GAVRETO® for RET+ metastatic NSCLC

GAVRETO is a once-daily oral targeted therapy for people living with RET-positive (RET+) 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-positive (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.

Take GAVRETO on an empty stomach. Do not eat for at least 2 hours before and at least 1 hour after taking GAVRETO.


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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RET gene

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

Cancer cell

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 metastatic non-small cell 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.

mNSCLC=metastatic non–small cell lung cancer

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

Take GAVRETO once daily by mouth

Stomach

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.

*Assuming a recommended starting dose of 400 mg, once daily.

While taking GAVRETO: Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment of 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.


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

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

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.

[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]
Lung Cancer HELPLine:
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]
Lung Cancer HelpLine:
800-298-2436

GENERAL

Cancer Support Community

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

[email protected]
Cancer Support Helpline:
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]
CancerCare's Hopeline:
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. 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.

Committed to helping you find assistance options for GAVRETO® (pralsetinib)

There may be options to help you afford your 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 your Genentech medicine?

  • 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

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 your Genentech medicine, we can refer you to an independent co-pay assistance foundation.*

 

Learn More

 

*Independent co-pay assistance foundations have their own rules for eligibility. We cannot guarantee a foundation will help you. We only can 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.

You Might Qualify for a Referral to the Genentech Patient Foundation

The Genentech Patient Foundation provides free Genentech medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income 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, which may also affect normal cells.

  • The use of drugs to destroy cancer cells. It usually works by keeping the cancer cells from growing, dividing, and making more cells.

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

  • A type of targeted therapy that blocks chemical messengers in cancer cells to stop cancer cells from growing or dividing.

  • 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.

  • When cancer spreads to other parts of the body.

  • Caused by fusions or mutations, these genes drive the uncontrolled growth of cells that leads to cancer.

  • 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.

  • 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.

  • 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.

  • 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 course of treatment. 

  • When cancer spreads 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.

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

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.