A TARGETED THERAPY FOR NTRK+ CANCER

Whether you’re considering targeted therapy for the first time or you’ve had it before, AUGTYRO offers people like yourself a specific treatment option.

AUGTYRO was studied in people whose cancer was NTRK+. This study included people in two important groups: 40 people who had no previous treatment with targeted therapy, and 48 people who were previously treated with targeted therapy.

lighbult

Many tumors in
different areas of the
body can be NTRK+

U.S. Full Prescribing Information.

nrtk chart
results icon

AUGTYRO has been shown to provide results for people with NTRK+ cancer.

medication icon

AUGTYRO, taken orally in pill form, is targeted to treat NTRK+ cancer. Response to treatment may vary.

Study Results

Study Results in people with NTRK+ cancer who were given AUGTYRO

NTRK+ tumors can occur in many different types of cancer throughout the body. The AUGTYRO study included people with non-small cell lung cancer, salivary gland cancer, thyroid cancer, soft-tissue sarcoma, breast cancer, glioblastoma, and several other cancers.

Study Results Chart Study Results Chart

Individual experience may vary. If tumors disappear during treatment, continuing treatment is still necessary.

*The disappearance of many measurable tumors in response to treatments does not necessarily mean the cancer has been cured.

NOT ALL CANCERS ARE THE SAME.

To determine your specific type, your cancer may have been
tested for a unique marker, called a biomarker. Some cancers,
like yours, test positive for NTRK. While your diagnosis is a rare
type of cancer, knowing your biomarker helped your doctor
determine that AUGTYRO may be right for you.

WHAT YOU KNOW MATTERS.

WHAT YOU DO NEXT  MATTERS EVEN MORE. 

Biomarkers May Have All The Details Biomarkers May Have All The Details

Biomarkers (also called tumor markers) can offer valuable insight into your cancer. They are determined through biomarker testing. This is when your doctor checks a blood or tissue sample for certain genes, proteins, or other markers that could be a sign of a specific disease or cancer.

Here’s why knowing your biomarker is important:

  • Biomarkers give you and your doctor details about your cancer so that your doctor can accurately diagnose it.
  • They help determine the best plan of action. Think of biomarkers as keys that help you and your doctor unlock treatment options.
unlock

All in all, biomarker testing (also referred to as tumor testing or molecular testing) helped you and your doctor determine that you have NTRK+ cancer and that AUGTYRO may be an effective treatment for you.

About AUGTYRO

WHAT TYPE OF TREATMENT IS AUGTYRO?

AUGTYRO is a targeted therapy to treat NTRK+ cancer. It’s a prescription oral treatment that’s designed to help identify certain cancer cells, and shut off their “grow” signals.

AUGTYRO is not chemotherapy—it’s a targeted NTRK+ treatment.

target

AUGTYRO is a targeted therapy which means it zeroes in on proteins related to the NTRK gene. Most types of targeted therapies like AUGTYRO help fight specific proteins that cause tumors to grow and spread throughout the body.

AUGTYRO is a precise way of helping fight NTRK+ cancer.

How AUGTYRO is Taken

Taking AUGTYRO

How-AUGTYRO-is-Taken How-AUGTYRO-is-Taken

Take AUGTYRO as directed

If you miss a dose or vomit at any time after taking a dose of AUGTYRO, do not take an extra dose. Take your next dose at the regularly scheduled time. Do not take 2 doses at the same time to make up a missed or vomited dose.

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AUGTYRO treats NTRK+ cancer with an oral treatment in pill form that you can take from the comfort of your home.

utensil

AUGTYRO can be taken with or without food. It should be swallowed whole with water at about the same time each day as prescribed. Avoid eating grapefruit or drinking grapefruit juice during your treatment with AUGTYRO. Remember not to open, crush, chew, or dissolve the capsule. Do not take a capsule if it is broken, cracked, or damaged.

