On the Road to Risk Reduction With NERLYNX

Transcription

1 On the Road to Risk Reduction With NERLYNX * *34% reduction in the risk of recurrence. Recurrence is defined as an invasive disease event or death. INDICATIONS AND USAGE NERLYNX is a prescription medicine used to treat adults who have early-stage breast cancer, which: is HER2-positive and has previously been treated with the medicine trastuzumab. It is not known if NERLYNX is safe and effective in children. Please see additional IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information.

2 With NERLYNX, you know you re doing everything you can to reduce the risk of your HER2+ breast cancer returning. NERLYNX is a once-daily oral medicine for women who have just finished trastuzumab therapy (i.e., Herceptin ) for early-stage breast cancer. NERLYNX works inside the cell to block the pathways that drive HER2+ breast cancer. NERLYNX is FDA approved. Now you and your doctor have decided that NERLYNX is right for you. Select IMPORTANT SAFETY INFORMATION Gain access to free tips and medication reminders on NERLYNX. What is the most important information I should know about NERLYNX (ner links)? Text LYNX to 90803* NERLYNX (neratinib) may cause serious side effects, including: Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. You may lose too much body salts and fluids, and get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 months (56 days) of NERLYNX and then as needed. Learn more on page 12. *At no cost with an unlimited texting plan; otherwise, message & data rates may apply. Message frequency determined by user. Text HELP to for help. Text STOP to to cancel. For terms: carespeak.com/terms. For privacy: carespeak.com/privacy. Please see additional IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 2

3 In one clinical study, more than 1,400 women showed a 34% reduction in the risk of their cancer returning* by taking NERLYNX compared to taking a placebo.1 NERLYNX was also evaluated in an exploratory analysis at five years, which showed similar results.2 *Recurrence (cancer returning) is defined as an invasive disease event or death. Getting Started With NERLYNX NERLYNX is the next step in your treatment after infusion therapy, and it works to help reduce the risk of your cancer returning. So by committing to NERLYNX, you commit to that next step in treating your HER2+ breast cancer. Consider this brochure your 1-year map to treatment with NERLYNX. With it, you ll learn what NERLYNX is, how it works and ways to help you stay on the road to risk reduction. Select IMPORTANT SAFETY INFORMATION To help prevent or reduce diarrhea: - Tell your healthcare provider if you have more than 2 bowel movements in 1 day, or you have diarrhea that does not go away. - Call your healthcare provider right away, as instructed, if you have severe diarrhea or if you have diarrhea along with weakness, dizziness, or fever. Your healthcare provider may change your dose of NERLYNX, temporarily stop or completely stop NERLYNX if needed to manage your diarrhea. Please see additional IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 3

4 NERLYNX: A Different Kind of Treatment NERLYNX is an extended adjuvant oral therapy, meaning it s designed to be taken after you have completed your adjuvant trastuzumab-based therapy (i.e., Herceptin ). NERLYNX isn t chemotherapy, but it was designed specifically to target HER2+ cancer cells. STOP Normally, HER2 receptors on healthy cells send signals to tell them when to grow. In HER2+ breast cancer, some cancer cells have too many HER2 receptors. These cells grow and divide uncontrollably. Other HER2 treatments may work by interfering with the HER2 receptor from outside the cell. NERLYNX interacts with multiple HER family receptors and works inside the cell to block multiple growth pathways. This alters the signals that lead to cancer growth. Select IMPORTANT SAFETY INFORMATION See What are the possible side effects of NERLYNX? for more information about side effects. Before taking NERLYNX, tell your healthcare provider about all of your medical conditions, including if you: have liver problems. You may need a lower dose of NERLYNX. Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems: - tiredness - nausea - vomiting - pain in the right upper stomach-area (abdomen) - fever - rash - itching - yellowing of your skin or whites of your eyes Please see additional IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 4

