your guide to differentiated thyroid cancer and

A resource for patients with differentiated thyroid carcinoma (DTC, a type of thyroid cancer)

that can no longer be treated with radioactive iodine (RAI) and is progressing

Please see additional Important Safety Information throughout this brochure. For important risk and use information, please click here for the full Prescribing Information.

NEXAVAR® (sorafenib) has not been studied in children.

Pictures are for illustrative purposes only, not an actual patient.

Your Guide to Differentiated

Thyroid Cancer and

http://labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf

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Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Living with Differentiated Thyroid Cancer (DTC) . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Getting Started with NEXAVAR® (sorafenib) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

How to Take NEXAVAR® (sorafenib) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Treatment Tracker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Side Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Your DTC Treatment Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Financial Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Helping Yourself . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

NEXAVAR is a prescription medicine used to treat a type of thyroid cancer called differentiated thyroid carcinoma (DTC) that can no longer be treated with radioactive iodine and is progressing.

Table of Contents


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Important Safety InformationWhat is NEXAVAR® (sorafenib)?

NEXAVAR is a prescription medicine used to treat: a type of liver cancer called hepatocellular carcinoma (HCC) that cannot be removed by surgerya type of kidney cancer called renal cell carcinoma (RCC) a type of thyroid cancer called differentiated thyroid carcinoma (DTC) that can no longer be treated with radioactive iodine and is progressing

It is not known if NEXAVAR is safe and effective in children.

Important Safety Information

Do not take NEXAVAR if you:

are allergic to sorafenib or any of the other ingredients in NEXAVAR. have squamous cell lung cancer and receive carboplatin and paclitaxel.

Before taking NEXAVAR, tell your healthcare provider about all of your medical conditions, including if you:

have heart problems including a condition called “congenital long QT syndrome”have chest pain have abnormal magnesium, potassium, or calcium blood levels have bleeding problems have high blood pressure plan to have surgery or have had a recent surgery. You should stop taking NEXAVAR at least 2 weeks before planned surgery. are pregnant or plan to become pregnant. NEXAVAR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with NEXAVAR.

For females who are able to become pregnant:

o Your healthcare provider should do a pregnancy test before you start treatment with NEXAVAR. o Use effective birth control (contraception) during your treatment with NEXAVAR and for 6 months after the

last dose of NEXAVAR.

For males with female partners who are able to become pregnant:

o Use effective birth control (contraception) during your treatment with NEXAVAR and for 3 months after the last dose of NEXAVAR.

o NEXAVAR may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

are breastfeeding or plan to breastfeed. It is not known if NEXAVAR passes into your breast milk. Do not breastfeed during treatment with NEXAVAR and for 2 weeks after receiving the last dose of NEXAVAR.

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 the medicine warfarin.


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Important Safety Information (cont)What are the possible side effects of NEXAVAR® (sorafenib)?

NEXAVAR may cause serious side effects, including:

decreased blood flow to the heart, heart attack and heart failure. Get emergency help right away if you get symptoms such as chest pain, shortness of breath, racing heartbeat, swelling in lower legs, feet and abdomen, feel lightheaded or faint, tiredness, nausea, vomiting, or sweat a lot.

increased risk of bleeding. Bleeding is a common side effect of NEXAVAR that can be serious and can lead to death. Tell your healthcare provider right away if you have any signs of bleeding during treatment with NEXAVAR:

high blood pressure. High blood pressure is a common side effect of NEXAVAR and can be serious. Your blood pressure should be checked every week during the first 6 weeks of starting NEXAVAR. Your blood pressure should be checked regularly and any high blood pressure should be treated during treatment with NEXAVAR.

skin problems. A condition called hand-foot skin reactions and skin rash are common with NEXAVAR treatment and can be severe. NEXAVAR may also cause severe skin and mouth reactions that can be life threatening. Tell your healthcare provider if you have any of the following symptoms:

o skin rash o skin redness o pain or swelling o blistering and peeling of your skin o blistering and peeling on the inside of your mouth o blisters on the palms of your hand or soles of your feet

an opening in the wall of your stomach or intestines (gastrointestinal perforation). Tell your healthcare provider right away if you get fever, nausea, vomiting or severe stomach (abdominal) pain.

