Now approved

Introducing GAVRETO™
for RET+ metastatic NSCLC

GAVRETO is a once-daily oral targeted therapy for people living with RET-positive non–small cell lung cancer (NSCLC) that has spread to other parts of the body, or metastasized.

RET=rearranged during transfection.

GAVRETO is a once-daily oral targeted therapy for people living with RET+ non–small cell lung cancer (NSCLC) that has spread to other parts of the body, or metastasized.

RET=rearranged during transfection.

GAVRETO is not chemotherapy or immunotherapy and can be taken orally at home.

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

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

What is RET+ metastatic NSCLC?

Non–small cell lung cancer (NSCLC) is a common type of lung cancer. Metastatic NSCLC (mNSCLC) means that the cancer has spread to other parts of the body.

If your cancer is driven by abnormal RET genes, it is referred to as RET positive (RET+).

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 give the cells in your body instructions to perform certain functions.

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Gene RET

But inside a tumor, when a RET gene breaks off and reattaches to another gene, it becomes a RET fusion.

Cancer

RET fusions may be found in non–small cell lung cancer (NSCLC) and are known to drive the uncontrolled growth of cells, leading to cancer.

RET+

RET fusions are found in up to 2% of people with NSCLC.1

Reference: 1. 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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To see if your lung cancer is RET+, your doctor will need to perform a type of test called a biomarker test. A biomarker test can help your doctor decide if GAVRETO could be right for you.

What is GAVRETO (pralsetinib) and how does it work?

Pralsetinib is a targeted RET therapy used to treat people living with RET+ mNSCLC.

Blocker

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

Cancer

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

Talk to your doctor
about GAVRETO.

How do I take GAVRETO?

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

  • have a history of lung or breathing problems other than lung cancer
  • are pregnant or plan to become pregnant, or
  • are breastfeeding or plan to breastfeed

Take your prescribed dose of GAVRETO exactly as advised by your doctor.

Do not change your dose or stop taking GAVRETO unless your doctor tells you to.


1x Daily
Stomach

Take GAVRETO once daily by mouth

Take on an empty stomach

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. It’s important to remember to take GAVRETO capsules as directed by your doctor.

If you miss a dose: Take it 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.

While taking GAVRETO: Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment of GAVRETO if you develop side effects.


How do I STORE GAVRETO?

  • At room temperature between 68 °F to 77 °F (20 °C to 25 °C)
  • Protect from moisture
  • Be sure to keep GAVRETO and all medications out of the reach of children

What are the possible side effects of GAVRETO?

SERIOUS SIDE EFFECTS

GAVRETO may cause serious side effects, including

Lungs Heart Liver Blood Kidney Arm in sling
Lungs

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.

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. 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

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.

Blood

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.

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 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.

Arm in sling

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.

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, 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 may report side effects to the FDA at 1-800-FDA-1088.

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

Resources and support

Empower yourself with information by reading more about GAVRETO.

Product Resources

Educational Resources

These materials are intended for digital use only. If you decide to print them, please be sure to print and attach a copy of the full Prescribing Information as well.


You are not alone in your journey.

To stay informed and strengthen your support network, you can connect with patient communities and organizations:

Lung

RET Renegades Facebook Group

A Facebook group offering support, community, and education for patients with the RET mutation and their caregivers.

LUNGevity Foundation

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


Lung Cancer HELPLine:

GO2 Foundation for Lung Cancer

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


Lung Cancer HelpLine:

General

Cancer Support Community

A support community focused on educational resources, research and public policy, and volunteer opportunities for people impacted by cancer.


Cancer Support Helpline:

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.


CancerCare's Hopeline:

Blueprint Medicines is not affiliated with these organizations, does not endorse any particular service or group, and is 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.

REGISTER FOR UPDATES ABOUT GAVRETO
Clinical patient

Blueprint Medicines and Genentech would like to thank all of those who participated in our clinical trials, including their families.

YourBluePrint

YourBlueprint is a patient support program designed to assist you throughout your treatment with GAVRETO by providing:

Financial Assistance

Financial
Assistance Programs*

Temporary Treatment Programs*

Temporary
Treatment Programs*

A Dedicated Case Manager

A Dedicated
Case Manager

Learn more about YourBlueprint

or call 1-888-BLUPRNT (1-888-258-7768) today.
Monday–Friday 8am–8pm Eastern Time (ET).

Personalized Services

When you enroll in YourBlueprint, you will receive 1-on-1 support from a dedicated case manager. Your case manager can help you:

  • Understand your insurance
  • Check eligibility for financial assistance
  • Work with your insurance provider and healthcare provider to help minimize treatment delays
  • Answer questions about GAVRETO

Financial Assistance Options

No matter what your insurance status, YourBlueprint will help you understand the types of assistance programs offered and whether you qualify.

We offer the following financial assistance options to help cover the costs of treatment.

YourBluePrint Copay Card

Co-Pay Assistance Program
If you have commercial insurance through your job, a partner’s job, or you buy it yourself, you may be eligible to pay as little as $0 for your prescription. This program covers co-pay, co-insurance, or deductible expenses for those who qualify.

Sign Up for Co-Pay
Assistance Program

For additional program details, click here or call YourBlueprint to learn more.

Patient Assistance Program (PAP)

Patient Assistance Program (PAP)
If you do not have insurance or if your coverage is limited, you may be eligible to receive your medication at no cost through this program. For additional information, including eligibility requirements, speak with a dedicated case manager to learn more.


No matter which insurance you have, a member of our team is ready to help you determine your financial assistance program eligibility. Call 1-888-BLUPRNT (1-888-258-7768) today.

Visit YourBlueprint to see programs and services offered beyond these financial assistance options.

*For terms and conditions, call 1-888-BLUPRNT (1-888-258-7768).