Source: FDA, National Drug Code (US) Revision Year: 2026
JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration (2.1), Clinical Studies (14.1)].
Before initiating JIDEYTRO, evaluate creatine phosphokinase (CPK) level, electrocardiogram (ECG), electrolytes, lipase and amylase [see Warnings and Precautions (5.2, 5.5, 5.6)].
The recommended dosage of JIDEYTRO is 100 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity [see Clinical Pharmacology (12.3)].
Swallow JIDEYTRO tablets whole. Do not split, chew, crush, or dissolve the tablet prior to swallowing.
If a dose of JIDEYTRO is missed within 12 hours of the regularly scheduled dose, administer the missed dose as soon as possible. If a dose is missed by 12 hours or more, take the next dose at its scheduled time.
If vomiting occurs at any time after taking JIDEYTRO, take the next dose at its scheduled time.
The recommended dosage reductions of JIDEYTRO for the management of adverse reactions are provided in Table 1.
Table 1. Recommended Dose Reductions for JIDEYTRO Adverse Reactions:
| Dose Reduction | Recommended Dose and Schedule |
| First | 75 mg once daily |
| Second | 50 mg once daily |
| Permanently discontinue JIDEYTRO in patients unable to tolerate 50 mg once daily. After dose reduction of JIDEYTRO for adverse reactions, do not re-escalate the dose. | |
The recommended dosage modifications of JIDEYTRO for the management of adverse reactions are provided in Table 2.
Table 2. Recommended Dosage Modifications of JIDEYTRO for Adverse Reactions:
| Adverse Reaction | Severity* | Dosage Modification |
| Central Nervous System Adverse Reactions [see Warnings and Precautions (5.1)] | Intolerable Grade 2 | • Withhold JIDEYTRO until Grade ≤ 1 or baseline. • Resume JIDEYTRO at same or reduced dose, as clinically appropriate. |
| Grade 3 | • Withhold JIDEYTRO until Grade ≤ 1 or baseline. • Resume JIDEYTRO at reduced dose. | |
| Grade 4 | • Permanently discontinue JIDEYTRO. | |
| QTc Interval Prolongation [see Warnings and Precautions (5.2)] | Grade 2 (QTc interval 481-500 msec) | • Withhold JIDEYTRO until recovery to Grade ≤ 1 or baseline. • Correct electrolytes and/or change concomitant medications. • Resume JIDEYTRO at same dose. |
| Grade 3 (QTc interval ≥501 msec or QTc interval increase of >60 msec from baseline) | • Withhold JIDEYTRO until recovery to Grade ≤ 1 or baseline. • Correct electrolytes and/or change concomitant medications. • Resume JIDEYTRO at a reduced dose. | |
| Grade 4 (Torsade de pointes; polymorphic ventricular tachycardia; signs/symptoms of serious arrhythmia) | • Permanently discontinue JIDEYTRO. | |
| Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.3)] | Grade 1 | • Withhold JIDEYTRO if ILD/pneumonitis occurs or is suspected until recovery to Grade 0. • If resolved within 6 weeks, resume JIDEYTRO at the same dose. • If unresolved after 6 weeks, permanently discontinue JIDEYTRO. Recurrence: • Permanently discontinue JIDEYTRO. |
| Grade 2 | • Withhold JIDEYTRO if ILD/pneumonitis occurs or is suspected until recovery to Grade 0 or baseline. • If resolved within 6 weeks, resume JIDEYTRO at a reduced dose. • If unresolved after 6 weeks, permanently discontinue JIDEYTRO. Recurrence: • Permanently discontinue JIDEYTRO. | |
| Grade 3 or 4 | • Permanently discontinue JIDEYTRO. | |
| Creatine Phosphokinase (CPK) Elevation [see Warnings and Precautions (5.5)] | CPK elevation >5 times ULN | • Withhold JIDEYTRO until recovery to baseline or ≤2.5 times ULN, then resume JIDEYTRO at same dose. |
| CPK elevation >10 times ULN or Recurrence of CPK elevation of >5 times ULN | • Withhold until recovery to baseline or ≤2.5 times ULN, then resume JIDEYTRO at a reduced dose. | |
| Increased lipase or amylase [see Warnings and Precautions (5.6)] | Grade 3 | • Withhold JIDEYTRO until Grade ≤2 or baseline. • If recovered to baseline or Grade ≤2 within 14 days, resume JIDEYTRO at a reduced dose; otherwise permanently discontinue JIDEYTRO. |
| Grade 4 | • Permanently discontinue JIDEYTRO. | |
| Pancreatitis [see Warnings and Precautions (5.6)] | Grade 3 or Grade 4 | • Permanently discontinue JIDEYTRO. |
| Other Adverse Reactions [see Adverse Reactions (6.1)] | Intolerable Grade 2 or Grade 3 or Grade 4 | • Withhold JIDEYTRO until Grade ≤1 or baseline. • If resolution occurs within 4 weeks, resume JIDEYTRO at the same dose for intolerable Grade 2 or Grade 3 adverse reactions. • If resolution occurs within 4 weeks, resume JIDEYTRO at the next lower dose for Grade 4 adverse reactions. • Permanently discontinue JIDEYTRO if adverse reaction does not resolve within 4 weeks. • Permanently discontinue JIDEYTRO for recurrent Grade 4 events. |
* Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Store JIDEYTRO at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
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