumab) Injectin fr intravenus infusin Read this Medicatin Guide befre yu start receiving LEMTRADA and befre yu begin each treatment curse. There may be new infrmatin. This infrmatin des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r treatment. What is the mst imprtant infrmatin I shuld knw abut LEMTRADA? LEMTRADA can cause serius side effects, including: 1. Serius autimmune prblems. Sme peple receiving LEMTRADA develp a cnditin where the immune cells in yur bdy attack ther cells r rgans in the bdy (autimmunity) which can be serius and may cause death. Serius autimmune prblems may include: immune thrmbcytpenic purpura (ITP). LEMTRADA may cause the number f platelets in yur bld t be reduced (ITP). ITP can cause severe bleeding that, if nt treated, may cause life-threatening prblems. Call yur healthcare prvider right away if yu have any f the fllwing symptms: easy bruising bleeding frm a cut that is hard t stp heavier menstrual perids than nrmal bleeding frm yur gums r nse that is new r takes lnger than usual t stp small, scattered spts n yur skin that are red, pink, r purple kidney prblems. LEMTRADA may cause a serius kidney prblem, called anti-glmerular basement membrane disease. If this happens and yu d nt get treated, anti-glmerular basement membrane disease can lead t severe kidney damage, kidney failure that needs dialysis, a kidney transplant, r death. Call yur healthcare prvider right away if yu have any f the fllwing symptms: bld in the urine (red r tea-clred urine) swelling in yur legs r feet cughing up bld Side effects may happen while yu receive LEMTRADA and fr 4 years after yu stp receiving LEMTRADA. Yur healthcare prvider will rder bld and urine tests befre yu receive, while yu are receiving, and every mnth fr 4 years after yu receive yur last LEMTRADA infusin. Yu may need t cntinue these bld and urine tests after 4 years if yu have any autimmune signs r symptms. The bld and urine tests will help yur healthcare prvider watch fr signs and symptms f serius autimmune prblems. 1

2 It is imprtant t have yur bld and urine tested, even if yu are feeling well and d nt have any symptms frm LEMTRADA and yur multiple sclersis. This may help yur healthcare prvider find any prblems early and will increase yur chances f getting better. 2. Serius infusin reactins. LEMTRADA can cause serius infusin reactins that may cause death. Serius infusin reactins may happen while yu receive, r up t 24 hurs r lnger after yu receive LEMTRADA. Yu will receive yur infusin at a healthcare facility with equipment and staff trained t manage infusin reactins. Yu will be watched while yu receive and fr 2 hurs after yu receive LEMTRADA. It is imprtant that yu stay at the infusin center fr 2 hurs after yur infusin is finished r lnger if yur healthcare prvider decides yu need t stay lnger. If a serius infusin reactin happens while yu are receiving LEMTRADA, yur infusin may be stpped. Tell yur healthcare prvider right away if yu have any f the fllwing symptms f a serius infusin reactin during the infusin, and after yu have left the healthcare facility: swelling in yur muth r thrat truble breathing weakness fast, slw, r irregular heart beat chest pain rash T lwer yur chances f getting a serius infusin reactin, yur healthcare prvider will give yu a medicine called crticsterids befre yur first 3 infusins f a treatment curse. Yu may als be given ther medicines befre r after the infusin t try reduce yur chances f these reactins r t treat them after they happen. 3. Certain cancers. Receiving LEMTRADA may increase yur chance f getting sme kinds f cancers, including thyrid cancer, skin cancer (melanma), and bld cancers called lymphprliferative disrders and lymphma. Call yur healthcare prvider if yu have the fllwing symptms that may be a sign f thyrid cancer: new lump truble swallwing r breathing swelling in yur neck cugh that is nt caused by a cld pain in the frnt f yur neck harseness r ther vice changes that d nt g away Yu shuld have yur skin checked befre yu start receiving LEMTRADA and each year while yu are receiving treatment t mnitr symptms f skin cancer. 2

3 Because f yur risk f autimmunity, infusin reactins and the risk f sme kinds f cancers, LEMTRADA is nly available thrugh a restricted prgram called the LEMTRADA Risk Evaluatin and Mitigatin Strategy (REMS) Prgram. Call t enrll in the LEMTRADA REMS Prgram. Yu and yur healthcare prvider must be enrlled in the LEMTRADA REMS Prgram. LEMTRADA can nly be given at a certified healthcare facility that participates in the LEMTRADA REMS Prgram. Yur healthcare prvider can give yu infrmatin n hw t find a certified healthcare facility. Read the LEMTRADA REMS What Yu Need t Knw Abut LEMTRADA Treatment: A Patient Guide and What yu Need t Knw Abut LEMTRADA Treatment and Infusin Reactins: A Patient Guide after yu are enrlled in the prgram. Carry yur LEMTRADA REMS Patient Safety Infrmatin Card with yu in case f an emergency. What is LEMTRADA? LEMTRADA is a prescriptin medicine used t treat adults with relapsing frms f multiple sclersis (MS). Because f its risks, LEMTRADA is generally used in peple wh have tried 2 r mre MS medicines that have nt wrked well enugh. It is nt knwn if LEMTRADA is safe and effective fr use in children under 17 years f age. Wh shuld nt receive LEMTRADA? D nt receive LEMTRADA if yu are infected with human immundeficiency virus (HIV). What shuld I tell my healthcare prvider befre receiving LEMTRADA? Befre receiving LEMTRADA, tell yur healthcare prvider if yu: are taking a medicine called Campath. Alemtuzumab, the active ingredient in LEMTRADA, is the same drug as Campath. have bleeding prblems have thyrid prblems have kidney prblems have a recent histry f infectin have HIV have received a live vaccine in the past 6 weeks befre receiving LEMTRADA r plan t receive any live vaccines. Ask yur healthcare prvider if yu are nt sure if yur vaccine is a live vaccine. are pregnant r plan t becme pregnant. LEMTRADA may harm yur unbrn baby. Yu shuld use birth cntrl while receiving LEMTRADA and fr 4 mnths after yur curse f treatment. 3

4 are breastfeeding r plan t breastfeed. It is nt knwn if LEMTRADA passes int yur breast milk. Yu and yur healthcare prvider shuld decide if yu shuld receive LEMTRADA r breastfeed. Yu shuld nt d bth. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and ver-the-cunter medicines, vitamins, and herbal supplements. LEMTRADA and ther medicines may affect each ther causing side effects. Especially tell yur healthcare prvider if yu take medicines that increase yur chance f getting infectins, including medicines used t treat cancer r t cntrl yur immune system. Knw the medicines yu take. Keep a list f them t shw yur healthcare prvider and pharmacist when yu get a new medicine. Hw will I receive LEMTRADA? LEMTRADA is given thrugh a needle placed in yur vein (IV infusin). It takes abut 4 hurs t receive a full dse f LEMTRADA each day. Yu will receive LEMTRADA ver 2 treatment curses. Yu will receive LEMTRADA fr 5 days in a rw (cnsecutive) fr the first treatment curse and then fr 3 days in a rw (cnsecutive) abut 1 year later fr yur secnd treatment curse. What are the pssible side effects f LEMTRADA? LEMTRADA may cause serius side effects including: See What is the mst imprtant infrmatin I shuld knw abut LEMTRADA? thyrid prblems. Sme peple wh receive LEMTRADA may get thyrid prblems including an veractive thyrid (hyperthyridism) r an underactive thyrid (hypthyridism). Yur healthcare prvider will d bld tests t check hw yur thyrid is wrking. Call yur healthcare prvider if yu have any f the symptms f thyrid prblems. Symptms f hyperthyridism may include: excessive sweating nervusness unexplained weight lss fast heartbeat eye swelling Symptms f hypthyridism may include: unexplained weight gain wrsening tiredness feeling cld cnstipatin lw bld cunts (cytpenias). LEMTRADA may cause a decrease in sme types f bld cells. Sme peple with these lw bld cunts have increased infectins. Symptms f cytpenias may include: weakness chest pain 4

