A TREATMENT GUIDE FOR YOU

Transcription

1 FOR PATIENTS AND CAREGIVERS A TREATMENT GUIDE FOR YOU What is BRAFTOVI + MEKTOVI? BRAFTOVI and MEKTOVI are prescription medicines used together 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 BRAFTOVI should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you. It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

2 2 BRAFTOVI + MEKTOVI A NEW TREATMENT OPTION Today, there s a new targeted oral combination therapy called BRAFTOVI (pronounced braf-toe-vee) + MEKTOVI (pronounced mek-toe-vee) designed for appropriate patients with metastatic melanoma who have a BRAF mutation. This treatment guide contains information to help you and your caregiver. There is even a glossary of terms on pages 20 and 21 to help you understand medical words you may not know. Keep this booklet handy. You may want to refer to it during your treatment. If you have questions about treatment with BRAFTOVI + MEKTOVI, be sure to ask your healthcare provider. For additional information, please visit Tovi2.com. Remember, this booklet is being provided for your information only and does not replace the medical advice of your healthcare provider. BE SURE TO CONSULT YOUR HEALTHCARE PROVIDER REGARDING ANY QUESTIONS OR CONCERNS YOU MAY HAVE ABOUT YOUR SPECIFIC MEDICAL CONDITION OR TREATMENT PLAN. Images in this brochure do not depict actual patients or healthcare providers. 3

3 4 TABLE OF CONTENTS Understanding metastatic melanoma with a BRAF mutation... 6 Why your doctor prescribed this treatment...7 Before starting your treatment... 9 How to take BRAFTOVI + MEKTOVI Potential side effects Indication and Important Safety Information Questions to ask your healthcare provider Glossary of terms Learn more about metastatic melanoma...22 About Array BioPharma

4 6 UNDERSTANDING METASTATIC MELANOMA WITH A BRAF MUTATION WHY YOUR DOCTOR PRESCRIBED THIS TREATMENT 7 What is metastatic melanoma with a BRAF mutation? Your type of melanoma is an advanced melanoma with a BRAF mutation because it s caused by a specific change, or mutation, in your BRAF gene. If it is called metastatic melanoma with a BRAF mutation, this means it has spread to other parts of the body. If it is called unresectable melanoma with a BRAF mutation, this means the cancer cannot be removed with surgery. How common is this type of melanoma? Approximately half of all people with metastatic melanoma test positive for a mutation, or abnormality, in their BRAF gene. How does the BRAF mutation affect melanoma? Melanoma cells that have the BRAF mutation cause the cells to grow out of control. About 50% test positive for BRAF-mutation melanoma Mutated BRAF gene Out-of-control growth of melanoma cells The good news is that now, PATIENTS WHO HAVE METASTATIC MELANOMA WITH A BRAF MUTATION HAVE A NEW TARGETED ORAL COMBINATION THERAPY BRAFTOVI + MEKTOVI. To learn more, visit Tovi2.com. What is BRAFTOVI + MEKTOVI? BRAFTOVI + MEKTOVI is not chemotherapy or immunotherapy. BRAFTOVI and MEKTOVI are prescription medicines that are used in combination to treat people with a type of skin cancer called metastatic melanoma. This melanoma has spread to other parts of the body or cannot be removed by surgery. It also has a certain type of abnormality called a mutation in a gene called BRAF. BRAFTOVI should not be used to treat melanoma with a normal BRAF gene. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you. It is not known if BRAFTOVI or MEKTOVI is safe and effective in children. It s important that the two medicines be taken exactly as prescribed by your doctor. BRAFTOVI AND MEKTOVI ARE TWO TARGETED ORAL THERAPIES THAT ARE DESIGNED TO BE TAKEN TOGETHER TO HELP FIGHT YOUR METASTATIC MELANOMA WITH A BRAF MUTATION. How is this targeted oral combination therapy thought to work? BRAFTOVI and MEKTOVI work together to help block signals that can cause melanoma cells to grow out of control. What is the most important information I should know about BRAFTOVI? BRAFTOVI may cause serious side effects, including: Risk of new skin cancers. BRAFTOVI, when used alone or with MEKTOVI, may cause skin cancers called cutaneous squamous cell carcinoma or basal cell carcinoma Talk to your healthcare provider about your risk for these cancers Check your skin and tell your healthcare provider right away about any skin changes, including a new wart, skin sore or reddish bump that bleeds or does not heal, or change in size or color of a mole Your healthcare provider should check your skin before and during treatment, and for up to 6 months after you stop treatment to look for any new skin cancers Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment

