This is for US residents only.

Tykerb for:

HER2+ Metastatic Breast Cancer

Important Safety Information, including Boxed WARNING
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
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Indication

TYKERB is used with a medicine called Xeloda® (capecitabine) for the treatment of people with advanced or metastatic breast cancer whose tumors overexpress HER2, and who have received prior therapy including an anthracycline, a taxane, and Herceptin® (trastuzumab). Tumors that are HER2 positive make a large amount of a protein called human epidermal growth factor receptor-2.

Limitation of use: Patients should have disease progression on Herceptin prior to initiation of treatment with TYKERB in combination with Xeloda.

When your human epidermal growth factor receptor 2-positive (HER2+) advanced or metastatic breast cancer progresses, ask your doctor about TYKERB

About TYKERB

TYKERB® (lapatinib) 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
  • When 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 breast cancer cells
  • Once inside the cell, TYKERB binds to the part of the HER2 protein inside the cell
  • When tested in animals and in breast cancer cells grown outside the body, TYKERB blocked HER2 receptors and cell growth

Your Regimen

TYKERB is an oral medicine

  • You take TYKERB by mouth with a glass of water every day
  • 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
  • If you take too much TYKERB, call your doctor or go to the nearest hospital emergency room right away

 

When taking TYKERB with Xeloda:

  • Take 5 tablets of TYKERB all at once, once a day, every day
  • Take the TYKERB tablets together and at the same time every day
  • Your doctor will tell you the dose of Xeloda® (capecitabine) you should take and when you should take it
  • Take TYKERB on an empty stomach at least 1 hour before or 1 hour after a meal
  • Take Xeloda with food or within 30 minutes after food
  • Take TYKERB and Xeloda exactly as instructed by your doctor; your doctor may change your dose of TYKERB if needed
  • Talk to your doctor if you have any questions about your treatment or experience any side effects

 

Getting Started

Take time to learn about TYKERB

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

Co-Pay Assistance Program

You may be eligible for immediate co-pay savings on your next prescription:

• Most eligible commercially insured patients pay no more than $25 per month

• Annual maximum of $15,000 per calendar year; patient responsible for any difference over $15,000

To find out if you are eligible to save on your next prescription

Call 1-877-577-7756 or visit us on www.copay.novartisoncology.com

Limitations apply. See program terms and conditions. This offer is not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice.

 

Terms and Conditions

This offer is valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid, or any other federal or state program. Not valid for cash-paying patients, where product is not covered by patient’s commercial insurance, or where plan reimburses you for entire cost of your prescription drug. Offer is not valid where prohibited by law. Valid only in the United States and Puerto Rico. This program is not health insurance. Offer may not be combined with any other rebate, coupon, or offer. The card is the property of Novartis Pharmaceuticals Corporation and must be returned upon request. Novartis reserves the right to rescind, revoke, or amend the program without notice. Patient certifies responsibility for complying with applicable limitations, if any, of any commercial insurance and reporting receipt of program rewards, if necessary, to any commercial insurer. 

This offer expires on December 31, 2016.

Patient Instructions:

Patients with commercial insurance will be responsible for up to $25 and the program pays the remaining co-pay or coinsurance until you reach the yearly maximum of $15,000. After the program maximum, you will be responsible for the difference. Questions should be directed to 1-877-577-7756. When you use this offer, you are certifying that you understand the program rules, regulations, and terms and conditions, and that you will disclose and report the use of this offer as may be required by your insurer. You are not eligible if prescriptions are paid by any federal or state program, or where prohibited by law; and you will otherwise comply with the terms and conditions above.

Patient Assistance

Patient Assistance Now Oncology (PANO)

Novartis Oncology is committed to helping patients living with cancer receive the medicines they need. PANO offers quick and easy access to information about our wide range of resources.

 

You can get information about our PANO support program by calling 1-800-282-7630 to speak with a member of our knowledgeable staff, which is dedicated to making access to therapy as simple and convenient as possible.

IMPORTANT SAFETY INFORMATION

 

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 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. Tell your doctor right away if you develop a skin rash, blisters, or peeling of the skin. 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. You should not become pregnant when taking TYKERB because the unborn baby can be harmed. Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if TYKERB passes into breast milk. You and your doctor should decide if you will take TYKERB or breastfeed. You should not do both.

 

When TYKERB is taken with Xeloda, common side effects include diarrhea; red, painful hands and feet; nausea; rash; vomiting; tiredness or weakness; mouth sores; indigestion; dry skin; and nail disorders such as nail bed changes, nail pain, infection, and swelling of the cuticles.

 

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.