Taletrectinib Adipate: uses, dosing, side effects & brands
Taletrectinib Adipate is a kinase inhibitor sold in the U.S. under one brand, for non-small-cell lung carcinoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Kinase Inhibitor
- Treats
- Non-Small-Cell Lung Carcinoma
- Available as
- Capsule
- Sold as
- Ibtrozi
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How taletrectinib adipate is dosed
From the FDA label for Ibtrozi (application NDA219713). Other taletrectinib adipate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Select patients for the treatment of locally advanced or metastatic NSCLC based on the presence of ROS1 rearrangement(s). ( 2.1 ) Recommended Dosage: 600 mg orally once daily on an empty stomach (no food intake at least 2 hours before and 2 hours after taking IBTROZI). ( 2.3 ) Continue treatment until disease progression or unacceptable toxicity. ( 2.3 ) 2.1 Patient Selection Select patients for the treatment of locally advanced or metastatic NSCLC with IBTROZI based on the presence of ROS1 rearrangement(s) in tumor specimens [see Clinical Studies ( 14.1 )] . An FDA-approved test to detect ROS1 rearrangement(s) for selecting patients for treatment with IBTROZI is not currently available. 2.2 Recommended Testing and Evaluation Before Initiating IBTROZI Before initiating IBTROZI, evaluate liver function tests (including ALT, AST, and bilirubin), electrolytes, ECG, and uric acid [see Warnings and Precautions ( 5.1 , 5.3 , 5.4 )]. 2.3 Recommended Dosage and Administration The recommended dosage of IBTROZI is 600 mg orally once daily on an empty stomach (no food intake at least 2 hours before and 2 hours after taking IBTROZI) [see Clinical Pharmacology ( 12.2 , 12.3 )] until disease progression or unacceptable toxicity. Take IBTROZI at approximately the same time each day. Swallow IBTROZI capsules whole. Do not open, chew, crush, or dissolve the capsule prior to swallowing. Avoid…
Taletrectinib Adipate side effects
The following adverse reactions are discussed in greater detail in the WARNINGS AND PRECAUTIONS section: Hepatotoxicity [see Warnings and Precautions ( 5.1 )] Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions ( 5.2 )] QTc Interval Prolongation [see Warnings and Precautions ( 5.3 )] Hyperuricemia [see Warnings and Precautions ( 5.4 )] Myalgia with Creatine Phosphokinase Elevation [see Warnings and Precautions ( 5.5 )] Skeletal fractures [see Warnings and Precautions ( 5.6 )] The most frequently reported adverse reactions (≥20%) were: diarrhea, nausea, vomiting, dizziness, rash, constipation, and fatigue. ( 6.1 ) The most frequently reported Grade 3 or 4 laboratory abnormalities (≥5%) were: increased ALT, increased AST, decreased neutrophils, and increased creatine phosphokinase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Nuvation Bio Inc. at 1-844-688-4550 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS section and below reflects exposure to IBTROZI as a single agent at 600 mg orally…
Who shouldn’t take taletrectinib adipate
None. None ( 4 )
Taletrectinib Adipate drug interactions
Strong and Moderate CYP3A inhibitors : Avoid concomitant use. ( 7.1 ) Strong and Moderate CYP3A inducers: Avoid concomitant use. ( 7.1 ) Gastric Acid Reducing Agents: Avoid concomitant use with proton pump inhibitors (PPIs) and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer IBTROZI 2 hours before or 2 hours after taking a locally acting antacid. ( 7.1 ) Drugs That Prolong the QTc Interval: Avoid concomitant use. ( 7.2 ) 7.1 Effects of Other Drugs on IBTROZI Strong and Moderate CYP3A Inhibitors Avoid concomitant use with strong or moderate CYP3A inhibitors. Taletrectinib is a CYP3A substrate. Concomitant use of IBTROZI with a strong or moderate CYP3A inhibitor increases taletrectinib exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of IBTROZI adverse reactions. Strong and Moderate CYP3A Inducers Avoid concomitant use with strong or moderate CYP3A inducers. Concomitant use of IBTROZI with a strong or moderate CYP3A inducer decreases taletrectinib exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce the effectiveness of IBTROZI. Gastric Acid Reducing Agents Avoid concomitant use with proton pump inhibitors (PPI) and H2 receptor antagonists. Administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI [see Clinical Pharmacology ( 12.3 )]. Concomitant use of a proton pump inhibitor decreases taletrectinib exposure [see Clinical Pharmacology ( 12.3 )], which may reduce the effectiveness of IBTROZI. 7.2. Drugs That Prolong the QTc Interval Avoid concomitant use of IBTROZI with other drug(s) with a known potential to prolong the QTc interval, such as antiarrhythmic drugs. If concomitant use cannot be avoided, adjust the frequency of monitoring as recommended [see Warnings and Precautions ( 5.3 ), Clinical Pharmacology ( 12.2 )]. Withhold IBTROZI if the QTc interval is >500 msec or the change from baseline is >60 msec [see Dosage and Administration ( 2.4 )]. IBTROZI causes QTc interval prolongation [see Warnings and Precautions ( 5.3 ), Clinical Pharmacology ( 12.2 )] . Concomitant use of IBTROZI with other drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation.
Every taletrectinib adipate product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Ibtrozi.
What people report to the FDA about taletrectinib adipate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 6 reports naming taletrectinib adipate, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- diarrhoea2 reports
- vomiting2 reports
- blindness transient1 reports
- brain neoplasm malignant1 reports
- degenerative bone disease1 reports
- drug eruption1 reports
- erythema1 reports
- gait disturbance1 reports
Read these as a signal, not a rate. A report does not mean taletrectinib adipate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
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Frequently asked questions
What is taletrectinib adipate?
Ibtrozi (Taletrectinib Adipate) is a kinase inhibitor used to treat Non-Small-Cell Lung Carcinoma.
What kind of drug is taletrectinib adipate?
The FDA classifies taletrectinib adipate as a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take taletrectinib adipate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run taletrectinib adipate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does taletrectinib adipate come in?
Across the brands we track, taletrectinib adipate is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic taletrectinib adipate?
We do not currently list a generic-labelled taletrectinib adipate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Taletrectinib Adipate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/taletrectinib-adipate
- MLA
- “Taletrectinib Adipate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/taletrectinib-adipate.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for taletrectinib adipate on DailyMed (NIH) ↗.