MEDICATION GUIDE REVLIMID (rev-li-mid) (lenalidmide) capsules What is the mst imprtant infrmatin I shuld knw abut REVLIMID? Befre yu begin taking REVLIMID, yu must read and agree t all f the instructins in the REVLIMID REMS prgram. Befre prescribing REVLIMID, yur healthcare prvider will explain the REVLIMID REMS prgram t yu and have yu sign the Patient-Physician Agreement Frm. REVLIMID may cause serius side effects including: Pssible birth defects (defrmed babies) r death f an unbrn baby. Females wh are pregnant r wh plan t becme pregnant must nt take REVLIMID. REVLIMID is similar t the medicine thalidmide. We knw thalidmide can cause severe lifethreatening birth defects. REVLIMID has nt been tested in pregnant females. REVLIMID has harmed unbrn animals in animal testing. Females must nt get pregnant: Fr at least 4 weeks befre starting REVLIMID While taking REVLIMID During any breaks (interruptins) in yur treatment with REVLIMID Fr at least 4 weeks after stpping REVLIMID Females wh can becme pregnant: Will have pregnancy tests weekly fr 4 weeks, then every 4 weeks if yur menstrual cycle is regular, r every 2 weeks if yur menstrual cycle is irregular. If yu miss yur perid r have unusual bleeding, yu will need t have a pregnancy test and receive cunseling. Must agree t use tw acceptable frms f birth cntrl at the same time, fr at least 4 weeks befre, while taking, during any breaks (interruptins) in yur treatment, and fr at least 4 weeks after stpping REVLIMID. Talk with yur healthcare prvider t find ut abut ptins fr acceptable frms f birth cntrl that yu may use t prevent pregnancy befre, during, and after treatment with REVLIMID. If yu had unprtected sex r if yu think yur birth cntrl has failed, stp taking REVLIMID immediately and call yur healthcare prvider right away. If yu becme pregnant while taking REVLIMID, stp taking it right away and call yur healthcare prvider. If yur healthcare prvider is nt available, yu can call Celgene Custmer Care Center at 1-888-423-5436. Healthcare prviders and patients shuld reprt all cases f pregnancy t: FDA MedWatch at 1-800-FDA-1088, and Celgene Crpratin at 1-888-423-5436 There is a pregnancy expsure registry that mnitrs the utcmes f females wh take REVLIMID during pregnancy, r if their male partner takes REVLIMID and they are expsed during pregnancy. Yu can enrll in this registry by calling Celgene Crpratin at the phne number listed abve. REVLIMID can pass int human semen: Males, including thse wh have had a vasectmy, must always use a latex r synthetic cndm during any sexual cntact with a pregnant female r a female that can becme pregnant while taking REVLIMID, during any breaks (interruptins) in yur treatment with REVLIMID, and fr up t 4 weeks after stpping REVLIMID. D nt have unprtected sexual cntact with a female wh is r culd becme pregnant. Tell yur healthcare prvider if yu d have unprtected sexual cntact with a female wh is r culd becme pregnant. D nt dnate sperm while taking REVLIMID, during any breaks (interruptins) in yur treatment, and fr 4 weeks after stpping REVLIMID. If a female becmes pregnant with yur sperm, the baby may be expsed t REVLIMID and may be brn with birth defects. Men, if yur female partner becmes pregnant, yu shuld call yur healthcare prvider right away. Lw white bld cells (neutrpenia) and lw platelets (thrmbcytpenia). REVLIMID causes 42
lw white bld cells and lw platelets in mst peple. Yu may need a bld transfusin r certain medicines if yur bld cunts drp t lw. Yur healthcare prvider shuld check yur bld cunts ften especially during the first several mnths f treatment with REVLIMID, and then at least mnthly. Tell yur healthcare prvider if yu develp any bleeding r bruising, during treatment with REVLIMID. Bld clts. Bld clts in the arteries, veins, and lungs happen mre ften in peple wh take REVLIMID. This risk is even higher fr peple with multiple myelma wh take the medicine dexamethasne with REVLIMID. Heart attacks and strkes als happen mre ften in peple wh take REVLIMID with dexamethasne. T reduce this increased risk, mst peple wh take REVLIMID will als take a bld thinner medicine. Befre taking REVLIMID, tell yur healthcare prvider: If yu have had a bld clt in the past If yu have high bld pressure, smke, r if yu have been tld yu have a high level f fat in yur bld (hyperlipidemia) Abut all the medicines yu take. Certain ther medicines can als increase yur risk fr bld clts Call yur healthcare prvider r get medical