Ibtrozi (Oral)
Taletrectinib is used in adults to treat non-small cell lung cancer that has spread within your chest or to other parts of the body (metastatic).
Your doctor will make sure you have the correct tumor type to be treated with taletrectinib.
Taletrectinib may also be used for purposes not listed in this medication guide.
uses
What is Ibtrozi (Oral) used for?
- Non-Small Cell Lung Cancer
warnings
What is the most important information I should know about Ibtrozi (Oral)?
Tell your doctor if you have or have ever had:
- gout or high levels of uric acid in the blood;
- heart problems, including long QT syndrome (in you or a family member);
- lung or breathing problems (other than lung cancer); or
- liver disease.
You may be more likely to have a broken bone while using taletrectinib. Talk with your doctor about ways to keep your bones healthy.
Taletrectinib can harm an unborn baby if the mother or the father is using this medicine.
- If you are a woman, you will need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 3 weeks after your last dose.
- If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control during treatment and for at least 3 weeks after your last dose.
- Tell your doctor right away if a pregnancy occurs.
Do not breastfeed while using this medicine, and for at least 3 weeks after your last dose.
Taletrectinib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.
Side Effects
What are the side effects of Ibtrozi (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- sudden pain or trouble moving your hip, wrist, or back;
- heart problems--swelling, rapid weight gain, feeling short of breath, fast or pounding heartbeats, fluttering in your chest, or sudden dizziness (like you might pass out);
- high levels of uric acid in blood--joint problems, stomach pain, little or no urination, nausea, vomiting, pink or brown urine;
- lung problems--sudden chest pain, wheezing, dry cough, feeling short of breath;
- muscle problems--unexplained muscle pain, tenderness, weakness; or
- liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- nausea, vomiting, diarrhea, constipation;
- abnormal blood tests;
- dizziness, tiredness; or
- rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Ibtrozi (Oral) if I’m pregnant or breastfeeding?
Do not breastfeed while using this medicine, and for at least 3 weeks after your last dose.
Interactions
What drugs and food should I avoid while taking Ibtrozi (Oral)?
Taletrectinib could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors while using this medicine and for at least 5 days after your last dose.
Ask your doctor before taking an antacid, and take only the type your doctor recommends.
Grapefruit may interact with taletrectinib and cause side effects. Avoid consuming grapefruit products.
Dosage Guidelines & Tips
How to take Ibtrozi (Oral)?
Use Ibtrozi (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Your doctor will perform tests to make sure taletrectinib is the right treatment for you.
Taletrectinib is usually taken once per day, but take it the same way each time.
Take on an empty stomach, at least 2 hours before or 2 hours after a meal.
Do not change your dose or stop taking taletrectinib without your doctor's advice.
Swallow the capsule whole and do not crush, chew, break, or open it.
If you vomit shortly after taking taletrectinib, do not take another dose. Take your next dose as scheduled.
You will need frequent medical tests including tests to check your liver and heart function. Your cancer treatments may change, be delayed or discontinued based on the results.
Store at room temperature away from moisture and heat.
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Ibtrozi (Oral)?
Images
TAL 200
Color: white
Shape: capsule
Imprint: TAL 200