For the RETREATMENT of people whose multiple myeloma has come back (relapsed) after responding to VELCADE Continue your treatment journey with VELCADE® (bortezomib) “I am prepared to continue my fight knowing that VELCADE might work again for me.” Visit VELCADE.com to join the patient support program and get easy access to the tips, information, and resources you need. VELCADE (bortezomib) is approved for the treatment of people with multiple myeloma (a cancer of the plasma cells). Before you receive treatment with VELCADE, tell your doctor about all of your medical conditions. You should not receive VELCADE if you are allergic to bortezomib, boron, or mannitol. VELCADE must not be administered into your spinal fluid (intrathecally). Please see Important Safety Information inside this brochure and accompanying full Prescribing Information for VELCADE. What are the benefits of retreatment with VELCADE? How long will I be retreated How will I be on VELCADE? withlong VELCADE? Retreatment with VELCADE® (bortezomib) may offer an additional benefit ▼ Retreatment schedule with VELCADE® (bortezomib) In a clinical trial, 130 people who had multiple myeloma that had come back (relapsed) at least 6 months after having achieved a benefit with VELCADE (bortezomib) received VELCADE again ▼ Your retreatment schedule with VELCADE (bortezomib) may be different from your original treatment schedule ▼ In a clinical trial, VELCADE retreatment was given twice a week for 2 weeks, followed by a 10-day rest period. This was repeated up to 8 times (about 6 months) – Patients received VELCADE with or without dexamethasone – 3 out of 8 people responded to retreatment with VELCADE, with responses lasting about 6.5 months* Retreatment cycles 1-8 TWICE WEEKLY, 3 WEEKS x8 (MAXIMUM) *Half the patients’ responses lasted less than 6.5 months and half the patients’ responses lasted more than 6.5 months. F:10” FS:9.5” “Given that VELCADE had worked before, I was thankful to know that retreatment was an option.” ▼ ▼ If you achieved a benefit with your first therapy but have relapsed more than 6 months later, ▼ NATIONAL CANCER TREATMENT GUIDELINES RECOMMEND RETREATMENT with the same therapy you received before. 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 VELCADE Your doctor may start your retreatment with VELCADE at the last dose you were receiving VELCADE can be given subcutaneously (under your skin) or intravenously (into your vein) C WEEKLY M 1 2 8 9 15 16 22 23 29 30 – Your doctor may consider starting you on subcutaneous VELCADE if you have numbness, tingling, burning, or weakness in your hands or feet (peripheral neuropathy)TWICE WEE or are at high risk for these symptoms It’s essential to take treatment as prescribed 1 2 by your healthcare team. There are many 9 8 things to consider when choosing a treatment plan that’s right for you 15 16 It’s important to stay committed to your treatment plan. Get the most out of VELCADE. Please see Important Safety Information inside this brochure. 1 F Please see Important Safety Information inside this brochure. T:2 B:20 S:1 What I expect with What cancan expect with What can II expect with VELCADE retreatment? VELCADE retreatment? retreatment? VELCADE While receiving While receiving While receiving ® ® (bortezomib), it’s ® VELCADE VELCADE (bortezomib), it’s it’s VELCADE (bortezomib), important speak about important toto speak upup about important to speak up about how you feel how you feel how you feel a clinical of retreatment with InaaIn clinical trialtrial ofretreatment retreatment with In clinical trial of with VELCADE (bortezomib), most common VELCADE (bortezomib), thethe most common sideside VELCADE (bortezomib), the most common side effects were: effectswere: were: effects ▼ Abnormal ▼ Abnormal levels of blood cells as determined ▼ Abnormal levels ofblood blood cells asdetermined determined by by levels of cells as by regular blood tests regularblood bloodtests tests regular ▼ Tingling ▼ Tingling or numbness in the hands, arms, feet, ▼ Tingling ornumbness numbness inthe the hands, arms, feet, or in hands, arms, feet, or legs (peripheral neuropathy) orlegs legs (peripheral neuropathy) or (peripheral neuropathy) 13% of patients stopped treatment to side effects. 13% ofpatients patients stopped treatment duedue toside side effects. 