5 8 BEFORE STARTING YOUR TREATMENT What to tell your healthcare provider before starting BRAFTOVI + MEKTOVI It s important to share information about yourself and your medical history with your healthcare provider and discuss possible limitations you may have when taking this treatment for metastatic melanoma with a BRAF mutation. Be sure to let your healthcare provider know if you: have had bleeding problems have had blood clots have eye problems have lung or breathing problems have heart problems, including a condition called long QT syndrome have any muscle problems have been told that you have low blood levels of potassium, calcium, or magnesium are pregnant or plan to become pregnant. BRAFTOVI + MEKTOVI can harm your unborn baby have liver or kidney problems are breastfeeding or plan to breastfeed have high blood pressure (hypertension) Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines can affect how other medicines work and may cause side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider can let you know if there are any medicines you should avoid at this time. To learn more, visit Tovi2.com. 9

6 10 HOW TO TAKE BRAFTOVI + MEKTOVI 11 Starting daily dose taken with or without food and no refrigeration required: 1st Dose morning Three (15-mg) MEKTOVI tablets About 12 hours after the first dose 2nd Dose evening Three (15-mg) MEKTOVI tablets If you miss a dose of BRAFTOVI: Take it as soon as you remember. But if it is within 12 hours of your next scheduled dose, just take your next dose at your regular time. Do not make up for the missed dose. Do not take an extra dose if you vomit after taking your scheduled dose. Take your next dose at your regular time. If you miss a dose of MEKTOVI: Take it as soon as you remember. But if it is within 6 hours of your next scheduled dose, just take your next dose at your regular time. Do not make up for the missed dose. Do not take an extra dose if you vomit after taking your scheduled dose. Take your next dose at your regular time. Once Daily Six (75-mg) BRAFTOVI capsules Take BRAFTOVI at the same time each day with either the morning dose or evening dose of MEKTOVI Do not stop taking either medication without first talking to your healthcare provider. Please note the starting dose may be lower or changed during treatment for some patients based on direction by your healthcare provider. Please read the BRAFTOVI Medication Guide and MEKTOVI Patient Information. THINGS TO REMEMBER WHEN TAKING BRAFTOVI + MEKTOVI Take BRAFTOVI + MEKTOVI exactly as your healthcare provider tells you. Don t change your dose unless your healthcare provider tells you to. To learn more, visit Tovi2.com. Avoid grapefruit during treatment with BRAFTOVI. Grapefruit products may increase the amount of BRAFTOVI in your body.

7 12 POTENTIAL SIDE EFFECTS The most common side effects of BRAFTOVI in combination with MEKTOVI include: BRAFTOVI: Fatigue, nausea, vomiting, pain or swelling of your joints, abdominal pain MEKTOVI: Fatigue, nausea, diarrhea, vomiting, abdominal pain BRAFTOVI may cause serious side effects, including: Risk of new skin cancers, bleeding problems, eye problems, changes in the electrical activity of your heart called QT prolongation MEKTOVI may cause serious side effects, including: Heart problems including heart failure, blood clots, eye problems, lung or breathing problems, liver problems, muscle problems (rhabdomyolysis), bleeding problems These are not all the possible side effects of BRAFTOVI and MEKTOVI. For more information, ask your healthcare provider. You may report side effects to the FDA at FDA-1088 or Array BioPharma Inc. at Stay on top of any side effects you may experience. BE SURE TO TELL YOUR HEALTHCARE PROVIDER IF YOU EXPERIENCE ANY SIDE EFFECT(S). Healthcare provider: Phone number: Please see Important Safety Information on pages 14 to 17. Please see both accompanying full BRAFTOVI Prescribing Information, including Medication Guide, and full MEKTOVI Prescribing Information, including Patient Information, for additional information. 13

