Taletrectinib Adipate Capsule

Basic Drug Information
Generic Name‌: taletrectinib adipate
Brand Name‌: IBTROZI
Dosage Form & Strength‌: immediate-release hard capsule; 200 mg (counted as taletrectinib free base)
Initial U.S. Approval‌: 2025
Packager‌: Nuvation Bio Inc.
Indications and Usage

IBTROZI is a kinase inhibitor indicated for the treatment of adult patients with ‌locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)‌.

Dosage and Administration
Patient Selection‌: Confirm the presence of ROS1 rearrangement(s) in tumor specimen prior to initiation of treatment.
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).
Continue treatment until disease progression or unacceptable toxicity.
Dosage Forms and Strengths

Capsules: 200 mg of taletrectinib (free base), equivalent to 272 mg of taletrectinib adipate.

Contraindications

None

Warnings and Precautions
Hepatotoxicity‌: Monitor liver function tests prior to initiating treatment, every 2 weeks during the first 2 months of treatment, then monthly thereafter as clinically indicated. More frequent testing is required for patients who develop transaminase elevations. Withhold, resume at reduced dose, or permanently discontinue based on severity.
Interstitial Lung Disease (ILD)/Pneumonitis‌: Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold in patients with suspected ILD/pneumonitis. Resume at the same or reduced dose, or permanently discontinue based on severity and resolution.
QTc Interval Prolongation‌: Monitor ECG and electrolytes prior to initiating and periodically during treatment. Withhold, then resume at same or reduced dose, or permanently discontinue based on severity.