Collagenase clostridium histolyticum

  • Biologic
  • XIAFLEX

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

Collagenase clostridium histolyticum: storage and handling

Refrigerate
Yes, as the label states
Label statement
Prior to reconstitution, the vials of XIAFLEX and diluent should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). [ see Dosage and Administration (2.1 , 2.2 )] .
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
up to 1 hour at or below 25°C (77°F)
Label statement
The reconstituted XIAFLEX solution can be kept at room temperature (20°C to 25°C/68°F to 77°F) for up to 1 hour or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours prior to administration [ see Dosage and Administration (2.1 , 2.2 )] .
Back into the refrigerator
Not addressed
Light
Not addressed
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.

Beyond the room-temperature allowance the label states. The label does not state stability beyond it.

Entered: 1 day at up to 77°F (25°C).

The reconstituted XIAFLEX solution can be kept at room temperature (20°C to 25°C/68°F to 77°F) for up to 1 hour or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours prior to administration [ see Dosage and Administration (2.1 , 2.2 )] .

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 (3)
  • Prior to reconstitution, the vials of XIAFLEX and diluent should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). [ see Dosage and Administration (2.1 , 2.2 )] .
  • Do not freeze.
  • The reconstituted XIAFLEX solution can be kept at room temperature (20°C to 25°C/68°F to 77°F) for up to 1 hour or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours prior to administration [ see Dosage and Administration (2.1 , 2.2 )] .

FDA label version 46, effective April 22, 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.