Patient Medication Information: uses, side effects, how to take - Augtyro
What AUGTYRO is used for:
AUGTYRO is used to treat adults with non-small cell lung cancer (NSCLC). This lung cancer:
- has spread within your chest or to other parts of the body, and
- is caused by an abnormal ROS1 gene.
How AUGTYRO works:
AUGTYRO works by blocking the action of proteins that do not work properly. These abnormal proteins can cause cancer cells to grow uncontrollably. AUGTYRO may slow or stop cancer cell growth and may help shrink your cancer.
The ingredients in AUGTYRO are:
Medicinal ingredients: repotrectinib
Non-medicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate (160 mg only) microcrystalline cellulose, and sodium lauryl sulfate. Capsule shell contains FD&C Blue #1 (160 mg only), FD&C Blue #2 aluminum lake (40 mg only), gelatin, shellac, and titanium dioxide.
AUGTYRO comes in the following dosage forms:
Capsules: 40 mg and 160 mg.
Do not use AUGTYRO if:
- you are allergic to repotrectinib or any of the other ingredients in AUGTYRO or the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AUGTYRO. Talk about any health conditions or problems you may have, including if you:
- have nervous system (neurological) problems.
- have lung or breathing problems other than lung cancer.
- have liver problems.
- bone problems or had radiation therapy.
Other warnings you should know about:
Female patients:
If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
- You should not take AUGTYRO if you are pregnant. It may harm your unborn baby.
If you are able to get pregnant:
- Your healthcare provider will do a pregnancy test before you start treatment with AUGTYRO.
- Avoid becoming pregnant while you are taking AUGTYRO. Use effective non-hormonal birth control during treatment and for 2 months after the last dose of AUGTYRO. Talk to your healthcare professional about birth control methods that are right for you.
- Tell your healthcare professional right away if you become pregnant or think you may be pregnant during treatment with AUGTYRO.
- Do not breastfeed during treatment and for 10 days after the last dose of AUGTYRO. Talk to your healthcare professional about the best way to feed your baby during this time.
Male patients:
- During treatment with AUGTYRO, use effective birth control each time you have sex with a woman who is pregnant, may be pregnant or could get pregnant. Keep using effective birth control for at least 4 months after stopping treatment. Talk to your healthcare professional about birth control methods that are right for you.
- If, during your treatment with AUGTYRO, your sexual partner becomes pregnant or thinks she may be pregnant, tell your healthcare professional right away.
Children and Adolescents:
- AUGTYRO is not for children and adolescents under 18 years old.
Driving and using machines
- Before you drive or use machines, wait until you know how AUGTYRO affects you.
- AUGTYRO can cause dizziness or trouble with balance, coordination, concentration or attention. It can also cause blurred vision, memory loss, changes in mental status, confusion or hallucinations. Do not drive or operate machines until you feel well.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with AUGTYRO:
- medicines used to treat fungal infections such as itraconazole
- medicines used to treat bacterial infections such as rifampin
- a medicine used to produce sleepiness or drowsiness called midazolam
- birth control that contains hormones
- an herbal treatment for depression called St. John’s wort
- Grapefruit and grapefruit juice. You should not drink grapefruit juice or eat grapefruit during your treatment with AUGTYRO. It can affect how AUGTYRO works and may lead to side effects.
How to take AUGTYRO:
- Take AUGTYRO exactly as your healthcare professional tells you to take it. Check with your healthcare professional if you are not sure on your dose.
Take AUGTYRO at about the same time each day with or without food.
- Swallow AUGTYRO capsules whole with water. Do not open, crush, chew or dissolve the capsule.
Usual dose:
- Adults: Take exactly as directed. Your healthcare professional will decide on the right dose for you.
- Your healthcare professional may change your dose, stop treatment for a period of time, or stop treatment completely. This may happen if you experience side effects.
Overdose:
| If you think you, or a person you are caring for, have taken too much AUGTYRO, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed dose:
- If you miss a dose, or vomit at any time after taking a dose of AUGTYRO, do not take an extra dose. Skip the missed dose and continue with your next scheduled dose.
- Do not take 2 doses at the same time to make up a missed or vomited dose.
Possible side effects from using AUGTYRO:
These are not all the possible side effects you may have when taking AUGTYRO. If you experience any side effects not listed here, tell your healthcare professional.
- dizziness
- headache
- change in sense of taste
- feeling of numbness or tingling in your arms or legs
- swelling
- constipation or diarrhea
- muscle pain, weakness
- weight gain
- lower appetite
- vision problems
- trouble with balance, coordination, and walking
- falling
- fractures
- shortness of breath
- problems with thinking, such as forgetfulness or confusion, memory problems and hallucinations
- tiredness
- trouble sleeping
- nausea, vomiting
AUGTYRO can cause abnormal blood test results. Your healthcare professional will do blood tests before, during and after your treatment. These will tell your healthcare professional how AUGTYRO is affecting your blood, liver and muscle health.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
| COMMON | ||||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, shortness of breath, weakness | √ | |||
| Bone fracture (broken bone): area around break will be painful and swollen, bulge or bump at site of break, broken bone may push through skin | √ | |||
| Eye problems: blurred vision, loss of vision in eye, increased sensitivity of the eyes to light, eye pain or redness, swelling and itching of the eyelids, decreased sharpness of vision, eye irritation, blocked eye veins | √ | |||
| Hepatotoxicity (liver problems): jaundice (yellowing of the skin or whites of eyes), urine turns dark, light-colored stool, loss of appetite for several days or longer, nausea, lower stomach pain | √ | |||
| Lung problems (Interstitial Lung Disease (ILD), pneumonitis): dry cough (without mucus), productive cough (with mucus), wheezing, or trouble breathing, shortness of breath, chest pain | √ | |||
| Mood problems: elevated or irritable mood, racing thoughts, anxiety | √ | |||
| Myalgia (muscle pain): aching muscles, tenderness or weakness | √ | |||
| Nervous system problems: dizziness, difficulty with fine motor tasks such as eating, writing or buttoning shirt; difficulty walking, loss of balance, slurring speech, | √ | |||
| severe headache, problems with thinking (forgetfulness, confusion, memory), severe sharp shooting pain, numbness and tingling, shaking/trembling |
|---|
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store AUGTYRO at room temperature (15°C to 30°C).
Keep out of reach and sight of children.
If you want more information about AUGTYRO:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website, https://www.bms.com/ca, or by calling the sponsor, Bristol-Myers Squibb Canada, at: 1-866-463-6267.
Date of Authorization: 2025-05-07