Cenegermin

  • Part D specialty tier in 79% of formularies (2026Q3)
  • Biologic
  • OXERVATE

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

Cenegermin: storage and handling

Refrigerate
Yes, as the label states
Label statement
Patient Storage Within 5 hours of delivery, store the weekly carton(s) containing OXERVATE vials in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 14 days.
Frozen storage
Stated
Label statement
Pharmacy Storage Store the weekly cartons containing OXERVATE vials in the freezer at or below -4°F (-20°C).
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
up to 12 hours at or below 25°C (77°F)
Label statement
A vial opened for daily use may be stored in the original weekly carton in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature up to 77°F (25°C), for up to 12 hours [see Dosage and Administration (2.1) ] .
Room temperature
at or below 25°C (77°F)
Label statement
Thaw the vial at room temperature up to 77°F (25°C).
Room temperature
up to 12 hours at or below 25°C (77°F)
Label statement
Once opened, the vial can be kept in the original weekly carton in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 12 hours or at room temperature up to 77°F (25°C), but must be used within 12 hours.
Back into the refrigerator
Not addressed
Light
Not addressed
Shaking
Do not shake
Label statement
Do not shake the vials.

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 (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).

Thaw the vial at room temperature up to 77°F (25°C).
Discard the opened vial after 12 hours even if there is still some solution left inside.
After 12 hours, advise patients to discard the vial with any unused amount.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-833-366-7387 (the number printed on the label) about this product.

Where the label prints this number
at 1-833-366-7387 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
All storage statements on the label (18)
  • Pharmacy Storage Store the weekly cartons containing OXERVATE vials in the freezer at or below -4°F (-20°C).
  • Patient Storage Within 5 hours of delivery, store the weekly carton(s) containing OXERVATE vials in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 14 days.
  • A vial opened for daily use may be stored in the original weekly carton in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature up to 77°F (25°C), for up to 12 hours [see Dosage and Administration (2.1) ] .
  • Do not shake the vials.
  • Discard the opened vial after 12 hours even if there is still some solution left inside.
  • Remove the weekly carton(s) of OXERVATE from the insulated pack and store it for up to 14 days in a refrigerator in the original carton as soon as you can.
  • Store the weekly carton(s) at 36°F to 46°F (2°C to 8°C) no later than 5 hours from when you receive the medicine from your pharmacy.
  • Do not freeze.
  • OXERVATE is stored in a freezer at the pharmacy.
  • If you start treatment right away after receiving the weekly carton, you will have to wait until the first vial is thawed.
  • Thaw the vial at room temperature up to 77°F (25°C).
  • Thawing the vial could take up to 30 minutes when kept at room temperature.
  • Gather your supplies: Remove 1 vial of OXERVATE from the refrigerator in the morning (always at the same time each morning) to use during the day.
  • If OXERVATE is to be used in both eyes, remove 2 vials from the refrigerator. 1 vial adapter 1 pipette (if both eyes 2 pipettes) 1 sterile disinfectant wipe (if both eyes 2 sterile disinfectant wipes) Dose Recording Card Step 1.
  • Information Instruct the patient to remove the weekly carton(s) containing 7 OXERVATE vials from the insulated pack within 5 hours of receiving it from the pharmacy and store the weekly carton(s) in the refrigerator [36°F to 46°F (2°C to 8°C)].
  • Do not shake the vial.
  • Once opened, the vial can be kept in the original weekly carton in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 12 hours or at room temperature up to 77°F (25°C), but must be used within 12 hours.
  • After 12 hours, advise patients to discard the vial with any unused amount.

FDA label version 15, effective December 31, 2024. 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

17%of plans list it
100%of those: prior authorization
0%step therapy
44%quantity limit
98%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.