5 How to Take NERLYNX Take 6 pills once a day (a total of 240 mg) with food for 12 months Avoid grapefruit and grapefruit products Take NERLYNX around the same time every day Do not chew, crush or split tablets Never take more than one dose (6 pills) per day. If you miss a dose, continue with your next scheduled dose on the following day Be sure to let your healthcare provider know about any missed doses during appointments Your provider may recommend that you take an antidiarrheal medication such as loperamide (Imodium ) when you first start NERLYNX. Your provider will decide what dose you should take Ask your doctor if there are any foods or medicines you should avoid while taking NERLYNX. IMPORTANT INSTRUCTIONS Store NERLYNX at room temperature between 68 and 77 F (20 and 25 C) Notify your healthcare provider immediately if you take more than 6 pills at once MAKE NERLYNX A PART OF YOUR DAILY ROUTINE Think about and plan for a meal time that works best for taking NERLYNX. Daily Reminders to Take NERLYNX To sign up for free, text LYNX to 90803* You can have helpful reminders to take NERLYNX sent straight to your phone. *At no cost with an unlimited texting plan; otherwise, message & data rates may apply. Message frequency determined by user. Text HELP to for help. Text STOP to to cancel. For terms: carespeak.com/terms. For privacy: carespeak.com/privacy. Please see IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 5

6 The First 2 Months Because NERLYNX is an oral medication taken once a day, you have the freedom to take it from anywhere. When first starting NERLYNX, you may experience certain side effects. Diarrhea is one of the most common and early side effects but there are medicines available to help. For example, initiating loperamide (Imodium ) with the first dose of NERLYNX and continuing during the first 2 months of treatment is recommended to help minimize any diarrhea you may experience. Your doctor will tell you the best way to take this medication. WAYS TO MINIMIZE DIARRHEA The following tips may help you minimize diarrhea, but always talk to your doctor or nurse first before making any changes to your diet. WHAT TO EAT Foods that are low in fiber Visit familydoctor.org and search BRAT diet to learn more. Foods that are high in protein Foods that are high in potassium Yogurt Yogurt contains good bacteria known as probiotics, which can shorten the duration of diarrhea. e.g., bananas, white rice, applesauce, white bread e.g., beef, skinless chicken, turkey, eggs e.g., bananas, skinless potatoes, avocados, asparagus tips yogurt WHAT TO AVOID Other dairy products Alcohol, caffeinated drinks and sugary sodas Greasy, fatty and spicy foods Foods that are high in fiber Foods that cause intestinal gas Grapefruit and grapefruit products e.g., milk, cheese, ice cream e.g., beer, wine, coffee, soda e.g., fried chicken, pizza, peppers e.g., popcorn, pickles, whole grain bread, brown rice e.g., broccoli, cabbage, beans, cauliflower grapefruit Please see IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 6

7 OTHER TIPS TO HELP MINIMIZE DIARRHEA Eat smaller, more frequent meals Drink 8 to 10 large glasses of clear liquids every day to help prevent dehydration GETTING HELP Make sure you work closely with your healthcare team to help minimize diarrhea. Keep a record of how often you experience diarrhea along with any other symptoms. Share this record and talk with your doctor or nurse early and often to better manage your side effects. Aside from over-the-counter medicines, like loperamide (Imodium ), your healthcare team can provide other ways to help you control your diarrhea, including medications and dietary recommendations. Select IMPORTANT SAFETY INFORMATION Before taking NERLYNX, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant. NERLYNX can harm your unborn baby. If you are a female who can become pregnant: - Your healthcare provider should do a pregnancy test before you start taking NERLYNX. - You should use effective birth control (contraception) during treatment and for at least 1 month after your last dose of NERLYNX. - Talk with your healthcare provider about forms of birth control that you can use during this time. - Tell your healthcare provider right away if you become pregnant during treatment with NERLYNX. Please see additional IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 7

8 Common Side Effects In the clinical study, most of the 1,400 participants who took NERLYNX experienced diarrhea. In addition to diarrhea, other side effects commonly experienced included nausea stomach-area (abdomen) pain tiredness vomiting rash dry or inflamed mouth, or mouth sores decreased appetite muscle spasms upset stomach nail problems including color change dry skin swelling of your stomach-area weight loss urinary tract infection There are ways to manage the potential side effects of NERLYNX, so don t let them discourage you. And don t be afraid to talk to your doctor or nurse about how to manage side effects. Your doctor can prescribe medication or adjust the dose. Your doctor can also tell you about over-the-counter medicines that can help. Please see additional IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 8

