Brand Name
Ryoncil
Generic Name
Remestemcel-L-Rknd
View Brand Information FDA approval date: March 17, 2025
Form: Kit
What is Ryoncil (Remestemcel-L-Rknd)?
RYONCIL is indicated for the treatment of steroid refractory acute graft versus host disease in pediatric patients 2 months of age and older. RYONCIL is an allogeneic bone marrow-derived mesenchymal stromal cell therapy indicated for the treatment of steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older.
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Brand Information
RYONCIL (remestemcel-l-rknd)
1INDICATIONS AND USAGE
RYONCIL is indicated for the treatment of steroid refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older.
2DOSAGE AND ADMINISTRATION
For intravenous use only.
2.1Recommended Dosage
- The recommended dosage of RYONCIL is 2 × 10
- Assess response 28 ± 2 days after the first dose and administer further treatment as appropriate as described in Table 1 based on Day 28 response.
2.2Preparation and Administration Instructions
Receipt and Storage of RYONCIL
RYONCIL is shipped directly to the clinical facility in a liquid nitrogen dry shipper maintained at a temperature of ≤ -135°C.
RYONCIL must remain frozen at ≤ -135°C in liquid nitrogen vapor phase until thawed immediately prior to administration
Preparation
RYONCIL and Plasma-Lyte
Prepare a sterile water bath to a minimum depth of 4 inches and warm to 37°C (± 2°C) at least 30 minutes prior for thawing.
Supplies needed for preparation of RYONCIL and Plasma-Lyte
- RYONCIL vials
- Plasma-Lyte
- Infusion bag
- Interlink blood bag spikes (2)
- Interlink threaded lock cannula (1 per syringe)
- 60 mL luer-lock syringe (1)
- 5 mL luer-lock syringe (1 per each thawed vial)
- 18-gauge needle (1 per each thawed vial)
- Airtight zip seal plastic bag(s) (1 per each vial for thaw)
- Water bath
- Alcohol wipes
Note: Plasma-Lyte
Preparation of Plasma-Lyte
- Insert the Interlink blood bag spike into the Plasma-Lyte
- Aseptically attach the threaded lock cannula to a 60 mL syringe.
- Use an alcohol wipe to scrub the membrane of the Plasma-Lyte
- Attach the threaded lock cannula/syringe assembly to the Plasma-Lyte
- Measure and withdraw 40 mL of Plasma-Lyte
Note: DO NOT remove the syringe containing Plasma-Lyte
Preparation of RYONCIL
- Prior to RYONCIL thaw, verify that the pre-arranged time for the RYONCIL administration is still feasible. Patient infusion must occur
- Remove RYONCIL vial(s) from cryo-storage.
- Place vial(s) into an airtight zip seal plastic bag(s) and immerse closed bag(s) into the water bath (37ºC), maintaining the top closure above the water line. Use a separate zip seal plastic bag for each vial of RYONCIL.
- To thaw, gently agitate the sealed zip seal bag(s) with the vial(s) for approximately 5 to 8 minutes to thaw.
- Remove vials from the water bath prior to the last visible crystal of ice melting.
- Inspect vial(s) while still in the bag(s) to identify there is no leakage of vial contents.
- Remove the RYONCIL vial(s) from the sealed plastic bag(s).
- Inspect for foreign particulate matter (FPM). If FPM is found via visual inspection – DO NOT USE! Retain the offending vial(s). Call the Mesoblast contact number 844-889-MESO (6376).
- Remove the tab from the RYONCIL vial cap to expose the vial stopper and wipe the exposed surface of the stopper with one provided sterile alcohol wipe.
- Promptly withdraw the required amount of RYONCIL (based on actual patient body weight) from the vial(s).
- Carefully remove the needle from the syringe containing RYONCIL.
- Attach the threaded lock cannula to the syringe.
- Retrieve the infusion bag.
- Wipe the membrane of the infusion bag interlink spike injection site with sterile alcohol wipe.
