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.

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Helpful information to remember

What is AUGTYRO?

AUGTYRO (repotrectinib) is an oral prescription medicine used to treat:

  • Adults with non-small cell lung cancer (NSCLC) that:
  • Has spread within your chest or to other parts of the body AND
  • Is caused by an abnormal ROS1 gene.
  • 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 with ROS1-positive NSCLC or 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 an abnormal ROS1 gene or 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.