Ofatumumab

  • Part D specialty tier in 78% of formularies (2026Q3)
  • Biologic
  • KESIMPTA

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

Ofatumumab: storage and handling

Refrigerate
Yes, as the label states
Label statement
KESIMPTA Sensoready pens and prefilled syringes must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF).
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
up to 7 days at or below 30°C (86°F)
Label statement
If necessary, KESIMPTA may be stored for up to 7 days at room temperature, not to exceed 30°C (86°F).
Room temperature
up to 7 days at or below 30°C (86°F)
Label statement
If needed, KESIMPTA Sensoready Pen may be stored for up to 7 days at room temperature, up to 86°F (30°C).
Back into the refrigerator
Allowed, as stated
Label statement
If stored below 30°C (86°F), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days or discarded after 7 days.
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
To avoid foaming, 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 7 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).

If necessary, KESIMPTA may be stored for up to 7 days at room temperature, not to exceed 30°C (86°F).
If stored below 30°C (86°F), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days or discarded after 7 days.
If this KESIMPTA is not used within those 7 days, then discard the medicine.

If anything else happened to the product, or you are unsure, Contact the manufacturer about this product; the label text ClinDose has does not print a phone number for it.

All storage statements on the label (15)
  • KESIMPTA Sensoready pens and prefilled syringes must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF).
  • Keep the product in the original carton to protect from light until the time of use.
  • Do not freeze.
  • To avoid foaming, do not shake.
  • If necessary, KESIMPTA may be stored for up to 7 days at room temperature, not to exceed 30°C (86°F).
  • Write the date removed from the refrigerator in the space provided on the carton labeling.
  • If stored below 30°C (86°F), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days or discarded after 7 days.
  • Store your carton of KESIMPTA Sensoready Pen in a refrigerator, between 36°F to 46°F (2°C to 8°C).
  • Keep KESIMPTA Sensoready Pen in the original carton until ready to use to protect from light.
  • If needed, KESIMPTA Sensoready Pen may be stored for up to 7 days at room temperature, up to 86°F (30°C).
  • Write the date taken out of the refrigerator in the space provided on the carton.
  • If stored below 86°F (30°C), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days.
  • If this KESIMPTA is not used within those 7 days, then discard the medicine.
  • Do not freeze KESIMPTA Sensoready Pen.
  • Figure C Before your injection Take the KESIMPTA Sensoready Pen out of the refrigerator 15 to 30 minutes before injecting to allow it to reach room temperature.

FDA label version 11, effective April 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.

Loading dosing schedules…

Medicare Part D coverage

83%of plans list it
78%of those: prior authorization
0%step therapy
79%quantity limit
96%specialty tier

5,496 Part D plans, CMS formulary files 2026Q3. Look up tier, PA, step therapy and quantity limits by plan

Patient assistance

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.