5 yellwing f the skin r whites dark urine f eyes (jaundice) fast heartbeat Yur healthcare prvider will d bld tests t check fr cytpenias. Call yur healthcare prvider right away if yu have symptms listed abve. serius infectins. LEMTRADA may cause yu t have serius infectins while yu receive and after receiving a treatment curse. Serius infectins may include: herpes viral infectins. Sme peple taking LEMTRADA have an increased chance f getting herpes viral infectins. Yur healthcare prvider will prescribe medicines t reduce yur chances f getting these infectins. Take these medicines exactly as yur healthcare prvider tells yu t. human papillma virus (HPV). Females have an increased chance f getting a cervical HPV infectin. If yu are a female, yu shuld have an HPV screening each year. tuberculsis. Yur healthcare prvider shuld check yu fr tuberculsis befre yu receive LEMTRADA. fungal infectins. listeria. Peple wh receive LEMTRADA have an increased chance f getting an infectin caused by the bacteria listeria, which can lead t significant cmplicatins r death. Avid fds that may be a surce fr listeria (fr example, deli meat, unpasteurized milk and cheese prducts, sft cheeses, r undercked meat, seafd r pultry) r make sure that the fd yu eat which may cntain listeria is heated well if yu receive treatment with LEMTRADA. Call yur healthcare prvider right away if yu have symptms f a serius infectin, such as fever r swllen glands. Yu may need t g t the hspital fr treatment if yu get a serius infectin. It is imprtant t tell the healthcare prviders that yu have received LEMTRADA. Talk t yur healthcare prvider befre yu get vaccinatins after receiving LEMTRADA. Certain vaccinatins may increase yur chances f getting infectins. Inflammatin f the gallbladder withut gallstnes (acalculus chlecystitis). LEMTRADA may increase yur chance f getting inflammatin f the gallbladder withut gallstnes, a serius medical cnditin that can be lifethreatening. Call yur healthcare prvider right away if yu have any f the fllwing symptms f acalculus chlecystitis, which may include: stmach pain r discmfrt fever nausea r vmiting 5

6 swelling f lung tissue (pneumnitis). Sme peple have had swelling f the lung tissue while receiving LEMTRADA. Call yur healthcare prvider right away if yu have the fllwing symptms: shrtness f breath chest pain r tightness cugh cughing up bld wheezing The mst cmmn side effects f LEMTRADA include: rash fungal infectin headache jint pain thyrid prblems pain in yur arms r legs fever back pain swelling f yur nse and thrat diarrhea (naspharyngitis) sinus infectin nausea muth pain r sre thrat urinary tract infectin tingling sensatin feeling tired dizziness truble sleeping stmach pain upper respiratry tract infectin sudden redness in face, neck, r herpes viral infectin chest hives itching vmiting Tell yur healthcare prvider if yu have any side effect that bthers yu r that des nt g away. These are nt all the pssible side effects f LEMTRADA. 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 General infrmatin abut the safe and effective use f LEMTRADA. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use LEMTRADA fr a cnditin fr which it was nt prescribed. D nt give LEMTRADA 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 LEMTRADA. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu can ask yur pharmacist r healthcare prvider fr infrmatin abut LEMTRADA that is written fr health prfessinals. 6

7 Fr mre infrmatin, g t r call Genzyme at What are the ingredients in LEMTRADA? Active ingredient: alemtuzumab Inactive ingredients: sdium chlride, dibasic sdium phsphate, ptassium chlride, ptassium dihydrgen phsphate, plysrbate 80, disdium edetate dihydrate, and water fr injectin. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Manufactured and distributed by: Genzyme Crpratin 500 Kendall Street Cambridge, MA US License Number: 1596 LEMTRADA and CAMPATH are registered trademarks f Genzyme Crpratin Genzyme Crpratin. All rights reserved. Revised: 12/2017 7