SELECT SAFETY INFORMATION What is the most important information I should know about IMFINZI? IMFINZI is a medicine that may treat a type of cancer in the bladder and urinary tract or certain types of lung cancer by working with your immune system. IMFINZI can cause your immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. IMFINZI may not work for everyone. It is not known if IMFINZI is safe and effective in children. I’M IN for the moments that matter WHAT IS IMFINZI? IMFINZI ® (durvalumab) is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC). It is not known if IMFINZI is safe and effective in children. EXTENSIVE STAGE SCLC I’M IN with IMFINZI + chemotherapy: A treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) For additional Important Safety Information, please see pages 16-19.
Transcript
SELECT SAFETY INFORMATIONWhat is the most important information I should know about IMFINZI?
IMFINZI is a medicine that may treat a type of cancer in the bladder and urinary tract or certain types of lung cancer by working with your immune system.
IMFINZI can cause your immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.IMFINZI may not work for everyone. It is not known if IMFINZI is safe and effective in children.
I’M IN for the moments that matter
WHAT IS IMFINZI?IMFINZI® (durvalumab) is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC).
It is not known if IMFINZI is safe and effective in children.
EXTENSIVE STAGE
S C L C
I’M IN with IMFINZI + chemotherapy: A treatment for adults with extensive-stage small cell lung cancer (ES-SCLC)
For additional Important Safety Information, please see pages 16-19.
2SELECT SAFETY INFORMATIONCall or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse: Lung problems (pneumonitis). Signs and symptoms may include new or worsening cough, shortness of breath, and chest pain.
I’M IN to seize the day
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Facing a diagnosis of extensive-stage small cell lung cancer (ES-SCLC) can be shocking, and finding the information you need can be overwhelming. This guide was created to help you understand more about ES-SCLC and how treatment with IMFINZI may help so you can feel informed, confident, and ready to plan your next steps.
INSIDE YOU’LL FIND ANSWERS TO THESE FREQUENTLY ASKED QUESTIONS:
What is small cell lung cancer? What is IMFINZI? How can IMFINZI + chemotherapy help adults with ES-SCLC?
How does IMFINZI work and what should I expect with treatment? Where can I find support and connect with others like me?
How can I help those that support me?
GETTING STARTED
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
Small cell lung cancer is sometimes called “oat cell cancer,” because the cells are oval-shaped and smaller than healthy cells.
• Usually begins in the major airways in the center of the chest that lead to the lungs
SCLC differs from NSCLC in several ways including where the cancer begins, how the cancer cells look, and the way the cancer progresses
• Common to have already spread at the time of diagnosis
• 10%-15% of all lung cancers are SCLC• Grows and spreads more aggressively than NSCLC
Normal, healthy cell
Cells of small cell lung cancer
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Extensive-stage small cell lung cancer (ES-SCLC) means that cancer has spread from one lung to the other, to lymph nodes on the other side of the chest, or to other parts of the body.
THERE ARE 2 STAGES OF SCLC:
DID YOU KNOW?Staging is a way of describing if and where cancer has spread and whether it is affecting other parts of the body. Knowing the stage of lung cancer may help determine the best way to treat it.
Limited-stage small cell lung cancer (LS-SCLC) means that the cancer is located in one lung or is confined to one side of the chest.
• Extensive-stage is the most common type of small cell lung cancer—almost 70% of people have this type when they are diagnosed
6SELECT SAFETY INFORMATIONLiver problems (hepatitis). Signs and symptoms may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual.
for the next adventure
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IMFINZI IS AN IMMUNOTHERAPY TREATMENT
IMFINZI is a prescription medicine that works with the immune system to help the body fight cancer. IMFINZI is FDA approved to be used as the initial treatment, in combination with chemotherapy, for adults with ES-SCLC.
DURVALUMAB (IMFINZI) IS RECOMMENDED BY NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®) NCCN Guidelines® recommend Durvalumab (IMFINZI) with chemotherapy as a preferred initial treatment option for eligible patients with ES-SCLC.*†
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
SELECT SAFETY INFORMATIONIntestinal problems (colitis). Signs and symptoms may include diarrhea or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.
Hormone gland problems (especially the thyroid, adrenals, pituitary, and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches; extreme tiredness; weight gain or weight loss; dizziness or fainting; feeling more hungry or thirsty than usual; hair loss; feeling cold; constipation; your voice gets deeper; urinating more often than usual; nausea or vomiting; stomach-area (abdomen) pain; and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
HOW DO IMFINZI + CHEMOTHERAPY WORK TO FIGHT CANCER?
When cancer cells appear in your body, your immune system works to recognize and attack them.
PD-L1 is a protein that disguises cancer cells from the immune system.
