Entrectinib
- Part D specialty tier in 80% of formularies (2026Q3)
- Rozlytrek
Therapy management checklist
Screening, baseline and ongoing monitoring with the label's stated frequency, hold and discontinue criteria, and counseling points, each quoted from the FDA label.
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Storage and cold chain
Entrectinib: storage and handling
- Freezing
- Not addressed
- Room temperature
- at or below 30°C (86°F)
Label statement
Storage: Store 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] .
- Room temperature
- at or below 30°C (86°F)
Label statement
Storage : Store 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] .
- Room temperature
- at or below 25°C (77°F)
Label statement
Storing ROZLYTREK Store ROZLYTREK capsules at room temperature between 68°F to 77°F (20°C to 25°C).
- Room temperature
- up to 2 hours at or below 30°C (86°F)
Label statement
Do not store ROZLYTREK prepared as a suspension for more than 2 hours at room temperature below 86°F (30°C).
- Room temperature
- at or below 25°C (77°F)
Label statement
ROZLYTREK capsules Store ROZLYTREK at room temperature between 68°F to 77°F (20°C to 25°C).
- Room temperature
- at or below 25°C (77°F)
Label statement
ROZLYTREK oral pellets Store ROZLYTREK oral pellets at room temperature between 68°F to 77°F (20°C to 25°C).
- Back into the refrigerator
- Not addressed
- Light
- Not addressed
- Shaking
- Not addressed
All storage statements on the label (12)
- Storage: Store 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] .
- Store ROZLYTREK capsules in the original container and keep the bottle tightly closed in order to protect from moisture.
- Storage time should not exceed 2 hours (below 30°C (86°F)) if capsules are prepared as an oral suspension using drinking water or milk.
- Discard any unused suspension if not used within 2 hours of preparation.
- Storage : Store 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] .
- Store ROZLYTREK oral pellets in the original container in order to protect from moisture.
- Storing ROZLYTREK Store ROZLYTREK capsules at room temperature between 68°F to 77°F (20°C to 25°C).
- Do not store ROZLYTREK prepared as a suspension for more than 2 hours at room temperature below 86°F (30°C).
- Store ROZLYTREK capsules in the original container and keep the bottle tightly closed to protect from moisture.
- ROZLYTREK capsules Store ROZLYTREK at room temperature between 68°F to 77°F (20°C to 25°C).
- ROZLYTREK oral pellets Store ROZLYTREK oral pellets at room temperature between 68°F to 77°F (20°C to 25°C).
- Store ROZLYTREK oral pellets in the original container to protect from moisture.
FDA label version 18, effective December 4, 2025. DailyMed
Dosing and titration calendar
Built only from the schedules the label states (loading, titration, day schedules, cycles and weight bands). Steps the label states in words the calendar cannot place are shown, not guessed.
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Medicare Part D coverage
5,496 Part D plans, CMS formulary files 2026Q3. Look up tier, PA, step therapy and quantity limits by plan
Patient assistance
No manufacturer program page is listed for this drug yet.
Independent foundations and the full directory (checked 2026-11-06). Eligibility and amounts are set by each program; open its page for them.
For licensed clinicians. Use with clinical judgment. Statements are quoted from the FDA label; confirm against the label for the product you are using.