TYKERB® (lapatinib) | HR+ Metastatic Breast Cancer

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING AND APPROVED USE:

Some people may develop liver damage while taking TYKERB. Liver problems can be severe and deaths have happened. Before taking TYKERB, tell your doctor if you have liver problems. You may need a lower dose of TYKERB. Your doctor should do blood tests to check your liver before and during treatment with TYKERB. You should contact your doctor right away if you have itching, yellowing of your skin or the white part of your eyes, dark urine, pain, or pain or discomfort in the right upper stomach area.

Do not take TYKERB if you are allergic to any of the ingredients in TYKERB.

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

Before taking TYKERB, tell your doctor if you have heart problems. Some people may develop heart problems while taking TYKERB, including decreased pumping of blood from the heart and an abnormal heartbeat. Call your doctor right away if you feel like your heart is pounding or racing; if you are dizzy, tired, or light-headed; or if you are short of breath. Your doctor should check your heart before and during treatment with TYKERB.

Diarrhea is common with TYKERB and may sometimes be severe. Severe diarrhea can cause loss of fluid (dehydration) and some deaths have happened. Call your doctor right away if you have a change in bowel pattern or if you have severe diarrhea. Follow your doctor’s instructions for what to do to help prevent or treat diarrhea.

If you have a cough that will not go away or are short of breath, talk with your doctor. These may be signs of lung problems.

TYKERB may cause severe skin reactions. If you develop skin rash; red skin; blistering of the lips, eyes, or mouth; peeling skin; fever; or any combination of these, tell your doctor right away. As severe skin reactions can be life-threatening, your doctor may tell you to stop taking TYKERB.

Tell your doctor right away if you are or plan to become pregnant. TYKERB can harm your unborn baby. Your doctor should check to see if you are pregnant before you start taking TYKERB. You should use effective birth control (contraception) during treatment with TYKERB and for 1 week after the last dose of TYKERB. Tell your doctor right away if you become pregnant during treatment with TYKERB. Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with TYKERB and for 1 week after the last dose of TYKERB. Talk to your doctor about the best way to feed your baby if you breastfeed. Males with female partners who are able to become pregnant should use effective contraception during treatment with TYKERB and for 1 week after the last dose. Talk to your doctor right away if your female partner becomes pregnant during treatment with TYKERB.

Common side effects of TYKERB include diarrhea; red, painful hands and feet; nausea; rash; vomiting; inflamed mouth, digestive tract, and airways; mouth sores; headache; unusual hair loss or thinning; shortness of breath; dry skin; itching; tiredness; painful arms, legs, and back; loss of appetite; indigestion; nosebleeds; nail disorders such as nail bed changes, nail pain, infection, and swelling of the cuticles; and difficulty sleeping.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not eat or drink grapefruit products while taking TYKERB.

Please see accompanying full Prescribing Information, including Patient Information, which includes a discussion of the risks with TYKERB, including serious liver problems.

Approved Use:

TYKERB^® (lapatinib) tablets is a prescription medicine used with the medicine letrozole to treat women who:

have gone through the change of life (postmenopausal), and
who have metastatic breast cancer that is hormone receptor-positive, HER2-positive (tumors that produce large amounts of a protein called human epidermal growth factor receptor-2), and hormonal therapy is a treatment option for them

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Prescribing Info including Patient info

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Important Safety Information, including Boxed WARNING:

Approved Use:

TYKERB^® (lapatinib) tablets is a prescription medicine used with the medicine letrozole to treat women who:

have gone through the change of life (postmenopausal), and
who have metastatic breast cancer that is hormone receptor-positive, HER2-positive (tumors that produce large amounts of...

Important Safety Information, including Boxed WARNING:

Do not take TYKERB if you are allergic to any of the ingredients in TYKERB.

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

If you have a cough that will not go away or are short of breath, talk with your doctor. These may be signs of lung problems.

Please see accompanying full Prescribing Information, including Patient Information, which includes a discussion of the risks with TYKERB, including serious liver problems.

Approved Use:

TYKERB^® (lapatinib) tablets is a prescription medicine used with the medicine letrozole to treat women who:

have gone through the change of life (postmenopausal), and
who have metastatic breast cancer that is hormone receptor-positive, HER2-positive (tumors that produce large amounts of a protein called human epidermal growth factor receptor-2), and hormonal therapy is a treatment option for them

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About treatment

TYKERB^® (lapatinib) tablets is designed to inhibit HER2 receptors

HER2 is a type of protein found on normal cells as well as breast cancer cells
In women with HER2+ breast cancer, the breast cancer cells have too many HER2 receptors (designated as HER2+)
When these HER2 receptors join together, they direct cancer cells to grow and divide

TYKERB works inside cancer cells to block HER2 receptors

TYKERB is a small molecule that passes through the surface of cells and may help block HER2 receptor activity
Once inside the cell, TYKERB binds to the HER2 protein receptor inside the cell

When tested in animals and in human breast cancer cells grown outside the body, TYKERB blocked HER2 receptors and cell growth.

