Ibtrozi

Pronunciation: ib-TRO-zee
Generic name: taletrectinib
Dosage form: capsules for oral use (200 mg)

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 12, 2025.

What is Ibtrozi?

Ibtrozi is used to treat non-small cell lung cancer (NSCLC) in adults that has spread within the chest or to other parts of the body and is caused by an abnormal ROS1 gene. It is an oral capsule taken once daily on an empty stomach (no food intake for 2 hours before or after taking).

• Your cancer specialist will identify if you are suitable for Ibtrozi treatment based on genetic testing for ROS1 rearrangements.

Ibtrozi is a kinase inhibitor that works by blocking specific proteins (ROS1 and TRK) that fuel cancer growth. When these proteins become overactive through genetic changes called fusions or mutations, they send signals that cause cancer cells to multiply uncontrollably. By inhibiting these proteins, Ibtrozi’s mechanism inhibits tumor growth.

Ibtrozi (taletrectinib) gained FDA approval on June 11, 2025. There is no generic. FDA approval was based on TRUST clinical trials showing Ibtrozi's high response rates and brain penetration.

• TKI-naive patients achieved 85-90% response rates with durable responses exceeding 30-46 months. TKI-pretreated patients had 52-62% response rates.
• Intracranial responses occurred in 73% of naive and 63% of pretreated patients.

Side effects

The most common side effects of Ibtrozi include:

• diarrhea
• nausea
• vomiting
• dizziness
• rash
• constipation
• tiredness
• changes in your liver function tests
• decreased white blood cell levels.

Serious side effects and warnings

Ibtrozi can cause the following serious side effects:

• Liver problems. Changes in liver function can happen during treatment with Ibtrozi and can lead to liver injury and death. Your healthcare provider will do blood tests to check your liver function before starting, every 2 weeks during the first 2 months of treatment, then monthly as needed during your treatment with Ibtrozi.

Tell your healthcare provider right away if you develop signs and symptoms of liver problems, including:

• • yellowing of your skin or the white part of your eyes (jaundice)
  • loss of appetite
  • nausea or vomiting
  • dark or “tea-colored” urine
  • pain on the upper right side of your stomach
  • light-colored stools (bowel movements)
  • feeling tired or weak.
• Lung problems. Ibtrozi can cause lung problems that are severe, life-threatening or lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough (with or without mucus), or fever.

• Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will do tests before and during your treatment with Ibtrozi to check the electrical activity of your heart and your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during your treatment with Ibtrozi. These may be symptoms related to QT prolongation.

• Increased uric acid level in your blood (hyperuricemia). Your healthcare provider will check your uric acid blood levels before and during your treatment with Ibtrozi. Your healthcare provider may prescribe medicine to lower uric acid if needed. Tell your healthcare provider if you develop any of the following symptoms of hyperuricemia:
  • red, hot, tender, or swollen joints, especially in your big toe
  • pain in your stomach
  • nausea or vomiting
  • pink or brown urine.
• Muscle pain, tenderness, and weakness (myalgia). Ibtrozi can cause myalgia with or without an increase in the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your CPK blood levels every 2 weeks during the first month and as needed if you experience unexplained muscle pain, tenderness, or weakness during your treatment with Ibtrozi. Tell your healthcare provider if you develop unexplained muscle pain, tenderness, or weakness.

• Bone fractures. Ibtrozi can increase your risk of bone fractures. Bone fractures may happen with or without a fall or other injury. Tell your healthcare provider if you develop pain, changes in movement, or bone abnormalities.

Ibtrozi may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

It is not known if Ibtrozi is safe and effective in children.

Your healthcare provider may decrease your dose, temporarily stop, or completely stop your treatment with Ibtrozi if you have serious side effects. These are not all the possible side effects of Ibtrozi. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

Before taking Ibtrozi, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems.
• have lung or breathing problems other than lung cancer.
• have any heart problems, including a condition called long QT syndrome.
• have gout.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Ibtrozi can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Ibtrozi.

Females who can become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Ibtrozi.
• You should use effective birth control (contraception) during treatment and for 3 weeks after the last dose of
• Ibtrozi.
• Talk to your healthcare provider about birth control methods that may be right for you.

Males with female partners who can become pregnant:

• You should use effective birth control (contraception) during treatment and for 3 weeks after the last dose of Ibtrozi.

Breastfeeding

It is not known if Ibtrozi passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after the last dose of Ibtrozi. Talk to your healthcare provider about the best way to feed your baby during this time.

How should I take Ibtrozi?

Take Ibtrozi exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Ibtrozi unless your healthcare provider tells you to.

• Ibtrozi is taken once a day.
• Take Ibtrozi on an empty stomach. Do not eat food for at least 2 hours before or 2 hours after taking Ibtrozi.
• Take it at about the same time each day.
• Swallow the capsules whole. Do not open, crush, chew, or dissolve the capsule before swallowing.

Avoid taking proton pump inhibitors (PPIs) or H2 blocker medicines. If you take an antacid, take it at least 2 hours before or 2 hours after taking Ibtrozi.

What happens if I miss a dose or vomit?

If you miss a dose or vomit at any time after taking a dose of Ibtrozi, take your next dose at your regularly scheduled time the next day.

Dosing information

Dose of Ibtrozi for NSCLC with ROS1 mutations:

• 600 mg orally once daily on an empty stomach.
• No food intake at least 2 hours before and 2 hours after taking Ibtrozi.

Continue treatment until disease progression or unacceptable toxicity occurs.

What should I avoid while taking Ibtrozi?

You should limit time in the sun during treatment with Ibtrozi. Ibtrozi may make your skin sensitive to sunlight. Wear a hat and clothes that cover your skin and use sunscreen with sun protective factor (SPF) if you are in the sun during treatment with Ibtrozi and for at least 5 days after your last dose of Ibtrozi.

You should avoid grapefruit, grapefruit juice, or products that contain grapefruit during your treatment with Ibtrozi. Grapefruit may increase the amount of Ibtrozi in your blood, which may increase the risk of Ibtrozi side effects

What other drugs will affect Ibtrozi?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Avoid taking proton pump inhibitors (PPIs), or H2 blocker medicines. If you take an antacid, take it at least 2 hours before or 2 hours after taking Ibtrozi.

Avoid grapefruit and grapefruit drinks or products.

Ibtrozi may affect the way other medicines work, and other medicines may affect how Ibtrozi works. You should not start or stop any medicine before you talk with your healthcare provider that prescribed Ibtrozi.

Storage

Store Ibtrozi at room temperature between 68°F to 77°F (20°C to 25°C).

Keep out of the reach of children.

Ibtrozi ingredients

Active ingredient: taletrectinib adipate

Inactive ingredients: colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, mannitol, pregelatinized starch, sodium stearyl fumarate. Capsule shell contains hypromellose and titanium dioxide. Blue printing ink contains butyl alcohol, dehydrated alcohol, FD&C Blue#1 Aluminum Lake, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, and titanium dioxide.

Available as 200 mg capsules.

Company

Ibtrozi (taletrectinib) is distributed by Nuvation Bio Inc., Burlington, MA 01803 and is a trademark of Nuvation Bio Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer