Not an actual patient. Individual results may vary. AKYNZEO Before Chemo Focus on You, Not on Nausea and Vomiting

Your guide to AKYNZEO and chemo-related nausea and vomiting

What is AKYNZEO? AKYNZEO ( and palonosetron) capsules/(fosnetupitant and palonosetron) for injection is a prescription medicine called an “.” AKYNZEO is used in combination with the medicine in adults to help prevent the nausea and vomiting that happens right away or later with certain anti-cancer medicines (chemotherapy). It is not known if AKYNZEO is safe and effective in children under 18 years of age. Only take AKYNZEO as prescribed by your doctor. For additional information about AKYNZEO, talk to your doctor. Please see the Summary of Important Information about AKYNZEO on the next page.

The information in this brochure is intended for educational purposes only and is not a substitute for medical advice. Important Safety Considerations • are breastfeeding or plan to migraine medicines and can breastfeed. It is not known if lead to death. Go to the • AKYNZEO may cause serious allergic reactions, such as anaphylaxis. AKYNZEO passes into your nearest hospital emergency Get emergency medical help right away if you get any of the following breast milk. You and your room right away if you get any symptoms of a serious allergic reaction: hives, swollen face, trouble breathing, doctor should decide if you will of the following symptoms: or chest pain take AKYNZEO or breastfeed. agitation, hallucinations or •  syndrome can happen with AKYNZEO particularly with certain You should not do both. other changes in mental status, other medicines such as anti-depressants and anti-migraine medicines What other medications might dizziness, muscle twitching and can be life-threatening. Stop taking AKYNZEO capsules and go to interact with AKYNZEO? (overactive reflexes), or the nearest hospital emergency room right away if you get any of the seizures. following symptoms: agitation, hallucinations or other changes in mental Tell your doctor about all of the The most common side effects of status, dizziness, fast heartbeat, sweating, low body temperature, shaking medicines you take, including AKYNZEO are headache, weakness, (tremors), unsteady movements, muscle twitching (overactive reflexes), or prescription and over-the-counter fatigue, upset stomach, constipation, seizures with or without nausea, vomiting, and diarrhea medicines, vitamins, and herbal supplements as they might interact and skin redness. • The most common side effects of AKYNZEO capsules and injection include: with AKYNZEO. These are not all the possible side headache, weakness, fatigue, upset stomach, constipation, and skin redness • AKYNZEO can effect effects of AKYNZEO. Call your • Tell your doctor or nurse about all your medical conditions including if you are certain medications that are doctor for medical advice about taking other medications or if you are pregnant or breastfeeding or plan to metabolized through the . side effects. You may report side become pregnant or breastfeed effects to FDA at 1-800-FDA-1088. • In addition, certain medications, Only take AKYNZEO as prescribed by your doctor. For additional when taken with AKYNZEO may The risk information provided information about AKYNZEO, talk to your doctor or see the full Prescribing lead to a serious side effect here is not comprehensive. Information at www.akynzeo.com known as . For additional information on You may report side effects to the FDA at www.fda.gov/medwatch or call Serotonin syndrome can be AKYNZEO: 1-800-FDA-1088. fatal. • Talk to your healthcare What are the possible side effects provider or pharmacist Summary of Important Information about Akynzeo of AKYNZEO? • Visit www.AkynzeoPI.com AKYNZEO may cause serious side (https://www.akynzeo.com/ What is AKYNZEO? What should I tell my doctor effects, including: assets/pdf/Prescribing_ AKYNZEO (netupitant and before taking AKYNZEO? Information.pdf) to obtain the • Allergic Reactions, such as palonosetron) capsules/ Before taking AKYNZEO, tell your FDA approved full Prescribing anaphylaxis. Get emergency (fosnetupitant and palonosetron) for doctor about all your medical Information medical help right away if injection is a prescription medicine conditions, including if you: you get any of the following • Contact Helsinn Medical called an “antiemetic.” AKYNZEO • have had an allergic reaction symptoms of a serious allergic Information at 1-84HELSINN-U is used in combination with the to palonosetron or another reaction with AKYNZEO: hives, (1-844-357-4668; option 1) medicine dexamethasone in adults medication for nausea or swollen face, trouble breathing, to help prevent the nausea and vomiting. or chest pain. vomiting that happens right away or later with certain anti-cancer • have liver or kidney problems • Serotonin syndrome which medicines (chemotherapy). • are pregnant or plan to become can happen with AKYNZEO particularly with certain It is not known if AKYNZEO is safe pregnant. It is not known if other medicines such as and effective in children under AKYNZEO will harm your and anti- 18 years of age. unborn baby. ©2018 Helsinn Therapeutics (U.S.) Inc.

