AUGTYRO

Generic Name/API: repotrectinib

Manufacturer: Bristol Myers Squibb company

Packaging:
• Bottles of 60 capsules
• Bottles of 120 capsules

Strength: Strength: 40mg

Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F
to 86°F) [See USP Controlled Room Temperature]

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
What is AUGTYRO?

AUGTYRO (repotrectinib) is an oral prescription medicine used to treat non-small cell lung cancer (NSCLC) in adults that:

Has spread within your chest or to other parts of the body,
AND
Is caused by an
abnormal ROS1 gene
It is not known if AUGTYRO is safe and effective in children.

Talk to your healthcare team
for more information about what it means to have an abnormal ROS1 gene.

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 and during treatment with AUGTYRO. 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, at least 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.

Scroll to Top