Denosumab

  • Biologic
  • Prolia

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

Denosumab: storage and handling

Refrigerate
Yes, as the label states
Label statement
Store Prolia refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
at or below 25°C (77°F)
Label statement
Prior to administration, Prolia may be allowed to reach room temperature up to 25°C (77°F) in the original container.
Room temperature
up to 30 days at or below 25°C (77°F)
Label statement
Once removed from the refrigerator, Prolia must not be exposed to temperatures above 25°C (77°F) and must be used within 30 days.
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Store Prolia refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Shaking
Do not shake
Label statement
Avoid vigorous shaking of Prolia.

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 25°C (77°F)). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

Prior to administration, Prolia may be allowed to reach room temperature up to 25°C (77°F) in the original container.
Discard Prolia if not used within the 30 days.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-877-562-4111 (the number printed on the label) about this product.

Where the label prints this number
For more copies see www.prolia.com or call 1-877-562-4111.
All storage statements on the label (7)
  • Store Prolia refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
  • Do not freeze.
  • Prior to administration, Prolia may be allowed to reach room temperature up to 25°C (77°F) in the original container.
  • Once removed from the refrigerator, Prolia must not be exposed to temperatures above 25°C (77°F) and must be used within 30 days.
  • Discard Prolia if not used within the 30 days.
  • Protect Prolia from direct light and heat.
  • Avoid vigorous shaking of Prolia.

FDA label version 186, effective June 26, 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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Biosimilars

Xgeva: 20 licensed biosimilar products, 20 interchangeable (FDA Purple Book). Compare presentations and dates

Medicare Part D coverage

100%of plans list it
62%of those: prior authorization
2%step therapy
89%quantity limit
2%specialty tier

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.