BEQVEZ™ How Supplied/Storage and Handling

(fidanacogene elaparvovec-dzkt)

16 HOW SUPPLIED/STORAGE AND HANDLING

  

16.1 How Supplied

BEQVEZ is supplied as a clear to slightly opalescent, colorless to slightly brown suspension with each mL containing 1 × 1013 vg.

BEQVEZ is shipped frozen (−100 °C to −60 °C [−148 °F to −76 °F]) in plastic vials with an elastomeric stopper and plastic snap fit cap with an extractable volume of 1 mL.

BEQVEZ is provided as a customized kit containing the number of vials (NDC 0069-0422-01) required to meet dosing requirements for each patient [see Dosage and Administration (2.1)]. The customized kit is accompanied with patient’s specific identifier number (Pfizer Patient Identifier) on the outer carton.

The kit sizes and National Drug Codes (NDC) are provided in Table 6.

Table 6. BEQVEZ Multi-Vial Kits

Patient Dose Weight (kg)

Total Number of Vials per Kit

NDC Number

≤75

4

0069-2004-04

>75 to ≤95

5

0069-2005-05

>95 to ≤115

6

0069-2006-06

>115 to ≤135

7

0069-2007-07

16.2 Storage and Handling

BEQVEZ is shipped and delivered frozen between −100 °C to −60 °C (−148 °F to −76 °F) in clear vials.

Upon receipt, immediately place in a freezer between −90 °C to −60 °C (−130 °F to −76 °F).

Store in the original package to avoid direct sunlight and ultraviolet light exposure.

Store upright in the original package. If cartons or individual vials are tipped over or inverted during storage and handling, place the carton or individual vials back in the upright orientation immediately.

Frozen vials in the inner carton will take up to 1 hour to thaw at room temperature (up to 30 °C [86 °F]). Vials may be gently swirled but not shaken or inverted. The total time at room temperature between removing vials from frozen storage until the beginning of dose preparation should be no more than 3 hours. Once thawed, the medicinal product should not be re-frozen and may be stored refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the inner carton up to 24 hours.

Following dilution in 0.9% sodium chloride with 0.25% HSA, chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 30 °C (36 °F to 86 °F).

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

  

16.1 How Supplied

BEQVEZ is supplied as a clear to slightly opalescent, colorless to slightly brown suspension with each mL containing 1 × 1013 vg.

BEQVEZ is shipped frozen (−100 °C to −60 °C [−148 °F to −76 °F]) in plastic vials with an elastomeric stopper and plastic snap fit cap with an extractable volume of 1 mL.

BEQVEZ is provided as a customized kit containing the number of vials (NDC 0069-0422-01) required to meet dosing requirements for each patient [see Dosage and Administration (2.1)]. The customized kit is accompanied with patient’s specific identifier number (Pfizer Patient Identifier) on the outer carton.

The kit sizes and National Drug Codes (NDC) are provided in Table 6.

Table 6. BEQVEZ Multi-Vial Kits

Patient Dose Weight (kg)

Total Number of Vials per Kit

NDC Number

≤75

4

0069-2004-04

>75 to ≤95

5

0069-2005-05

>95 to ≤115

6

0069-2006-06

>115 to ≤135

7

0069-2007-07

16.2 Storage and Handling

BEQVEZ is shipped and delivered frozen between −100 °C to −60 °C (−148 °F to −76 °F) in clear vials.

Upon receipt, immediately place in a freezer between −90 °C to −60 °C (−130 °F to −76 °F).

Store in the original package to avoid direct sunlight and ultraviolet light exposure.

Store upright in the original package. If cartons or individual vials are tipped over or inverted during storage and handling, place the carton or individual vials back in the upright orientation immediately.

Frozen vials in the inner carton will take up to 1 hour to thaw at room temperature (up to 30 °C [86 °F]). Vials may be gently swirled but not shaken or inverted. The total time at room temperature between removing vials from frozen storage until the beginning of dose preparation should be no more than 3 hours. Once thawed, the medicinal product should not be re-frozen and may be stored refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the inner carton up to 24 hours.

Following dilution in 0.9% sodium chloride with 0.25% HSA, chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 30 °C (36 °F to 86 °F).

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