ELEVIDYS Suspension for solution for infusion Ref.[107289] Active ingredients: Delandistrogene moxeparvovec

Source: FDA, National Drug Code (US) Revision Year: 2023

Product description

ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells.

ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 × 10¹³ vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188.

Dosage Forms and Strengths
ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 × 10¹³ vg/mL. ELEVIDYS is provided in a customized kit containing ten to seventy 10 mL single-dose vials, with each kit constituting a dosage unit based on the patient’s body weight [see How Supplied/Storage and Handling (16.1)]. The intravenous dosage is determined by patient body weight, with a recommended dose of 1.33 × 10¹⁴ vector genomes (vg)/kg.

How Supplied

ELEVIDYS is shipped frozen (≤ -60ºC [-76ºF]) in 10 mL vials.

ELEVIDYS is supplied as a customized kit to meet dosing requirements for each patient [see Dosage and Administration (2.1)]. Each kit contains:

Ten (10) to seventy (70) single-dose vials of ELEVIDYS
One alcohol wipe per vial

Each ELEVIDYS pack may contain a maximum of two different drug product lots.

The total number of vials in each kit corresponds to the dosing requirement for the individual patient, based on the patient’s body weight, and is specified on the package [see Dosage and Administration (2.2)]. Each kit includes a specified number of ELEVIDYS vials (with a minimum of 10 vials for a patient with 10.0 – 10.4 kg body weight range, and a maximum of 70 vials for a patient with body weight of 69.5 kg and above).

Kit sizes and National Drug Codes (NDC) are provided in Table 7.

Table 7. ELEVIDYS Multi-vial Kits:

Patient Weight (kg)	Total Vials per Kit	Total Dose Volume per Kit (mL)	NDC Number
10.0 – 10.4	10	100	60923-501-10
10.5 – 11.4	11	110	60923-502-11
11.5 – 12.4	12	120	60923-503-12
12.5 – 13.4	13	130	60923-504-13
13.5 – 14.4	14	140	60923-505-14
14.5 – 15.4	15	150	60923-506-15
15.5 – 16.4	16	160	60923-507-16
16.5 – 17.4	17	170	60923-508-17
17.5 – 18.4	18	180	60923-509-18
18.5 – 19.4	19	190	60923-510-19
19.5 – 20.4	20	200	60923-511-20
20.5 – 21.4	21	210	60923-512-21
21.5 – 22.4	22	220	60923-513-22
22.5 – 23.4	23	230	60923-514-23
23.5 – 24.4	24	240	60923-515-24
24.5 – 25.4	25	250	60923-516-25
25.5 – 26.4	26	260	60923-517-26
26.5 – 27.4	27	270	60923-518-27
27.5 – 28.4	28	280	60923-519-28
28.5 – 29.4	29	290	60923-520-29
29.5 – 30.4	30	300	60923-521-30
30.5 – 31.4	31	310	60923-522-31
31.5 – 32.4	32	320	60923-523-32
32.5 – 33.4	33	330	60923-524-33
33.5 – 34.4	34	340	60923-525-34
34.5 – 35.4	35	350	60923-526-35
35.5 – 36.4	36	360	60923-527-36
36.5 – 37.4	37	370	60923-528-37
37.5 – 38.4	38	380	60923-529-38
38.5 – 39.4	39	390	60923-530-39
39.5 – 40.4	40	400	60923-531-40
40.5 – 41.4	41	410	60923-532-41
41.5 – 42.4	42	420	60923-533-42
42.5 – 43.4	43	430	60923-534-43
43.5 – 44.4	44	440	60923-535-44
44.5 – 45.4	45	450	60923-536-45
45.5 – 46.4	46	460	60923-537-46
46.5 – 47.4	47	470	60923-538-47
47.5 – 48.4	48	480	60923-539-48
48.5 – 49.4	49	490	60923-540-49
49.5 – 50.4	50	500	60923-541-50
50.5 – 51.4	51	510	60923-542-51
51.5 – 52.4	52	520	60923-543-52
52.5 – 53.4	53	530	60923-544-53
53.5 – 54.4	54	540	60923-545-54
54.5 – 55.4	55	550	60923-546-55
55.5 – 56.4	56	560	60923-547-56
56.5 – 57.4	57	570	60923-548-57
57.5 – 58.4	58	580	60923-549-58
58.5 – 59.4	59	590	60923-550-59
59.5 – 60.4	60	600	60923-551-60
60.5 – 61.4	61	610	60923-552-61
61.5 – 62.4	62	620	60923-553-62
62.5 – 63.4	63	630	60923-554-63
63.5 – 64.4	64	640	60923-555-64
64.5 – 65.4	65	650	60923-556-65
65.5 – 66.4	66	660	60923-557-66
66.5 – 67.4	67	670	60923-558-67
67.5 – 68.4	68	680	60923-559-68
68.5 – 69.4	69	690	60923-560-69
69.5 and above	70	700	60923-561-70

A 10 mL single-dose vial carton for ELEVIDYS (NDC 60923-562-01) is not sold individually.

Manufactured for Sarepta Therapeutics, Inc., Cambridge, MA 01242 USA

Drugs

Drug	Countries
ELEVIDYS	United States

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.