Insulin human U-500
- Biologic
- Humulin R U-500 KwikPen
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 human U-500: storage and handling
- Refrigerate
- Yes, as the label states
Label statement
Unopened vials: Store unopened vials in the refrigerator.
- Freezing
- Do not freeze
Label statement
Do not freeze.
- Room temperature
- up to 28 days
Label statement
Table 2: Storage Conditions for HUMULIN R U-500 Pens a When stored at room temperature, HUMULIN R U-500 KwikPen can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time.
- Room temperature
- up to 28 days at or below 30°C (86°F)
Label statement
Not In-use (Unopened) In-use (Opened) Room Temperature (up to 86°F [30°C]) Refrigerated (36° to 46°F [2° to 8°C]) Room Temperature (up to 86°F [30°C]) Refrigerated (36° to 46°F [2° to 8°C]) 3 mL single-patient-use HUMULIN R U-500 KwikPen a 28 days Until expiration date 28 days Do not refrigerate.
- Room temperature
- up to 40 days at or below 30°C (86°F)
Label statement
After the vial has been opened: Store opened vials in the refrigerator or at room temperature (up to 86°F [30°C]) for up to 40 days.
- Back into the refrigerator
- Not addressed
- Light
- Not addressed
- Shaking
- Do not shake
Label statement
Do not shake the vial.
All storage statements on the label (12)
- Protect from heat and light.
- Do not freeze.
- Do not use if it has been frozen.
- Do not shake the vial.
- Table 2: Storage Conditions for HUMULIN R U-500 Pens a When stored at room temperature, HUMULIN R U-500 KwikPen can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time.
- Not In-use (Unopened) In-use (Opened) Room Temperature (up to 86°F [30°C]) Refrigerated (36° to 46°F [2° to 8°C]) Room Temperature (up to 86°F [30°C]) Refrigerated (36° to 46°F [2° to 8°C]) 3 mL single-patient-use HUMULIN R U-500 KwikPen a 28 days Until expiration date 28 days Do not refrigerate.
- Keep away from heat and out of direct light.
- Unopened vials: Store unopened vials in the refrigerator.
- Do not freeze Humulin R U-500.
- If it has been frozen, do not use it.
- If unopened vials have been stored in the refrigerator, you may use them until the expiration date.
- After the vial has been opened: Store opened vials in the refrigerator or at room temperature (up to 86°F [30°C]) for up to 40 days.
FDA label version 41, effective July 1, 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
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.