2 3 Chemo-Related Nausea and Vomiting

What Is It? How Does It Happen? Going through Chemotherapy-related nausea When you receive chemo, two and vomiting are side effects of things may happen in your body: chemo for the chemotherapy medicines, or chemo, • A certain part of your brain for short. Side effects happen when is triggered chemo damages healthy cells. fi rst time, or You may also hear or see the term • Certain areas of your chemotherapy-induced nausea esophagus, stomach, and again, is tough. and vomiting, or CINV. small and large intestine are triggered • Nausea is the feeling you These triggers start a process that It may be more diffi cult if have when you need to vomit, or throw up leads to nausea and vomiting. you have side effects such as • Vomiting is the act of throwing nausea and vomiting. up what is in your stomach Medicines can be used to block this process to help Some people may or may not have prevent nausea and vomiting. This brochure was designed these side effects. Some people may have nausea or vomiting, or both. as a guide to help you and For some people, nausea can be your loved ones learn more worse than vomiting, because once it starts it can be hard to stop. Brain about chemo-related nausea The goal is prevention. and vomiting.

It will also introduce you to Esophagus AKYNZEO (a kin zee oh), a prescription medicine used to help prevent the nausea and vomiting that happens

right away or later with Stomach certain chemo medicines. Small intestine

Large intestine

4 Please see the Important Safety Considerations for AKYNZEO on pages 2-3. 5 Chemo-Related Nausea and Vomiting

When Can It Affect Me? Am I at Risk? Here are some of the individual risk factors that may increase your risk of chemo-related nausea and vomiting: Chemo-related nausea and vomiting The risk factors for chemo-related can happen soon after treatment nausea and vomiting are different for Your type of chemo You have a history of with chemo or as long as several everyone. regimen motion sickness days later. Some people are more likely than • Acute chemo-related nausea others to have nausea and vomiting. You suffered nausea and vomiting usually occurs Nausea and vomiting caused by You are a woman and vomiting during past chemo treatments within the fi rst 24 hours after chemo can happen for different you receive chemo treatment reasons. Some of those reasons You had episodes You don’t drink may include your individual risk or drink it only • Delayed chemo-related of vomiting during factors, such as your age or medical pregnancy occasionally nausea and vomiting occurs history. 24 hours or more after you You are younger receive chemo treatment Your chemo medicines may be more <50 than 50 years old likely to cause these effects, and different types of chemo are more likely than others to do this. If any of these apply to you, it may be even more important to get treatment to prevent chemo-related nausea and vomiting.

Speak with your doctor about your options for stopping chemo-related nausea and vomiting before it starts.

Not an actual patient. Individual results may vary.

6 Please see the Important Safety Considerations for AKYNZEO on pages 2-3. 7 Chemo-Related Nausea and Vomiting

What Types of Chemo Medicines Cause It? Ways to Prevent It Some chemo medicines are more likely than others to cause nausea and Medicines used to help prevent nausea and vomiting are called . vomiting. Chemo medicines are grouped according to how likely they are to There are different classes, or groups, of antiemetics. They are grouped cause nausea and vomiting. according to how they work in the body.

