16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

ZOLGENSMA is shipped frozen (≤ -60°C [-76°F]) in 10 mL vials with 2 fill volumes (either 5.5 mL or 8.3 mL).

ZOLGENSMA is provided as a customized kit to meet dosing requirements for each patient [see Dosage and Administration (2.1)], with each kit containing:

Two (2) to fourteen (14) vials of ZOLGENSMA (see below)
One alcohol wipe per vial

Kit sizes and National Drug Codes (NDC) are provided in Table 3.

Table 3: ZOLGENSMA Kit Sizes
Patient weight (kg)	5.5 mL viala	8.3 mL vialb	Total vials per kit	NDC number
aVial nominal concentration is 2.0 × 1013 vg/mL and contains an extractable volume of not less than 5.5 mL. bVial nominal concentration is 2.0 × 1013 vg/mL and contains an extractable volume of not less than 8.3 mL.
2.6 – 3.0	0	2	2	71894-120-02
3.1 – 3.5	2	1	3	71894-121-03
3.6 – 4.0	1	2	3	71894-122-03
4.1 – 4.5	0	3	3	71894-123-03
4.6 – 5.0	2	2	4	71894-124-04
5.1 – 5.5	1	3	4	71894-125-04
5.6 – 6.0	0	4	4	71894-126-04
6.1 – 6.5	2	3	5	71894-127-05
6.6 – 7.0	1	4	5	71894-128-05
7.1 – 7.5	0	5	5	71894-129-05
7.6 – 8.0	2	4	6	71894-130-06
8.1 – 8.5	1	5	6	71894-131-06
8.6 – 9.0	0	6	6	71894-132-06
9.1 – 9.5	2	5	7	71894-133-07
9.6 – 10.0	1	6	7	71894-134-07
10.1 – 10.5	0	7	7	71894-135-07
10.6 – 11.0	2	6	8	71894-136-08
11.1 – 11.5	1	7	8	71894-137-08
11.6 – 12.0	0	8	8	71894-138-08
12.1 – 12.5	2	7	9	71894-139-09
12.6 – 13.0	1	8	9	71894-140-09
13.1 – 13.5	0	9	9	71894-141-09
13.6 – 14.0	2	8	10	71894-142-10
14.1 – 14.5	1	9	10	71894-143-10
14.6 – 15.0	0	10	10	71894-144-10
15.1 – 15.5	2	9	11	71894-145-11
15.6 – 16.0	1	10	11	71894-146-11
16.1 – 16.5	0	11	11	71894-147-11
16.6 – 17.0	2	10	12	71894-148-12
17.1 – 17.5	1	11	12	71894-149-12
17.6 – 18.0	0	12	12	71894-150-12
18.1 – 18.5	2	11	13	71894-151-13
18.6 – 19.0	1	12	13	71894-152-13
19.1 – 19.5	0	13	13	71894-153-13
19.6 – 20.0	2	12	14	71894-154-14
20.1 – 20.5	1	13	14	71894-155-14
20.6 – 21.0	0	14	14	71894-156-14

16.2 Storage and Handling

Product is shipped and delivered frozen (≤ -60°C [-76°F]) in clear vials.
Upon receipt, immediately place the kit in a refrigerator at 2°C to 8°C (36°F to 46°F).
ZOLGENSMA is stable for 14 days from receipt when stored at 2°C to 8°C (36°F to 46°F).
DO NOT REFREEZE.
Must use within 14 days of receipt.