patients treated with TABRECTA live longer or if their symptoms improve.
There are ongoing studies to find out how TABRECTA works over a longer
period of time.
It is not known if TABRECTA is safe and effective in children.
Important Safety Information
TABRECTA may cause serious side effects, such as lung or breathing
problems. TABRECTA may cause inflammation of the lungs during treatment
that may lead to death. Patients should be advised to contact their
health care provider right away if they develop any new or worsening
symptoms, including cough, fever, trouble breathing, or shortness of
TABRECTA may cause abnormal blood test results, which may be a sign of
liver problems. Patients should be advised that their health care
provider will do blood tests to check their liver before starting and
during treatment with TABRECTA. Patients should be advised to contact
their health care provider right away if they develop any signs and
symptoms of liver problems including the skin or the white part of their
eyes turning yellow (jaundice), dark or "tea-colored" urine,
light-colored stools (bowel movements), confusion, loss of appetite for
several days or longer, nausea and vomiting, pain, aching, or tenderness
on the right side of the stomach area (abdomen), or weakness or swelling
in the stomach area.
The skin may be sensitive to the sun (photosensitivity) during treatment
with TABRECTA. Patients should be advised to use sunscreen or wear
clothes that cover their skin during treatment with TABRECTA to limit
direct sunlight exposure.
For women of reproductive potential, TABRECTA can harm their unborn
baby. They should use an effective method of birth control during
treatment with TABRECTA and for 1 week after the last dose. Men who have
partners who can become pregnant should use effective birth control
during treatment with TABRECTA and for 1 week after the last dose.
Before taking TABRECTA, patients should tell their health care provider
about all their medical conditions, including if they have or have had
lung or breathing problems other than lung cancer, have or have had
liver problems, or if they are pregnant or plan to become pregnant, as
TABRECTA can harm their unborn babies. Females who are able to become
pregnant should have a pregnancy test before they start treatment with
TABRECTA and should use effective birth control during treatment and for
1 week after the last dose of TABRECTA. Patients should be advised to
talk to their health care provider about birth control choices that
might be right for them during this time and to tell their health care
provider right away if they become pregnant or think they may be
pregnant during treatment with TABRECTA. Males who have female partners
who can become pregnant should use effective birth control during
treatment and for 1 week after their last dose of TABRECTA.
Patients should tell their health care provider about all the medicines
they take or start taking, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
The most common side effects of TABRECTA include swollen hands, ankles,
or feet (peripheral edema); nausea and/or vomiting; tiredness and/or
weakness (fatigue, asthenia); shortness of breath (dyspnea); loss of
appetite; changes in bowel movements (diarrhea or constipation); cough;
pain in the chest; fever (pyrexia); back pain; and decreased weight.
Please see full Prescribing Information for Tabrecta available at :
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