TYKERB® (lapatinib) tablets is a prescription medicine used:
- with the medicine capecitabine to treat people with breast cancer that is advanced or that has spread to other parts of the body (metastatic), and:
- 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
Before taking TYKERB with capecitabine, your breast cancer should have gotten worse (progressed) with the medicine trastuzumab.
- 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
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, 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.