Ustekinumab
- Biologic
- Stelara
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
Ustekinumab: storage and handling
- Refrigerate
- Yes, as the label states
Label statement
Store STELARA vials and prefilled syringes refrigerated between 2 ºC to 8 ºC (36 ºF to 46 ºF).
- Freezing
- Do not freeze
Label statement
Do not freeze.
- Room temperature
- up to 30 days at or below 30°C (86°F)
Label statement
If needed, individual prefilled syringes may be stored at room temperature up to 30 °C (86 °F) for a maximum single period of up to 30 days in the original carton to protect from light.
- Room temperature
- up to 30 days
Label statement
Discard the syringe if not used within 30 days at room temperature storage.
- Room temperature
- up to 30 days at or below 30°C (86°F)
Label statement
If needed, individual STELARA prefilled syringes may be stored at room temperature up to 86 °F (30 °C) for a maximum single period of up to 30 days in the original carton to protect from light.
- Room temperature
- up to 30 days
Label statement
Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature storage.
- Back into the refrigerator
- Not allowed
Label statement
Once a syringe has been stored at room temperature, do not return to the refrigerator.
- Light
- Protect from light
Label statement
Keep the product in the original carton to protect from light until the time of use.
- Shaking
- Do not shake
Label statement
Do not shake.
All storage statements on the label (17)
- Store STELARA vials and prefilled syringes refrigerated between 2 ºC to 8 ºC (36 ºF to 46 ºF).
- Store STELARA vials upright.
- Keep the product in the original carton to protect from light until the time of use.
- Do not freeze.
- Do not shake.
- If needed, individual prefilled syringes may be stored at room temperature up to 30 °C (86 °F) for a maximum single period of up to 30 days in the original carton to protect from light.
- Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided.
- Once a syringe has been stored at room temperature, do not return to the refrigerator.
- Discard the syringe if not used within 30 days at room temperature storage.
- Do not use STELARA after the expiration date on the carton or on the prefilled syringe.
- Storing STELARA prefilled syringes Store STELARA prefilled syringes in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C).
- Store STELARA prefilled syringes in the original carton to protect from light.
- Do not freeze STELARA prefilled syringes.
- If needed, individual STELARA prefilled syringes may be stored at room temperature up to 86 °F (30 °C) for a maximum single period of up to 30 days in the original carton to protect from light.
- Record the date when the prefilled syringe is removed from the refrigerator on the carton in the space provided.
- After a prefilled syringe has been stored at room temperature, do not return it to the refrigerator.
- Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature storage.
FDA label version 49, effective September 8, 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
Stelara: 10 licensed biosimilar products, 10 interchangeable (FDA Purple Book). Compare presentations and dates
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.