9 Talking With Your Healthcare Team Don t be embarrassed to talk openly with your doctor or nurse and ask questions that you may feel are silly. It s okay to speak up and say when you don t understand something. You and your healthcare team are partners when it comes to your health. That means communication is key. WHAT TO ASK TO GET THE INFORMATION YOU NEED I want to make sure I take NERLYNX correctly. What s the best way to take it? Can you tell me about the side effects I should expect? What can I do to manage the most common ones? How can I minimize any diarrhea I may experience? If I m tired, what can I do to help get through the day or finish tasks that are important to me? What should I do if a side effect worsens or starts to concern me? Always keep your healthcare team in the loop with how you re feeling and what you re thinking. Don t just ask questions. Tell your team what s going on. Maybe start by writing down and sharing any side effects that you experience. Select IMPORTANT SAFETY INFORMATION - Males with female partners who can become pregnant should use effective birth control during treatment and for 3 months after your final dose of NERLYNX. Before taking NERLYNX, tell your healthcare provider about all of your medical conditions, including if you: are breastfeeding or plan to breastfeed. It is not known if NERLYNX passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after your last dose of NERLYNX. Please see additional IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 9

10 Getting the Most Out of NERLYNX NERLYNX can only do its job if you commit to taking it every day. And during this time of physical and emotional readjustment, managing any stress you may experience is important to staying committed to NERLYNX. Select IMPORTANT SAFETY INFORMATION What is the most important information I should know about NERLYNX (ner links)? NERLYNX (neratinib) may cause serious side effects, including: Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. You may lose too much body salts and fluids, and get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 months (56 days) of NERLYNX and then as needed. Please see additional IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 10

11 Managing Stress During Treatment Some women feel pressure to pick back up the responsibilities they had before their cancer diagnosis. Others feel a drop in the kind of support they experienced from their healthcare provider and friends that comes with fighting cancer. Whatever you re feeling, if you can take time to understand and accept how you feel in the present moment without judgment of those feelings you can learn to better manage stress and anxiety. Deep breathing is a proven way to reduce stress in the body. Things that happen when you re stressed, like increased heart rate, fast breathing and high blood pressure, all decrease as you relax through deep breathing. REPEAT THIS 3 TO 10 TIMES TRY BREATHING TO RELAX Sit or lie flat in a comfortable position Put one hand on your belly just below your ribs and the other hand on your chest Take a deep breath in through your nose, and let your inhale push your hand out. Your chest shouldn t move Breathe out through pursed lips as if you re whistling. Feel the hand on your belly go in, and use it to push all the air out Do this routine 3 to 10 times. Take your time with each breath. When you re finished, compare how you feel now to when you first started. Please see IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 11

12 Support With You ve charted a 1-year course with NERLYNX (neratinib), but you don t have to travel alone. You can gain free access to valuable guidance and resources to help you out along the way. With Puma Patient Lynx TM, you ll receive s and texts that help you to Stay committed to taking NERLYNX Manage side effects Reduce stress and anxiety Get the most out of your healthcare appointments TO SIGN UP FOR FREE, TEXT LYNX to 90803* Additional Support With Specialty Pharmacy Services NERLYNX is available through several specialty pharmacies that offer helpful services, including Processing your prescription and helping with timely delivery Helping you understand your insurance coverage Providing you with information about NERLYNX, including answering questions about side effects Nurse and Pharmacist counselors who can provide educational support to help you manage your treatment *At no cost with an unlimited texting plan; otherwise, message & data rates may apply. Message frequency determined by user. Text HELP to for help. Text STOP to to cancel. For terms: carespeak.com/terms. For privacy: carespeak.com/privacy. Please see IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 12

13 Reimbursement Support Through We re committed to helping patients have access to NERLYNX. That s why reimbursement services are available to Make referrals to nonprofit foundations for patients who are not commercially insured and in need of financial support Provide support with benefit investigations and prior authorization assistance Answer questions about prescription coverage CO-PAY SUPPORT FOR COMMERCIALLY INSURED PATIENTS Commercially insured, eligible patients treated with NERLYNX may pay as little as $10 per prescription.* Patients will be enrolled through their specialty pharmacy. THE PATIENT ASSISTANCE PROGRAM NERLYNX is provided free to patients who are uninsured and meet certain financial qualifications. Please call our Reimbursement Specialists at for more information. NERLYNX QUICK START Provides a free 3-week supply of NERLYNX to eligible patients experiencing delays in gaining access to therapy. FOR MORE INFORMATION, GO TO NERLYNX.COM * Limitations apply. Patient must have commercial insurance. Offer is not valid under Medicare, Medicaid, or any other federal or state program. Puma Biotechnology reserves the right to rescind, revoke, or amend this program without notice. For full terms and conditions, visit or call Please see IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. 13