13% of stopped treatment due to effects. Side effects worse Side effects diddid notnot getget worse Side effects did not get worse with retreatment. with retreatment. with retreatment. ▼ When starting retreatment, be sure to talk ▼ When When starting retreatment, be sure sure to talk talk to to ▼ starting retreatment, be to to your doctor about other health conditions your doctor about anyany other health conditions your doctor about any other health conditions have or medications you’re taking youyou have or medications medications you’re taking you have or you’re taking ▼you If you have effects with VELCADE, ▼ If If you have anyany sideside effects with VELCADE, ▼ have any side effects with VELCADE, tell your doctor or nurse right away tell your your doctor doctor or or nurse nurse right right away away tell ▼ Your healthcare team might decide to change ▼ Your Your healthcare team might decide to change change ▼ healthcare team might decide to your dose or schedule of VELCADE to help your dose or schedule of VELCADE to help your dose or schedule of VELCADE to help you stay on treatment you stay stay on on treatment treatment you ▼ Ask your doctor about treatment shingles ▼ Ask Ask your doctor about treatment forfor shingles ▼ your doctor about treatment for shingles when starting retreatment with VELCADE when starting retreatment with VELCADE when starting retreatment with VELCADE Please Important Safety Information Please seesee Important Safety Information Please see Important Safety Information on adjacent pages. onadjacent adjacent pages. on pages. Indication and Important Indication and Important Indication and Important Safety Information Safety Information forfor Safety Information for ® ® ® VELCADE(bortezomib) (bortezomib) VELCADE (bortezomib) VELCADE What is VELCADE used for? What is VELCADE VELCADE used for? What is used for? VELCADE (bortezomib) is approved for VELCADE(bortezomib) (bortezomib)isisapproved approvedfor forthe thethe VELCADE treatment of patients with multiple myeloma treatmentof ofpatients patientswith withmultiple multiplemyeloma myeloma treatment (a cancer of the plasma cells). (acancer cancer ofthe the plasma cells). (a of plasma cells). How is VELCADE administered? How is VELCADE VELCADE administered? How is administered? VELCADE is prescribed a physician VELCADE is prescribed by aby a physician physician VELCADE is prescribed by experienced in the use of medications to treat experienced in the use of medications to treat treat experienced in the use of medications to cancer. It is administered by a healthcare cancer. It is administered by a healthcare cancer. It is administered by a healthcare professional as injection an injection your vein professional as an an injection intointo your vein professional as into your vein (intravenously, or IV) or under your skin (intravenously, or IV) or under your skin (intravenously, or IV) or under your skin (subcutaneously). VELCADE must (subcutaneously). VELCADE must notnot be be (subcutaneously). VELCADE must not be administered into your spinal fluid (intrathecally). administered into your spinal fluid (intrathecally). administered into your spinal fluid (intrathecally). Who should receive VELCADE? Who should notnot receive VELCADE? Who should not receive VELCADE? Before receive treatment with VELCADE, tell your Before youyou receive treatment with VELCADE, tellyour your Before you receive treatment with VELCADE, tell doctor about allyour of your medical conditions. should doctor about allof of your medical conditions. YouYou should doctor about all medical conditions. You should receive VELCADE if you allergic to bortezomib, notnot receive VELCADE you areare allergic tobortezomib, bortezomib, not receive VELCADE ififyou are allergic to boron, or mannitol. boron, ormannitol. mannitol. boron, or What possible side effects of VELCADE? What areare thethe possible side effects ofVELCADE? VELCADE? What are the possible side effects of VELCADE cause serious effects, including: VELCADE cancan cause serious sideside effects, including: VELCADE can cause serious side effects, including: ▼ ▼ Peripheral Peripheral neuropathy. VELCADE ▼ Peripheral neuropathy. VELCADE cancan neuropathy. VELCADE can cause damage to the nerves, a condition called cause damage to the the nerves, condition called cause damage to nerves, aa condition called peripheral neuropathy. may muscle peripheral neuropathy. YouYou may feelfeel muscle peripheral neuropathy. You may feel muscle weakness, tingling, burning, pain, weakness, tingling, burning, pain, andand lossloss of of weakness, tingling, burning, pain, and loss of feeling in your hands feet, of which feeling in your your hands andand feet, anyany of which which cancan feeling in hands and feet, any of can be severe. your doctor if you notice be severe. severe. TellTell your doctor you notice anyany of of be Tell your doctor ifif you notice any of these symptoms. Your doctor may change these symptoms. Your doctor may change thethe these symptoms. Your doctor may change the dose and/or schedule of VELCADE or stop dose and/or schedule of VELCADE VELCADE or stop stop dose and/or schedule of or itit it altogether. If you have peripheral neuropathy altogether. you have peripheral neuropathy altogether. IfIf you have peripheral neuropathy before starting VELCADE, your doctor could before starting VELCADE, your doctor could before starting VELCADE, your doctor could consider giving VELCADE subcutaneously. consider giving youyou VELCADE subcutaneously. consider giving you VELCADE subcutaneously. ▼ Low ▼ Low blood pressure. VELCADE cause ▼ Low blood pressure. VELCADE cancan cause