Golimumab subcutaneous

  • Part D specialty tier in 77% of formularies (2026Q3)
  • Biologic
  • Simponi

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.

Loading the therapy management checklist…

Storage and cold chain

Golimumab subcutaneous: storage and handling

Refrigerate
Yes, as the label states
Label statement
Refrigerate SIMPONI between 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light until the time of use.
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
up to 30 days at or below 25°C (77°F)
Label statement
If needed, SIMPONI may be stored at room temperature up to 77 °F (25 °C) for a maximum single period of 30 days in the original carton to protect from light.
Room temperature
up to 30 days
Label statement
If not used within 30 days at room temperature, discard SIMPONI.
Room temperature
up to 30 days at or below 25°C (77°F)
Label statement
If needed, store SIMPONI at room temperature, up to 77 °F (25 °C) for one period of time up to 30 days.
Room temperature
up to 30 days
Label statement
Throw away (dispose of) if not used within 30 days at room temperature.
Back into the refrigerator
Not allowed
Label statement
Once a syringe or autoinjector has been stored at room temperature, do not return the product to the refrigerator.
Light
Protect from light
Label statement
Refrigerate SIMPONI between 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light until the time of use.
Shaking
Do not shake
Label statement
Do not shake.

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 30 days 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).

If needed, SIMPONI may be stored at room temperature up to 77 °F (25 °C) for a maximum single period of 30 days in the original carton to protect from light.
Once a syringe or autoinjector has been stored at room temperature, do not return the product to the refrigerator.
If not used within 30 days at room temperature, discard SIMPONI.
Throw away (dispose of) if not used within 30 days at room temperature.

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

Where the label prints this number
For additional assistance or to share your feedback call 1-800-JANSSEN (1-800-526-7736).
All storage statements on the label (18)
  • Refrigerate SIMPONI between 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light until the time of use.
  • Do not freeze.
  • Do not shake.
  • Do not use SIMPONI beyond the expiration date (EXP) on the carton or the expiration date on the prefilled syringe (observed through the viewing window) or the prefilled SmartJect ® autoinjector.
  • If needed, SIMPONI may be stored at room temperature up to 77 °F (25 °C) for a maximum single period of 30 days in the original carton to protect from light.
  • Once a syringe or autoinjector has been stored at room temperature, do not return the product to the refrigerator.
  • If not used within 30 days at room temperature, discard SIMPONI.
  • Storage information Store SIMPONI in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C).
  • If needed, store SIMPONI at room temperature, up to 77 °F (25 °C) for one period of time up to 30 days.
  • Do not return it to the refrigerator.
  • Throw away (dispose of) if not used within 30 days at room temperature.
  • Do not freeze SIMPONI prefilled syringe.
  • Do not shake SIMPONI prefilled syringe.
  • Keep SIMPONI prefilled syringe in the original carton to protect from light before use.
  • Prefilled syringe parts Before use After use You will need these supplies: 1 SIMPONI prefilled syringe Not provided in the SIMPONI prefilled syringe carton: 1 Alcohol swab 1 Cotton ball or gauze pad 1 Adhesive bandage 1 Sharps container (See Step 3 ) Inspect carton Remove your SIMPONI prefilled syringe carton from the refrigerator.
  • Remove the prefilled syringe from the carton and let it sit on a flat surface at room temperature for at least 30 minutes before use.
  • Do not warm the prefilled syringe any other way.
  • Check the expiration date ('EXP') on the back panel of the carton and on the prefilled syringe (through the viewing window).

FDA label version 42, effective October 29, 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.

Loading dosing schedules…

Biosimilars

Simponi: 2 licensed biosimilar products, 2 interchangeable (FDA Purple Book). Compare presentations and dates

Medicare Part D coverage

1%of plans list it
98%of those: prior authorization
0%step therapy
51%quantity limit
89%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.