8 14 INDICATION AND IMPORTANT SAFETY INFORMATION 15 What is BRAFTOVI + MEKTOVI? BRAFTOVI and MEKTOVI are prescription medicines used together 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 BRAFTOVI should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you. It is not known if BRAFTOVI or MEKTOVI is safe and effective in children. IMPORTANT SAFETY INFORMATION What is the most important information I should know about BRAFTOVI? BRAFTOVI may cause serious side effects, including: Risk of new skin cancers. BRAFTOVI, when used alone or with MEKTOVI, may cause skin cancers called cutaneous squamous cell carcinoma or basal cell carcinoma Talk to your healthcare provider about your risk for these cancers Check your skin and tell your healthcare provider right away about any skin changes, including a new wart, skin sore or reddish bump that bleeds or does not heal, or change in size or color of a mole Your healthcare provider should check your skin before and during treatment, and for up to 6 months after you stop treatment to look for any new skin cancers Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment Bleeding problems. BRAFTOVI, when taken with MEKTOVI, can cause serious bleeding problems, including in your stomach or brain, that can lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, including: headaches, dizziness, or feeling weak; cough up blood or blood clots; vomit blood or your vomit looks like coffee grounds ; red or black stools that look like tar Eye problems. Tell your healthcare provider right away if you develop any of these symptoms of eye problems: blurred vision, loss of vision, or other vision changes; see colored dots; see halos (blurred outline around objects); eye pain, swelling, or redness Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider should do tests before you start and during your treatment to check your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or if you feel your heart beating irregularly or fast MEKTOVI may cause serious side effects, including: Heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment. Call your healthcare 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 light-headed Blood clots. MEKTOVI can cause blood clots in your arms or legs, which can travel to your lungs and can 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 and legs; a cool, pale arm or leg Eye problems. MEKTOVI can cause serious eye problems that might lead to blindness. Call your healthcare provider right away if you develop any of these symptoms of eye problems: blurred vision, loss of vision, or other vision changes; see colored dots; see halos (blurred outline around objects); eye pain, swelling, or redness Lung or breathing problems. MEKTOVI can cause lung or breathing problems. Tell your healthcare provider if you have any new or worsening symptoms of lung or breathing problems, including: shortness of breath; cough Liver problems. Your healthcare provider should perform blood tests to check your liver function before and during treatment. Tell your healthcare provider if you have any of the following signs and symptoms of a liver problem: yellowing of your skin or the white part of your eyes (jaundice); dark or brown (tea-colored) urine; nausea or vomiting; loss of appetite Muscle problems (rhabdomyolysis). MEKTOVI can cause muscle problems that can be severe. Your healthcare provider should perform a blood test to check your levels of an enzyme in your blood called creatine phosphokinase (CPK) before and during treatment. Tell your healthcare provider right away if you develop any of these symptoms: weakness; muscle aches or pain; dark, reddish urine Bleeding problems. MEKTOVI, when taken with BRAFTOVI, can cause serious bleeding problems, including in your brain or stomach, that can lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, including: headaches, dizziness, or feeling weak; cough up blood or blood clots; vomit blood or your vomit looks like coffee grounds ; red or black stools that look like tar Continued on next page Please see both accompanying full BRAFTOVI Prescribing Information, including Medication Guide, and full MEKTOVI Prescribing Information, including Patient Information, for additional information.

