Important Safety Information, Including Boxed WARNING:
Some people may develop liver damage while taking TYKERB® (lapatinib). 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, 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. 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 capecitabine, common side effects include diarrhea; red, painful hands and feet; nausea; rash; vomiting; feeling tired or weak; mouth sores; pain in hands and feet; shortness of breath; back pain; indigestion; dry skin; 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.
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