help right away if yu get any f the fllwing during treatment with REVLIMID: Signs r symptms f a bld clt in the lung, arm, r leg may include: shrtness f breath, chest pain, r arm r leg swelling Signs r symptms f a heart attack may include: chest pain that may spread t the arms, neck, jaw, back, r stmach area (abdmen), feeling sweaty, shrtness f breath, feeling sick r vmiting Signs r symptms f strke may include: sudden numbness r weakness, especially n ne side f the bdy, severe headache r cnfusin, r prblems with visin, speech, r balance What is REVLIMID? REVLIMID is a prescriptin medicine, used t treat peple with: multiple myelma (MM) in cmbinatin with the medicine dexamethasne, r as maintenance treatment after autlgus hematpietic stem cell transplantatin (a type f stem cell transplant that uses yur wn stem cells) a cnditin called myeldysplastic syndrmes (MDS). REVLIMID is fr the type f MDS with a chrmsme prblem where part f chrmsme 5 is missing. This type f MDS is knwn as deletin 5q MDS. Peple with this type f MDS may have lw red bld cell cunts that require treatment with bld transfusins. mantle cell lymphma (MCL) when the disease cmes back r becmes wrse after treatment with tw prir medicines, ne f which included brtezmib. MCL is a cancer f a type f white bld cell called lymphcytes that are in the lymph ndes. REVLIMID shuld nt be used t treat peple wh have chrnic lymphcytic leukemia (CLL) unless they are participants in a cntrlled clinical trial. It is nt knwn if REVLIMID is safe and effective in children. Wh shuld nt take REVLIMID? D nt take REVLIMID if yu: are pregnant, plan t becme pregnant, r becme pregnant during treatment with REVLIMID. See What is the mst imprtant infrmatin I shuld knw abut REVLIMID? are allergic t lenalidmide r any f the ingredients in REVLIMID. See the end f this Medicatin Guide fr a cmplete list f ingredients in REVLIMID. 43
What shuld I tell my healthcare prvider befre taking REVLIMID? Befre yu take REVLIMID, tell yur healthcare prvider abut all f yur medical cnditins, including if yu: have liver prblems have kidney prblems r receive kidney dialysis treatment have thyrid prblems have had a serius skin rash with thalidmide treatment. Yu shuld nt take REVLIMID. are lactse intlerant. REVLIMID cntains lactse. are breastfeeding. D nt breastfeed during treatment with REVLIMID. It is nt knwn if REVLIMID passes int yur breast milk and can harm yur baby. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and ver-thecunter medicines, vitamins, and herbal supplements. REVLIMID and ther medicines may affect each ther, causing serius side effects. Talk with yur healthcare prvider befre taking any new medicines. Knw the medicines yu take. Keep a list f them t shw yur healthcare prvider and pharmacist. Hw shuld I take REVLIMID? Take REVLIMID exactly as prescribed and fllw all the instructins f the REVLIMID REMS prgram Swallw REVLIMID capsules whle with water 1 time a day. D nt pen, break, r chew yur capsules. REVLIMID may be taken with r withut fd. Take REVLIMID at abut the same time each day. D nt pen r break REVLIMID capsules r handle them any mre than needed. If pwder frm the REVLIMID capsule cmes in cntact with yur skin, wash the skin right away with sap and water. If pwder frm the REVLIMID capsule cmes in cntact with the inside f yur eyes, nse, r muth, flush well with water. If yu miss a dse f REVLIMID and it has been less than 12 hurs since yur regular time, take it as sn as yu remember. If it has been mre than 12 hurs, just skip yur missed dse. D nt take 2 dses at the same time. If yu take t much REVLIMID, call yur healthcare prvider right away. What shuld I avid while taking REVLIMID? See What is the mst imprtant infrmatin I shuld knw abut REVLIMID? Females: D nt get pregnant and d nt breastfeed while taking REVLIMID. Males: D nt dnate sperm. D nt share REVLIMID with ther peple. It may cause birth defects and ther serius prblems. D nt dnate bld while yu take REVLIMID, during any breaks (interruptins) in yur treatment, and fr 4 weeks after stpping REVLIMID. If smene wh is pregnant gets yur dnated bld, her baby may be expsed t REVLIMID and may be brn with birth defects. 44
