Nipocalimab

  • Biologic
  • IMAAVY

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

Nipocalimab: storage and handling

Refrigerate
Yes, as the label states
Label statement
Unopened Vials Store vials refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF) in the original carton to protect from light until the time of use.
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
No allowance stated
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Unopened Vials Store vials refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF) 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.

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

Entered: 1 day at up to 77°F (25°C).

Unopened Vials Store vials refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF) in the original carton to protect from light until the time of use.
Do not freeze.

Contact the manufacturer at 1-800-526-7736 (the number printed on the label) about this product.

Where the label prints this number
If IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY, your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com.
All storage statements on the label (3)
  • Unopened Vials Store vials refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF) in the original carton to protect from light until the time of use.
  • Do not freeze.
  • Do not shake.

FDA label version 5, effective August 21, 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.