FOCUS WHERE IT MATTERS.

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

RET=rearranged during transfection.

Image does not depict actual patient.

What is GAVRETO and who is it for?

GAVRETO, also known as pralsetinib, is a targeted therapy that is taken by mouth once daily. It is used to treat cancer caused by abnormal RET genes in adults with non–small cell lung cancer that has spread (also known as metastatic) whether or not they received treatment in the past.

It is not known if GAVRETO is safe and effective in children. 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.

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.

Your doctor will do a biomarker test to decide if GAVRETO is right for you.

What is metastatic non–small cell lung cancer (mNSCLC)?

about 85%

Lung cancer is the 2nd most common cancer in the United States for both men and women. About 85% of all lung cancers are NSCLC.1,2

lung

NSCLC starts in the lungs when cells grow out of control and form tumors.

metastasized

When NSCLC spreads to other parts of the body and forms new tumors, it is called “metastatic NSCLC (or mNSCLC).” 

About 54% of NSCLC patients have mNSCLC when they are diagnosed.3

What is RET’s role in metastatic NSCLC?

Gene

RET is a type of gene that everyone has within their cells. Genes are pieces of DNA that tell the cells in your body instructions to do certain functions.

RET gene

In specific types of cancer, the RET gene is abnormal. Abnormal RET genes drive the uncontrolled growth of cells, which leads to cancer.

RET+

If your cancer is caused by abnormal RET genes, it’s called “RET positive (or RET+).”

Two Percent

Abnormal RET genes are found in up to 2% of people with NSCLC.4

References: 1. American Cancer Society. What is lung cancer? https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed January 19, 2022. 2. American Cancer Society. Key statistics for lung cancer. https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed January 19, 2022. 3. Howlader N, Noone AM, Krapcho M, et al (eds). SEER Cancer Statistics Review, 1975-2017. National Cancer Institute. https://seer.cancer.gov/csr/1975_2017/. Accessed January 31, 2022. 4. Kato S, Subbiah V, Marchlik E, Elkin SK, Carter JL, Kurzrock R. RET aberrations in diverse cancers: next-generation sequencing of 4,871 patients. Clin Cancer Res. 2017;23(8):1988-1997.

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Biomarker testing may help your doctor decide the treatment that’s right for you.

Whether you are newly diagnosed or considering a different treatment, it’s important to know your cancer’s biomarker status—including if your cancer is RET+.
RET is one of several biomarkers with available targeted therapies for patients.

Do you know your cancer’s biomarker status?

Knowing your cancer’s biomarker status may help you and your doctor:

  • Understand if biomarkers are driving your cancer 
  • Find out if you’re eligible for treatments that target those drivers

That’s why it’s important to test for all known biomarkers using “comprehensive biomarker testing.”
This test is done using a sample of the tumor, or sometimes a blood test.

Speak with your doctor to see if your metastatic NSCLC has been tested for biomarkers, including RET.

patient cornhole lung

About GAVRETO

GAVRETO, also known as pralsetinib, is not chemotherapy or an immunotherapy. GAVRETO is a targeted therapy that is taken by mouth once daily.

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.

How does GAVRETO® (pralsetinib) work?

Blocker

Pralsetinib blocks the uncontrolled growth caused by the cancer’s abnormal RET genes.

Cancer

This may help slow the growth and spread of your cancer.

How do I take GAVRETO?

1x Daily

Take GAVRETO once daily by mouth

Stomach

Take on an empty stomach
(water is okay)

Do not eat for at least 2 hours before taking GAVRETO. Do not eat for at least 1 hour after taking GAVRETO.

Do not eat for at least 2 hours before
taking GAVRETO

Do not eat for at least 1 hour
after
taking GAVRETO

*Assuming a recommended starting dose of 400 mg, once daily. Dosing can vary from person to person.

DOSING CAN VARY FROM PERSON TO PERSON

  • Remember to take GAVRETO capsules exactly as directed by your doctor.
  • Do not change your dose or stop taking GAVRETO unless your doctor tells you to.
  • Reporting side effects can help your doctor decide if a lower dose may be better for you.
  • Before taking GAVRETO: Tell your doctor about all of your medical conditions and all of the medicines you take. 
  • While taking GAVRETO: Your doctor may change your dose, temporarily stop, or permanently stop treatment with GAVRETO if you develop side effects.
  • If you miss a dose: Take the missed dose as soon as possible on the same day. Then take your next dose of GAVRETO at your regular time the next day. 
  • If you vomit after taking a dose: Do not take an extra dose. Take your next dose of GAVRETO at your regular time the next day.

Tips for taking GAVRETO

clock daily routine

Make GAVRETO part of your daily routine

Take GAVRETO at the same time every day on an empty stomach. For example, take it right when you wake up and then wait to eat breakfast for at least 1 hour. Or, eat dinner 2 hours before your regular bedtime and then take it before going to bed.

nightstand tips

Keep GAVRETO where you can see it

Place your medicine in a spot you’ll be sure to notice, like on your nightstand or next to your cell phone charger. That way, you’re less likely to forget a dose.

reminder tips

Set a daily reminder

Create an alarm on your cell phone or a calendar reminder to alert you to take your medicine at the same time every day.

