FDA approves Tagrisso
Tagrisso is the first approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer.
The U.S. Food and Drug Administration (FDA) has approved Tagrisso (osimertinib), a kinase inhibitor indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA approved test, who have progressed on or after EGFR TKI therapy.
Important information
Tagrisso may cause serious side effects, including:
lung problems. Tagrisso may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever.
heart problems, including heart failure. Tagrisso may cause heart problems that may lead to death. Your doctor should check your heart function before you start, and during treatment. Call your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded.
Tagrisso is a prescription medicine used to treat non-small cell lung cancer (NSCLC). Tagrisso may be used when your non-small cell lung cancer has spread to other parts of the body and:
has a certain type of abnormal epidermal growth factor receptor (EGFR) gene, and
you have had previous treatment with an EGFR tyrosine kinase inhibitor medicine and it has stopped working. Your doctor will perform a test to make sure that Tagrisso is right for you.
It is not known if this medicine is safe and effective in children.
Before taking Tagrisso, tell your doctor about all of your medical conditions, including if you:
have lung or breathing problems
have heart problems, including a condition called long QTc syndrome
have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
are pregnant or plan to become pregnant. Tagrisso can harm your unborn baby. Tell your doctor right away if you become pregnant during treatment, or think you may be pregnant.
Females who are able to become pregnant should use an effective birth control during treatment, and for six weeks after the final dose.
Males who have female partners that are able to become pregnant should use effective birth control during treatment, and for four months after the final dose.
are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Do not breastfeed during treatment, and for two weeks after your final dose. Talk to your doctor about the best way to feed your baby during this time.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine.
Tagrisso side effects
Tagrisso may cause serious side effects, including:
See Important information.
The most common side effects are:
diarrhea
rash
dry skin
changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects. For more information, ask your doctor or pharmacist.
Source: drugs.com
