FOR PATIENTS WITH A CERTAIN TYPE OF BRAF+ ADVANCED MELANOMA

Transcription

1 FOR PATIENTS WITH A CERTAIN TYPE OF BRAF+ ADVANCED MELANOMA My Treatment Diary INDICATION TAFINLAR (dabrafenib) and MEKINIST (trametinib) are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma: That has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and That has a certain type of abnormal BRAF (V600E or V600K mutation-positive) gene. TAFINLAR, in combination with MEKINIST, is not used to treat people with a type of skin cancer called wild-type BRAF melanoma. MEKINIST should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma. Your health care provider will perform a test to make sure that TAFINLAR and MEKINIST, in combination, are right for you. It is not known if TAFINLAR and MEKINIST, in combination, are safe and effective in children. Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages 4-9.

2 IMPORTANT SAFETY INFORMATION TAFINLAR (dabrafenib) and MEKINIST (trametinib) may cause serious side effects, including the risk of new cancers: TAFINLAR, when used in combination with MEKINIST, may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuscc). New melanoma lesions have also occurred. TAFINLAR and MEKINIST in combination may cause new cancers, including basal cell carcinoma. Talk with your health care provider about your risk for these cancers. Check your skin and tell your health care provider right away about any skin changes, including a new wart, skin sore, or reddish bump that bleeds or does not heal, or a change in size or color of a mole. Your health care provider should check your skin before you start treatment, and every 2 months while on treatment, to look for any new skin cancers. Your health care provider should continue to check your skin for 6 months after you stop taking TAFINLAR and MEKINIST. Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages

3 Summary of IMPORTANT INFORMATION What are TAFINLAR (dabrafenib) and MEKINIST (trametinib)? TAFINLAR and MEKINIST are prescription medicines used in combination to treat people with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal BRAF gene. Your health care provider will perform a test to make sure that TAFINLAR and MEKINIST are right for you. TAFINLAR and MEKINIST are not used to treat people with a type of skin cancer called wild-type BRAF melanoma. MEKINIST should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma. It is not known if TAFINLAR and MEKINIST are safe and effective in children. What is the most important information I should know about TAFINLAR and MEKINIST? TAFINLAR and MEKINIST may cause serious side effects, including the risk of new cancers such as a type of skin cancer called cutaneous squamous cell carcinoma, basal cell carcinoma, or new melanoma lesions. Talk to your health care provider about your risk for these cancers. Check your skin and tell your health care provider right away about any skin changes including a new wart, skin sore, or reddish bump that bleeds or does not heal, or a mole that changes size or color. Your health care provider should check your skin before treatment with TAFINLAR and MEKINIST, every 2 months during treatment and for up to 6 months after you stop taking TAFINLAR and MEKINIST to look for any new skin cancers. Your health care provider should also check for cancers that may not occur on the skin. Tell your health care provider about any new symptoms that develop during treatment with TAFINLAR and MEKINIST. What warnings should I know about TAFINLAR and MEKINIST? TAFINLAR and MEKINIST may cause serious side effects, including: Bleeding problems. TAFINLAR and MEKINIST in combination can cause serious bleeding problems, especially in your brain or stomach, and can lead to death. Call your health care provider and get medical help right away if you have any signs of bleeding, including: headaches, dizziness, or feeling weak coughing up blood or blood clots vomiting blood or your vomit looks like coffee grounds red or black stools that look like tar Blood clots. TAFINLAR and MEKINIST in combination can cause blood clots in your arms or legs, which can travel to your lungs and lead to death. Get medical help right away if you have the following symptoms: chest pain sudden shortness of breath or trouble breathing pain in your legs with or without swelling swelling in your arms or legs a cool pale arm or leg Heart problems, including heart failure. Your health care provider should check your heart function before you start taking TAFINLAR and MEKINIST in combination, and during treatment. Call your health care provider right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing shortness of breath swelling of your ankles and feet feeling lightheaded Eye problems. TAFINLAR and MEKINIST, in combination, can cause severe eye problems that can lead to blindness. Call your health care provider right away if you get these symptoms of eye problems: blurred vision, loss of vision, or other vision changes Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages

4 Summary of IMPORTANT INFORMATION (continued) seeing color dots halo (seeing blurred outline around objects) eye pain, swelling, or redness Lung or breathing problems. TAFINLAR (dabrafenib) and MEKINIST (trametinib), in combination, can cause lung or breathing problems. Tell your health care provider if you have any new or worsening symptoms of lung or breathing problems such as shortness of breath or cough. Fever. Fever is common during treatment with TAFINLAR and MEKINIST, but it may also be serious. When taking TAFINLAR and MEKINIST, in combination, fever may happen often or may be severe. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Call your health care provider right away if you get a fever while taking TAFINLAR or MEKINIST. Skin reactions. Rash is a common side effect of TAFINLAR and MEKINIST in combination. In some cases these rashes and other skin reactions can be severe, and may need to be treated in a hospital. Call your health care provider if you get any of the following symptoms: skin rash that bothers you or does not go away acne redness, swelling, peeling, or tenderness of hands or feet skin redness Increased blood sugar (hyperglycemia). Some people may develop high blood sugar or worsening diabetes during treatment with TAFINLAR and MEKINIST in combination. If you are diabetic, your health care provider should check your blood sugar levels closely during treatment with TAFINLAR and MEKINIST. Your diabetes medicine may need to be changed. Tell your health care provider if you have symptoms of severe high blood sugar such as increased thirst, urinating more often than normal, or urinating an increased amount of urine. Glucose-6-phosphate dehydrogenase (G6PD) deficiency. TAFINLAR may cause healthy red blood cells to break down too early in people with G6PD deficiency. This may lead to a type of anemia called hemolytic anemia, where the body does not have enough healthy red blood cells. Tell your health care provider if you have any of the following signs or symptoms: yellow skin (jaundice), weakness or dizziness, or shortness of breath. What should I tell my health care provider before taking TAFINLAR and MEKINIST? Before you take TAFINLAR and MEKINIST, tell your health care provider if you: Have had bleeding problems or blood clots Have heart problems Have eye problems Have lung or breathing problems Have high blood pressure (hypertension) Have liver or kidney problems Have diabetes Have a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme Have any other medical conditions Plan to have surgery, dental, or other medical procedures Are pregnant or plan to become pregnant TAFINLAR and MEKINIST, in combination, may harm your unborn baby. Females who are able to become pregnant should use birth control (contraception) during treatment with TAFINLAR Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages

5 Summary of IMPORTANT INFORMATION (continued) and MEKINIST, in combination, and for 4 months after stopping treatment with TAFINLAR (dabrafenib) and MEKINIST (trametinib). Birth control using hormones (such as birth control pills, injections, or patches) may not work as well while you are taking TAFINLAR and MEKINIST in combination. You should use another effective method of birth control while taking TAFINLAR and MEKINIST in combination. Talk to your health care provider about birth control methods that may be right for you during this time. TAFINLAR and MEKINIST in combination may cause fertility problems in females. This could affect your ability to become pregnant. TAFINLAR may cause lower sperm counts in males. This could affect the ability to father a child. Talk to your health care provider if this is a concern for you. Are breastfeeding or planning to breastfeed It is not known if TAFINLAR or MEKINIST passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of TAFINLAR and MEKINIST. Talk to your health care provider about the best way to feed your baby during this time. Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TAFINLAR and MEKINIST with certain other medicines can affect each other, causing side effects. TAFINLAR and MEKINIST may affect the way other medicines work, and other medicines can affect how TAFINLAR and MEKINIST work. You can ask your pharmacist for a list of medicines that may interact with TAFINLAR and MEKINIST. Know the medicines you take. Keep a list of them to show your health care provider and pharmacist when you get a new medicine. What are other side effects of TAFINLAR and MEKINIST in combination? Other common side effects of TAFINLAR and MEKINIST in combination include: Nausea Chills Diarrhea Vomiting High blood pressure (hypertension) Your health care provider should check your blood pressure during treatment. Call your health care provider right away if you develop high blood pressure, your blood pressure worsens, or you have a severe headache, lightheadedness, or dizziness Swelling of the face, arms, or legs Headache Joint aches Cough General Information about the Safe and Effective Use of TAFINLAR and MEKINIST Do not use TAFINLAR and MEKINIST for a condition for which it was not prescribed. Do not give TAFINLAR and MEKINIST to other people, even if they have the same symptoms that you have. It may harm them. You can ask your health care provider or pharmacist for information about TAFINLAR and MEKINIST that is written for health care professionals. These are not all of the possible side effects of TAFINLAR and MEKINIST. For more information, talk with your health care provider or pharmacist or call The FDA-approved product labeling or prescribing information can be found at You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages

6 THIS DIARY BELONGS TO ONCOLOGIST NAME ADDRESS PHONE NUMBER NURSE NAME PHONE NUMBER Table of Contents My current medications My appointment calendar Questions for my doctor or nurse Tracking my side effects Coping with cancer My journal PRIMARY CARE PROVIDER PHONE NUMBER EMERGENCY CONTACT NAME PHONE NUMBER Remember : Stay on top of your treatment. Keep track of all your upcoming appointments and important notes. SPECIALTY PHARMACY PHONE NUMBER 10 11

7 My current medications Know the medicines you take. It s important for your doctor to be aware of what medicines you are taking. Use the following pages to write down the prescription drugs, nonprescription medicines, vitamins, and herbal supplements you take, and show a list to your health care provider and pharmacist when you get a new medicine. MEDICATION FOR DOSE WHEN I TAKE IT NOTES 12 13

8 My current medications (continued) MEDICATION FOR DOSE WHEN I TAKE IT NOTES 14 15

9 My appointment calendar The following pages can be used to track upcoming doctor appointments, record notes about past visits, and set up reminders to refill prescriptions. Fill in the current month at the top of each page. Attitude is a little thing that makes a big difference. Winston Churchill MONTH SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY NOTES EXAMPLE CALENDAR 16 17

10 My appointment calendar MONTH SUNDAY MONDAY TUESDAY WEDNESDAY Surround yourself with only people who are going to lift you higher. Oprah Winfrey THURSDAY FRIDAY SATURDAY NOTES 18 19

11 My appointment calendar MONTH Enjoy the little things, for one day you may look back and realize they were the big things. Kurt Vonnegut SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY NOTES 20 21

12 My appointment calendar MONTH Spend each day with some laughter and some thought, to get your emotions going. Jim Valvano SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY NOTES 22 23

13 My appointment calendar MONTH SUNDAY MONDAY TUESDAY WEDNESDAY We must embrace pain and burn it as fuel for our journey. Kenji Miyazawa THURSDAY FRIDAY SATURDAY NOTES 24 25

14 My appointment calendar MONTH You never know how strong you are until being strong is the only choice you have. Bob Marley SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY NOTES 26 27

15 My appointment calendar MONTH SUNDAY MONDAY TUESDAY WEDNESDAY Toughness is in the soul and spirit, not in muscles. Alex Karras THURSDAY FRIDAY SATURDAY NOTES 28 29

16 My appointment calendar MONTH When you have exhausted all possibilities, remember this: you haven t. Thomas Edison SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY NOTES 30 31

17 My appointment calendar MONTH SUNDAY MONDAY TUESDAY WEDNESDAY It s hard to beat a person who never gives up. Babe Ruth THURSDAY FRIDAY SATURDAY NOTES 32 33

18 My appointment calendar MONTH SUNDAY MONDAY TUESDAY WEDNESDAY A journey of a thousand miles begins with a single step. Lao Tzu THURSDAY FRIDAY SATURDAY NOTES 34 35

19 My appointment calendar MONTH Hope sees the invisible, feels the intangible, and achieves the impossible. Helen Keller SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY NOTES 36 37

20 My appointment calendar MONTH SUNDAY MONDAY TUESDAY WEDNESDAY Optimism is the foundation of courage. Nicholas Murray Butler THURSDAY FRIDAY SATURDAY NOTES 38 39

21 My appointment calendar MONTH SUNDAY MONDAY TUESDAY WEDNESDAY It s not the years in your life that count. It s the life in your years. Edward J. Stieglitz THURSDAY FRIDAY SATURDAY NOTES 40 41

22 Questions for my doctor or nurse ASK DR ABOUT Record any questions you might have for your health care team, as well as notes from your visit. ASK DR ABOUT ANSWER ANSWER ASK DR ABOUT ANSWER 42 43

23 Questions for my doctor or nurse (continued) ASK DR ABOUT Record any questions you might have for your health care team, as well as notes from your visit. ASK DR ABOUT ANSWER ANSWER ASK DR ABOUT ANSWER 44 45

24 Questions for my doctor or nurse (continued) ASK DR ABOUT Record any questions you might have for your health care team, as well as notes from your visit. ASK DR ABOUT ANSWER ANSWER ASK DR ABOUT ANSWER 46 47

25 Tracking my side effects Record any side effects and the dates you experienced them. SIDE EFFECT SIDE EFFECT MEDICATIONS TAKEN, IF ANY MEDICATIONS TAKEN, IF ANY SIDE EFFECT SIDE EFFECT MEDICATIONS TAKEN, IF ANY MEDICATIONS TAKEN, IF ANY SIDE EFFECT SIDE EFFECT MEDICATIONS TAKEN, IF ANY MEDICATIONS TAKEN, IF ANY 48 49