blood pressure. VELCADE can cause aa a drop in blood pressure. Tell your doctor if you have dropin inblood bloodpressure. pressure.Tell Tellyour yourdoctor doctorififyou youhave have drop low blood pressure, feel dizzy, or feel as though lowblood bloodpressure, pressure,feel feeldizzy, dizzy,or orfeel feelas asthough though low might faint. If you taking drugs lower youyou might faint. you areare taking drugs thatthat lower you might faint. IfIfyou are taking drugs that lower blood pressure, your medications might need bloodpressure, pressure,your yourmedications medicationsmight mightneed needto to to blood be adjusted. If you are not drinking enough liquids, beadjusted. adjusted.IfIfyou youare arenot notdrinking drinkingenough enoughliquids, liquids, be your doctor may need to administer IV fluids. yourdoctor doctormay mayneed needto toadminister administerIV IVfluids. fluids. your ▼ Heart ▼ Heart problems. Treatment with VELCADE ▼ Heart problems. Treatment with VELCADE cancan problems. Treatment with VELCADE can cause or worsen heart rhythm problems and heart cause or worsen heart rhythm problems and heart cause or worsen heart rhythm problems and heart failure. Your doctor may closely monitor you if failure. Your doctor may closely monitor you if failure. Your doctor may closely monitor you if have, or are at risk heart disease. your youyou have, orare are atrisk risk for,for, heart disease. TellTell your you have, or at for, heart disease. Tell your doctor if you experience chest pressure or pain, doctor if you experience chest pressure or pain, doctor if you experience chest pressure or pain, palpitations, swelling of your ankles or feet, palpitations, swelling ofyour your ankles orfeet, feet, or or palpitations, swelling of ankles or or shortness of breath. shortness of breath. shortness of breath. ▼ Lung ▼ Lung problems. There have been reports ▼ Lung problems. There have been reports of of problems. There have been reports of lung disorders in patients receiving lung disorders inpatients patients receiving lung disorders in receiving VELCADE (bortezomib). Some of these events VELCADE (bortezomib). Some ofthese these events VELCADE (bortezomib). Some of events have been fatal. your doctor if you experience have been fatal. TellTell your doctor you experience have been fatal. Tell your doctor ififyou experience coughing, shortness of breath, wheezing, anyany coughing, shortness ofbreath, breath, wheezing, or or any coughing, shortness of wheezing, or difficulty breathing. difficulty breathing. difficulty breathing. ▼ Liver ▼ Liver problems. If you have liver problems, it can ▼ Liver problems. you have liver problems, can problems. IfIfyou have liver problems, ititcan be harder for your body to get rid of VELCADE. beharder harder foryour your body toget get ridof ofVELCADE. VELCADE. be for body to rid VELCADE caused sudden liver failure VELCADE hashas caused sudden liver failure in in VELCADE has caused sudden liver failure in patients who were taking many medications patients who were taking many medications or or patients who were taking many medications or other serious medical conditions. Symptoms hadhad other serious medical conditions. Symptoms had other serious medical conditions. Symptoms of liver problems include a yellow discoloration ofliver liver problems include yellow discoloration of of of problems include aayellow discoloration of eyes (jaundice) changes in liver thethe eyes andand skinskin (jaundice) andand changes inliver liver the eyes and skin (jaundice) and changes in enzymes measured in blood tests. Your doctor enzymes measured inblood blood tests. Your doctor willwill enzymes measured in tests. Your doctor will closely monitor if you have liver disease. closely monitor youyou you have liver disease. closely monitor you ififyou have liver disease. ▼ Posterior ▼ Posterior reversible encephalopathy ▼ Posterior reversible encephalopathy reversible encephalopathy syndrome (PRES). There have been reports syndrome (PRES). There have been reports ofaaof a syndrome (PRES). There have been reports of rare, reversible condition involving brain, called rare, reversible condition involving thethe brain, called rare, reversible condition involving the brain, called PRES, in patients treated with VELCADE. Patients PRES, inpatients patients treated with VELCADE. Patients PRES, in treated with VELCADE. Patients with PRES have seizures, high blood pressure, with PRES cancan have seizures, high blood pressure, with PRES can have seizures, high blood pressure, headaches, tiredness, confusion, blindness, or other headaches, tiredness, confusion, blindness, orother other headaches, tiredness, confusion, blindness, or vision problems. Treatment with VELCADE should vision problems. Treatment with VELCADE should vision problems. Treatment with VELCADE should be stopped in cases of PRES. bestopped stopped incases cases ofPRES. PRES. be in of ▼ Gastrointestinal ▼ Gastrointestinal problems. VELCADE ▼ Gastrointestinal problems. VELCADE problems. VELCADE treatment can cause nausea, vomiting, diarrhea, treatmentcan cancause causenausea, nausea,vomiting, vomiting,diarrhea, diarrhea, treatment and constipation. If your symptoms are severe, your andconstipation. constipation.IfIfyour yoursymptoms symptomsare aresevere, severe, your and your doctor may recommend IV fluids and/or medications. doctormay mayrecommend recommendIV IVfluids fluidsand/or and/ormedications. medications. doctor ▼ Neutropenia ▼ Neutropenia (low levels of neutrophils, ▼ Neutropenia (low levels of neutrophils, (low levels of neutrophils, aa a type of white blood cell). VELCADE cause type of white blood cell). VELCADE cancan cause type of white blood cell). VELCADE can cause low levels of white blood cells (infection-fighting low levels of white blood cells (infection-fighting low levels of white blood cells (infection-fighting cells). If your white blood cells become cells). your white blood cells become low,low, youyou cancan cells). IfIfyour white blood cells become low, you can be at higher risk for infections. Tell your doctor be at higher risk for infections. Tell your doctor if be at higher risk for infections. Tell your doctor if if develop a fever or believe have an infection. youyou develop fever orbelieve believe youyou have aninfection. infection. you develop aafever or you have an ▼ Thrombocytopenia ▼ Thrombocytopenia (low levels of platelets). ▼ Thrombocytopenia (low levels of platelets). platelets). (low levels of VELCADE cause levels of platelets (clotVELCADE cancan cause lowlow levels ofplatelets platelets (clotVELCADE can cause low levels of (clotforming cells). If platelets become very there forming cells). platelets become very low,low, there forming cells). IfIfplatelets become very low, there isincreased an increased of bleeding. Your doctor may an increased riskrisk ofbleeding. bleeding. Your doctor may isisan risk of Your doctor may recommend a platelet transfusion. recommend platelet transfusion. recommend aaplatelet transfusion. have regular blood tests to check your YouYou willwill have regular blood tests tocheck check your cellcell You will have regular blood tests to your cell counts during your treatment with VELCADE. If the counts during your treatment with VELCADE. the counts during your treatment with VELCADE. IfIfthe number of these cells is very low, your doctor may number of these cells is very low, your doctor may number of these cells is very low, your doctor may change dose and/or schedule of VELCADE. change thethe dose and/or schedule ofVELCADE. VELCADE. change the dose and/or schedule of ▼ Tumor ▼ Tumor lysis syndrome (TLS). TLS ▼ Tumor lysis syndrome (TLS). TLS lysis syndrome (TLS). TLS isis aais a syndrome causes a chemical imbalance syndrome thatthat causes chemical imbalance in in syndrome that causes aa chemical imbalance in blood could lead to heart and/or kidney thethe blood thatthat could lead to heart heart and/or kidney the blood that could lead to and/or kidney problems. TLS occur with cancer treatments, problems. TLS cancan occur with cancer treatments, problems. TLS can occur with cancer treatments, your doctor be monitoring your blood andand your doctor willwill be monitoring monitoring your blood and your doctor will be your blood urine signs of this syndrome. If you andand urine forfor anyany signs of this this syndrome. you and urine for any signs of syndrome. IfIf you develop TLS, your doctor take appropriate develop TLS, your doctor willwill take appropriate develop TLS, your doctor will take appropriate steps to treat steps to treat treat it. it. steps to it. More than 5 patients (20%) receiving More than in155inpatients patients (20%) receiving More than 11 in (20%) receiving VELCADE (bortezomib) have experienced VELCADE (bortezomib) have experienced VELCADE (bortezomib) have experienced following side effects: nausea, diarrhea, thethe following side effects: nausea, diarrhea, the following side effects: nausea, diarrhea, thrombocytopenia, neutropenia, peripheral thrombocytopenia, neutropenia, peripheral thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia (nerve pain), neuropathy, fatigue, neuralgia (nerve pain), neuropathy, fatigue, neuralgia (nerve pain), anemia, leukopenia (low levels of white blood anemia, leukopenia (low levels of white white blood anemia, leukopenia (low levels of blood cells), constipation, vomiting, lymphopenia (low cells), constipation, vomiting, lymphopenia (low cells), constipation, vomiting, lymphopenia (low levels a certain type of white blood cells), levels of aaofcertain certain type of white white blood cells), levels of type of blood cells), rash, pyrexia (fever), anorexia. rash, pyrexia (fever), andand anorexia. rash, pyrexia (fever), and anorexia. What other information should you discuss What other information should you discuss What other information should you discuss with your doctor? with your your doctor? doctor? with Women should avoid