- Insert 1 interlink blood bag spike into the outermost port on the infusion bag (leave the middle port for the infusion line.)
- Attach the syringe to the spike and transfer the RYONCIL into the infusion bag.
- Remove the syringe with the threaded lock cannula and discard the syringe and the threaded lock cannula.
- Repeat for each syringe until the required volume of RYONCIL is added to the infusion bag.
Transfer of Plasma-Lyte
- Retrieve the bag and 60 mL syringe containing Plasma-Lyte
- Verify the syringe contains 40mL of Plasma-Lyte
- Aseptically remove the 60 mL syringe with the threaded lock cannula containing the 40mL Plasma-Lyte
- Use alcohol wipes to clean the membrane of the infusion bag interlink spike injection site.
- Aseptically attach the 60mL syringe containing the Plasma-Lyte
- Slowly transfer the 40mL Plasma-Lyte
- Gently mix cells with the Plasma-Lyte
- Remove the syringe with the threaded lock cannula and discard the syringe and threaded lock cannula.
- Label the bag according to Institutional Policy.
- Transport infusion bag to patient infusion area.
Administration
Note: Patient infusion must occur
- Administer RYONCIL under the supervision of a qualified health professional experienced in the management of SR-aGvHD.
- Administer RYONCIL using an infusion pump.
- Use blood filter with a pore size of 40-260 microns for infusion of RYONCIL.
- Flush lines per institutional practice and/or policy for cellular infusions.
- Pretreatment
Premedicate patients with corticosteroids and antihistamines 30-60 minutes prior to administration of RYONCIL to reduce the potential for infusion reactions. - Infusion Rates
- For patients weighing 35 kg or more, infuse RYONCIL at a rate of no more than 6mL/ minute.
- For patients weighing less than 35 kg, infuse RYONCIL over the course of 60 minutes.
- Discard unused, thawed RYONCIL vials per institutional policy.
3DOSAGE FORMS AND STRENGTHS
RYONCIL is available as a cell suspension for intravenous infusion in a target concentration of 6.68 X 10
Each 6 mL cryovial contains approximately 25 x 10
Cryopreserved MSCs are combined with Plasma-Lyte
4CONTRAINDICATIONS
Do not use RYONCIL in patients with known hypersensitivity to dimethyl sulfoxide (DMSO) or porcine and bovine proteins.
5DESCRIPTION
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 10
6CLINICAL STUDIES
The efficacy of RYONCIL was evaluated in a multicenter, prospective, single-arm study (MSB-GVHD 001; NCT02336230). The study enrolled pediatric patients with SR-GvHD Grade B to D (excluding Grade B skin alone) as per International Blood and Marrow Transplantation Registry Severity Index Criteria (IBMTR) after receiving allogeneic hematopoietic stem cell transplantation (HSCT). SR-aGvHD was defined as aGvHD that progressed within 3 days or did not improve within 7 consecutive days of treatment with methylprednisolone 2 mg/kg/day or equivalent. Patients who received a second line therapy for aGvHD prior to screening were excluded.
RYONCIL was administered by intravenous infusion at a dosage of 2 x 10
A total of 55 patients were enrolled, and 54 were treated with RYONCIL. Among the treated patients (n=54), the demographic characteristics were as follows: median age was 7 years (range: 7 months to 17 years); 36% were females; 56% were White, 19% reported “other” race, 15% were Black, 6% were Asian, 6% American Indian or Alaska Native, 33% were Hispanic and 65% were non-Hispanic. Among enrolled patients, hematologic malignancies (67%) and non-malignant diseases (33%) were the underlying reasons for allogenic HSCT. SR-GvHD severity was as follows at baseline: Grade B (11%), Grade C (43%), Grade D (46%). Organ involvement at baseline were as follows: skin alone (26%), lower gastrointestinal tract only (39%), multi-organ involvement (35%). The median duration of prior corticosteroid treatment at baseline was 8 days (range: 2 to 46 days).