risk of wound healing problems. Wounds may not heal properly during NEXAVAR treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with NEXAVAR.

o You should stop taking NEXAVAR at least 10 days before planned surgery. o Your healthcare provider should tell you when you may start taking NEXAVAR again after surgery.

changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider may do tests during your treatment with NEXAVAR to check the levels of potassium, magnesium, and calcium in your blood, and check the electrical activity of your heart with an electrocardiogram (ECG). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy or feel your heart beating irregularly or fast during your treatment with NEXAVAR.

o vomiting blood or if your vomit looks like coffee-groundso pink or brown urineo red or black (looks like tar) stoolso coughing up blood or blood clots

o heavier than normal menstrual cycleo unusual vaginal bleedingo frequent nose bleedso bruising


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liver problems (drug-induced hepatitis). NEXAVAR® (sorafenib) may cause liver problems that may lead to liver failure and death. Your healthcare provider will do blood tests to check your liver function regularly during your treatment with NEXAVAR. Tell your healthcare provider right away if you develop any of the following symptoms:

• change in thyroid hormone levels. If you have differentiated thyroid cancer, you can have changes in your thyroid hormone levels during treatment with NEXAVAR. Your healthcare provider may need to change your dose of thyroid medicine during treatment with NEXAVAR. Your healthcare provider should check your thyroid hormone levels every month during treatment with NEXAVAR.

The most common side effects of NEXAVAR include:

These are not all of the possible side effects of NEXAVAR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Important Safety Information (cont)

o yellowing of your skin or the whites of your eyes o dark “tea-colored” urine o light-colored bowel movements (stools) o worsening nausea or vomiting

o pain on the right side of your stomach area o bleeding or bruising more easily than normal o loss of appetite

o diarrhea (frequent or loose bowel movements) o tirednesso infection o hair thinning or patchy hair losso rash

o weight losso loss of appetiteo nauseao stomach-area (abdomen) paino low blood calcium levels in people with

differentiated thyroid cancer


There are 2 kinds of cells in the thyroid gland:

Follicular cellsThese cells use iodine to make thyroid hormone, which helps regulate metabolism

C cells

These cells make calcitonin, which helps control how your body uses calcium

Thyroid gland

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Living with Differentiated Thyroid Cancer (DTC)DTC is a type of cancer that starts in the cells of the thyroid gland.

The thyroid gland is located below the thyroid cartilage or Adam’s apple. It has 2 lobes joined by a thin piece of tissue and is a little larger than a quarter.

DTC develops from the follicular cells. It is the most common type of thyroid cancer.


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Your treatment for DTC so farSurgery is usually the first step in the treatment of thyroid cancer. You may have had surgery to remove all or part of your thyroid. It is also common to be treated with radioactive iodine, or RAI.You can either take RAI as pills or in a liquid form. The RAI travels to the thyroid and helps destroy cancer cells. It can also help destroy thyroid cancer cells that have spread to other parts of the body.Why your cancer can no longer be treated with RAIRAI is a good treatment option for many people with thyroid cancer. But it does not work in some people, or it stops working. If RAI does not work, the thyroid cancer may progress (spread, grow, or get worse).Also, if you have been treated numerous times with RAI, your healthcare provider may feel you should not take any more. For these reasons, your healthcare provider may feel it is time to try another treatment.Other important treatmentIf you have had thyroid surgery, you will need to take thyroid hormone medication. An example of a thyroid hormone medication is levothyroxine.

Your thyroid hormone medication helps you in 2 ways:

It helps stop remaining cancer cells from growing by controlling another hormone called TSH (thyroid-stimulating hormone).TSH encourages thyroid cells to grow. It also might cause thyroid cancer cells to grow— if any remain.