HOW IMFINZI WORKS TO HELP FIGHT ES-SCLC:
IMFINZI is an immunotherapy treatment that works by helping your body’s immune system
1 2
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IMFINZI works by binding to and blocking PD-L1 to remove the disguise…
…so your immune system is better able to find and attack these cancer cells. There is a chance that IMFINZI may affect healthy cells, too.
Healthy cell
Cancer cell
IMFINZIImmune systemMEET THE KEY PLAYERS:
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
The immune system serves as your body’s defense system against infections and diseases, and can typically detect and destroy unhealthy cells.
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HOW CHEMOTHERAPY WORKS TO HELP FIGHT ES-SCLC:
Chemotherapy is a treatment that destroys fast-growing cancer cells in the body.
Unhealthy cells, if not detected and destroyed by the immune system, may eventually turn into cancer.
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SELECT SAFETY INFORMATIONKidney problems, including nephritis and kidney failure. Signs of kidney problems may include decrease in the amount of urine, blood in your urine, swelling of your ankles, and loss of appetite.
Skin problems. Signs may include rash, itching, and skin blistering.
HOW DO IMFINZI + CHEMOTHERAPY WORK TO FIGHT CANCER? (continued)
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Cancer cells grow abnormally and multiply quickly. This is where chemotherapy, a type of cancer treatment, can help.
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Chemotherapy has the ability to destroy rapidly growing cells—such as cancer cells—throughout the body. Since chemotherapy can destroy fast-growing cells, healthy cells may also be affected.
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Healthy cell
Cancer cell
Immune system ChemotherapyUnhealthy
cell
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
SELECT SAFETY INFORMATIONProblems in other organs. Signs and symptoms may include neck stiffness; headache; confusion; fever; chest pain, shortness of breath, or irregular heartbeat (myocarditis); changes in mood or behavior; low red blood cells (anemia); excessive bleeding or bruising; muscle weakness or muscle pain; blurry vision, double vision, or other vision problems; and eye pain or redness.
Severe infections. Signs and symptoms may include fever, cough, frequent urination, pain when urinating, and flu-like symptoms.
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HOW WAS IMFINZI STUDIED IN PEOPLE WITH ES-SCLC?
IMFINZI was studied in a clinical trial that included people diagnosed with ES-SCLC who had not yet undergone treatment.
Everyone in the clinical trial received the standard treatment for ES-SCLC, which included a combination of 2 types of chemotherapy:
&
People were given IMFINZI + chemotherapy
People were given only chemotherapy
268 269268 269 etoposide& carboplatin or cisplatin
HOW IMFINZI WAS STUDIED
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
14SELECT SAFETY INFORMATIONSevere infusion reactions. Signs and symptoms may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, and facial swelling.
WHAT WERE THE CLINICAL TRIAL RESULTS WITH IMFINZI?
Among people in the trial, half of the people treated with IMFINZI + chemotherapy were alive at 13 months, vs half of the people given chemotherapy alone were alive at 10.3 months.
People taking IMFINZI + chemotherapy had a 27% lower risk of dying compared to those taking chemotherapy alone.
IMFINZI + CHEMOTHERAPY HELPED PEOPLE LIVE LONGER
IMFINZI + chemotherapy
months months13 10.3chemotherapy alone
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PEOPLE WHO SAW THEIR TUMORS SHRINK
~6 out of 10 people on chemotherapy alone
~7 out of 10 people on IMFINZI + chemotherapy
Percentage of people who saw their tumors shrink*:
on IMFINZI+ chemotherapy
68%
on chemotherapy alone
58% Among people in the trial, half of the people lived without their tumors growing or spreading for 5.1 months when treated with IMFINZI + chemotherapy and 5.4 months when treated with chemotherapy alone.
PEOPLE WHO WERE ALIVE WITHOUT THEIR CANCER GROWING OR SPREADING
18% 5%of people
treated with IMFINZI + chemotherapy
At 1 year*:
of people treated with
chemotherapy alone
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
*Based on limits of the analysis, results are descriptive and your experience may differ.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT IMFINZI?
IMFINZI is a medicine that may treat a type of cancer in the bladder and urinary tract or certain types of lung cancer by working with your immune system.
IMFINZI can cause your immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.
Lung problems (pneumonitis). Signs and symptoms may include new or worsening cough, shortness of breath, and chest pain. Liver problems (hepatitis). Signs and symptoms may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual. Intestinal problems (colitis). Signs and symptoms may include diarrhea or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.
