Detailed Bayer Nubeqa Medicine Information
For nmCRPC Non-Metastatic Castration-Resistant Prostate Cancer
NUBEQA HELPS YOU LIVE FOR WHAT YOU LOVE
EVEN WITH RISING PSA ON HORMONE THERAPY*
NUBEQA clinical study was designed to measure metastasis-free survival (MFS) and also overall survival (OS). NUBEQA extended OS by lowering the risk of death by 31% compared with hormone therapy alone. See the clinical results on page 8.
*Hormone therapy includes drug treatments or surgery that lowers testosterone. PSA=prostate-specific antigen.
WHAT IS NUBEQA ® ? NUBEQA ® (darolutamide) is a prescription medicine used to treat adults with prostate cancer that has not spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (non-metastatic castration-resistant prostate cancer or nmCRPC). It is not known if NUBEQA is safe and effective in women or children. IMPORTANT SAFETY INFORMATION Before taking NUBEQA, tell your healthcare provider about all your medical conditions, including if you:
• have heart problems, high blood pressure, diabetes, or high amounts of fat or cholesterol in your blood (dyslipidemia)
Please see additional Important Safety Information throughout and the full Prescribing Information.
Pronounced new-BEH-kah
Whether you’ve already started NUBEQA, or you’re thinking about it THIS BROCHURE IS FOR YOU
If hormone therapy* no longer controls your prostate cancer that has not spread to other parts of the body
TAKING ACTION When you need more than your current hormone therapy*. . . . 4 Rising PSA levels mean that your cancer could spread. . . . . . 5 CHOOSING NUBEQA When it’s time to take action, there’s NUBEQA. . . . . . . . 6 HowNUBEQAworks.. . . . . . . . . . . . . . . .7 NUBEQA is clinically proven . . . . . . . . . . . . . . 8 NUBEQA offers men other benefits. . . . . . . . . . . . 10 Possible side effects with NUBEQA. . . . . . . . . . . . 12 HowtotakeNUBEQA.. . . . . . . . . . . . . . . 14 Support services for men taking NUBEQA. . . . . . . . . 16 MORE INFORMATION For people who care for someone with prostate cancer. . . . . 18 Where to find more information . . . . . . . . . . . . . 19 Mytreatmentteam.. . . . . . . . . . . . . . . . 20 What should you discuss with your doctor? . . . . . . . . . 21 Glossary. . . . . . . . . . . . . . . . . . . . .22
TAKE ACTION
*Hormone therapy includes drug treatments or surgery that lowers testosterone.
Take notes on page 23 at each visit with your doctor so you can refer to them later
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Throughout the brochure, you’ll see bolded terms . Flip to page 22 of this brochure for a glossary of these terms.
IMPORTANT SAFETY INFORMATION (continued) Before taking NUBEQA, tell your healthcare provider about all your medical conditions, including if you (continued): • have a history of seizures, brain injury, stroke, or brain tumors
*Hormone therapy includes drug treatments or surgery that lowers testosterone.
Please see additional Important Safety Information throughout and the full Prescribing Information.
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TAKING ACTION
WHEN YOU NEED MORE THAN YOUR CURRENT HORMONE THERAPY *
RISING PSA LEVELS MEAN THAT YOUR CANCER COULD SPREAD
When you have prostate cancer, the testosterone in your body causes it to grow and spread. You may already be on a hormone therapy , such as Lupron Depot ® , to bring your testosterone down to very low levels, but it may not be enough to keep the cancer from starting to grow again. When that happens, you may need to add another medication to the one you are already taking.
• It is very important that your doctor monitors your PSA levels. Your PSA levels may rise even if you are on hormone therapy* • If your PSA levels rise, that‘s because your prostate cancer is castration-resistant (CR) . That means that the prostate cancer keeps growing even when the amount of testosterone in the body is brought down to very low levels
PSA
When hormone therapy works, your prostate-specific antigen (PSA) level drops and stays low
THE GOAL OF TREATMENT IS TO DELAY THE SPREAD OF CANCER
But when your hormone therapy stops working, your PSA levels rise, even if your cancer has not spread. That means you have nmCRPC
PSA
CANCER SPREADING OUTSIDE THE PROSTATE
CANCER IN THE PROSTATE
WHAT IS nmCRPC?