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From Day 1 to Day 14, your doctor will start you on a once-daily dose. Starting on Day 15, the dose may be increased to twice daily.

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If you are experiencing any side effects, contact your care team. Your healthcare team will work closely with you to help manage these side effects with changes in dosing. In some cases they may temporarily or permanently stop treatment.

Sticking to Your Schedule

It’s necessary to take AUGTYRO as prescribed by your doctor. This will help enable your treatment to be effective as you fight NTRK+ cancer. Below are ways to help you remember to take a dose:

Develop a routine
Take AUGTYRO at about the same time each day to make it easier to remember. For example, at 8 AM and 8 PM.
Or maybe before you brush your teeth in the morning and before you brush at night.

Give yourself a reminder
Place a note where you’re likely to see it or set an alarm on your phone.

Use a child-resistant pill box
Keep track of your dosing schedule with a pill box labeled with the days of the week.

Record each dose
Use a calendar or a reminder app to check off when you’ve taken AUGTYRO each day.

Be prepared when traveling
Carry your AUGTYRO with you.

Possible side effects

Possible Side Effects to Look Out For

During treatment with AUGTYRO, side effects may occur. It’s important to be mindful, track changes, and assess how you’re feeling.

Rely on your care team

To have helpful conversations with them, remember to let your team know if you are experiencing any new or different symptoms at any time during your treatment.

AUGTYRO may cause serious side effects, including:

  • Central nervous system (CNS) effects
  • Lung problems (pneumonitis)
  • Liver problems
  • Muscle problems
  • Increased uric acid in your blood (hyperuricemia)
  • Bone
    fractures

The most common side effects of AUGTYRO include:

  • Dizziness
  • Change in sense of taste
  • Feeling of numbness or tingling in your arms or legs
  • Constipation
  • Shortness of breath
  • Tiredness
  • Trouble with balance, coordination,
    and walking
  • Problems with thinking, such as forgetfulness or confusion, memory problems and hallucinations
  • Muscle
    weakness
  • Nausea

Find Support

Help You Stay You

During this journey, remember that you're not alone. Reach out to your healthcare team, caregivers, friends, and loved ones. Here are some organizations that offer support to help you stay you.*

*Bristol Myers Squibb does not endorse these organizations. The information/links provided by Bristol Myers Squibb are meant for informational purposes only and are not meant to replace a physician’s medical advice.

Common Questions

WHAT TO DISCUSS WITH YOUR DOCTOR

Don’t hesitate to reach out to your doctor or healthcare team. Here are some questions to help you start a conversation with them.

  • How does AUGTYRO work?
  • Do you think AUGTYRO will help me?
  • What are the potential side effects that I may experience?
  • How often will I need scans or follow-up visits during treatment?
  • How will I know if AUGTYRO is working?
  • Will this treatment impact my daily life in any way?

BMS Access support

BMS Access support

At BMS, we provide support with purpose.

The BMS Access Support program is dedicated to helping patients access their prescribed BMS
medications. BMS Access Support provides resources to help patients understand their insurance
coverage, offers educational materials to support patients throughout their treatment journey,
and provides information on financial support options, including co-pay assistance for eligible
commercially-insured patients.

To learn more, ask your doctor, visit BMS Access Support, or call BMS Access Support at
1-800-861-0048, 8 am to 8 pm ET, Monday – Friday.

BMSASlogo

Learn About AUGTYro
Pricing Information

Specialty Pharmacies

How to get AUGTYRO

You can get AUGTYRO through certain specialty pharmacies that handle treatments, including AUGTYRO, which are not stocked at regular neighborhood pharmacies.

Most specialty pharmacies deliver medications by mail.

Here are some steps your doctor’s office and the specialty pharmacy must do before AUGTYRO can be shipped to you:

  • Make sure that your health insurance plan has approved AUGTYRO.
  • Discuss shipping details with you.
  • Collect your co-pay.