14 Important Safety Information What is the most important information I should know about NERLYNX (ner links)? NERLYNX (neratinib) may cause serious side effects, including: Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. You may lose too much body salts and fluids, and get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 months (56 days) of NERLYNX and then as needed. To help prevent or reduce diarrhea: - Tell your healthcare provider if you have more than 2 bowel movements in 1 day, or you have diarrhea that does not go away. - Call your healthcare provider right away, as instructed, if you have severe diarrhea or if you have diarrhea along with weakness, dizziness, or fever. Your healthcare provider may change your dose of NERLYNX, temporarily stop or completely stop NERLYNX if needed to manage your diarrhea. See What are the possible side effects of NERLYNX? for more information about side effects. What is NERLYNX? NERLYNX is a prescription medicine used to treat adults who have early-stage breast cancer, which: is HER2-positive and has previously been treated with the medicine trastuzumab. It is not known if NERLYNX is safe and effective in children. Before taking NERLYNX, tell your healthcare provider about all of your medical conditions, including if you: have liver problems. You may need a lower dose of NERLYNX. are pregnant or plan to become pregnant. NERLYNX can harm your unborn baby. If you are a female who can become pregnant: - Your healthcare provider should do a pregnancy test before you start taking NERLYNX. - You should use effective birth control (contraception) during treatment and for at least 1 month after your last dose of NERLYNX. - Talk with your healthcare provider about forms of birth control that you can use during this time. - Tell your healthcare provider right away if you become pregnant during treatment with NERLYNX. - Males with female partners who can become pregnant should use effective birth control during treatment and for 3 months after your last dose of NERLYNX. are breastfeeding or plan to breastfeed. It is not known if NERLYNX passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after your last dose of NERLYNX. Please see additional IMPORTANT SAFETY INFORMATION on page 15 and accompanying Patient Information. 14

15 Important Safety Information, cont. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines used to decrease stomach acid, called proton pump inhibitors or PPIs, and H-2 receptor antagonists. You should avoid taking these medicines during treatment with NERLYNX. What are the possible side effects of NERLYNX? NERLYNX may cause serious side effects, including: See What is the most important information I should know about NERLYNX? liver problems. Changes in liver function tests are common with NERLYNX. Your healthcare provider should do blood tests before you begin treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. Your healthcare provider will stop your treatment with NERLYNX if your liver tests show severe problems. Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems: - tiredness - nausea - vomiting - pain in the right upper stomach-area (abdomen) - fever - rash - itching - yellowing of your skin or whites of your eyes Common side effects of NERLYNX include: diarrhea nausea stomach-area (abdomen) pain tiredness vomiting rash dry or inflamed mouth, or mouth sores decreased appetite muscle spasms upset stomach nail problems including color change dry skin swelling of your stomach-area weight loss urinary tract infection These are not all the possible side effects of NERLYNX. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA Please see accompanying Patient Information. References: 1. NERLYNX (neratinib) tablets Prescribing Information, Puma Biotechnology, Inc. 07/ Martin M, Holmes FA, Ejlertsen B, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(12):

16 Move Forward in Confidence With NERLYNX Select IMPORTANT SAFETY INFORMATION What is the most important information I should know about NERLYNX (ner links)? NERLYNX (neratinib) may cause serious side effects, including: Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. You may lose too much body salts and fluids, and get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 months (56 days) of NERLYNX and then as needed. Please see additional IMPORTANT SAFETY INFORMATION on pages and accompanying Patient Information. NERLYNX is a registered trademark of Puma Biotechnology, Inc. Herceptin is a registered trademark of Genentech, Inc. Imodium is a registered trademark of Johnson & Johnson Corporation Puma Biotechnology, Inc. All Rights Reserved. PRC-US-NER /18