• The ones most likely to cause nausea and vomiting are called highly • Some block triggers and signals from your brain emetogenic (eh-MET-oh-JEN-ic) • Others block triggers and signals from your stomach, saliva gland, and • Other chemo medicines that are less likely to cause these effects are intestines considered moderately emetogenic Doctors may prescribe medicines to help prevent nausea and vomiting that Emesis is a medical term for vomiting. Emetogenic refers to a medicine that work in other ways. causes nausea and vomiting. Antiemetics are taken in different ways: When some chemo medicines are given in high doses, or when they are given together, they can make the nausea and vomiting worse. You can take antiemetics by mouth in the form of a pill or capsule, either swallowed or dissolved under your tongue Without any preventive treatments, Without any preventive treatments, moderately emetogenic medicines highly emetogenic medicines cause They may also be given by a doctor through an injection or an cause nausea and vomiting in nausea and vomiting in intravenous (IV) line 30% TO 90% MORE THAN 90% Your doctor will tell you when to take your antiemetic before OF PATIENTS. OF PATIENTS. your chemo treatment

Is your nausea and Ask your doctor if the chemotherapy vomiting being prevented?

prescribed for you is likely to cause Find out how well your nausea and vomiting. treatment is working for you by taking the short quiz at www.AKYNZEO.com.

8 Please see the Important Safety Considerations for AKYNZEO on pages 2-3. Not an actual patient. Individual results may vary. 9 Chemo-Related Nausea and Vomiting AKYNZEO Before Chemo

Working With Your Doctor How AKYNZEO Works It is important to talk to your doctor about your risk of chemo-related nausea AKYNZEO is a prescription medicine that is used in people to help prevent the and vomiting so that he or she can you help you prevent it. Here are some tips nausea and vomiting that happens right away (acute) or later (delayed) with to help you speak with your doctor. certain chemo medicines.

Be descriptive. It can be hard for you to describe how much nausea AKYNZEO is a combination medicine. It contains two medicines: affects you, so try to be as detailed and descriptive as possible when PALONOSETRON and NETUPITANT or FOSNETUPITANT. These medicines you talk to your doctor about it. Make sure to tell your doctor any are from two different classes. Two different classes means AKYNZEO works other symptoms that you have when you have nausea. on two different pathways in your body to prevent nausea and vomiting.

Keep a journal. Try to keep track of the side effects and of how you are feeling during treatment. You may wish to use a journal to help keep your information in one place. This journal can help your NETUPITANT doctor understand how often or how badly nausea and vomiting has is thought to work by affected you. blocking signals from your brain to protect against Ask questions. You should fi nd out about the possible side effects nausea and vomiting. It of the chemo you will be receiving. Ask your doctor if the therapy helps relieve the nausea prescribed for you is likely to cause nausea and vomiting. and vomiting that happens right away or later (acute or delayed). Fosnetupitant is converted to netupitant Not an actual patient. Individual results may vary. within the body.

PALONOSETRON is thought to work by blocking signals from the stomach to protect Need help getting the against nausea and conversation started? vomiting that happens Download the patient right away (acute). discussion guide at www.AKYNZEO.com.

AKYNZEO is the fi rst and only combination medicine that blocks both of these pathways.

