Ryoncil

Pronunciation: rye-on-sil
Generic name: remestemcel-L-rknd
Dosage form: suspension for intravenous infusion

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 22, 2024.

What is Ryoncil?

Ryoncil is used to treat steroid-refractory, acute graft-versus-host disease (SR-aGVHD) in adults and children 2 months of age and older.

Ryoncil (generic name remestemcel-L-rknd) is a donor bone marrow-derived mesenchymal stromal cell (MSC) therapy. MSCs are a type of cell that can differentiate into multiple other types of cells with various roles in the body.

Ryoncil’s mechanism of action is thought to involve changes to immune system function, possibly inhibition of T-cell activation (T-cells mediate the inflammation, cell damage, and organ damage associated with acute GvHD), although the exact way Ryoncil works is unclear.

Ryoncil gained FDA approval on December 18, 2024, and is the first MSC therapy to be approved. There is no Ryoncil generic.

Ryoncil side effects

The most common side effects of Ryoncil are:

• infections, caused by viruses, bacteria, or unknown pathogens
• fever
• excessive bleeding
• fluid retention (edema)
• stomach pain
• high blood pressure
• laboratory changes.

Serious side effects and warnings

Ryoncil may cause the following serious side effects.

Hypersensitivity and acute infusion reactions. Serious reactions, including anaphylaxis, may occur during the infusion or following it because Ryoncil contains DMSO (dimethyl sulfoxide- a solvent) as well as trace amounts of porcine (pig) and bovine (cow or beef) protein. Symptoms may include fever, breathing, and low blood pressure during or after the Ryoncil infusion. Your healthcare provider will give you or the person you are caring for, antihistamine and corticosteroid medication before the infusion to reduce the risk of a reaction and monitor you closely afterwards. Seek urgent medical attention if you or the person you are caring for experience fever, rash or hives, low blood pressure, or breathing problems following a Ryoncil infusion.

Transmission of infectious agents. Because Ryoncil contains cells from human donors and is manufactured using human, porcine, and bovine-derived substances, there is still a risk of transmission of infectious proteins, despite extensive screening. Donors are screened for and tested for Human Immune-deficiency Virus 1 (HIV-1); Human Immune-deficiency Virus 2 (HIV-2); Hepatitis B Virus (HBV); Hepatitis C Virus (HCV); Human T-cell Leukemia-lymphoma Virus 1 (HTLV-1); Human T-cell Leukemia-lymphoma Virus 2 (HTLV-2); West Nile Virus (WNV); Cytomegalovirus (CMV); Epstein-Barr Virus (EBV); and Syphilis (Treponema pallidum). Only screening was performed for Creutzfeldt-Jakob disease (CJD) and infectious disease risks associated with Bone marrow transplantation. Ryoncil cell banks are tested for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. Human and animal-derived reagents are tested for human and animal viruses, bacteria, fungi, and mycoplasma before use. However, these measures do not eliminate the risk of transmitting these or other infectious diseases or agents.

Ectopic Tissue Formation (tissue developing outside of an area where it is usually found). Because Ryoncil contains MSCs, there is a risk of ectopic tissue formation due to the ability of MSCs to differentiate into other cells such as bone, cartilage and fat cells.

This is not a complete list of side effects. For a full list see the Ryoncil Prescribing Information. To report suspected side effects, contact Mesoblast toll-free phone #1-844-889-MESO (6376) or the FDA at 1-800-FDA1088 or www.fda.gov/medwatch.

Related/similar drugs

Before receiving

Patients who have experienced previous serious or life-threatening reactions with Ryoncil, or who are allergic to DMSO, porcine or bovine proteins, or remestemcel-L-rknd, should not receive it.

Before receiving Ryoncil, tell your healthcare provider about all your medical conditions including if you:

• have any allergies or hypersensitivities, especially to pig, cow/beef, or DMSO
• are pregnant or planning to become pregnant
• are breastfeeding.

Pregnancy

Ryoncil is not recommended during pregnancy.

Breastfeeding

There is no information as to whether Ryoncil passes into breast milk. Talk to your healthcare provider about how to feed your baby during Ryoncil treatment.

How do I receive Ryoncil?

Ryoncil is administered as an IV infusion (an infusion into a vein) by a healthcare provider in a facility providing adequate healthcare support.

• Your healthcare provider will treat you 30 to 60 minutes before receiving Ryoncil with corticosteroids and antihistamines to reduce the potential for infusion reactions.

Ryoncil Infusion Rates

For patients weighing 35 kg or more, your healthcare provider will infuse Ryoncil at a rate of no more than 6mL/ minute.

For patients weighing less than 35 kg, your healthcare provider will infuse Ryoncil over 60 minutes.

Ryoncil dosing information

The recommended dosage of Ryoncil is 2 × 10⁶ MSC/kg body weight per intravenous infusion given 2 times a week for 4 consecutive weeks.

• Infusions should be administered at least 3 days apart.
• Your healthcare provider will assess your response 28 ± 2 days after the first dose of Ryoncil and provide further treatment as described in the Ryoncil Prescribing Information.

Ryoncil ingredients

Ryoncil active ingredient: remestemcel-L-rknd, comprised of culture-expanded 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).

Other ingredients: 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.

Ryoncil is provided as a frozen cell suspension in a 6mL cryogenic vial with a target concentration of 6.68 X 10⁶ MSCs per mL in 3.8 mL.

Who makes Ryoncil?

Mesoblast, Inc. makes Ryoncil.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer