Apalutamide

  • Part D specialty tier in 80% of formularies (2026Q3)
  • ERLEADA

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

Apalutamide: storage and handling

Freezing
Not addressed
Room temperature
at or below 30°C (86°F)
Label statement
Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 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
Store ERLEADA at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Store in original package to protect from light and moisture.
Shaking
Not addressed

Temperature excursion helper

Answers only from this label's storage statements. It does not judge whether a product is still usable beyond what the label states.

Within the label's stated room-temperature allowance (at up to 30°C (86°F)). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] .
Do not discard desiccant.
Do not throw away (discard) the desiccant.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-800-526-7736 (the number printed on the label) about this product.

Where the label prints this number
Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA For patent information: www.janssenpatents.com © 2019, 2023 Janssen Pharmaceutical Companies For more information, call Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or go to www.erleada.com.
All storage statements on the label (6)
  • Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] .
  • Store in original package to protect from light and moisture.
  • Do not discard desiccant.
  • Store ERLEADA at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
  • Store ERLEADA in the original package to protect from light and moisture.
  • Do not throw away (discard) the desiccant.

FDA label version 29, effective July 2, 2026. 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

100%of plans list it
98%of those: prior authorization
0%step therapy
81%quantity limit
97%specialty tier

5,496 Part D plans, CMS formulary files 2026Q3. Look up tier, PA, step therapy and quantity limits by plan

Patient assistance

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.