When prostate cancer spreads to other parts of the body, it can cause symptoms like bone pain and worsen fatigue. It‘s important to talk to your doctor if you feel new symptoms. WHY DOES DELAYING THE SPREAD OF CANCER MATTER?
nm non-metastatic
castration - resistant prostate cancer CR PC
TAKE ACTION to delay the spread of cancer to other parts of your body. THE BOTTOM LINE
The cancer has NOT spread to other parts of the body
Cancer that starts in the prostate gland and keeps growing even when the amount of testosterone in the body is reduced to very low levels
Please see additional Important Safety Information throughout and the full Prescribing Information.
*Hormone therapy includes gonadotropin-releasing hormone (GnRH), such as Lupron Depot ® (drug treatment), or surgery that lowers testosterone. Lupron Depot is a registered trademark of AbbVie Inc.
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CHOOSING NUBEQA
WHEN IT‘S TIME TO TAKE ACTION, THERE‘S NUBEQA
HOW NUBEQA WORKS
Within every prostate cell, there are special molecules called androgen receptors, or ARs for short. When testosterone attaches to an AR, it causes cancer cells to grow. NUBEQA attaches to the AR and blocks testosterone from attaching to it, which helps delay cancer growth.
WHAT IS NUBEQA?
NUBEQA is a pill for prostate cancer that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.
Testosterone
Testosterone attaches to an AR, causing prostate cancer cells to grow
Actual pill size.
Androgen Receptors
NUBEQA blocks testosterone from attaching to the AR, helping to delay the cancer cell from growing
IMPORTANT SAFETY INFORMATION (continued) Before taking NUBEQA, tell your healthcare provider about all your medical conditions, including if you (continued): • have kidney or liver problems • are pregnant or plan to become pregnant. NUBEQA can cause harm to your unborn baby and loss of pregnancy (miscarriage)
NUBEQA HELPS YOU LIVE FOR WHAT YOU LOVE See overall survival data on page 8
Please see additional Important Safety Information throughout and the full Prescribing Information.
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CHOOSING NUBEQA
NUBEQA IS CLINICALLY PROVEN
NUBEQA HAS BEEN PROVEN TO WORK IN THE LARGEST CLINICAL TRIAL OF ITS KIND NUBEQA was studied in a clinical trial with more than 1500 men with nmCRPC. In this study, 955 men added NUBEQA to their hormone therapy* and 554 received hormone therapy alone. This study measured the length of time living without the cancer spreading to other parts of the body, also called metastasis-free survival (MFS) . The study also measured overall survival (OS) , which is how long a person may live after starting therapy.
ADDING NUBEQA HELPED KEEP nmCRPC IN ITS PLACE
without their prostate cancer spreading to other parts of the body when they added NUBEQA to hormone therapy vs hormone therapy alone
(median † 3.4 years vs 1.5 years) 2X LONGER MEN LIVED
In a clinical trial
NUBEQA HELPS YOU LIVE FOR WHAT YOU LOVE
*Hormone therapy includes drug treatments or surgery that lowers testosterone. † Median is the middle value in a set of numbers, not the average.
31 % LOWER RISK OF DEATH
NUBEQA MAY ALSO HELP YOU LIVE LONGER The study also showed that NUBEQA significantly extended OS compared with hormone therapy*alone. • NUBEQA extended OS by lowering the risk of death by 31% compared with hormone therapy alone
IMPORTANT SAFETY INFORMATION (continued) Before taking NUBEQA, tell your healthcare provider about all your medical conditions, including if you (continued): • have a partner who may become pregnant. Males who have female partners who may become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of NUBEQA. Talk with your healthcare provider about birth control methods • are breastfeeding or plan to breastfeed. It is not known if NUBEQA passes into breast milk
*Hormone therapy includes drug treatments or surgery that lowers testosterone.
Please see additional Important Safety Information throughout and the full Prescribing Information.
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CHOOSING NUBEQA
ADDING NUBEQA TO HORMONE THERAPY* OFFERS MEN OTHER BENEFITS
NUBEQA GAVE MEN MORE TIME WITHOUT PAIN In the same clinical trial, hormone therapy + NUBEQA relieved pain by nearly 15 months longer than hormone therapy alone.