Getting Started

Take time to learn about TYKERB

Be sure you understand how to take TYKERB with letrozole according to your doctor's directions. If you have any questions, contact your doctor or nurse. This is important for fighting your cancer

Tell your doctor

Before you take TYKERB, tell your doctor if you:

Have heart problems
Have liver problems. You may need a lower dose of TYKERB
Have any other medical conditions
Are pregnant or plan to become pregnant. TYKERB can harm your unborn baby. You should not become pregnant while taking TYKERB. Tell your doctor right away if you become pregnant during treatment with TYKERB
Are breastfeeding or plan to breastfeed. It is not known if TYKERB passes into your breast milk. You and your doctor should decide if you will take TYKERB or breastfeed. You should not do both

Tell your doctor about the medicines

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TYKERB may affect the way other medicines work, and other medicines may affect the way TYKERB works. Especially tell your doctor if you take:

Antibiotics and antifungal medicines (used to treat infections)
HIV medicines
Medicines used to treat seizures
Medicines used to treat heart problems or high blood pressure
Antidepressants
Medicines that reduce stomach acid (antacids)
St John’s wort

Talk to your doctor about side effects.

It is important to know that you may experience side effects while taking TYKERB.

Always speak with your doctor or nurse about any side effects you have while taking TYKERB.

Your Regimen

TYKERB is an oral medicine

Take 6 tablets of TYKERB all at once, one time a day, every day (unless your doctor directs otherwise)
You take TYKERB by mouth with a glass of water
Do not crush, break, or chew tablets
You can take TYKERB at home or wherever you happen to be—you don't need to go to the doctor’s office or clinic
Take TYKERB on an empty stomach (at least 1 hour before or 1 hour after a meal)
Do not eat or drink grapefruit products during treatment with TYKERB. Grapefruit may increase the amount of TYKERB in your blood
If you miss a dose of TYKERB, take your next dose at your regular time the next day. Do not take 2 doses at 1 time
If you take too much TYKERB, call your doctor or go to the nearest hospital emergency room right away

When taking TYKERB with letrozole:

Take your prescribed dose of TYKERB tablets together and at the same time every day
Your doctor will tell you the dose of letrozole you should take and when you should take it
The recommended dose of letrozole while taking TYKERB is 1 tablet, once a day
Take TYKERB on an empty stomach (at least 1 hour before or 1 hour after a meal)
You can take letrozole on an empty or full stomach
Continue this regimen as directed by your doctor
Talk to your doctor if you have any questions about your treatment or experience any side effects

Side effects

Serious Side Effects

Expand all

Heart problems

Heart problems, including decreased pumping of blood from the heart and an abnormal heartbeat
Signs and symptoms of an abnormal heartbeat include:
- Feeling like your heart is pounding or racing
- Dizziness
- Tiredness
- Feeling light-headed
- Shortness of breath
Your doctor should check your heart function before you start taking TYKERB and during treatment

Liver problems

Liver problems can be severe and deaths have happened
Signs and symptoms of liver problems include:
- Itching
- Yellowing of your skin or the white part of your eyes
- Dark urine
- Pain or discomfort in the right upper stomach area
Your doctor should do blood tests to check your liver before you start taking TYKERB and during treatment

Lung problems

Symptoms of lung problems with TYKERB include:
- A cough that will not go away
- Shortness of breath

Severe skin reactions

TYKERB may cause severe skin reactions
Tell your doctor right away if you develop:
- Skin rash
- Red skin
- Blistering of the lips, eyes, or mouth
- Peeling skin
- Fever
- Any combination of these reactions
Severe skin reactions can be life threatening, so your doctor may tell you to stop taking TYKERB

Diarrhea

Diarrhea is common with TYKERB and may sometimes be severe
Severe diarrhea can cause loss of body fluid (dehydration) and some deaths have happened
Call your doctor right away if you have a change in bowel pattern or if you have severe diarrhea
Follow your doctor’s instructions for what to do to help prevent or treat diarrhea

Call your doctor right away if you have any of the signs or symptoms of the serious side effects listed.

Please see the full Prescribing Information for a full listing of the serious side effects.

When TYKERB is taken with letrozole, common side effects include:

Diarrhea
Nausea
Rash
Tiredness or weakness
Vomiting
Headache
Dry skin
Unusual hair loss or thinning
Itching
Loss of appetite
Nosebleeds
Nail disorders such as nail bed changes, nail pain, infection, and swelling of the cuticles

Novartis Oncology Patient Support Program

Support designed for patients and caregivers

Insurance and Medicare education to help you understand the insurance process
Financial assistance for eligible patients*
Patient Navigators who provided 1-on-1 support specific to your Novartis medicine(s)*
Information about independent organizations that can assist you with your day-to-day needs beyond medical care
Patient Support Counselors who are able to provide information in over 160 languages

*Varies by product

To learn more about what’s available, call 1-800-282-7630 or visit www.Patient.NovartisOncology.com/.