Teplizumab

  • Biologic
  • TZIELD

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

Teplizumab: storage and handling

Refrigerate
Yes, as the label states
Label statement
Refrigerate TZIELD vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Freezing
Do not freeze
Label statement
Do not freeze or shake the vials.
Room temperature
No allowance stated
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Refrigerate TZIELD vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
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.

The label does not state a room-temperature allowance for this product.

Entered: 1 day at up to 77°F (25°C).

Refrigerate TZIELD vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Do not freeze or shake the vials.

Contact the manufacturer at 1-800-633-1610 (the number printed on the label) about this product.

Where the label prints this number
Advise patients who are exposed to TZIELD during pregnancy to contact Provention Bio, Inc.'s Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi [see Use in Specific Populations (8.1) ] .
All storage statements on the label (3)
  • Refrigerate TZIELD vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
  • Store upright.
  • Do not freeze or shake the vials.

FDA label version 11, effective August 14, 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

No Part D formulary in the CMS files (2026Q3) lists this drug. It may be covered under Part B or not covered.

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.