NUBEQA LOWERED PSA LEVELS In a clinical trial, nearly 25% of men treated with NUBEQA + hormone therapy had PSA levels low enough that they could not be measured compared with men who took hormone therapy alone.
40.3 MONTHS
Hormone Therapy + NUBEQA
25.4 MONTHS
Hormone Therapy Alone
0
10
20
30
40
Months (median † )
NUBEQA CAN DELAY THE START OF CHEMOTHERAPY Also in the clinical trial, more men on hormone therapy + NUBEQA had not started chemotherapy at 3 years compared with men who stayed on hormone therapy alone.
83 % Hormone therapy + NUBEQA
75 % Hormone therapy alone
IMPORTANT SAFETY INFORMATION (continued) Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NUBEQA may affect the way other medicines work and other medicines may affect how NUBEQA works. You should not start or stop any medicine before you talk with the healthcare provider that prescribed NUBEQA.
vs
Please see additional Important Safety Information throughout and the full Prescribing Information.
*Hormone therapy includes drug treatments or surgery that lowers testosterone. † Median is the middle value in a set of numbers, not the average.
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CHOOSING NUBEQA
POSSIBLE SIDE EFFECTS WITH NUBEQA
NUBEQA may cause fertility problems in males, which may affect their ability to father children. Talk to your healthcare provider if you have concerns about fertility. COMMON SIDE EFFECTS WITH NUBEQA The most common side effects of hormone therapy + NUBEQA vs hormone therapy* alone are: • Increase in liver function tests (AST increased; 23% vs 14% on hormone therapy alone) • Decreased white blood cells (neutropenia; 20% vs 9% on hormone therapy alone) • Feeling more tired than usual (16% vs 11% on hormone therapy alone) • Increase in liver function tests (bilirubin increased; 16% vs 7% on hormone therapy alone) • Pain in arm, leg, hand, or foot (6% vs 3% on hormone therapy alone) • Rash (4% vs 1.4% on hormone therapy alone) Overall, serious side effects with NUBEQA were moderately higher than those with hormone therapy alone. • Serious side effects happened in 25% of men who added NUBEQA to hormone therapy compared with 20% who took hormone therapy alone • Serious side effects that happened in 1% or more of men who added NUBEQA to their hormone therapy included: not being able to urinate completely, pneumonia, and blood in the urine
Sometimes side effects can cause a person to stop treatment when another treatment is added. IN A CLINICAL STUDY, THE TOLERABILITY PROFILE OF NUBEQA ENABLED MOST PATIENTS TO STAY ON THERAPY There was no difference in the percentage of men (9%) who permanently stopped treatment due to side effects between those who took hormone therapy* + NUBEQA and those who took hormone therapy alone. That means that most men (more than 90%) did not permanently stop taking NUBEQA due to side effects, similar to men who took hormone therapy alone. • Side effects that caused men to permanently stop taking NUBEQA were heart failure (0.4%) and death (0.4%) 13% of men had to stop taking NUBEQA and then start it again because of side effects. • The most common side effects that caused men to stop taking NUBEQA and then start it again were high blood pressure (hypertension; 0.6%), diarrhea (0.5%), and pneumonia (0.5%) 6% of men taking NUBEQA had to reduce their dosage because of side effects. • The most common side effects that caused men to reduce their dosage included fatigue (0.7%), high blood pressure (hypertension; 0.3%), and nausea (0.3%) TALK TO YOUR DOCTOR ABOUT THE MEDICINES YOU ARE TAKING Although NUBEQA has a limited potential to interfere with other medicines, it may interfere with some medicines you are taking. So be sure to tell your doctor about all the medicines you are taking, including over-the-counter medicines and supplements.
*Hormone therapy includes drug treatments or surgery that lowers testosterone.
