RYONCIL Suspension for infusion Ref.[115503] Active ingredients: Remestemcel

Source: FDA, National Drug Code (US) Revision Year: 2025

Product description

RYONCIL is provided as a frozen cell suspension in a cryogenic vial. The active ingredient in RYONCIL is comprised of culture-expanded mesenchymal stromal cells (MSCs) isolated from the bone marrow of healthy human adult donors. Each cryovial contains nominally 25 x 10⁶ MSCs in 3.8 mL (a target concentration 6.68 x 10⁶ cells/mL) formulated in Plasma Lyte-A (70% v/v), Human Serum Albumin (HSA) Solution (25%) (20% v/v) and Dimethyl sulfoxide (DMSO) (10% v/v). The product is thawed and combined with Plasma-Lyte A prior to intravenous administration.

Dosage Forms and Strengths
RYONCIL is available as a cell suspension for intravenous infusion in a target concentration of 6.68 X 10⁶ MSCs per mL in 3.8 mL at cryopreservation contained in a 6 mL cryovial. Each 6 mL cryovial contains approximately 25 x 10⁶ MSCs. Cryopreserved MSCs are combined with Plasma-Lyte A for administration.

How Supplied

RYONCIL is supplied as a sterile, cryopreserved cell suspension of ex-vivo culture-expanded allogeneic bone marrow-derived mesenchymal stromal cells (MSC) in vials.

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

Cartons containing sufficient RYONCIL for one infusion based on the patient weight (see Table 5)
Sufficient alcohol wipes for preparation of the RYONCIL infusions.

Kit sizes and National Drug Codes (NDC) are provided in Table 5.

Table 5. RYONCIL Kit Sizes:

Patient weight (kg)	Kit contents (single infusion)					Number of kits needed for:
Patient weight (kg)	4-vial cartons	1-vial cartons	Total cartons	Number of alcohol wipes	NDC Number	Initial course	2^nd course	Relapse after CR
<12.5	0	1	1	1	73648-111-01	8	4	8
12.5-<25	0	2	2	2	73648-112-02
25-<37.5	0	3	3	3	73648-113-03
37.5-<50	1	0	1	4	73648-114-01
50-<62.5	1	1	2	5	73648-115-02
62.5-<75	1	2	3	6	73648-116-03
75-<87.5	1	3	4	7	73648-117-04
87.5-<100	2	0	2	8	73648-118-02

RYONCIL is shipped to the clinical facility in a liquid nitrogen dry shipper maintained at a temperature of ≤ -135°C.

Manufactured for: Mesoblast, Inc., 1114 Sixth Avenue, Fourth Floor, New York, NY 10036

Drugs

Drug	Countries
RYONCIL	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.