What are the pssible side effects f REVLIMID? REVLIMID can cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut REVLIMID? Increased risk f death in peple wh have chrnic lymphcytic leukemia (CLL). Peple with CLL wh take REVLIMID have an increased risk f death cmpared with peple wh take the medicine chlrambucil. REVLIMID may cause yu t have serius heart prblems that can lead t death, including atrial fibrillatin, heart attack, r heart failure. Yu shuld nt take REVLIMID if yu have CLL unless yu are participating in a cntrlled clinical trial. Risk f new cancers (malignancies). An increase in new (secnd) cancers has happened in patients wh received REVLIMID and melphalan, r a bld stem cell transplant, including certain bld cancers, such as acute myelgenus leukemia (AML), and myeldysplastic syndrme (MDS) and certain ther types f cancers f the skin and ther rgans. Talk with yur healthcare prvider abut yur risk f develping new cancers if yu take REVLIMID. Yur healthcare prvider will check yu fr new cancers during yur treatment with REVLIMID. Severe liver prblems, including liver failure and death. Yur healthcare prvider shuld d bld tests t check yur liver functin during yur treatment with REVLIMID. Tell yur healthcare prvider right away if yu develp any f the fllwing symptms f liver prblems: yellwing f yur skin r the white part f pain n the upper right side f yur stmach yur eyes (jaundice) area (abdmen) dark r brwn (tea-clred) urine bleeding r bruising mre easily than nrmal feeling very tired Severe skin reactins including severe allergic reactins can happen with REVLIMID and may cause death. Call yur healthcare prvider right away if yu develp any f these signs r symptms f a severe allergic reactin r severe skin reactin during treatment with REVLIMID: swelling f yur face, eyes, lips, tngue, skin rash, hives, r peeling f yur skin thrat blisters truble swallwing rash with fever and r swllen glands truble breathing Tumr lysis syndrme (TLS). TLS is caused by the fast breakdwn f cancer cells. TLS can cause kidney failure and the need fr dialysis treatment, abnrmal heart rhythm, seizure and smetimes death. Yur healthcare prvider may d bld tests t check yu fr TLS. Wrsening f yur tumr (tumr flare reactin). Tell yur healthcare prvider if yu get any f these symptms f tumr flare reactin while taking REVLIMID: tender swllen lymph ndes, lw grade fever, pain, r rash. Yur healthcare prvider may tell yu t decrease yur dse, temprarily stp r permanently stp taking REVLIMID if yu develp certain serius side effects during treatment with REVLIMID. Thyrid prblems. Yur healthcare prvider may check yur thyrid functin befre yu start taking REVLIMID and during treatment with REVLIMID. Risk f Early Death in MCL. In peple wh have Mantle Cell Lymphma (MCL), there may be a risk f dying sner (early death) when taking REVLIMID. Talk with yur healthcare prvider abut any cncerns and pssible risk factrs. The mst cmmn side effects f REVLIMID include: diarrhea cnstipatin rash tiredness nausea fever itching swelling f the limbs and skin cugh These are nt all the pssible side effects f REVLIMID. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t the FDA at 1-800- FDA-1088. Hw shuld I stre REVLIMID? Stre REVLIMID at rm temperature between 68 F t 77 F (20 C t 25 C). Return any unused REVLIMID t Celgene r yur healthcare prvider. Keep REVLIMID and all medicines ut f the reach f children. 45
General infrmatin abut the safe and effective use f REVLIMID Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt take REVLIMID fr cnditins fr which it was nt prescribed. D nt give REVLIMID t ther peple, even if they have the same symptms yu have. It may harm them and may cause birth defects. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut REVLIMID that is written fr health prfessinals. What are the ingredients in REVLIMID? Active ingredient: lenalidmide Inactive ingredients: lactse anhydrus, micrcrystalline cellulse, crscarmellse sdium, and magnesium stearate. The 5 mg and 25 mg capsule shell cntains gelatin, titanium dixide and black ink. The 2.5 and 10 mg capsule shell cntains gelatin, FD&C blue #2, yellw irn xide, titanium dixide and black ink. The 15 mg capsule shell cntains gelatin, FD&C blue #2, titanium dixide and black ink. The 20 mg capsule shell cntains gelatin, FD&C blue #2, yellw irn xide, titanium dixide and black ink. Manufactured fr: Celgene Crpratin, Summit, NJ 07901 REVLIMID and REVLIMID REMS are registered trademarks f Celgene Crpratin. Pat. http://www.celgene.cm/therapies 2005-2017 Celgene Crpratin All rights reserved. REVPlyMG.024 12/2017 Fr mre infrmatin, call 1-888-423-5436 r g t www.celgeneriskmanagement.cm. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Revised: December 2017 46