treatment calendar Hilde D. EMPLICITI patient Looking forward to what s ahead
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1 treatment calendar Hilde. MPLICITI patient Looking forward to what s ahead
2 The story behind the selfie: Hilde Hilde. MPLICITI patient njoying custard at our favorite shop My family is really important to me. I married Bill seven years ago and we have eight grandkids from previous marriages. We always wanted to feel like one big family, so we call the grandkids the middles and the bookends the bookends are the youngest, and the oldest. I love taking these two middles down the street to the custard shop. I really don t think I could be as happy and content as I am now without them. 2
3 Hilde. MPLICITI patient How can a treatment calendar help me and my healthcare team? Filling out a treatment calendar along with your healthcare team may help you keep track of the medicine you re taking each. MPLICITI is a prescription medicine used to treat multiple myeloma in adults in combination with other medications, VLIMI (lenalidomide) and dexamethasone, in patients who have received 1 to 3 prior multiple myeloma treatments. The information in this treatment calendar should not replace talking to your healthcare team. If you have questions about your treatment, be sure to talk with your doctor or nurse. What should I discuss with my healthcare team before starting MPLICITI? Talk to your healthcare team about all of your medical conditions, including if you have an infection. Let your healthcare team know as soon as possible if you are a woman who is pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if MPLICITI can harm an unborn baby. However, VLIMI may cause birth defects or death of an unborn baby. It is not known if MPLICITI passes into breastmilk. You should not breastfeed during treatment with MPLICITI with VLIMI and dexamethasone. Please read more Important Facts about MPLICITI on pages Unless otherwise indicated as an MPLICITI patient, individuals depicted are models used for illustrative purposes only. 3
4 The story behind the selfie: ick ick N. MPLICITI patient eady for our nature walk through the woods When we ve got two grandbabies, three godchildren, and they re all young and full of energy, they keep us going. My motivation is seeing their pretty faces in the morning. That s a blessing. 4
5 ick N. MPLICITI patient What do I need to know about my treatment schedule? Your MPLICITI treatment schedule is divided into cycles that are 28 s (4 weeks) long. What is a cycle? A cycle is a set number of s that you are taking your treatments, and also includes the s during your rest period. What is a rest period? A rest period is the number of s in your treatment cycle that you will not be taking any MPLICITI, VLIMI (lenalidomide), or dexamethasone. est periods are usually at the end of each treatment cycle. What are the serious side effects of MPLICITI? Infusion reactions can happen during your MPLICITI infusion or within 24 hours after your infusion. Symptoms of an infusion reaction may include: fever chills rash trouble breathing dizziness light-headedness Before every MPLICITI infusion, your healthcare team will give you medications to help reduce the risk of infusion reactions. If you have an infusion reaction while receiving MPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely. Call your healthcare provider or get medical help right away if you have any of the above symptoms after your infusion with MPLICITI. Please read more Important Facts about MPLICITI, including serious side effects, on pages
6 ick N. MPLICITI patient How often will I receive MPLICITI and how long will the infusion take? MPLICITI is usually given one time every week for cycles 1 and 2 (28- cycles), and one time every 2 weeks for cycles 3 and up (28- cycles). VLIMI (lenalidomide) and dexamethasone are also given during these cycles as part of the treatment. Before each infusion, your healthcare provider will give you medicines to help reduce the risk of an infusion reaction. The length of each MPLICITI infusion will depend on your body weight and how many times you have received MPLICITI in the past. After the first two times, all other MPLICITI infusions will take about an hour* * Based on a weight of 165 pounds. If infusion reactions occur or become worse, it may take more time to receive your MPLICITI infusion. When should I be taking my treatments? The tables below can help you see which s you should be taking your treatments and which s you should be resting. CYCLS 1 & 2 (28 AYS ACH) CYCLS 3 & UP (28 AYS ACH) MPLICITI VLIMI OAL XAMTHASON AY 1 AY 1 AY 8 AY 8 AYS 1-21 AY 15 AY 15 AY 22 AY 22 AYS ST PIO MPLICITI VLIMI OAL XAMTHASON AY 1 AY 1 AY 8 AYS 1-21 AY 15 AY 15 AY 22 AYS ST PIO What are the serious side effects of MPLICITI? (cont d) Infections may develop in patients who receive MPLICITI with VLIMI and dexamethasone, and can be serious. Symptoms of an infection may include: fever flu-like symptoms cough shortness of breath burning with urination painful skin rash Call a healthcare provider right away if you have any of the signs and symptoms of an infection. Please read more Important Facts about MPLICITI, including serious side effects, on pages