becoming pregnant or breastWomen should avoid becoming pregnant orbreastbreastWomen should avoid becoming pregnant or feeding while being treated with VELCADE. feeding while being treated with VELCADE. feeding while being treated with VELCADE. Discuss with your doctor when is safe to restart Discuss with your doctor when safe torestart restart Discuss with your doctor when ititisisitsafe to breast-feeding after finishing your treatment. breast-feeding after finishing your treatment. breast-feeding after finishing your treatment. should also your doctor if you: YouYou should also telltell your doctor you: You should also tell your doctor ifif you: ▼ Have ▼ Have kidney disease. If you on dialysis, ▼ Have kidney disease. you areare ondialysis, dialysis, kidney disease. IfIfyou are on your doctor will administer VELCADE after your doctor will administer VELCADE after your doctor will administer VELCADE after the dialysis procedure. the dialysis procedure. the dialysis procedure. ▼ Are ▼ Are taking medication for diabetes. VELCADE ▼ Are taking medication fordiabetes. diabetes. VELCADE taking medication for VELCADE can affect your blood glucose levels. doctor can affect your blood glucose levels. Your doctor can affect your blood glucose levels. YourYour doctor may require close monitoring of your blood may require close monitoring of your blood may require close monitoring of your blood glucose levels change dose of your glucose levels andand change thethe dose ofyour your glucose levels and change the dose of diabetes medicine while you are being treated diabetes medicine while you are being treated diabetes medicine while you are being treated with VELCADE. with VELCADE. with VELCADE. ▼ Have ▼ Have liver disease. ▼ Have liver disease. liver disease. ▼ Are ▼ Are using other medications, including ▼ Are using anyany other medications, including using any other medications, including prescription over-the-counter drugs, prescription andand over-the-counter drugs, prescription and over-the-counter drugs, herbal or dietary supplements, or holistic herbal or dietary dietary supplements, or holistic holistic herbal or supplements, or treatments. St. John’s wort should be avoided. treatments. St. John’s John’s wort should be avoided. avoided. treatments. St. wort should be ▼ ▼ Develop Develop a rash of any type while ▼ Develop rash of any any type while aa rash of type while receiving VELCADE. receiving VELCADE. receiving VELCADE. side effects of VELCADE may impair your TheThe side effects of VELCADE VELCADE may impair your The side effects of may impair your ability to drive or operate machinery. ability to drive or operate machinery. ability to drive or operate machinery. These all of the possible side effects These areare notnot all of of the the possible side effects These are not all possible side effects with VELCADE. It is important to always with VELCADE. It is important to always with VELCADE. It is important to always contact your doctor if you experience side contact your doctor you experience anyany side contact your doctor ifif you experience any side effects while on VELCADE. If you have any effects while on VELCADE. If you have any effects while on VELCADE. If you have any questions about VELCADE, contact your doctor. questions about VELCADE, contact your doctor. questions about VELCADE, contact your doctor. Additional information is available on the Additional information is available on the Additional information is available on the website at VELCADE.com. website at VELCADE.com. VELCADE.com. website at Please accompanying Prescribing Information Please seesee accompanying fullfull Prescribing Information Please see accompanying full Prescribing Information for VELCADE. forVELCADE. VELCADE. for Inside: Benefits of VELCADE® (bortezomib) Retreatment with VELCADE (bortezomib) may offer an additional benefit. Treatment schedules Managing side effects Understand side effects of VELCADE and talk to your healthcare team about managing them. How can VELCADE offer me support? The VELCADE patient support program offers many resources to help you along your journey Services include: ▼ Tips for your journey with VELCADE ▼ A Patient Resource Kit for multiple myeloma ▼ Up-to-date information on VELCADE and multiple myeloma ▼ Access to web-based material weekly for the next 6 months ▼ Invitations to hear from experts and other people like you Visit VELCADE.com to join the patient support program and get easy access to the tips, information, and resources you need. Please see Important Safety Information inside this brochure and accompanying full Prescribing Information for VELCADE. VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners. Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2014, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA V-14-0353 10/14 Please see full Prescribing Information at velcade.com/Files/PDFs/VELCADE_PRESCRIBING_INFORMATION.pdf
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