Taking your thyroid hormone medication will help you keep your TSH levels down. Your healthcare provider will probably monitor your TSH levels from time to time with a blood test.

It provides your body with the missing thyroid hormone that your thyroid gland would normally make. Thyroid hormone helps keep your body running smoothly. It helps regulate your heartbeat, sleep, nerves, appetite, weight, energy levels, and temperature.

CalciumYou may have low calcium levels in your blood due to your thyroid surgery.

Calcium is a very important mineral in the body. Normal levels are needed for healthy bones, teeth, and other body tissues. Calcium helps regulate your nervous system and heart. Low levels can cause muscle spasms, as well as tingling in your hands and feet.

Your healthcare provider will measure your calcium levels from time to time with a blood test. If you need more calcium, you may need to take a calcium tablet and a special form of vitamin D such as calcitriol.


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Pictures are for illustrative purposes only, not an actual patient.

NEXAVAR has not been studied in children.Please see additional Important Safety Information throughout this brochure. For important risk and use information, please click here for the full Prescribing Information.

You have been prescribed NEXAVAR for differentiated thyroid cancer (DTC) that can no longer be treated with radioactive iodine and is progressing (growing, spreading, or getting worse).

Living with thyroid cancer can be challenging at times. This resource can help answer some of your questions about NEXAVAR, such as how to take it, what to do about side effects, and how the members of your treatment team will help you along the way. It also contains useful facts about thyroid cancer and provides a place to take notes and record key information, so you’ll want to keep it in a safe place.

This resource does not take the place of talking to your doctor or other members of your healthcare team. If you have questions or concerns about NEXAVAR, talk to one of them first.

Getting Started with NEXAVAR® (sorafenib)


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Recommended daily dose

2 tablets, 2 times a day, taken 12 hours apart

Taken by mouth, without food

1 HOUR BEFORE or 2 HOURS AFTER a meal

Tablets shown are not actual size.

Pictures are for illustrative purposes only, not an actual doctor.

How to Take NEXAVAR® (sorafenib)

NEXAVAR is only available by prescription. You can get NEXAVAR from your healthcare provider,

hospital, or specialty pharmacy provider (SPP).

NEXAVAR is a prescription medicine used to treat a type of thyroid cancer called differentiated thyroid carcinoma (DTC) that can no longer be treated with radioactive iodine and is progressing.Tablets shown are not actual size.

The image below describes how most people take NEXAVAR. Your healthcare provider will tell you if

you should take NEXAVAR in a different way.



Forgot?

J F M A

M J J A

S O N D

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After a while, taking NEXAVAR should become part of your daily routine. If you need help remembering to take your dose, set up reminders. Maybe set the alarm to go off on your cell phone, or ask someone to remind you.

How to Remember to Take Your NEXAVAR

If you take too much NEXAVAR, call your healthcare provider or go to the nearest hospital emergency room right away.

Your healthcare provider may change your dose, temporarily stop treatment, or completely stop treatment if you have side effects.

If you miss a dose of NEXAVAR® (sorafenib), skip the missed dose and take your next dose at your regular time. Do not double your dose of NEXAVAR.

In a clinical study, people with your type of cancer took NEXAVAR for an average of nearly 11 months. Some people took NEXAVAR for a few days and some took it for over 2.5 years.

How Long Will I Take NEXAVAR?


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1st #pills______ AM #pills______ PM

2nd #pills______ AM #pills______ PM

3rd #pills______ AM #pills______ PM

4th #pills______ AM #pills______ PM


















22nd #pills______ AM #pills______ PM

23rd #pills______ AM #pills______ PM









Treatment Tracker Month _____________________

Day Day

Any change in dose? If yes, what is your new dose?

Additional MedicationsTell your healthcare provider about all the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements. Do not take other medicines with NEXAVAR® (sorafenib) until you have talked with your healthcare provider. List all other medications you are currently taking (including OTC and herbal):

Medication How much? How often?