IN A CLINICAL TRIAL
When NUBEQA was added to hormone therapy, MOST MEN (84%) DID NOT REPORT FEELING MORE TIRED THAN USUAL
(Men who did feel more tired than usual: 16% vs 11% on hormone therapy alone)
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CHOOSING NUBEQA
HOW TO TAKE NUBEQA
FOLLOW YOUR DOCTOR’S INSTRUCTIONS WHILE TAKING NUBEQA
TAKE NUBEQA EXACTLY AS YOUR DOCTOR TELLS YOU
TAKE YOUR PRESCRIBED DOSE OF NUBEQA 2 TIMES A DAY WITH FOOD
• Your doctor may change your dose if needed. Do not stop taking your prescribed dose of NUBEQA without talking with your doctor first • You should continue hormone therapy* during your treatment with NUBEQA unless you had surgery to lower the amount of testosterone in your body (surgical castration) • If you take more NUBEQA than prescribed, call your healthcare provider right away
Morning with food
Evening with food
Pills not actual size.
The recommended dose of NUBEQA is 600 mg (two 300 mg tablets) taken by mouth, twice daily. • Swallow NUBEQA tablets whole • If you miss a dose of NUBEQA, take your normal dose as soon as possible prior to the next scheduled dose — Return to your normal schedule on the following day. Do not take 2 doses together to make up for a missed dose
Set a reminder on your phone or put the NUBEQA magnet on your refrigerator to remind you when to take NUBEQA
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IMPORTANT SAFETY INFORMATION (continued) Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine. NUBEQA may cause serious side effects, including: • Heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with NUBEQA. Your healthcare provider will monitor you for signs and symptoms of heart problems during your treatment with NUBEQA. Call your healthcare provider or get medical help right away if you get chest pain or discomfort at rest or with activity, or shortness of breath during your treatment with NUBEQA
NUBEQA HELPS YOU LIVE FOR WHAT YOU LOVE See overall survival data on page 8
*Hormone therapy includes drug treatments or surgery that lowers testosterone.
Please see additional Important Safety Information throughout and the full Prescribing Information.
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CHOOSING NUBEQA
SUPPORT SERVICES FOR MEN TAKING NUBEQA
ACCESS SERVICES BY BAYER™ IS HERE TO HELP With a range of services and resources to support you, including:
ACCESS SERVICES BY BAYER IS HERE TO HELP FIND THE FINANCIAL ASSISTANCE THAT IS RIGHT FOR YOU
NUBEQA Free Trial Program Patients who are NEW to NUBEQA can get 1 month of free medication †
Access to a nurse who can answer
Assistance to help you
Connecting you with financial assistance to help pay for NUBEQA
Assistance with insurance coverage barriers
NUBEQA $0 Co-Pay Program —for eligible patients with insurance through an employer or insurance they have purchased themselves (also known as commercial or private insurance). ‡
understand your insurance benefits for NUBEQA
treatment questions
Check to see if you are eligible for the Nubeqa Copay Program by clicking here.
† The NUBEQA Free Trial Program provides 1 month’s supply of NUBEQA at no cost to patients who meet the program eligibility requirements and agree to the terms and conditions. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374. ‡ Restrictions may apply. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374 or visit NUBEQAcopayprogram.com. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the co-payment support provided under this program, eg, co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, as required Referral to Bayer US Patient Assistance Foundation —provides free medicine for patients who are uninsured or underinsured and meet certain eligibility criteria. § Referrals to charitable foundations —may be able to help patients with government-sponsored insurance (such as Medicare, Medigap, Medicaid, VA/DoD health plans, and TRICARE) with out-of-pocket costs. • Patient Access Specialists can verify your coverage for NUBEQA and provide information about any available foundations
To find out more about how these programs and other support services can help, call:
MONDAY-FRIDAY, 9:00 am -6:00 pm (ET) 1-800-288-8374
Save the Access Services by Bayer number in your phone so it doesn’t appear as spam, and answer all calls from the program
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by contract or otherwise. Void where prohibited by law, taxed, or restricted. Eligibility and participation are subject to review and may be modified or discontinued at any time. § Bayer provides NUBEQA free of charge for eligible patients who are uninsured or underinsured. In order to qualify for assistance, you must meet certain eligibility criteria.
Please see additional Important Safety Information throughout and the full Prescribing Information.