CALL OR SEE YOUR HEALTHCARE PROVIDER RIGHT AWAY IF YOU DEVELOP ANY SYMPTOMS OF THE FOLLOWING PROBLEMS OR IF THESE SYMPTOMS GET WORSE:
17For additional Important Safety Information, please see pages 18-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
Hormone gland problems (especially the thyroid, adrenals, pituitary, and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches; extreme tiredness; weight gain or weight loss; dizziness or fainting; feeling more hungry or thirsty than usual; hair loss; feeling cold; constipation; your voice gets deeper; urinating more often than usual; nausea or vomiting; stomach-area (abdomen) pain; and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
Kidney problems (including nephritis and kidney failure). Signs of kidney problems may include decrease in the amount of urine, blood in your urine, swelling of your ankles, and loss of appetite. Skin problems. Signs may include rash, itching, and skin blistering. Problems in other organs. Signs and symptoms may include neck stiffness; headache; confusion; fever; chest pain, shortness of breath, or irregular heartbeat (myocarditis); changes in mood or behavior; low red blood cells (anemia); excessive bleeding or bruising; muscle weakness or muscle pain; blurry vision, double vision, or other vision problems; and eye pain or redness. Severe infections. Signs and symptoms may include fever, cough, frequent urination, pain when urinating, and flu-like symptoms. Severe infusion reactions. Signs and symptoms may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, and facial swelling.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with IMFINZI. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment with IMFINZI if you have severe side effects.
Before you receive IMFINZI, tell your healthcare provider about all of your medical conditions, including if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant; have lung or breathing problems; have liver problems; or are being treated for an infection.
If you are pregnant or plan to become pregnant, tell your healthcare provider. IMFINZI can harm your unborn baby. If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 3 months after the last dose of IMFINZI. Talk to your healthcare provider about which birth control methods to use. Tell your healthcare provider right away if you become pregnant during treatment with IMFINZI.
If you are breastfeeding or plan to breastfeed, tell your healthcare provider. It is not known if IMFINZI passes into breast milk. Do not breastfeed during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI.
For additional Important Safety Information, please see pages 16-17. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
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Tell your healthcare provider about all the medicines you take. This includes prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of IMFINZI?
IMFINZI can cause serious side effects (see earlier).
The most common side effects of IMFINZI when used with other anticancer medicines with SCLC include: nausea, hair loss, and feeling tired or weak.Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IMFINZI. Ask your healthcare provider or pharmacist for more information.Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of AstraZeneca prescription drugs by calling 1-800-236-9933 or clicking here. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Please see accompanying complete Prescribing Information, including Patient Information (Medication Guide).
IMFINZI is an intravenous (IV) infusion, given through a needle placed in a vein by a healthcare professional. Treatments normally take place at a doctor’s office, hospital, or infusion center.
You will receive IMFINZI in combination with chemotherapy medications, etoposide and either carboplatin or cisplatin. Your doctor will have the flexibility to choose which chemotherapy option is right for you. Your doctor will also test your blood for certain side effects.
3 MONTHS3 ForEvery
WEEKS
IMFINZI
+
GET STARTED WITH IMFINZI + CHEMOTHERAPY
chemotherapy
STEP 1
THIS FIRST PART OF THE TREATMENT PROCESS IS THE INDUCTION PHASE
SELECT SAFETY INFORMATIONBefore you receive IMFINZI, tell your healthcare provider about all of your medical conditions, including if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant; have lung or breathing problems; have liver problems; or are being treated for an infection.
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During the next phase of treatment, you’ll receive IMFINZI by itself once a month for as long as your doctor recommends.
HELPFUL TIP: Keep a journal to write down how you are feeling and any questions you may have for your doctor.
MONTH1 EACH
TIME
CONTINUE IMFINZI WITHOUT CHEMOTHERAPY
chemotherapyWithout
IMFINZI
STEP 2
THE NEXT PART OF THE TREATMENT PROCESS IS THE MAINTENANCE PHASE
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
HOW DO I PREPARE FOR MY TREATMENT?The more prepared you are, the better your experience will be. Here are a few suggestions to help get you ready for treatment day.
SELECT SAFETY INFORMATIONIf you are pregnant or plan to become pregnant, tell your healthcare provider. IMFINZI can harm your unborn baby. If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 3 months after the last dose of IMFINZI. Talk to your healthcare provider about which birth control methods to use. Tell your healthcare provider right away if you become pregnant during treatment with IMFINZI.
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BEFORE treatment
• Drink plenty of water • Eat a small meal
AFTER treatment
DURING treatment Here are a few things to bring with you that may be useful on treatment day:
• Identification/insurance card
• List of medications you are currently taking
• Activities to keep you occupied, such as reading materials, puzzles, coloring books, digital devices (phone, laptop, tablet), and headphones. Don’t forget a charger for your devices!