The main efficacy outcome measures were Day-28 overall response rate (complete response rate and partial response rate) and the duration of response.
The efficacy results are summarized in Table 4.
Overall response rate at Day 28 by baseline disease severity is as follows: Grade B (3/6; 50%), Grade C (16/23; 70%), and Grade D (19/25; 76%).
Among the 38 responders, the median time from Day-28 response to either death or need for systemic therapy for aGvHD (non-RYONCIL systemic therapy for aGvHD or increase in the dose of corticosteroids to methylprednisolone 2 mg/kg or equivalent) was 111.5 days (range 9, 182+).
7HOW SUPPLIED/STORAGE AND HANDLING
RYONCIL is supplied as a sterile, cryopreserved cell suspension of
RYONCIL is provided as a customized kit to meet dosing requirements for a single dose for each patient
- Cartons containing sufficient RYONCIL for one infusion based on the patient weight (see
- Sufficient alcohol wipes for preparation of the RYONCIL infusions.
Kit sizes and National Drug Codes (NDC) are provided in Table 5.
RYONCIL is shipped to the clinical facility in a liquid nitrogen dry shipper maintained at a temperature of ≤ -135°C.
Storage conditions: RYONCIL must remain frozen at ≤ -135°C in liquid nitrogen vapor phase until thawed immediately prior to administration.
Handling: Restrict preparation and administration of RYONCIL to a medical facility in which the medical personnel are trained in aseptic technique.
Disposal: Dispose empty or partially used RYONCIL vials according to the institutional guidelines for disposal of biohazard materials.
Do not save thawed RYONCIL vials for future use.
8PATIENT COUNSELING INFORMATION
Discuss the following with patients and/or caregivers.
- Hypersensitivity and Acute infusion reactions: Inform patients and/or caregivers that hypersensitivity and acute infusion reactions due to the presence of porcine and bovine protein, and DMSO may occur with RYONCIL infusion. Advise patients and/or caregivers to seek immediate medical evaluation if any signs and symptoms of hypersensitivity or acute infusion reactions occur, such as fever, rash or hives, low blood pressure, breathing problems [see .
- Transmission of Infectious Agents: Inform patients and/or caregivers about the possible risk of transmission of infectious agents with RYONCIL administration [see .
- Ectopic Tissue Formation: Inform patients and/or caregivers about the possible risk of ectopic tissue formation with RYONCIL administration [see .
Manufactured for:
RYONCIL is a registered trademark of Mesoblast. All rights reserved.
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
remestemcel-L-rknd
Ryoncil
Target 25 X 10
For intravenous administration after thaw
See Prescribing Information for directions for use.
Store at ≤ -135°C
Single–use vial
Discard unused portion
See Prescribing Information for directions for use.
Store at ≤ -135°C
Single–use vial
Discard unused portion
Manufactured for Mesoblast Inc.
Rx only
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-
remestemcel-L-rknd
Ryoncil
Suspension for IV Infusion
Allogeneic bone marrow-derived mesenchymal stromal cells
For intravenous administration after thaw and resuspension
Rx only
11PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-
remestemcel-L-rknd
Ryoncil
Suspension for IV Infusion
Allogeneic bone marrow-derived mesenchymal stromal cells
For intravenous administration after thaw and resuspension
Rx only
12PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-111-01
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.024
13PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-112-02
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.025
14PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-113-03
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.026
15PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-114-01
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.027
16PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-115-02
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.028
17PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-116-03
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.029
18PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-117-04
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.030
19PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-118-02
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.031
20PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-119-03
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.038
21PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-120-04
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.039
22PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-121-05
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.040
23PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 73648-122-03
Suspension for IV Infusion
Kit for Patient Weight:
Kit Contents:
Single–use vial. Discard unused portion.
Manufactured for Mesoblast Inc.
GTIN: XXXXXXXXXXXXXX
PNTC-1154.041