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MORE INFORMATION
FOR PEOPLE WHO CARE FOR SOMEONE WITH PROSTATE CANCER
WHERE TO FIND MORE INFORMATION
THE FOLLOWING ORGANIZATIONS OFFER PATIENT AND CAREGIVER SUPPORT
CANCERABCs ™ www.cancerabcs.org 1-516-445-2026 CANCER care ® www.cancercare.org 1-800-813-HOPE (1-800-813-4673)
PROSTATE CANCER INTERNATIONAL www.pcainternational.org www.prostatecancerinfolink.net PROSTATE CANCER RESEARCH INSTITUTE (PCRI) www.pcri.org 1-310-743-2116 PROSTATE CONDITIONS EDUCATION COUNCIL (PCEC) www.prostateconditions.org 1-866-4PROST8 (1-866-477-6788) PROSTATE HEALTH EDUCATION NETWORK (PHEN) www.prostatehealthed.org 1-617-481-4020
TAKE CARE OF YOURSELF Caring for a person with cancer can be difficult. You may have many feelings that can affect you in many ways. It’s important to make sure you care for yourself as well. Taking care of yourself will help you to give the best support to your loved one.
CANCER SUPPORT COMMUNITY www.cancersupportcommunity.org 1-888-793-9355
Here are some ways to deal with the stress of caring for someone with cancer:
MALECARE www.malecare.org 1-212-673-4920 PROSTATE CANCER FOUNDATION www.pcf.org 1-800-757-CURE (1-800-757-2873)
Ask for help from family and friends in caring for your loved one
Eat healthy and exercise
Do things you enjoy and get out of the house; for example, meet a friend for lunch or take a walk
Seek out help from a support group or mental health professional
ZERO—THE END OF PROSTATE CANCER www.zerocancer.org 1-202-463-9455
Ask your doctor for a NUBEQA patient starter kit for additional support and reminders
Several of the organizations listed on the next page have resources for caregivers. The booklet “Caregiving for a Loved One With Prostate Cancer” and other resources are available from CANCER care ® at www.cancercare.org/publications.
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MORE INFORMATION
WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR?
MY TREATMENT TEAM
ONCOLOGIST Name
Take a minute to answer the questions below so that you can discuss with your doctor how NUBEQA can fit into your current lifestyle.
Phone #
How often are you able to exercise with your current hormone therapy?*
UROLOGIST Name
Phone #
How do you like to spend your free time?
PRIMARY CARE DOCTOR Name
Are you able to spend a lot of time with family and friends?
Phone #
NURSE Name
Do any side effects prevent you from enjoying your daily activities?
Phone #
Do you have a routine meal schedule?
CAREGIVER Name
Phone #
What other medical conditions do you have?
SPECIALTY PHARMACY Name
Phone #
What other medicines do you take?
Some men find it helpful to learn as much as possible about their cancer. See page 19 of this brochure for a list of organizations that offer information about cancer
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*Hormone therapy includes drug treatments or surgery that lowers testosterone.
21
MORE INFORMATION
NOTES
GLOSSARY
Castration-resistant (CR): Prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels. Hormone therapy: Includes gonadotropin-releasing hormone (GnRH), such as Lupron Depot ® (drug treatment), or surgery that lowers testosterone. Metastasis: The spread of cancer to other parts of the body. Metastasis-free survival (MFS): A term used to define how long a man lives before his prostate cancer spreads to other parts of his body. Overall survival (OS): How long a person may live after starting therapy. Prostate-specific antigen (PSA): PSA is a protein found in the blood. It is used to track changes in prostate cancer. Testosterone: Called the “male hormone,” it is an androgen-type hormone that causes men’s secondary sexual characteristics to develop. In men with prostate cancer, testosterone can also cause the cancer to grow and spread.
TAKE TIME TO ENJOY THE LITTLE THINGS. advice from a prostate cancer patient
IMPORTANT SAFETY INFORMATION (continued) NUBEQA may cause serious side effects, including (continued): • Seizure. Treatment with NUBEQA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure The most common side effects of NUBEQA in people with nmCRPC include:
IT’S IMPORTANT TO STAY POSITIVE. advice from a caregiver
• increase in liver function tests • decreased white blood cells (neutropenia)
• feeling more tired than usual • arm, leg, hand, or foot pain • rash
Please see additional Important Safety Information throughout and the full Prescribing Information.
