Insulin glargine U-300

  • Biologic
  • Insulin glargine U-300 Max

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

Insulin glargine U-300: storage and handling

Freezing
Not addressed
Room temperature
up to 56 days at or below 30°C (86°F)
Label statement
Room temperature only (Do not refrigerate) up to 86°F (30°C) 1.5 mL SoloStar single-patient-use prefilled pen Until expiration date 56 days 3 mL Max SoloStar single-patient-use prefilled pen Until expiration date 56 days
Back into the refrigerator
Not addressed
Light
Not addressed
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 (up to 56 days 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).

Room temperature only (Do not refrigerate) up to 86°F (30°C) 1.5 mL SoloStar single-patient-use prefilled pen Until expiration date 56 days 3 mL Max SoloStar single-patient-use prefilled pen Until expiration date 56 days
Discard Insulin Glargine, U-300 prefilled pen if it has been frozen.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-800-633-1610 (the number printed on the label) about this product.

Where the label prints this number
Need help? If you have any questions about your pen or about diabetes, ask your healthcare provider, go to www.winthropus.com or call sanofi-aventis at 1-800-633-1610 .
All storage statements on the label (5)
  • Insulin Glargine, U-300 SoloStar or Insulin Glargine, U-300 Max SoloStar prefilled pen should not be stored in the freezer and should not be allowed to freeze.
  • Discard Insulin Glargine, U-300 prefilled pen if it has been frozen.
  • Protect Insulin Glargine, U-300 SoloStar/ Insulin Glargine, U-300 Max SoloStar from direct heat and light.
  • Storage conditions are summarized in the following table: Insulin Glargine, U-300 Not in-use (unopened) Refrigerated 36°F–46°F (2°C–8°C) In-use (opened) To prevent degradation, always store the prefilled pens with the cap on during in-use period.
  • Room temperature only (Do not refrigerate) up to 86°F (30°C) 1.5 mL SoloStar single-patient-use prefilled pen Until expiration date 56 days 3 mL Max SoloStar single-patient-use prefilled pen Until expiration date 56 days

FDA label version 7, effective May 30, 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

10%of plans list it
2%of those: prior authorization
0%step therapy
10%quantity limit
0%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.