Augtyro (repotrectinib) - Uses, Side Effects, and More

What are the most common side effects of Augtyro?

The most common side effects of Augtyro are listed below. Tell your health care provider if you have any of these side effects that bother you.

• Tiredness
• Change in how things taste
• Numbness or tingling in your arms or legs
• Constipation
• Shortness of breath
• Central nervous system (CNS) problems (see below)
• Muscle weakness
• Nausea

There may be other side effects of Augtyro that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Augtyro?

While less common, the most serious side effects of Augtyro are described below, along with what to do if they happen.

Severe Allergic Reactions. Augtyro may cause allergic reactions, which can be serious. Stop taking Augtyro and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Trouble swallowing or throat tightness
• Itching, skin rash, or pale red bumps on the skin called hives
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain

Central Nervous System (CNS) Problems. Augtyro can affect your central nervous system (CNS). Call your health care provider right away if you have the following symptoms of CNS problems.

• Dizziness
• Sleep problems
• Confusion
• Trouble with balance or coordination
• Seeing or hearing things that others do not see or hear, also called hallucinations
• Trouble with thinking, memory, and focus
• Changes in mood or behavior

Lung Inflammation. Augtyro can cause inflammation in your lungs, also called interstitial lung disease orpneumonitis. This can be serious or even life-threatening. Get emergency help if you have new or worsening breathing problems. You may also have a cough, wheezing, fever, or chest pain. 

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Augtyro. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms of liver damage.

• Nausea or vomiting
• Stomach or belly pain
• Fever
• Weakness or unusual tiredness
• Itching
• Loss of appetite
• Light-colored poop
• Dark-colored urine (pee)
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Muscle Problems. Augtyro can cause muscle problems, including muscle pain, weakness, and tenderness, called myopathy. In some people, the muscle may break down (rhabdomyolysis), which can be serious and rarely lead to kidney damage and death. Get help right away if you have any of the following symptoms.

• Unexplained muscle pain, weakness, or tenderness
• Low energy levels or feeling easily tired, especially with activity
• Dark-colored urine (pee)
• Fever
• Muscle cramps
• Stomach pain
• Nausea or vomiting

High Levels of Uric Acid. Augtyro can cause high levels of uric acid (hyperuricemia) in your body. Tell your health care provider if you have had gout in the past or had high levels of uric acid. Attend all appointments for your provider to test your blood and urine so they can be sure that Augtyro is safe for you. Tell your health care provider right away if you have any of the following symptoms. 

• Red, hot, tender, or swollen joints, especially in your big toe
• Stomach pain or pain in your sides
• Less urine (pee) than normal
• Nausea or vomiting
• Pink or brown pee or blood in your pee

Weak Bones. Augtyro can cause your bones to break (fracture) more easily. Tell your health care provider if you break a bone, have any pain, or have changes in your ability to walk or move.