23
IMPORTANT FACTS ABOUT NUBEQA ® (darolutamide) tablets
Pronounced new-BEH-kah
WHAT IS NUBEQA? NUBEQA is a prescription medicine used to treat adults with prostate cancer: • That has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone (non-metastatic castration-resistant prostate cancer or nmCRPC), or • That has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (metastatic hormone-sensitive prostate cancer or mHSPC), in combination with docetaxel It is not known if NUBEQA is safe and effective in females or children. WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE TAKING NUBEQA? Tell your healthcare provider about all your medical conditions, including if you:
WHAT ARE THE POSSIBLE SIDE EFFECTS OF NUBEQA? NUBEQA may cause serious side effects, including:
• Heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with NUBEQA. Your healthcare provider will monitor you for signs and symptoms of heart problems during your treatment with NUBEQA. Call your healthcare provider or get medical help right away if you get chest pain or discomfort at rest or with activity, or shortness of breath during your treatment with NUBEQA. • Seizure. Treatment with NUBEQA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure. The most common side effects of NUBEQA in people with nmCRPC include:
• Increase in liver function tests • Decreased white blood cells (neutropenia) • Feeling more tired than usual
• Arm, leg, hand or foot pain • Rash
• Have a partner who may become pregnant. Males who have female partners who may become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of NUBEQA. Talk with your healthcare provider about birth control methods • Are breastfeeding or plan to breastfeed. It is not known if NUBEQA passes into breast milk
• Have heart problems, high blood pressure, diabetes, or high amounts of fat or cholesterol in your blood (dyslipidemia) • Have a history of seizures, brain injury, stroke, or brain tumors • Have kidney or liver problems • Are pregnant or plan to become pregnant. NUBEQA can cause harm to your unborn baby and loss of pregnancy (miscarriage)
The most common side effects of NUBEQA when used in combination with docetaxel in people with mHSPC include:
• Constipation • Rash • Decreased appetite • Bleeding • Weight gain • High blood pressure
• Decreased red blood cells (anemia) • High blood sugar levels • Decreased white blood cells • Increase in liver function tests • Low blood calcium levels
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NUBEQA may affect the way other medicines work and other medicines may affect how NUBEQA works. You should not start or stop any medicine before you talk with the healthcare provider that prescribed NUBEQA. Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine. HOW SHOULD I TAKE NUBEQA? • Take NUBEQA exactly as your healthcare provider tells you • Your healthcare provider may change your dose, temporarily stop, or completely stop your treatment with NUBEQA if you have certain side effects • Take your prescribed dose of NUBEQA 2 times a day with food • Swallow NUBEQA tablets whole • If you are receiving gonadotropin-releasing hormone (GnRH) analog therapy, you should continue with this treatment during your treatment with NUBEQA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration) • If you miss a dose of NUBEQA, take your normal dose as soon as possible before your next scheduled dose. Do not take 2 doses together to make up for a missed dose • If you take more NUBEQA than prescribed, call your healthcare provider right away
NUBEQA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of NUBEQA. Call your doctor for medical advice about side effects. HOW SHOULD I STORE NUBEQA? • Store NUBEQA at room temperature between 68°F to 77°F (20°C to 25°C) • Keep the bottle tightly closed after you first open it Keep NUBEQA and all medicines out of the reach of children. The information provided here is not comprehensive. TO LEARN MORE ABOUT NUBEQA: • Talk to your healthcare provider or pharmacist • Visit NUBEQA.com to obtain the FDA-approved product labeling • Call 1-888-842-2937
Please see additional Important Safety Information throughout and the full Prescribing Information.
25
NUBEQA HELPS YOU LIVE FOR WHAT YOU LOVE
Learn more at NUBEQA.com.
NUBEQA clinical study was designed to measure metastasis-free survival (MFS) and also overall survival (OS). NUBEQA extended OS by lowering the risk of death by 31% compared with hormone therapy alone. IMPORTANT SAFETY INFORMATION (continued) The most common side effects of NUBEQA in people with nmCRPC include (continued): NUBEQA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of NUBEQA. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see additional Important Safety Information throughout and the full Prescribing Information.
© 2023 Bayer. All rights reserved. BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer, and Access Services by Bayer is a trademark of Bayer. PP-NUB-US-2560-1 11/23
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