26 Tracking my side effects (continued) Record any side effects and the dates you experienced them. SIDE EFFECT SIDE EFFECT MEDICATIONS TAKEN, IF ANY MEDICATIONS TAKEN, IF ANY SIDE EFFECT SIDE EFFECT MEDICATIONS TAKEN, IF ANY MEDICATIONS TAKEN, IF ANY SIDE EFFECT SIDE EFFECT MEDICATIONS TAKEN, IF ANY MEDICATIONS TAKEN, IF ANY 50 51

27 Coping with cancer Being diagnosed with and living with melanoma can be difficult but, by making the right choices, you can take an active role in your treatment and live a healthier lifestyle. Here are some tips: Ask for support from family, friends, and others. Reach out to loved ones who are willing to help out, listen, or just keep you company Pay attention to your physical needs for rest, nutrition, and other self-care measures Find ways to express your feelings such as talking, playing an instrument, painting, or writing Give yourself solo time and space when you need it, and don t feel bad about letting others know if you prefer to be alone Walk or exercise. Be sure to talk with your cancer care team about your plans before starting a new exercise program or activity Find out what helped other patients and families cope with cancer, and/or talk with other people diagnosed with the same type of cancer. Ask your health care team to recommend a support group, or look for one online Talk with your doctor about other healthy lifestyle choices you can make You may experience stress or other negative emotions throughout your treatment journey. Here are simple things you can do that may help: Try a breathing technique, like the following one: 1. Lie down in a quiet room. Take a slow, deep breath 2. As you breathe in, tense a muscle or group of muscles. For example, clench your teeth or stiffen your arms or legs 3. Keep your muscles tense for a second or two while holding your breath. Then breathe out, release the tension, and let your body relax completely. Repeat the process with another muscle or muscle group Meditate Practice yoga Try guided imagery, which uses words and sounds to help you imagine positive feelings or experiences, to focus and relax Once you choose hope, anything s possible. Christopher Reeve 52 53

28 Coping with cancer (continued) It is common for people with cancer to experience anxiety, especially when they have an upcoming scan. This is sometimes called scanxiety, and it can interfere with your everyday well-being. Here are some tips for dealing with scanxiety: Schedule tests early in the day, when possible, to reduce waiting time Try the relaxation techniques mentioned on the previous page to help reduce negative thoughts Distract yourself with music or a favorite book, or invite a loved one to accompany you to your appointment Write down your thoughts in this diary. Express how this situation makes you feel and the emotions you are experiencing Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages 4-9. IMPORTANT SAFETY INFORMATION (continued) Your health care provider should also check for cancers that may not occur on the skin. Tell your health care provider about any new symptoms that have developed while taking TAFINLAR (dabrafenib) and MEKINIST (trametinib) in combination. TAFINLAR and MEKINIST in combination may cause serious side effects, including: Bleeding problems. TAFINLAR and MEKINIST in combination can cause serious bleeding problems, especially in your brain or stomach, and can lead to death. Call your health care provider and get medical help right away if you have any signs of bleeding, including: headaches, dizziness, or feeling weak coughing up blood or blood clots vomiting blood or your vomit looks like coffee grounds red or black stools that look like tar Blood clots. TAFINLAR and MEKINIST in combination can cause blood clots in your arms or legs, which can travel to your lungs and lead to death. Get medical help right away if you have the following symptoms: chest pain sudden shortness of breath or trouble breathing pain in your legs with or without swelling swelling in your arms or legs a cool pale arm or leg 54 55

29 IMPORTANT SAFETY INFORMATION (continued) Heart problems, including heart failure. Your health care provider should check your heart function before you start taking TAFINLAR (dabrafenib) and MEKINIST (trametinib) in combination, and during treatment. Call your health care provider right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing shortness of breath swelling of your ankles and feet feeling lightheaded Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages

30 IMPORTANT SAFETY INFORMATION (continued) Eye problems. TAFINLAR (dabrafenib) and MEKINIST (trametinib), in combination, can cause severe eye problems that can lead to blindness. Call your health care provider right away if you get these symptoms of eye problems: blurred vision, loss of vision, or other vision changes seeing color dots halo (seeing blurred outline around objects) eye pain, swelling, or redness Lung or breathing problems. TAFINLAR and MEKINIST, in combination, can cause lung or breathing problems. Tell your health care provider if you have any new or worsening symptoms of lung or breathing problems, including: shortness of breath cough Fever. Fever is common during treatment with TAFINLAR and MEKINIST, but it may also be serious. When taking TAFINLAR and MEKINIST, in combination, fever may happen often or may be severe. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Call your health care provider right away if you get a fever while taking TAFINLAR or MEKINIST. Skin reactions. Rash and other skin reactions are a common side effect of TAFINLAR and MEKINIST in combination. In some cases these rashes and other skin reactions can be severe, and may need to be treated in a hospital. Call your health care provider if you get any of the following symptoms: skin rash that bothers you or does not go away acne redness, swelling, peeling, or tenderness of hands or feet skin redness Increased blood sugar (hyperglycemia). Some people may develop high blood sugar or worsening diabetes during treatment with TAFINLAR and MEKINIST in combination. If you are diabetic, your health care provider should check your blood sugar levels closely during treatment with TAFINLAR and MEKINIST. Your diabetes medicine may need to be changed. Tell your health care provider if you have any of the following symptoms of severe high blood sugar: increased thirst urinating more often than normal, or urinating an increased amount of urine TAFINLAR may cause healthy red blood cells to break down too early in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency. This may lead to a type of anemia called hemolytic anemia, where the body does not have enough healthy red blood cells. Tell your health care provider if you have any of the following signs or symptoms: yellow skin (jaundice) weakness or dizziness shortness of breath TAFINLAR and MEKINIST, in combination, can harm your unborn baby. Females who are able to become pregnant should use birth control (contraception) during treatment with TAFINLAR and MEKINIST in combination, and for 4 months after stopping treatment with TAFINLAR and MEKINIST. Birth control using hormones (such as birth control pills, injections, or patches) may not work as well while you are taking TAFINLAR and MEKINIST in combination. You should use another effective method of birth control while taking TAFINLAR and MEKINIST in combination. Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages

31 IMPORTANT SAFETY INFORMATION (continued) Talk to your health care provider about birth control methods that may be right for you during this time. Tell your health care provider right away if you become pregnant, or think you might be pregnant, during treatment with TAFINLAR (dabrafenib) and MEKINIST (trametinib) in combination. Common side effects of TAFINLAR and MEKINIST when used in combination include: nausea chills diarrhea vomiting high blood pressure (hypertension) swelling of the face, arms, or legs headache joint aches cough New or worsening high blood pressure (hypertension). Your health care provider should check your blood pressure during treatment with MEKINIST. Call your health care provider right away if you develop high blood pressure, your blood pressure worsens or you have severe headache, lightheadedness, or dizziness. Fertility problems. TAFINLAR and MEKINIST, in combination, may cause fertility problems in females. This could affect your ability to become pregnant. Talk to your health care provider if this is a concern for you. Low sperm counts. TAFINLAR may cause lower sperm counts in males. This could affect the ability to father a child. Talk to your health care provider if this is a concern for you. Nursing mothers. It is not known if TAFINLAR and/or MEKINIST pass into your breast milk. Do not breastfeed during treatment, and for 4 months after your last dose of TAFINLAR and MEKINIST. Talk to your health care provider about the best way to feed your baby during this time. These are not all of the possible side effects of TAFINLAR and MEKINIST. For more information about side effects, ask your health care provider or pharmacist. Before you take TAFINLAR and MEKINIST in combination, tell your health care provider if you: have had bleeding problems or blood clots have heart problems have eye problems have lung or breathing problems have high blood pressure (hypertension) have liver or kidney problems have diabetes plan to have surgery, dental, or other medical procedures have a deficiency of the G6PD enzyme have any other medical conditions are pregnant or plan to become pregnant are breastfeeding or plan to breastfeed Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages

32 My journal 62 63

33 My journal 64 65

34 My journal 66 67

35 My journal 68 69

36 My journal 70 71

37 IMPORTANT SAFETY INFORMATION (continued) Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TAFINLAR (dabrafenib) and MEKINIST (trametinib) with certain other medicines can affect each other, causing side effects. TAFINLAR and MEKINIST may affect the way other medicines work, and other medicines can affect how TAFINLAR and MEKINIST work. You can ask your pharmacist for a list of medicines that may interact with TAFINLAR and MEKINIST. Know the medicines you take. Keep a list of them to show your health care provider and pharmacist when you get a new medicine. Please read the Medication Guide for TAFINLAR and the Patient Information for MEKINIST, and discuss any questions you have with your health care provider. Call your doctor for medical advice about side effects. You may report side effects to the FDA at FDA You may also report side effects to Novartis at Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages

38 Back Novartis Pharmaceuticals Corporation East Hanover, New Jersey Novartis 7/16 MAF