PATIENT INFORMATION

FDA-Approved Patient Labeling

TYKERB® (TIE-curb)
(lapatinib) tablets

Read this leaflet before you start taking TYKERB and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

What is TYKERB?

TYKERB is used with the medicine capecitabine for the treatment of patients with advanced or metastatic breast cancer that is HER2 positive, and who have already had certain other breast cancer treatments.

Before you start taking TYKERB, tell your doctor about all of your medical conditions, including if you:

• have heart problems.
• have liver problems. You may need a lower dose of TYKERB.
• are pregnant or may become pregnant. TYKERB may harm an unborn baby. If you become pregnant during treatment with TYKERB, tell your doctor as soon as possible.
• are breastfeeding. It is not known if TYKERB passes into your breast milk or if it can harm your baby. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines and herbal and dietary supplements. TYKERB and many other medicines may interact with each other. Your doctor needs to know what medicines you take so he or she can choose the right dose of TYKERB for you.

Especially tell your doctor if you take:

• antibiotics and anti-fungals (drugs used to treat infections)
• HIV (AIDS) treatments
• anticonvulsant drugs (drugs used to treat seizures)
• calcium channel blockers (drugs used to treat certain heart disorders or high blood pressure)
• antidepressants
• drugs used for stomach ulcers
• St. John's Wort or other herbal supplements

Know the medicines you take. Keep a list of your medicines with you to show your doctor. Do not take other medicines during treatment with TYKERB without first checking with your doctor.

Because TYKERB is given with another drug called capecitabine, you should also discuss with your doctor or pharmacist any medicines that should be avoided when taking capecitabine.

How should I take TYKERB?

• Take TYKERB exactly as your doctor has told you. TYKERB and capecitabine are taken in 21 day cycles. The usual dose of TYKERB is 1,250 mg (5 tablets) taken by mouth, one time a day on days 1 to 21. Your doctor will tell you the dose of capecitabine you should take and when you should take it.
• TYKERB should be taken at least one hour before, or at least one hour after food.
• Do not eat or drink grapefruit products while taking TYKERB.
• Your doctor may adjust your dose of TYKERB depending on how you tolerate the treatment.
• If you forget to take your dose of TYKERB, take it as soon as you remember that day. If you miss a day, do not double your dose the next day. Just skip the missed dose.

What are the possible side effects of TYKERB?

Serious side effects include:

• heart problems
  • decreased pumping of blood from the heart abnormal heartbeat
  • lung problems
• severe diarrhea, which may lead to you becoming dehydrated

Call your doctor right away if you have palpitations, persistent cough, shortness of breath, or severe diarrhea.

Common side effects of TYKERB in combination with capecitabine include:

• diarrhea
• red, painful hands and feet
• nausea
• rash
• vomiting
• tiredness
• mouth sores
• loss of appetite
• indigestion

Tell your doctor about any side effect that gets serious or that does not go away.

These are not all the side effects with TYKERB. Ask your doctor or pharmacist for more information.

You may also get side effects from capecitabine. Talk to your doctor about possible side effects with capecitabine.

How should I store TYKERB tablets?

• Store TYKERB tablets at room temperature between 59° and 86°F (15° to 30°C). Keep the container closed tightly.
• Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, it is out of the reach of children.
• Keep TYKERB and all medicines out of the reach of children.

General information about TYKERB

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use TYKERB for any other condition for which it was not prescribed. Do not give TYKERB to other people, even if they have the same condition that you have. It may harm them.

This leaflet summarizes the most important information about TYKERB. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about TYKERB that is written for health professionals. For more information you can call toll-free 1-888-825-5249.

What are the ingredients in TYKERB?

Active Ingredient: Lapatinib.

Inactive Ingredients: Tablet Core: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. Coating: Orange film-coat: FD&C yellow #6/sunset yellow FCF aluminum lake, hypromellose, macrogol/PEG 400, polysorbate 80, titanium dioxide.