Weight loss

Rash

Diarrhea (frequent or loose bowel movements)

Hair thinning or patchy hair loss

Tiredness

Ca Ca

Low blood calcium levels in people with DTC

Loss of appetite

Nausea

Stomach (abdominal) pain

Infection

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It is important for you to know about the side effects of NEXAVAR.

Some side effects, such as high blood pressure, hand-foot skin reaction, and rash usually occur early in therapy.

Ask your healthcare provider for medical advice about side effects.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider if you have any side effects that bother you or do not go away. These are not all the possible side effects of NEXAVAR® (sorafenib). Ask your doctor or pharmacist for more information.

The Most Common Side Effects Include:


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Here is more information about one of the most common side effects of NEXAVAR® (sorafenib). At the first sign of developing a reaction, tell your healthcare provider. If your HFSR worsens, your healthcare provider may have you take less NEXAVAR or tell you to stop taking NEXAVAR for a short time. Many people who take NEXAVAR have their dose lowered. In serious cases, your healthcare provider will have you stop taking NEXAVAR permanently.

Hand-foot skin reaction (HFSR)

What is it?HFSR is a skin problem that causes the following symptoms on the palms of the hands and/or soles of the feet:

• Redness• Pain• Swelling• Blisters

Most of the time, HFSR happens in the first 6 weeks of treatment, but it can happen at any time throughout the course of treatment.

If HFSR becomes severe, you may experience:

• Cracked, flaking, or peeling skin• Blisters, ulcers, or sores on your skin• Severe pain• Difficulty walking or using your hands

Information About a Common Side Effect Called Hand-foot Skin Reaction (HFSR)


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What Hand-foot Skin Reaction (HFSR) Looks Like:

Photos courtesy of Elizabeth Manchen, RN, MS, OCN.Reproduced with the patients’ permission.

Grade 1: Mild Grade 2: Moderate Grade 3: Severe

Your healthcare provider may also give you another medicine to treat the skin problems, or send you to a skin doctor, called a dermatologist (der-ma-TOL-o-jist), who can help you with these skin problems.

Some of the things you can do for managing HFSR

• At the first sign of developing a reaction, tell your healthcare provider. Your healthcare provider may change your dose, interrupt treatment for a while, or stop your treatment permanently

• Gently apply skin care creams to your hands and feet

• Avoid hot water as much as you can (for instance when doing the dishes or taking a shower)

• Wear loose clothes and shoes with padded insoles

• During activity, wear thick cotton socks and gloves and keep your palms and soles dry

• You can also wear cotton gloves and socks at night to retain moisture

• Cool your hands and feet with ice packs or cool compresses for 15 minutes at a time, but don’t apply ice directly to your skin


Surgeon: A doctor who removes or repairs a part of the body by operating on the patient

Otolaryngologist: A doctor who specializes in treating diseases of the ear, nose, and throat. Also called an ENT specialist

Radiation Oncologist: A doctor who uses radiation to treat cancer

Endocrinologist: A doctor who treats diseases in glands that secrete hormones, such as the thyroid gland

Nuclear Medicine Specialist: A doctor who uses small amounts of radioactive substances to make pictures of areas inside the body and to treat disease

Oncology Nurse: A nurse who specializes in treating and caring for people with cancer

Medical Oncologist: A doctor who uses chemotherapy and other medicines like NEXAVAR® (sorafenib) to treat cancer. The medical oncologist may be your main treatment provider

Nurse Practitioner (NP) or Physician Assistant (PA): Medical professionals trained to work closely with your doctors. They assess and manage the signs and symptoms of illness, and may be the person who examines you in the doctor’s office

Dispensing Pharmacist: A person who is licensed to dispense prescription drugs, and who has been taught how they work, how to use them, and what their side effects are

Additional Professionals may join your healthcare team as needed. They may include social workers, psychologists, financial counselors, and dietitians, among others

Oncology Pharmacy Specialist: A licensed pharmacist with special training in how to prepare, give, monitor, and change chemotherapy for cancer patients

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Your DTC Treatment TeamTeam members may include:


