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Patient Information Patient Information Full Prescribing Information Full
Prescribing Information Important Safety Information Important Safety
Information For Healthcare Professionals For Healthcare Professionals
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Patient Information Full Prescribing Information Important Safety Information
For Healthcare Professionals



FOCUS WHERE IT MATTERS


FOCUS WHERE IT MATTERS.

Targeting RET matters because abnormal RET genes may be the cause of your
metastatic non–small cell lung cancer or advanced thyroid cancer. If your cancer
is RET positive (RET+), GAVRETO®, a treatment designed to target RET, may be an
option for you.

RET+ METASTATIC NSCLC
RET+ ADVANCED THYROID CANCER
SIGN UP TO STAY IN TOUCH

RET=rearranged during transfection.

Images on this website do not depict actual patients.


FOCUS WHERE IT MATTERS


FOCUS WHERE IT MATTERS.

Targeting RET matters because abnormal RET genes may be the cause of your
metastatic non–small cell lung cancer or advanced thyroid cancer. If your cancer
is RET positive (RET+), GAVRETO®, a treatment designed to target RET, may be an
option for you.

RET+ METASTATIC NSCLC
RET+ ADVANCED THYROID CANCER
SIGN UP TO STAY IN TOUCH

RET=rearranged during transfection.

Images on this website do not depict actual patients.

GAVRETO, also known as pralsetinib, is a targeted therapy that is taken by mouth
once daily. It is used to treat certain cancers caused by abnormal RET genes.

It is not known if GAVRETO is safe and effective in children younger than 12
years of age. It is important to remember to take GAVRETO on an empty stomach.
Do not eat for at least 2 hours before and at least 1 hour after taking GAVRETO.

Ask your doctor if GAVRETO could be right for you.

 * A type of cancer treatment that targets specific types of cancer cells.

 * The most common type of lung cancer, named after the way cancer cells look
   under a microscope.

 * A type of cancer that forms in the thyroid and is a less common type of
   thyroid cancer.  

 * Thyroid cancer that has spread to nearby tissue or distant parts of the body.

 * A test performed by your healthcare provider to identify the gene(s) that may
   impact the way a tumor grows, spreads, or reacts to certain treatments.

 * RET stands for rearranged during transfection, and it’s a type of gene that
   everyone has within their cells. In specific types of cancer cells, the RET
   gene is abnormal.

 * The molecules inside cells that carry genetic information and pass it from
   one generation to the next.

 * May be in the form of fusions or mutations; these genes drive the
   uncontrolled growth of cells, leading to cancer.

 * RET positive (RET+) stands for rearranged during transfection positive, and
   the term RET+ is used to describe cancer caused by abnormal RET genes.

 * A molecule or gene measured in tissue, blood, or other bodily fluids that can
   help determine the type of disease you have, how aggressive it is, and the
   best treatment.

 * Biomarker testing that is performed by your doctor that includes testing for
   all of the biomarkers recommended by current guidelines.

 * Standard chemotherapy aims to stop the growth of cancer cells by blocking all
   rapidly dividing cells. Chemotherapy may be given by mouth, injection, or
   infusion, or put directly on the skin. This depends on the type and stage of
   cancer being treated.

 * A type of cancer treatment that helps your immune system fight cancer.

 * A type of lung cancer driven by abnormal RET genes that has spread to other
   parts of the body.

 * A butterfly-shaped organ that makes hormones to help regulate your heart
   rate, metabolism, blood pressure, and body temperature.

 * A substance produced by glands in the body that regulates the activities of
   different cells and organs.

 * A type of targeted therapy that targets multiple types of cancer cells.

 * A type of thyroid cancer driven by abnormal RET genes that has spread
   to nearby tissue or distant parts of the body.

 * A type of cancer that forms in the thyroid and is the most common type of
   thyroid cancer.

 * A treatment that shrinks or kills thyroid cells. It is used to treat certain
   types of thyroid cancer.

 * When cancer spreads to other parts of the body.

 * A piece of DNA that gives the cells in your body instructions to perform
   certain functions.

 * When a gene breaks off and reattaches to another gene.

 * Any change in a cell’s DNA sequence.

 * When cancer has spread to other parts of the body.

 * May be in the form of fusions or mutations; these genes drive the
   uncontrolled growth of cells that leads to cancer.

IMPORTANT SAFETY INFORMATION & INDICATIONS

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WHAT IS GAVRETO® (PRALSETINIB)?

GAVRETO is a prescription medicine used to treat certain cancers caused by
abnormal rearranged during transfection (RET) gene in:

 * adults with non-small cell lung cancer (NSCLC) that has spread
 * adults and children 12 years of age and older with advanced medullary thyroid
   cancer (MTC) or MTC that has spread who require a medicine by mouth or
   injection (systemic therapy)
 * adults and children 12 years of age and older with advanced thyroid cancer or
   thyroid cancer that has spread who require a medicine by mouth or injection
   (systemic therapy) and who have received radioactive iodine and it did not
   work or is no longer working

Your healthcare provider will perform a test to make sure that GAVRETO is right
for you.