9 16 INDICATION AND IMPORTANT 17 SAFETY INFORMATION (continued) The most common side effects of BRAFTOVI and MEKTOVI when taken in combination: fatigue, nausea, diarrhea, vomiting, pain or swelling of your joints, abdominal pain BRAFTOVI may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you. These are not all the possible side effects of BRAFTOVI and MEKTOVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA You may also report side effects to Array BioPharma Inc. at Before taking BRAFTOVI + MEKTOVI, tell your healthcare provider about all of your medical conditions, including if you: have had bleeding problems have eye problems have heart problems, including a condition called long QT syndrome have been told that you have low blood levels of potassium, calcium, or magnesium have liver or kidney problems To learn more, visit Tovi2.com. have had blood clots have lung or breathing problems have any muscle problems have high blood pressure (hypertension) Please see both accompanying full BRAFTOVI Prescribing Information, including Medication Guide, and full MEKTOVI Prescribing Information, including Patient Information, for additional information. are pregnant or plan to become pregnant. BRAFTOVI + MEKTOVI can harm your unborn baby. Females who are able to become pregnant should use effective nonhormonal birth control (contraception) during treatment and for at least 30 days after the final dose. Birth control methods that contain hormones (such as birth control pills, injections, or transdermal systems) may not work as well during treatment with BRAFTOVI Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with BRAFTOVI + MEKTOVI are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRAFTOVI and certain other medicines can affect each other, causing side effects or affecting how BRAFTOVI or other medicines work. You should also avoid grapefruit products during treatment with BRAFTOVI.

10 18 QUESTIONS TO ASK YOUR HEALTHCARE PROVIDER 19 When you meet with your healthcare provider, it s important that you discuss any concerns or questions you may have about your disease and your treatment for it. To help you start the conversation, here are some questions for you to consider asking. If you have additional questions or perhaps topics you would like to know more about, it s a good idea to write them down and add them to this list whenever you think of any. Bring these pages with you to your next appointment. Remember to jot down the answers you receive, so you can refer to them later. WHAT STAGE OF MELANOMA DO I HAVE? WHAT CAN I DO TO HELP MANAGE SIDE EFFECTS? AM I GOING TO LOSE MY HAIR? HAS MY MELANOMA SPREAD TO OTHER PARTS OF MY BODY? WHAT SHOULD MY FAMILY KNOW ABOUT MY TAKING BRAFTOVI + MEKTOVI? HOW LONG DO I NEED TO TAKE BRAFTOVI + MEKTOVI? SHOULD I STILL GO FOR SKIN EXAMS? HOW OFTEN? ARE THERE ANY SYMPTOMS OR SIDE EFFECTS I SHOULD TELL YOU ABOUT RIGHT AWAY? WILL I NEED TO CHANGE MY DOSE OF BRAFTOVI OR MEKTOVI DURING TREATMENT?

11 20 GLOSSARY OF TERMS 21 Advanced melanoma (mel-uh-no-muh) When melanoma moves from where it started to other parts of the body, it is referred to as advanced. This is also called cancer that is stage 3 or 4. If the melanoma has spread to parts of the body that are farther away from the original site, it is referred to as metastatic, or stage 4 disease. BRAF gene (BEE-raf jeen) Normally, the BRAF gene helps send signals within a cell. When the BRAF gene has a mutation, the signaling can change. BRAFTOVI and MEKTOVI work together to block signals that cause your melanoma cells to grow out of control. Chemotherapy (key-mo-ther-uh-pee) Also called chemo, chemotherapy is a form of treatment that is given a number of ways, including with an intravenous injection (IV), or taken in a pill. It is given by itself or with radiation or surgery. Chemotherapy attacks any quickly dividing cell in the body--normal or cancerous. Chemotherapy is often given to patients whose cancer has spread or has come back, or when there s a strong chance that it might return. Immunotherapy (im-yuh-no-ther-uh-pee) Cancer treatment that uses the body s own immune system to fight cancer is called immunotherapy. With immunotherapy, a cancer patient is given a treatment that boosts his or her own immune system. Metastatic (meh-tuh-stat-ick) Cancer cells that have spread beyond the original site, also called the primary site, are called metastatic. Cancer cells will often spread in the bloodstream or the lymph system. Cancer that has spread close to the primary site is called regional or local metastasis. A distant metastasis is farther way, such as when melanoma spreads to the brain. Mutation (mew-tay-shun) All cancer is caused when a single cell in a person s body changes, or mutates, in a harmful way. That cell then multiplies, creating new cancer-causing cells. Some mutations are genetic, meaning they are passed on from parent to child. Others, like BRAF-mutation melanoma, are not genetic and happen after birth. Radiation therapy (RAY-dee-AY-shun) Radiation therapy can be used to destroy cancer cells and shrink tumors. The source of the radiation can come from a machine outside the body or from radioactive material put into the body close to the cancer cells. The radiation used in radiation therapy to treat cancer is the same kind of radiation that is used in X-rays but at a much stronger dose. Targeted therapy (TAR-get-ed) The goal of targeted therapy is to focus on very specific cancer cells in the body. Chemotherapy is different. It attacks both normal and cancer cells in the body that multiply quickly, whether or not they have cancer. To learn more, visit Tovi2.com.