Your specialty pharmacy will call to confirm your details. Make sure you save their number in your phone so you can answer right away or return their calls. This will help you get your AUGTYRO treatment on time.

Prescribing Information Patient Information

 

Important Facts
about AUGTYRO™ (repotrectinib)

This is a summary of important information that you need to know about AUGTYRO. Your healthcare team can work with you to help answer any questions you may have about this medication. Keep this document in a safe place, so you can refer to it before and during your treatment.

Look out for the following
icons as you read:

Talk to your healthcare team

Call a healthcare provider right away

Helpful information to remember

What is AUGTYRO?

AUGTYRO (repotrectinib) is an oral prescription medicine used to treat adults and children 12 years and older with solid tumors (cancer) that:

  • Are caused by certain abnormal NTRK genes, AND
  • Have spread to other parts of the body or if surgery to remove your cancer is likely to cause severe complications, AND
  • Have grown or spread after any other treatment or there is no satisfactory alternative treatment option.

It is not known if AUGTYRO is safe and effective in children younger than 12 years of age with NTRK-positive solid tumors.

  • Talk to your healthcare team for more information about what it means to have abnormal NTRK genes.

What is the most important information I should know about AUGTYRO?

AUGTYRO may cause serious side effects. A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. The serious side effects of AUGTYRO may include:

Central nervous system (CNS) problems. Symptoms to look out for include:

  • dizziness
  • vertigo
  • changes in mood, such as anxiety, irritability,
    and depression
  • balance or coordination problems
  • problems with thinking, such as forgetfulness or
    confusion
  • seeing or hearing things that are not real
    (hallucinations)
  • problems with concentration, attention, memory,
    and sleep

Call your healthcare provider right away if you have any of these symptoms, or any worsening of CNS effects during treatment.

Lung problems (pneumonitis). AUGTYRO may cause pneumonitis (inflammation of the lungs), which may be severe or serious. New or worsening symptoms to look out for include:

  • Dry cough (without mucus)
  • Productive cough (with mucus)
  • Wheezing
  • Trouble breathing

Call your healthcare provider right away if you have any of these symptoms, or any worsening of your current lung problems.

Liver problems. Your healthcare provider will do blood tests to check your liver function before starting treatment with AUGTYRO™, every 2 weeks for the first month, and as needed during treatment. Symptoms of liver problems include:

  • your skin or the white part
    of your eyes turns yellow
  • dark or “tea-colored” urine
  • light-colored stools (bowel movements)
  • loss of appetite
  • nausea or vomiting
  • pain on the upper right side of your stomach area

Call your healthcare provider right away if you develop any of these symptoms of liver problems.

Muscle problems. Your healthcare provider will do blood tests before starting treatment with AUGTYRO, every 2 weeks for the first month, and as needed during treatment. Symptoms of muscle problems include:

  • unexplained muscle pain or muscle pain that does not go away
  • tenderness
  • weakness

Call your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems.

Increased uric acid level in your blood (hyperuricemia). AUGTYRO may cause an excess of uric acid in your blood. Your healthcare provider will do tests before and during your treatment with AUGTYRO to check the uric acid level in your blood. Your healthcare provider may prescribe medications if you have high blood uric acid levels. Tell your healthcare provider if you experience symptoms of increased uric acid, including:

  • red, hot, tender, or swollen joints, especially in your big toe
  • pain in your stomach-area or sides
  • decrease in your amount of urine or no
    urine at all
  • nausea or vomiting
  • pink or brown urine or blood in your urine

Bone fractures. AUGTYRO may increase your risk for bone fractures. Bone fractures may happen with or without a fall or other injury.

Call your healthcare provider right away if you have pain, changes in movement, or bone abnormalities.

What should I discuss with my healthcare team before starting treatment?