TAKE GAVRETO AT HOME OR WHEREVER YOU GO

How do I store GAVRETO?

  • At room temperature between 68 °F to 77 °F (20 °C to 25 °C)
  • Away from moisture
  • Out of the reach of children

GAVRETO can be briefly exposed to temperatures between 59 °F to 86 °F (15 °C to 30 °C). But if you think your medicine has been exposed to extreme temperatures, please contact your pharmacy.

What are the possible side effects of GAVRETO?

As you begin treatment with GAVRETO, it is helpful to know what to expect.

EVERYONE RESPONDS TO TREATMENT DIFFERENTLY

GAVRETO may cause serious side effects. You may or may not experience some of the side effects described below. Tell your doctor right away if you have any new of worsening symptoms including those described below.

Lungs

Lung problems: GAVRETO may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. 

Symptoms to look out for include: 

  • shortness of breath
  • cough
  • fever
Heart

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.

Symptoms to look out for include:

  • confusion
  • headaches
  • shortness of breath
  • dizziness 
  • chest pain
Liver

Liver problems: Liver problems can happen during treatment with GAVRETO and may sometimes be serious. Your doctor will do blood tests before and during treatment with GAVRETO to check you for liver problems

Symptoms to look out for include:

  • yellowing of your skin or the white part of your eyes (jaundice)
  • dark “tea-colored” urine
  • sleepiness
  • bleeding or bruising
  • loss of appetite
  • nausea or vomiting,
  • pain on the upper right side of your stomach area
Blood

Bleeding problems: GAVRETO can cause bleeding which can be serious and cause death.

Symptoms to look out for include: 

  • vomiting blood or if your vomit looks like coffee-grounds
  • pink or brown urine
  • red or black (looks like tar) stools
  • coughing up blood or blood clots
  • unusual bleeding or bruising of your skin
  • menstrual bleeding that is heavier than normal
  • unusual vaginal bleeding
  • nose bleeds that happen often
  • drowsiness or difficulty being awakened
  • confusion
  • headache
  • change in speech
Kidney

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 doctor may do blood tests to check you for TLS. You should stay well hydrated during treatment with GAVRETO.

Symptoms to look out for include:

  • nausea
  • vomiting
  • weakness
  • swelling
  • shortness of breath
  • muscle cramps
  • seizures
Arm in sling

Risk of wound healing problems:

  • Wounds may not heal properly during treatment with GAVRETO.
  • Tell your doctor 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 doctor should tell you when you may start taking GAVRETO again after surgery.
COMMON SIDE EFFECTS

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
  • decreased white blood cell, red blood cell, and platelet counts

GAVRETO may affect fertility in men and women, which may affect your ability to have children. Talk to your doctor if this is a concern for you.

These are not all of the possible side effects of GAVRETO.

 

patient talking

Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088.

You may also report side effects to Genentech at 1-888-835-2555.

Resources and support

Empower yourself by reading more about RET+ mNSCLC and GAVRETO® (pralsetinib).

MORE ABOUT RET+ mNSCLC

MORE ABOUT GAVRETO

PATIENT SUPPORT GROUPS

You are not alone in your journey. Stay informed and strengthen your support network by connecting with patient communities and organizations:

LUNG

RET Renegades Facebook Group

A Facebook group that's part of Lungevity. The group offers support, community, and education for patients with the RET mutation and their caregivers.

[email protected]

RETpositive

This group was formed for RET-positive cancer patients and caregivers to share information and emotional support and is invested in RET-specific research by funding labs directly and keeping their members up to date on the latest advances.

[email protected]

LUNGevity Foundation

The largest national lung cancer–focused nonprofit organization that provides patients and caregivers with lung cancer education, resources, and support.

[email protected]
HelpLine:
1-844-360-5864

GO2 Foundation for Lung Cancer

A national lung cancer nonprofit offering information, educational resources, and support to patients and caregivers.

[email protected]
HelpLine:
1-800-298-2436

GENERAL

Cancer Support Community

A support community focused on connecting people with the right support groups and providing free counseling for people impacted by cancer.

[email protected]
HelpLine:
1-888-793-9355

CancerCare

A national organization offering counseling and support over the phone, online, and in person, along with educational workshops, publications, and financial and co-pay assistance.

[email protected]
HelpLine:
1-800-813-HOPE (4673)

Blueprint Medicines and Genentech are not affiliated with these organizations, do not endorse any particular service or group, and are not responsible for the content on their websites or any services or resources they may provide. These advocacy groups are included as a reference for patients, and they do not imply endorsement of the company or products by the groups listed. Descriptions of resources have been provided by advocacy groups. The information provided by these organizations is not meant to replace a doctor’s medical advice. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

Clinical patient

Blueprint Medicines and Genentech would like to thank all of those who participated in our clinical trials, including their families. Without their time and commitment, this treatment would not be possible. Initially discovered and developed by Blueprint Medicines, GAVRETO is brought to you by a close collaboration between Blueprint and Genentech.

