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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 (tumors that produce large amounts of a protein called human epidermal growth factor receptor-2), and who have already had certain other breast cancer treatments.

TYKERB is also used with a type of medicine called letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2 positive metastatic breast cancer for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.

Who should not take TYKERB?

Do not take TYKERB if you are allergic to any of its ingredients. See the end of this leaflet for a list of ingredients in TYKERB.

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

• ever had a severe allergic (hypersensitivity) reaction to TYKERB. Check with your doctor if you think this applies to you. Don't take TYKERB.
• 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 breast-feeding. 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, vitamins, 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 that decrease stomach acidity
• 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 other drugs called capecitabine or letrozole, you should also discuss with your doctor or pharmacist any medicines that should be avoided during treatment.

How should I take TYKERB?

• Take TYKERB exactly as your doctor tells you to take it. Your doctor may change your dose of TYKERB if needed.
  • For patients with advanced or metastatic breast cancer, TYKERB and capecitabine are taken in 21 day cycles. The usual dose of TYKERB is 1,250 mg (5 tablets) taken by mouth all at once, 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.
  • For patients with hormone receptor positive, HER2 positive breast cancer, TYKERB and letrozole are taken daily. The usual dose of TYKERB is 1,500 mg (6 tablets) taken by mouth all at once, one time a day. Your doctor will tell you the dose of letrozole 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.
• If you forget to take your dose of TYKERB, do not take two doses at one time. Take your next dose at your scheduled time.
• If you take too much TYKERB, call your doctor or poison control center, or go to the nearest hospital emergency room right away. Take TYKERB tablets with you when possible.

What are the possible side effects of TYKERB?

Serious side effects include:

• 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 lightheaded
  • shortness of breath
    • Your doctor should check your heart function before you start taking TYKERB andduring treatment.
• liver problems. Signs and symptoms of liver problems include:
  • itching
  • yellow eyes or skin
  • dark urine
  • pain or discomfort in the right upper stomach area
  • death
    • Your doctor should do blood tests to check your liver before you start takingTYKERB and during treatment.
• diarrhea, which may cause you to become dehydrated. Follow your doctors instructions for what to do to help prevent or treat diarrhea.
• lung problems. Symptoms of a lung problem with TYKERB include a cough that will not go away or shortness of breath.

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

Common side effects of TYKERB in combination with capecitabine or letrozole include:

• diarrhea
• red, painful hands and feet
• nausea
• rash
• vomiting
• tiredness or weakness
• mouth sores
• loss of appetite
• indigestion
• unusual hair loss or thinning
• nose bleeds
• headache
• dry skin
• itching
• nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles.

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also get side effects from the other drugs taken with TYKERB. Talk to your doctor about possible side effects you may get during treatment.

How should I store TYKERB tablets?

• Store TYKERB tablets at room temperature at 59° to 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 or by visiting the website www.tykerb.com.

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.

TYKERB tablets are oval, biconvex, orange, film-coated with GS XJG printed on one side.

Last reviewed on RxList: 2/24/2012
This monograph has been modified to include the generic and brand name in many instances.