INDICATION
AUGTYRO® (repotrectinib) is a 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 of age 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 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.
IMPORTANT SAFETY INFORMATION
AUGTYRO® (repotrectinib) may cause serious side effects, including:
Central nervous system (CNS) effects. Tell your healthcare provider right away if you experience any new or worsening symptoms of CNS effects during treatment with AUGTYRO, including:
- 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
Lung problems (pneumonitis). Tell your healthcare provider right away if you have any new or worsening lung problems, including a dry cough (without mucus), productive cough (with mucus), wheezing, or trouble breathing.
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. Tell your healthcare provider right away if you develop symptoms of liver problems including: 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.
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. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
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. Tell your healthcare provider right way if you have pain, changes in movement, or bone abnormalities.
Before taking AUGTYRO, tell 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
- are pregnant or plan to become pregnant. AUGTYRO can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with AUGTYRO.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with AUGTYRO.
- You should use effective non-hormonal birth control (contraception) during treatment and for 2 months after the 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 provider about birth control methods that may be right for you.
Male patients with female partners who are able to become pregnant:
- You should use effective birth control during treatment with AUGTYRO and for 4 months after the last dose.
- are breastfeeding or plan to breastfeed. It is not known if AUGTYRO passes into your breast milk. Do not
breastfeed during treatment and for 10 days after the last dose of AUGTYRO. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
Taking AUGTYRO with certain other medicines may affect the amount of AUGTYRO or other medicines in your blood and may cause side effects 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.
What should I avoid while taking AUGTYRO?
- You should not drink grapefruit juice or eat grapefruit during your treatment with AUGTYRO. It may increase the amount of AUGTYRO in your blood to a harmful level.
- Do not drive or operate machinery until you know how AUGTYRO affects you. If you experience dizziness,
blurred vision, memory loss, changes in mental status, confusion, hallucinations or have trouble with balance or coordination or problems with concentration and attention, do not drive or operate machinery until your symptoms have resolved.
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; and nausea.
These are not all the possible side effects of AUGTYRO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see U.S. Full Prescribing Information and Patient Information for AUGTYRO.
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