Financial assistance options for GAVRETO® (pralsetinib)

There may be options to help you afford GAVRETO, no matter what type of health insurance you have.

Use our Patient Assistance Tool to find out which assistance option might be right for you.

  • Do you have health insurance?

  • Does your health insurance cover GAVRETO?

  • Do you have commercial health insurance?

  • Are you already getting financial assistance to help pay for your medicine?

  • Are you 18 years of age or older?

You Might Qualify for a Referral to the Genentech Oncology Co-pay Assistance Program

If you have commercial health insurance, GAVRETO Access Solutions can refer you to the Genentech Oncology Co-pay Assistance Program. It can help you with the out-of-pocket costs of GAVRETO, if you’re eligible.*

 

Learn More

 

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications and or administration of their Genentech medication. Patient must be taking the Genentech medication for an FDA-approved indication. See full Terms and Conditions at CopayAssistanceNow.com.

You Might Qualify for a Referral to an Independent Co-pay Assistance Foundation

If you need help with your co-pay for GAVRETO, we can refer you to an independent co-pay assistance foundation.*

 

Learn More

 

*These organizations are independent of Genentech or Blueprint Medicines and may require you to provide personal or financial information to enroll in their programs. Genentech and Blueprint Medicines cannot share any information you have provided to us.

Independent co-pay assistance foundations have their own rules for eligibility. We have no involvement or influence in independent foundation decision-making or eligibility criteria and do not know if a foundation will be able to help you. We can only refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse or show preference for any particular foundation. The foundations in this list may not be the only ones that might be able to help you.

You Might Qualify for a Referral to the Genentech Patient Foundation

The Genentech Patient Foundation provides free GAVRETO to people who don't have insurance coverage or who have financial concerns and meet eligibility criteria.*

 

Learn More

 

*If you have health insurance, you should try to get other types of financial assistance, if available. You also need to meet income requirements. If you do not have insurance, or if your insurance does not cover your Genentech medicine, you must meet a different set of income requirements.

Out of Pocket icon

The Genentech Oncology Co-pay Assistance Program*

The Genentech Oncology Co-pay Assistance Program helps people with commercial health insurance. This might be a plan you get through your employer or one you purchased through a Health Insurance Marketplace like HealthCare.gov. To qualify, you must also meet other criteria.

Patient assistance services icon

Independent Co-pay Assistance Foundations

If you need help with your co-pay for your Genentech medicine, GAVRETO Access Solutions can refer you to an independent co-pay assistance foundation. Independent co-pay assistance foundations help patients with public health insurance or commercial health insurance.

 Genentect Patient Foundation icon

Genentech Patient Foundation

The Genentech Patient Foundation gives free Genentech medicine to people who don’t have insurance coverage or who have financial concerns and meet eligibility criteria.

*This Genentech Oncology Co-pay Assistance Program is valid ONLY for patients with commercial insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid, or any other federal or state government program to pay for their medications are not eligible.

Under the program, the patient will pay a co-pay. After reaching the maximum program benefit, the patient will be responsible for all out-of-pocket expenses.

All participants are responsible for reporting the receipt of all program benefits as required by any insurer or by law. No party may seek reimbursement for all or any part of the benefit received through this Program. The program is only valid in the United States and U.S. Territories. This program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. The patient, guardian, prescriber, hospital and any other person using the program agree not to seek reimbursement for all or any part of the benefit received by the patient through the offer of this program. Genentech reserves the right to rescind, revoke or amend the program without notice at any time. Additional terms and conditions apply. Please visit CopayAssistanceNow.com for the full list of Terms and Conditions.
Independent co-pay assistance foundations have their own rules for eligibility. We cannot guarantee a foundation will help you. We only refer you to a foundation that supports your disease state. We do not endorse or show financial preference for any particular foundation. The foundations we refer you to are not the only ones that might be able to help you.
If you have health insurance, you should try to get other types of financial assistance, if available. You also need to meet income requirements. If you do not have insurance, or if your insurance does not cover your Genentech medicine, you must meet a different set of income requirements.

GAVRETO Access Solutions is a program that helps people who are taking a Genentech medicine. Your health insurance plan and the cost of your medicine might keep you from getting your prescribed treatment. We may be able to help.

Learn how we help.

Our Patient Assistance Tool helps you find out which of our patient assistance options may be right for you. Answer a few questions to learn which options you might qualify for.

Some options might require patients to confirm their annual household income. You can learn more about each option and its criteria at Genentech-Access.com/GAVRETO/patients.

To enroll, fill out the Patient Consent Form. Your doctor will have to fill out a separate form. We can begin helping you once we receive both forms.

Each option has its own time period for you to receive assistance. You can call us at (877) 436-3683 to find out how long you will receive assistance.

To ask questions or to learn more about how we can help, contact us at (877) 436-3683.

  • 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.

  • 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.

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.