Dovbleron Taletrectinib Adipate Capsules

1. Indications and Usage
The capsules are indicated for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 0.6 g (600 mg) taken orally once daily until disease progression or unacceptable toxicity.
Administration: The capsules should be swallowed whole with water. They must be taken in a fasting state (no food 2 hours before and 2 hours after administration).
Missed Dose: If a dose is missed and the next dose is more than 12 hours away, administer the missed dose. If less than 12 hours remain, skip the dose do not take two doses on the same day.
Dose Modifications: Dose interruptions, reductions, or permanent discontinuation should follow the principle of first interrupting treatment and then reducing the dose based on individual safety and tolerability.
3. Mechanism of Action
Taletrectinib is a small-molecule, highly selective tyrosine kinase inhibitor of ROS1. It inhibits uncontrolled cell proliferation by blocking downstream signaling pathways activated by ROS1 fusion. It is also capable of crossing the blood-brain barrier to exert central nervous system targeted inhibitory activity.
4. Safety and Warnings
Hepatotoxicity: Monitor liver function tests (ALT, AST, bilirubin) regularly. Dose interruptions or reductions are required for Grade 3 or higher elevations.
QTc Prolongation: Monitor ECG and electrolytes regularly. Dose interruption is required for Grade 3 QTc prolongation.
Interstitial Lung Disease (ILD): Any grade of ILD, regardless of causality, requires permanent discontinuation of the drug.
Embryo-Fetal Toxicity: Use during pregnancy may cause fetal harm.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions (incidence ≥20%) include elevated AST, elevated ALT, diarrhea, vomiting, nausea, and anemia.
Clinical Research: The indication was approved based on single-arm clinical trial results in patients with ROS1-positive NSCLC.
6. Drug Interactions
CYP3A Inhibitors: Avoid concomitant use of strong or moderate CYP3A inhibitors to prevent increased taletrectinib exposure and toxicity.
CYP3A Inducers: Avoid concomitant use of CYP3A inducers to prevent decreased taletrectinib exposure and loss of therapeutic effect.
7. Pharmaceutical Information
Composition: The active ingredient is Taletrectinib Adipate.
Appearance: White hard capsules containing white to off-white powder.
Storage: Store at controlled room temperature in the original packaging.