12 22 LEARN MORE ABOUT 23 ABOUT METASTATIC MELANOMA ARRAY BIOPHARMA As you proceed with treatment, it is important to remember that you are not alone. Here are a few of the organizations where you can find useful information and support. AIM at Melanoma aimatmelanoma.org Family Reach familyreach.org Melanoma International Foundation melanomainternational.org Melanoma Research Alliance curemelanoma.org Founded on science, focused on patients. Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development, and delivery of targeted small-molecule cancer drugs, including BRAFTOVI + MEKTOVI. Founded in 1998 and headquartered in Boulder, Colorado, Array BioPharma has a portfolio of oncology molecules in various stages of development. For over 20 years, Array BioPharma has been fully dedicated to improving the lives of those living with cancer. And this is just the beginning. To learn more, visit arraybiopharma.com. Melanoma Research Foundation melanoma.org National Cancer Institute cancer.gov/types/skin National Comprehensive Cancer Network (NCCN) nccn.org/patients/guidelines/melanoma Society for Melanoma Research societymelanomaresearch.org Array BioPharma does not control or endorse third-party organizations. The information provided by Array BioPharma or these organizations is meant for informational purposes only. It is not meant to replace your doctor s medical advice.

13 ARRAY IS COMMITTED TO HELPING FIND ASSISTANCE OPTIONS FOR YOUR TREATMENT COMMERCIALLY INSURED PATIENTS For eligible patients with questions about commercial, private, $ 0 Co-pay or employer insurance, contact ArrayACTS Array Co-Pay Savings Program Commercially insured patients may be eligible for a $0 co-pay for a month s supply of BRAFTOVI + MEKTOVI. Full terms and conditions apply* GOVERNMENT-INSURED PATIENTS For patients with commercial or government insurance like Medicare, Medicare Part D, and Medicaid, ArrayACTS may be able to help connect you with resources Independent Co-Pay Assistance Foundations ArrayACTS can provide you with a referral to independent co-pay assistance foundations, if you re eligible UNDER- AND UNINSURED PATIENTS For patients who do not have health insurance or who have health insurance but cannot afford their Array medicines Patient Assistance Program If you don t have insurance or prescription drug coverage and cannot afford to pay for BRAFTOVI + MEKTOVI, Array may be able to help if you qualify. Call ArrayACTS at ARRAYCS ( ) for more information For more information about Array patient assistance options, TALK TO YOUR DOCTOR OR CALL ArrayACTS AT ARRAYCS ( ). * To qualify for the Array Co-Pay Savings Program, you must have commercial insurance, like a plan you have through your employer. If you have Medicare, Medicaid, or other public insurance, you are not eligible for this program. You must also meet other criteria. Please see the full terms and conditions for this program. Independent co-pay assistance foundations have their own rules for eligibility. We cannot guarantee a foundation will help you. We can only refer you to a foundation that supports your disease state. We do not endorse or show financial preference for any particular foundation. The foundations we refer you to are not the only ones that might be able to help you. If you have health insurance, you must have already tried other types of patient assistance to qualify for the Patient Assistance Program. This includes the Array Co-Pay Savings Program and support from independent copay assistance foundations. You must also meet specific financial criteria. full BRAFTOVI Prescribing Information, including Medication Guide, and full MEKTOVI Prescribing Information, including Patient Information, for additional information. Discuss any questions you have with your healthcare provider. You are encouraged to report side effects to the FDA at FDA-1088 or Array BioPharma Inc. at MEKTOVI is a registered trademark of Array BioPharma Inc. in the United States and various other countries. BRAFTOVI is a trademark of Array BioPharma Inc Array BioPharma Inc. All rights reserved. Printed in the U.S.A. PM-US-BIN+ENC /18 v1