REACH®Resources for Expert Assistance and Care Helpline

Patient Starter Kit

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Resources for NEXAVAR® (sorafenib) Patients

Government Insured(eg, Medicare, Medicaid, Military)

Uninsured/Underinsured

Bayer US Patient Assistance Foundation

• Information on Part D prescription drug plans

• Financial assistance may be available through independent charitable organizations

• Alternate funding options

• Bayer US Patient Assistance Foundation is a charitable organization that helps eligible patients get Bayer prescription medicine at no cost

• If you cannot afford your prescription medication, Bayer may be able to help

• Visit the foundation website at www.patientassistance.bayer.us for information to see if you may qualify for assistance

• Alternate funding options

Call REACH to speak to a service counselor

1.866.639.2827Monday-Friday, 9 am-8 pm EST/EDT


Eligible NEXAVAR patients have the opportunity to enroll in the REACH® (Resources for Expert Assistance and Care Helpline) program sponsored by Bayer.

REACH is a valuable resource for patient education and support, as well as access to financial assistance for qualified patients.

For more information, please visit www.REACHPatientSupport.com.

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Make NEXAVAR® (sorafenib) Accessible to Patients with Well-rounded Support Programs

Help Smooth the Way to Treatment

• NEXAVAR has broad insurance coverage

• $0 Co-pay program saves each eligible patient up to $25,000 per year. You may enroll your eligible patients for the $0 Co-pay program by phone or through our website: 1.866.581.4992 or www.zerocopaysupport.com

• REACH is a free support program that provides patient education and assistance with patient access. Nurse Counselors are available to answer questions and provide education and guidance about most common AEs and when to alert the physician to determine if adjustments are needed

• REACH provides reimbursement support, including benefit verification, prior authorization, alternate coverage research, and a network of Specialty Pharmacy Providers (SPPs): 1.866.639.2827

NO monthly cap and up to $25,000 per year for privately insured patients.Annual enrollment is required.*

To enroll in REACH or for more information, contact your sales representative or call 1.866.639.2827 Visit us online at www.nexavar-us.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, e.g., co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payors of any benefits they receive and the value of this program, and may not participate if this program is prohibited by or conflicts with their private insurance policy, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Patients enrolled in Bayer’s Patient Assistance Program are not eligible. Bayer may determine eligibility, monitor participation, equitably distribute product and modify or discontinue any aspect of the REACH program at any time, including but not limited to this commercial co-pay assistance program.


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Helping YourselfStay as healthy as you canControl what you can about your health. Try to eat a healthy diet, get enough sleep, and exercise as often as you can.

Cancer can make you feel tired and weak. Exercise and “resistance training” may help. Do what you can, even if it’s just taking a walk every day. If walking is difficult, sit in a chair and move your muscles by pushing against something that offers resistance, like an elastic band.

Exercise may help improve your mood.

Prepare for your appointmentsKeep an up-to-date calendar to track your appointment. Use the Monthly Treatment Tracker in this booklet. Beforehand, write down any changes or symptoms you have noticed since your last visit—both physical and emotional.

Write down the questions you want to ask so you won’t forget them. It’s often good to have someone go with you to the visit. They can help you remember everything you need to say—get all your questions answered—take notes—and remember any instructions.

Bring something to keep you busy if you have to wait at the healthcare provider’s office.

Speak upSometimes it is hard to remember everything your healthcare provider tells you. When you have an appointment, take a family member or friend with you—two sets of ears are better than one. Take notes. Ask your healthcare provider to explain anything you don’t understand. Speak up and be your own advocate—

let your healthcare provider know what you need.


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Notes:


For more information, please visit

www.nexavar-us.com.

© 2020 Bayer. All rights reserved.100 Bayer Boulevard, PO Box 915, Whippany, NJ 07981 USABayer, the Bayer Cross, NEXAVAR, and REACH are registered trademarks of Bayer.PP-NEX-US-0509-1 07/20

Listed registered trademarks are owned by their respective companies.

your guide to differentiated thyroid cancer and

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