Ryoncil Dosage
Generic name: ALLOGENIC BONE-MARROW-DERIVED MESENCHYMAL STEM CELLS 6680000[arb'U] in 1mL; ISOPROPYL ALCOHOL 0.7mL in 1mL
Dosage form: intravenous infusion
Medically reviewed by Drugs.com. Last updated on Mar 11, 2025.
For intravenous use only.
Recommended Dosage
- The recommended dosage of RYONCIL is 2 × 106 mesenchymal stromal cells (MSC)/kg body weight per intravenous infusion given twice a week for 4 consecutive weeks for a total of 8 infusions. Administer infusions at least 3 days apart.
- 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.
Response | Recommendation |
---|---|
|
|
Complete Response | No further treatment with RYONCIL |
Partial or Mixed Response* | Repeat administration of RYONCIL once a week for additional 4 weeks (4 infusions total) |
No Response | Consider alternative treatments |
Recurrence of GvHD after complete response | Repeat administration of RYONCIL twice a week for an additional 4 consecutive weeks (8 infusions total) |
Preparation 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® A should be prepared following aseptic technique in a Biological Safety Cabinet (BSC). Spray and wipe down the following materials with 70% alcohol prior to transferring them into the BSC preparation area. All materials should remain in the BSC preparation area unless discarded.
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® A
- RYONCIL vials
- Plasma-Lyte® A
- 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)
Note: Use a 1mL syringe if volume to be removed from vial is less than 1mL - Airtight zip seal plastic bag(s) (1 per each vial for thaw)
- Water bath
- Alcohol wipes
Note: Plasma-Lyte® A may be substituted by Plasma-Lyte® 148 (pH 7.4 with no glucose).
Preparation of Plasma-Lyte® A
- 1-
- Insert the Interlink blood bag spike into the Plasma-Lyte® A bag.
- 2-
- Aseptically attach the threaded lock cannula to a 60 mL syringe.
- 3-
- Use an alcohol wipe to scrub the membrane of the Plasma-Lyte® A bag interlink spike injection site.
- 4-
- Attach the threaded lock cannula/syringe assembly to the Plasma-Lyte® A bag to the injection site.
- 5-
- Measure and withdraw 40 mL of Plasma-Lyte® A from the bag
Note: DO NOT remove the syringe containing Plasma-Lyte® A from the Plasma-Lyte® A bag. Set aside for later use.
Preparation of RYONCIL
- 1.
- Prior to RYONCIL thaw, verify that the pre-arranged time for the RYONCIL administration is still feasible. Patient infusion must occur within 5 hours from the start time of first vials of RYONCIL thaw.
- 2.
- Remove RYONCIL vial(s) from cryo-storage.
- 3.
- 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.
Note: A maximum of 4 vials can be thawed in the water bath at the same time. - 4.
- To thaw, gently agitate the sealed zip seal bag(s) with the vial(s) for approximately 5 to 8 minutes to thaw.
- 5.
- Remove vials from the water bath prior to the last visible crystal of ice melting.
Note: Do not exceed 15 minutes for each set of four vials. - 6.
- Inspect vial(s) while still in the bag(s) to identify there is no leakage of vial contents.
- 7.
- Remove the RYONCIL vial(s) from the sealed plastic bag(s).
- 8.
- 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).
- 9.
- 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.
- 10.
- Promptly withdraw the required amount of RYONCIL (based on actual patient body weight) from the vial(s). One syringe and an 18-gauge needle per thawed vial is required.
- 11.
- Carefully remove the needle from the syringe containing RYONCIL.
- 12.
- Attach the threaded lock cannula to the syringe.
- 13.
- Retrieve the infusion bag.
- 14.
- Wipe the membrane of the infusion bag interlink spike injection site with sterile alcohol wipe.
- 15.
- Insert 1 interlink blood bag spike into the outermost port on the infusion bag (leave the middle port for the infusion line.)
- 16.
- Attach the syringe to the spike and transfer the RYONCIL into the infusion bag.
- 17.
- Remove the syringe with the threaded lock cannula and discard the syringe and the threaded lock cannula.
- 18.
- Repeat for each syringe until the required volume of RYONCIL is added to the infusion bag.
Transfer of Plasma-Lyte® A into Infusion Bag
- 1.
- Retrieve the bag and 60 mL syringe containing Plasma-Lyte® A.
- 2.
- Verify the syringe contains 40mL of Plasma-Lyte® A.
- 3.
- Aseptically remove the 60 mL syringe with the threaded lock cannula containing the 40mL Plasma-Lyte® from the bag of Plasma-Lyte® A.
- 4.
- Use alcohol wipes to clean the membrane of the infusion bag interlink spike injection site.
- 5.
- Aseptically attach the 60mL syringe containing the Plasma-Lyte® A to the spike.
- 6.
- Slowly transfer the 40mL Plasma-Lyte® A into the infusion bag.
- 7.
- Gently mix cells with the Plasma-Lyte® A.
- 8.
- Remove the syringe with the threaded lock cannula and discard the syringe and threaded lock cannula.
- 9.
- Label the bag according to Institutional Policy.
- 10.
- Transport infusion bag to patient infusion area.
Administration
Note: Patient infusion must occur within 5 hours from the start time of first vial(s) of RYONCIL thaw.
- 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.
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