17 PATIENT INFORMATION NERLYNX (ner links) (neratinib) tablets What is the most important information I should know about NERLYNX? NERLYNX may cause serious side effects, including: Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. You may lose too much body salts and fluids, and get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 months (56 days) of NERLYNX and then as needed. To help prevent or reduce diarrhea: o You should start taking loperamide with your first dose of NERLYNX. o Keep taking loperamide during the first 2 months (56 days) of NERLYNX treatment and then as needed. Your healthcare provider will tell you exactly how much and how often to take loperamide. o Always take loperamide exactly as your healthcare provider tells you. o While taking loperamide, you and your healthcare provider should try to keep the number of bowel movements that you have at 1 or 2 bowel movements each day. o Tell your healthcare provider if you have more than 2 bowel movements in 1 day, or you have diarrhea that does not go away. o Call your healthcare provider right away, as instructed, if you have severe diarrhea or if you have diarrhea along with weakness, dizziness, or fever. o Your healthcare provider may also need to give you other medicines to manage diarrhea if loperamide does not work well enough. o After 2 months (56 days) of treatment with NERLYNX, follow your healthcare provider s instructions about taking loperamide as needed to control diarrhea. Your healthcare provider may change your dose of NERLYNX, temporarily stop or completely stop NERLYNX if needed to manage your diarrhea. See What are the possible side effects of NERLYNX? for more information about side effects. What is NERLYNX? NERLYNX is a prescription medicine used to treat adults who have early-stage breast cancer, which: is HER2-positive and has previously been treated with the medicine trastuzumab. It is not known if NERLYNX is safe and effective in children. Before taking NERLYNX, tell your healthcare provider about all of your medical conditions, including if you: have liver problems. You may need a lower dose of NERLYNX. are pregnant or plan to become pregnant. NERLYNX can harm your unborn baby. If you are a female who can become pregnant: o Your healthcare provider should do a pregnancy test before you start taking NERLYNX. o You should use effective birth control (contraception) during treatment and for at least 1 month after your last dose of NERLYNX. o Talk with your healthcare provider about forms of birth control that you can use during this time. o Tell your healthcare provider right away if you become pregnant during treatment with NERLYNX. o Males with female partners who can become pregnant should use effective birth control during treatment and for 3 months after the last dose of NERLYNX. are breastfeeding or plan to breastfeed. It is not known if NERLYNX passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after your last dose of NERLYNX. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines used to decrease stomach acid, called proton pump inhibitors or PPIs, and H-2 receptor antagonists. You should avoid taking these medicines during treatment with NERLYNX.

18 How should I take NERLYNX? Take NERLYNX exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose of NERLYNX if needed. Take NERLYNX with food. Take NERLYNX at about the same time each day. If you take an antacid medicine, take NERLYNX 3 hours after the antacid medicine. NERLYNX is usually taken for 1 year. If you miss a dose of NERLYNX, skip that dose and take your next dose at your regular scheduled time. If you take too much NERLYNX, call your healthcare provider right away or go to the nearest hospital emergency room. What should I avoid during treatment with NERLYNX? You should avoid eating products that contain grapefruit during treatment with NERLYNX. What are the possible side effects of NERLYNX? NERLYNX may cause serious side effects, including: See What is the most important information I should know about NERLYNX? Liver problems. Changes in liver function tests are common with NERLYNX. Your healthcare provider should do blood tests before you begin treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. Your healthcare provider will stop your treatment with NERLYNX if your liver tests show severe problems. Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems: o tiredness o fever o nausea o rash o vomiting o itching o pain in the right upper stomach-area (abdomen) o yellowing of your skin or whites of your eyes Common side effects of NERLYNX include: diarrhea decreased appetite nausea muscle spasms stomach-area (abdomen) pain upset stomach tiredness nail problems including color change vomiting dry skin rash swelling of your stomach-area dry or inflamed mouth, or mouth sores weight loss urinary tract infection These are not all the possible side effects of NERLYNX. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA How should I store NERLYNX? Store NERLYNX at room temperature between 68 to 77 F (20 to 25 C). Keep NERLYNX and all medicines out of the reach of children. General information about the safe and effective use of NERLYNX. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NERLYNX for a condition for which it was not prescribed. Do not give NERLYNX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NERLYNX that is written for health professionals. What are the ingredients in NERLYNX? Active ingredient: neratinib Inactive ingredients: Tablet Core: colloidal silicon dioxide, mannitol, microcrystalline cellulose, crospovidone, povidone, magnesium stearate & purified water. Coating: red film coat: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red. Distributed by: Puma Biotechnology, Inc Wilshire Blvd., Suite 2150 Los Angeles, CA , Puma Biotechnology, Inc. All rights reserved. For more information, go to or call This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 07/2017 All Rights Reserved. PRC-US-NER