7 Phillip G. When should I take my oral dexamethasone dose? On s that you are receiving MPLICITI, take your dexamethasone dose by mouth, exactly as prescribed, between 3 and 24 hours before your MPLICITI infusion treatment. On s that you are not receiving MPLICITI, take your dexamethasone dose by mouth, exactly as prescribed, according to your treatment schedule. Keep in mind the dose of oral dexamethasone may vary based on whether MPLICITI is given that. How do I know if MPLICITI is working? Immunotherapy is different from traditional chemotherapies because it works with your immune system. Your healthcare team can determine how your body is responding to MPLICITI in several ways for example, they may check the amount of M proteins in your blood, or for a change in size or number of bone lesions. Your healthcare team will monitor you closely to make sure you are responding to treatment. What are the serious side effects of MPLICITI? (cont d) eveloping new cancers (malignancies) is a risk in patients who receive MPLICITI with VLIMI (lenalidomide) and dexamethasone. Your healthcare provider will check you for new cancers during your treatment with MPLICITI. Talk to your healthcare team to learn more about your risk of developing new cancers if you receive MPLICITI with VLIMI and dexamethasone. Please read more Important Facts about MPLICITI, including serious side effects, on pages
8 Phillip G. How do I fill in my treatment calendar? Your healthcare team can work with you to fill in your personalized treatment calendar. Here s an example: MONTH Write the month(s) here. ATS AN AYS Fill in the s and numbers (1-28) of your treatment cycle with MPLICITI. month June on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur TATMNTS Check the boxes of the treatments you ll be taking each. Feel free to write other information, like your doses and appointment times. pm appt mg mg ST PIO Be sure to include your rest period on your treatment calendar. A rest period is the number of s within each treatment cycle that you will not be taking any MPLICITI, VLIMI (lenalidomide), or dexamethasone. Please read Important Facts about MPLICITI on pages
9 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
10 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
11 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
12 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
13 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
14 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
15 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
16 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
17 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
18 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
19 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
20 month on t forget to take your dexamethasone dose by mouth, 3-24 hours before your MPLICITI (elotuzumab) treatments! = MPLICITI = VLIMI (lenalidomide) = dexamethasone Sun Mon Tues Wednes Thurs Fri Satur Please read Important Facts about MPLICITI on pages
21 Important Facts About MPLICITI This is a summary of important information that you need to know about MPLICITI. Your healthcare team can work with you to help answer any questions you may have about MPLICITI. Keep this information in a safe place, so you can refer to it before and during your treatment. Look out for these icons as you read: Talk to your healthcare team Call a healthcare provider right away Helpful information to remember What is MPLICITI? MPLICITI is a prescription medicine used to treat multiple myeloma in combination with other medications: MPLICITI (elotuzumab) VLIMI + + (lenalidomide) emember to read the safety information for the other medications you are receiving. What are the possible side effects of MPLICITI? dexamethasone MPLICITI is for patients who have received one to three prior treatments for their multiple myeloma. MPLICITI is for adults. The safety and effectiveness of MPLICITI has not been studied in children. MPLICITI may cause side effects, some of which can be serious. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with MPLICITI. Serious side effects Infusion reactions can happen during your MPLICITI infusion or within 24 hours after your infusion. Symptoms of an infusion reaction may include: fever chills rash trouble breathing dizziness light-headedness Before every MPLICITI infusion, your healthcare team will give you medications to help reduce the risk of infusion reactions. If you have an infusion reaction while receiving MPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely. Call your healthcare provider or get medical help right away if you have any of the above symptoms after your infusion with MPLICITI. Continued on next page. 21