GAVRETO was approved based on the percentage of patients whose tumor size shrank
or disappeared after treatment and how long that response lasted. There are
ongoing studies to confirm the benefit of GAVRETO.


IMPORTANT SAFETY INFORMATION

GAVRETO may cause serious side effects, including

Lung Problems: GAVRETO may cause severe or life-threatening inflammation of the
lungs during treatment, that can lead to death. Tell your healthcare provider
right away if you have any new or worsening symptoms, including shortness of
breath, cough, or fever.

High blood pressure (hypertension): High blood pressure is common with GAVRETO
and may sometimes be severe. You should check your blood pressure regularly
during treatment with GAVRETO. Tell your healthcare provider if you have
increased blood pressure readings or get any symptoms of high blood pressure,
including confusion, dizziness, headaches, chest pain or shortness of breath.

Liver problems: Liver problems (increased liver function blood test results) can
happen during treatment with GAVRETO and may sometimes be serious. Your
healthcare provider will do blood tests before and during treatment with GAVRETO
to check you for liver problems. Tell your healthcare provider right away if you
get any signs or symptoms of liver problem during treatment, including yellowing
of your skin or the white part of your eyes (jaundice), loss of appetite, nausea
or vomiting, dark “tea-colored” urine, pain on the upper right side of your
stomach area, sleepiness, bleeding or bruising.

Bleeding problems: GAVRETO can cause bleeding which can be serious and cause
death. Tell your healthcare provider if you have any signs or symptoms of
bleeding during treatment, including vomiting blood or if your vomit looks like
coffee-grounds, unusual vaginal bleeding, nose bleeds that happen often, pink or
brown urine, drowsiness or difficulty being awakened, red or black (looks like
tar) stools, confusion, coughing up blood or blood clots, headache, unusual
bleeding or bruising of your skin, change in speech, or menstrual bleeding that
is heavier than normal.

Tumor lysis syndrome (TLS): TLS is caused by a fast breakdown of cancer cells.
TLS can cause you to have kidney failure and the need for dialysis treatment, an
abnormal heartbeat, and may sometimes lead to hospitalization. Your healthcare
provider may do blood tests to check you for TLS. You should stay well hydrated
during treatment with GAVRETO. Call your healthcare provider or get emergency
medical help right away if you develop any of these symptoms during treatment
with GAVRETO: nausea, shortness of breath, vomiting, muscle cramps, weakness,
seizures or swelling.

Risk of wound healing problems: Wounds may not heal properly during treatment
with GAVRETO. Tell your healthcare provider if you plan to have any surgery
before or during treatment with GAVRETO. You should not take GAVRETO for at
least 5 days before surgery. Your healthcare provider should tell you when you
may start taking GAVRETO again after surgery.

Before taking GAVRETO, tell your healthcare provider about all of your medical
conditions, including if you:

 * have lung or breathing problems other than lung cancer.
 * have high blood pressure
 * have bleeding problems
 * plan to have surgery
 * are pregnant or plan to become pregnant. GAVRETO can harm your unborn baby.
   
   Females who are able to become pregnant:
   
   * Your healthcare provider will do a pregnancy test before you start GAVRETO.
   * Should use an effective form of non-hormonal birth control (contraception)
     during treatment with GAVRETO and for 2 weeks after the final dose of
     GAVRETO.
   * Birth control methods that contain hormones (such as birth control pills,
     injections or transdermal system patches) may not work as well during
     treatment with GAVRETO.
   * Talk to your healthcare provider about birth control methods that may be
     right for you during this time.
   * Tell your healthcare provider right away if you become pregnant or think
     you might be pregnant during treatment with GAVRETO.
   
   Males with female partners who are able to become pregnant should use
   effective birth control (contraception) during treatment and for 1 week after
   your final dose of GAVRETO.

 * are breastfeeding or plan to breastfeed. It is not known if GAVRETO passes
   into your breast milk. Do not breastfeed during treatment and for 1 week
   after your last dose of GAVRETO.

Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
GAVRETO may affect the way other medicines work, and other medicines may affect
how GAVRETO works.

The most common side effects of GAVRETO include: constipation, decreased levels
of phosphate in the blood, high blood pressure, decreased levels of calcium in
the blood, tiredness, decreased levels of body salt (sodium) in the blood,
muscle and joint pain, diarrhea, abnormal liver function blood tests, and
decreased white blood cell, red blood cell, and platelet counts.

GAVRETO may affect fertility in males and females, which may affect your ability
to have children. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of GAVRETO. Call your doctor for
medical advice about side effects. You are encouraged to report side effects to
the FDA. Visit FDA MedWatch or call 1-800-FDA-1088. You may also report side
effects to Genentech at 888-835-2555.

Please see the full Prescribing Information and Patient Information for GAVRETO.


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