Talk to your healthcare provider about all your medical conditions, including if you:

  • have nervous system (neurological) problems
  • have lung or breathing problems other than lung cancer
  • have liver or kidney problems

Talk to your healthcare team about all the medicines you are taking, including:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

Taking AUGTYRO with certain other medicines may:

  • affect the amount of AUGTYRO or other medicines in your blood,
  • cause side effects, and/or
  • affect the way that AUGTYRO or other medicines work.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

These are not all the topics you should discuss with your healthcare team. Discuss any questions you may have with your healthcare team.

What should I discuss with my healthcare team about pregnancy, birth control, and breastfeeding before starting treatment?

Talk to your healthcare team if:

You are pregnant or plan to become pregnant — AUGTYRO™ may harm your unborn baby

If you are able to become pregnant, your healthcare team should do a pregnancy test before you start treatment with AUGTYRO.

If you are able to become pregnant, you should use effective non-hormonal birth control (contraception) during treatment and for 2 months after your last dose of AUGTYRO.

Birth control methods that contain hormones (such as birth control pills, injections, or transdermal system patches) may not work as well during treatment with AUGTYRO.

Talk to your healthcare team about birth control methods that may be right for you.

Call your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with AUGTYRO.

You are a male with a female partner who is able to become pregnant

You should use effective birth control during treatment with AUGTYRO and for 4 months after your last dose.

Call your healthcare provider right away if your partner becomes pregnant during treatment with AUGTYRO.

You are breastfeeding or plan to breastfeed

Do not breastfeed during treatment and for 10 days after the last dose of AUGTYRO. It is not known if AUGTYRO passes into your breast milk. Talk to your healthcare team about the best way to feed your baby during this time.

What are the most common side effects of AUGTYRO?

The most common side effects of AUGTYRO include:

  • Dizziness
  • Change in sense of taste
  • Feeling of numbness or
    tingling in your arms or legs
  • Constipation
  • Shortness of breath
  • Tiredness
  • Trouble with balance,
    coordination, and walking
  • Problems with thinking,
    such as forgetfulness or
    confusion, memory
    problems, and hallucinations
  • Muscle Weakness
  • Nausea

These are not all the possible side effects. Talk to your doctor for more information about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

How should AUGTYRO™ be taken?

Take AUGTYRO exactly as your healthcare provider tells you. The number of pills that you take will depend on your dose. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with AUGTYRO if you develop side effects. Do not change your dose or stop taking AUGTYRO without first talking to your healthcare provider.

pill-icon

AUGTYRO is a capsule with a white opaque cap and body, filled with a white to off-white powder. “REP 40” is printed in blue text on the cap.

Inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, and colloidal silicon dioxide.

Capsule coating inactive ingredients: gelatin and titanium dioxide.

Printing ink: shellac and FD & C blue #2 aluminum lake.

  • Do take AUGTYRO with or without food
  • Do take AUGTYRO at about the same time each day, such as in the morning or in the evening*
  • Do swallow AUGTYRO capsules whole with water
  • *Setting an alarm clock or a calendar notification is a great way to remember to take medication.
  • Do not open, crush, chew, or dissolve the capsule.
    Do not take broken, cracked, or damaged capsules
  • Do not eat grapefruit or drink grapefruit juice during treatment with AUGTYRO
  • Do not drive or operate machinery until you know how AUGTYRO affects you and you no longer have symptoms

What if I miss a dose of AUGTYRO?

If you miss a dose or vomit at any time after taking a dose of AUGTYRO, do not take an extra dose. Just skip the dose and take your next dose at the regularly scheduled time. Do not take 2 doses at the same time to make up a missed or vomited dose.

How do I store AUGTYRO?

AUGTYRO capsules should be stored at room temperature between 68°F to 77°F (20°C to 25°C).
Keep AUGTYRO and all medicines out of the reach of children.

For more information, please see accompanying U.S. Full Prescribing Information and Patient Information for AUGTYRO. Talk to your healthcare team for more information about this medication.