22 Serious side effects (cont d) Infections may develop in patients who receive MPLICITI with VLIMI (lenalidomide) and dexamethasone, and can be serious. Symptoms of an infection may include: fever flu-like symptoms cough shortness of breath burning with urination painful skin rash Call a healthcare provider right away if you have any of the signs and symptoms of an infection. eveloping new cancers (malignancies) is a risk in patients who receive MPLICITI with VLIMI and dexamethasone. Your healthcare provider will check you for new cancers during your treatment with MPLICITI. Talk to your healthcare team to learn more about your risk of developing new cancers if you receive MPLICITI with VLIMI and dexamethasone. Liver problems may occur in patients who receive MPLICITI. Symptoms of liver problems include: tiredness weakness loss of appetite yellowing of your skin or eyes color changes in your stools confusion swelling of the stomach area Your healthcare provider will do blood tests to check your liver function during your treatment with MPLICITI. Talk to your healthcare team if you have any of the signs and symptoms of liver problems. The most common side effects fatigue diarrhea fever constipation cough numbness, weakness, tingling, or burning pain in your arms or legs sore throat or runny nose upper respiratory tract infection decreased appetite pneumonia These are not all of the possible side effects of MPLICITI. Call your doctor for medical advice about side effects. You can report any side effects you experience to the FA by calling FA Continued on next page. 22
23 What should I discuss with my healthcare team before starting MPLICITI? Talk to your healthcare team about all of your medical conditions, including if you have an infection. Let your healthcare team know as soon as possible if you are a woman who is pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if MPLICITI can harm an unborn baby. However, VLIMI (lenalidomide) may cause birth defects or death of an unborn baby. It is not known if MPLICITI passes into breastmilk. You should not breastfeed during treatment with MPLICITI with VLIMI and dexamethasone. Before receiving MPLICITI with VLIMI and dexamethasone females and males must agree to the instructions in the VLIMI MS program. The VLIMI MS program has specific requirements about birth control (contraception), pregnancy testing, blood donation, and sperm donation that you need to know. Talk to your healthcare team to learn more about VLIMI. Interactions with other drugs may affect the way MPLICITI works in your body. Talk to your healthcare team about all of the medicines you are taking before starting MPLICITI, including: prescription medicines over-the-counter medicines vitamins herbal supplements Please click here to read the Patient Information in the Full Prescribing Information. 23
24 NOTS/AITIONAL TATMNTS:
25 For those: Considering MPLICITI Prescribed MPLICITI Caring for a loved one This complimentary program provides ongoing support and resources, including: Patient Stories There is a story behind every patient. Watch videos and hear stories from real MPLICITI patients and their loved ones. Helpful Materials eceive useful information throughout treatment, including guides to help you learn more about MPLICITI and the questions to ask your doctor. Other Patient esources Find organizations that may be helpful if you face challenges during treatment. Personalized Care Counselor Support If you are prescribed MPLICITI and sign up for this additional resource, you ll be able to speak with a registered nurse who can respond to questions about MPLICITI and help you keep an active role in treatment decisions. Care Counselors cannot offer medical advice. Your healthcare professional is the best source of information about your health. Ask your doctor about MPLICITI If you want to sign up for MPLICITI with You or if you have general questions about MPLICITI Call MPLICITI ( ) or Visit mpliciti.com MPLICITI and the related logo are trademarks of Bristol-Myers Squibb Company. VLIMI and VLIMI MS are registered trademarks of Celgene Corporation Bristol-Myers Squibb Company. All rights reserved. 689US /17
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