Omalizumab

  • Part D specialty tier in 80% of formularies (2026Q3)
  • Biologic
  • XOLAIR

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

Omalizumab: storage and handling

Refrigerate
Yes, as the label states
Label statement
XOLAIR prefilled syringe and autoinjector should be shipped and stored under refrigerated conditions 2°C to 8°C (36°F to 46°F) in the original carton.
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
up to 2 days
Label statement
The total combined time out of the refrigerator may not be more than 2 days.
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Protect from direct sunlight.
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 2 days). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

The total combined time out of the refrigerator may not be more than 2 days.
If the prefilled syringe is left at temperatures above 77°F (25°C), do not use it and throw away in a sharps disposal container.

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 (17)
  • XOLAIR prefilled syringe and autoinjector should be shipped and stored under refrigerated conditions 2°C to 8°C (36°F to 46°F) in the original carton.
  • Protect from direct sunlight.
  • XOLAIR prefilled syringe and autoinjector can be removed from and placed back in the refrigerator if needed.
  • The total combined time out of the refrigerator may not be more than 2 days.
  • Do not use if prefilled syringe or autoinjector is left at temperatures above 25°C (77°F).
  • Do not freeze.
  • Do not use if the prefilled syringe or autoinjector has been frozen.
  • XOLAIR should be shipped at controlled ambient temperature (≤30°C [≤86°F]).
  • Store XOLAIR under refrigerated conditions 2°C to 8°C (36°F to 46°F) in the original carton.
  • Do not use beyond the expiration date stamped on carton.
  • Keep your unused prefilled syringes in the original carton and store the carton in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not remove the prefilled syringe from its original carton during storage.
  • Before giving an injection, the carton can be removed from and placed back in the refrigerator if needed.
  • If the prefilled syringe is left at temperatures above 77°F (25°C), do not use it and throw away in a sharps disposal container.
  • Do not use if the prefilled syringe has been frozen.
  • Preparing for the Injection 1 Take the carton containing the prefilled syringe out of the refrigerator.
  • If you need more than 1 prefilled syringe to deliver your full dose (see Dosing Table ), take all cartons out of the refrigerator at the same time (each carton contains 1 prefilled syringe).

FDA label version 32, effective August 13, 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

Xolair: 1 licensed biosimilar product, 1 interchangeable (FDA Purple Book). Compare presentations and dates

Medicare Part D coverage

100%of plans list it
100%of those: prior authorization
0%step therapy
55%quantity limit
97%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.