10 Please see the Important Safety Considerations for AKYNZEO on pages 2-3. 11 AKYNZEO Before Chemo

Proven Protection When to Take AKYNZEO works to prevent In a clinical study involving AKYNZEO nausea and vomiting from highly 135 patients who were taking AKYNZEO is given by your doctor as If you are prescribed the AKYNZEO and moderately emetogenic cisplatin-based chemotherapy, a pill by mouth or as an intravenous pill, you take it about 1 hour before chemo medicines, including some patients given an oral dose of injection before your treatment at your chemo treatment. medicines that are used in the AKYNZEO with dexamethasone the start of each chemo cycle. treatment of breast and lung cancer. were compared against patients • If you are going to an given an oral dose of palonosetron, • AKYNZEO is given with infusion center for your AKYNZEO has also prevented a different antiemetic treatment, dexamethasone chemo treatment, you may nausea and vomiting for people who with dexamethasone: need to bring your AKYNZEO have had several cycles of chemo. • AKYNZEO can be taken with pill with you or without food In a clinical study for the AKYNZEO • Your doctor will tell you pill, the most common side If you are prescribed AKYNZEO exactly when to take your effects of stomach upset, fatigue, 90% for injection, it will be given to you AKYNZEO pill constipation, and skin redness of patients who received about 30 minutes before your occurred in 4% of patients or AKYNZEO had no chemo treatment. • If you take too much fewer. In another clinical study, the vomiting for as long as AKYNZEO, call your doctor or safety of AKYNZEO injection was 5 days after chemo. go to the nearest emergency found to be similar to that of the room right away AKYNZEO pill. Need help opening the 99% AKYNZEO pack? of patients who Download the Instructions for Use received AKYNZEO had card at www.AKYNZEO.com. no vomiting within 24 5 hours of chemo. days Actor portrayal. Individual results may vary.

In clinical studies, a single dose of oral AKYNZEO with dexamethasone prevented vomiting for as long as 5 days after chemo.

12 Please see the Important Safety Considerations for AKYNZEO on pages 2-3. 13 AKYNZEO Before Chemo

Dosing Recommendations Helsinn Cares Patient Support Program Dexamethasone is a steroid that is used to treat infl ammation, or swelling, in the You should focus on your fi ght with cancer, not nausea and vomiting. If you body and is usually given with most antiemetics, including AKYNZEO. are concerned about paying for AKYNZEO, you may be eligible to take part in the Helsinn Cares Patient Support Program. • When given with AKYNZEO, dexamethasone is usually taken by mouth

• For patients receiving a highly emetogenic chemo medicine, the doctor may also prescribe dexamethasone for 3 days after receiving chemo treatment

Type of chemo Day of chemo After chemo (days 2-4) medicine (day 1) AKYNZEO pill and Dexamethasone 8 mg dexamethasone 12 mg once a day Highly emetogenic or AKYNZEO injection and Dexamethasone 8 mg Visit HelsinnCares.com to fi nd dexamethasone 12 mg once a day out more about AKYNZEO patient AKYNZEO pill and access programs. Moderately emetogenic dexamethasone 12 mg

Before taking AKYNZEO, tell your doctor about all of your medical conditions, including if you • have had an allergic reaction to palonosetron or another medication for nausea or vomiting • have liver or kidney problems • are pregnant or plan to become pregnant. It is not known if AKYNZEO will harm your unborn baby AKYNZEO • are breastfeeding or plan to breastfeed. It is not known if AKYNZEO passes into your breast milk. You and your doctor should decide if you will take AKYNZEO or breastfeed. You should not do both Before Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as they might interact with AKYNZEO. Chemo • AKYNZEO can effect certain medications that are metabolized through the liver • In addition, certain medications, when taken with AKYNZEO may lead to a serious side effect known as serotonin syndrome. Serotonin syndrome

can be fatal *Restrictions apply. May not be available to patients enrolled in state or federal healthcare programs, including Medicare, Medicaid, Medigap, VA, DoD, or TRICARE.

14 Please see the Important Safety Considerations for AKYNZEO on pages 2-3. 15 Learn more Visit the AKYNZEO website at www.AKYNZEO.com for more information, tools, and resources about AKYNZEO and chemo-related nausea and vomiting.

The American Cancer Society www.cancer.org CancerCare AKYNZEO www.cancercare.org National Cancer Institute Before www.cancer.gov Chemo Cancer Support Community www.cancersupportcommunity.org Focus on You, Not on Nausea and Vomiting National Comprehensive Cancer Network www.nccn.org/patients

www.akynzeo.com

Please see the Important Safety Considerations for AKYNZEO on pages 2-3.

AKYNZEO® is a registered trademark of Helsinn Healthcare SA, Switzerland, distributed and marketed by Helsinn Therapeutics (U.S.), Inc. under license. © 2018 Helsinn Therapeutics (U.S.), Inc. All rights reserved. V-AKYN-US-0353 12/2018