• Water bottle to help stay hydrated
• Snacks in case you get hungry
• Lip balm, lotion, and hard candy to help soothe dry skin and lips
• A sweater or blanket, as it can get cold in the treatment center
• Be sure to schedule your next appointment before leaving the treatment center
• If possible, take it easy for the rest of the day
• Dress comfortably and in loose-fitting clothing • Write down any questions you may have and
bring them with you
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
GO2 Foundation for Lung Cancer A community providing life-changing patient information, support services, and resources to all those affected by lung cancer, free of charge. www.go2foundation.org
American Cancer Society Offers helpful tips, support programs, and services for people living with lung cancer. www.cancer.org
WHERE CAN I FIND MORE RESOURCES AND SUPPORT?
CONNECT AND LEARN MORE
Every person living with lung cancer has their own unique challenges, and needs for different kinds of support. The organizations listed on this page have been recommended by many patients as sources of helpful physical and emotional support, as well as information, when starting on treatment.
American Lung AssociationDedicated to improving lung health and preventing lung disease through education, advocacy, and research. www.lung.org
National Cancer Institute (NCI) Provides ongoing research and resources for lung cancer. www.cancer.gov
LUNGevity Foundation A community of empowerment, support, and hope, offering services and information on local events in your area. www.lungevity.org
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ASTRAZENECA WANTS YOU TO HAVE THE BEST SUPPORT OPTIONS AVAILABLE. TWO PROGRAMS THAT PROVIDE TREATMENT, ACCESS, AND FINANCIAL SUPPORT ARE:
The AstraZeneca Access 360TM program can help you get started with IMFINZI.
For more information, call
1-844-ASK-A360 (1-844-275-2360), Monday-Friday 8 AM-8 P M EST, or visit
MyAccess360.com.
HELPING YOU ACCESS THE CARE YOU NEED
Lighthouse provides you with constant support during your IMFINZI treatment, with help from medically trained Advocates. Lighthouse encourages you to monitor your
overall experience, including tracking any side effects.
For more information, ask your oncology team or visit LighthouseProgram.com.
SUPPORT DURING TREATMENT
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
HOW DO I SUPPORT THE PEOPLE WHO SUPPORT ME?Whether close friends or family members, caregivers can play an important role when it comes to your health. They can provide you with support and help you throughout your treatment. But as they are supporting you, there are some simple things you can do to help them in the process.
I’M IN because she’s in
SELECT SAFETY INFORMATION If you are breastfeeding or plan to breastfeed, tell your healthcare provider. It is not known if IMFINZI passes into breast milk. Do not breastfeed during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI. Tell your healthcare provider about all the medicines you take. This includes prescription and over-the-counter medicines, vitamins, and herbal supplements.
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Sometimes it can be easy to focus more on lung cancer than anything else. That’s why it’s important to plan fun, easygoing activities with one another, no matter how big or small they may be. It’s a nice way to take your mind off treatment, reduce stress, and show your caregiver how much you appreciate all he or she does for you.
MAKE EACH OTHER'S DAY
A support group can help you and your caregiver connect with people who understand what you’re going through. Try to find groups run by professional facilitators who can provide appropriate guidance for people in your situation.
JOIN A SUPPORT GROUP
Be open to asking and receiving help from others. Having a team of trusted friends and family willing to lend a helping hand can make a big difference. It can free up time for you and your caregiver, and help balance the load on each of your plates.
BRING IN A FRIEND
Communicating with your caregiver is essential. The more you talk about what you may and may not need help with, the more understanding and knowledgeable your caregiver will be when the time comes to address those needs.
TALK IT OUT
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
SELECT SAFETY INFORMATIONWhat are the possible side effects of IMFINZI? The most common side effects of IMFINZI when used with other anticancer medicines with SCLC include: nausea, hair loss, and feeling tired or weak.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IMFINZI. Ask your healthcare provider or pharmacist for more information.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
for a great conversation
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HOW SHOULD I TALK TO MY DOCTOR ABOUT ES-SCLC?
Given the limited time you may have with your doctor, it is important to make the most of your appointments. Questions, such as the ones below, may help you have an open and honest conversation with your doctor, who can discuss your ES-SCLC treatment with you.
QUESTIONS ABOUT SCLC
• What are the most important things I should know about ES-SCLC?
• How will ES-SCLC affect my day-to-day health?
• What can I do to reduce the risk of ES-SCLC growing or spreading?
• What changes to my daily life can I make to improve my overall health?
• Should I see a nutritionist?
• Aside from medication, what else can I do to keep my lungs as healthy as possible?
QUESTIONS ABOUT TREATMENT
• What are the side effects I may have with IMFINZI?
• How will I know if IMFINZI is working?
• Is IMFINZI + chemotherapy right for me?
• Why will I stop taking chemotherapy and continue with IMFINZI?
Remember, your doctor is there to help you. Don't be afraid to ask questions and dig deeper
For additional Important Safety Information, please see pages 16-19. Please see Important Safety Information throughout and complete Prescribing Information, including Patient Information (Medication Guide).
