Remestemcel-L-Rknd
Remestemcel-L-rknd (RYONCIL) is a cell-based therapy used to treat steroid-refractory acute graft versus host disease in children 2 months of age and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Remestemcel-L-Rknd: Patient Information Guide
A plain-language walkthrough of Remestemcel-L-Rknd — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
RYONCIL (remestemcel-L-rknd) is approved for one specific condition in pediatric patients:
- 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 — meaning acute GvHD that has not adequately responded to steroid treatment.
⚙️How it works▾
RYONCIL contains mesenchymal stromal cells (MSCs) — specialized cells harvested from human bone marrow. In graft versus host disease, donor immune cells (called T cells) mistakenly attack the transplant recipient's organs, causing dangerous inflammation. RYONCIL's MSCs appear to reduce T cell activation and lower the production of pro-inflammatory signals, helping to calm this immune attack. After treatment, clinical studies showed meaningful reductions in key inflammatory markers and activated T cells in the blood, though the full mechanism is still being studied.
💊How it's taken▾
RYONCIL is given by intravenous (IV) infusion only, always administered by a trained healthcare professional in a clinical setting. The standard course is twice a week for 4 consecutive weeks (8 infusions total), with infusions spaced at least 3 days apart. Response is assessed around day 28, and the schedule may continue, be reduced, or be stopped based on how the patient responds. Dosing is calculated based on the child's body weight — follow the care team's instructions exactly.
- Patients are pre-treated with antihistamines and corticosteroids 30–60 minutes before each infusion
- Infusion rate is adjusted based on the child's weight
- The infusion must be completed within 5 hours of preparation
🤒Side effects — in detail▾
In clinical studies, the most commonly reported side effects (occurring in 20% or more of patients) were:
- Viral infections
- Bacterial infections
- Infections from unspecified pathogens
- Fever (pyrexia)
- Bleeding (hemorrhage)
- Swelling (edema)
- Abdominal pain
- High blood pressure (hypertension)
Serious adverse reactions occurred in about 65% of patients in the clinical trial, including fever, respiratory failure, a bowel complication called pneumatosis intestinalis, and bloodstream bacterial infection (bacteremia) — reflecting how seriously ill these children are. Report any new or worsening symptoms to the care team immediately.
⚠️Warnings & precautions▾
- Serious allergic/infusion reactions: Reactions including anaphylaxis can occur during or after infusion, triggered by DMSO or trace animal proteins in the product. Patients are always pre-medicated and monitored. If a severe reaction happens, the infusion is stopped and should not be restarted.
- Risk of infection transmission: Because RYONCIL is made from human donor cells and animal-derived materials, there is a small risk of transmitting infectious agents (including viruses, bacteria, and fungi), even with rigorous donor screening and testing.
- Ectopic tissue formation: MSCs have the ability to develop into bone, cartilage, or fat cells. There is a risk that these cells could form tissue in unintended areas of the body after treatment.
🔀What it interacts with▾
The FDA label for RYONCIL does not identify specific drug, food, or supplement interactions.
- Always tell the care team about all medications, supplements, and treatments your child is receiving, as RYONCIL is given in a complex transplant setting where many other drugs may be in use.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to DMSO or animal proteins: RYONCIL must NOT be given to patients with a known allergy to dimethyl sulfoxide (DMSO) or to porcine (pig) or bovine (cow) proteins — this is an absolute contraindication.
- Pregnancy: RYONCIL is not recommended for pregnant women — there are no safety data and it is unknown whether it can harm a developing baby.
- Breastfeeding: It is not known whether RYONCIL passes into breast milk. Discuss risks and benefits with the care team.
- Children: RYONCIL is approved and studied specifically in pediatric patients 2 months and older. Safety and effectiveness have not been established in adults in this indication.
📡Pharmacodynamics — effects in the body▾
In a clinical study of 40 pediatric patients with SR-aGvHD, RYONCIL reduced blood levels of two key inflammatory proteins — TNFR1 (tumor necrosis factor receptor type I) and ST2 — by 79% and 75%, respectively, by day 180 compared to the start of treatment. These proteins are elevated during active GvHD and serve as markers of inflammation. The treatment also reduced circulating activated T cells (the immune cells driving GvHD) by 64% by day 180, suggesting a meaningful dampening of the immune response over time.
📦How to store it▾
RYONCIL must remain frozen at ≤ -135°C in liquid nitrogen vapor phase until thawed immediately prior to administration.
📄 Written from Remestemcel-L-Rknd’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Remestemcel-L-Rknd — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is RYONCIL and how is it different from a regular medicine? ▾
How will my child receive RYONCIL, and how often? ▾
What side effects should I watch for during or after an infusion? ▾
Is there any risk of my child catching an infection from this therapy? ▾
My child is very young — is this treatment safe for infants? ▾
What if my child is pregnant or I am breastfeeding — is RYONCIL safe? ▾
Is Remestemcel-L-Rknd available over the counter? ▾
When was Remestemcel-L-Rknd first available? ▾
💬 Answers drafted from Remestemcel-L-Rknd’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
📊 Remestemcel-L-Rknd across the U.S. market
How Remestemcel-L-Rknd appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Kit (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
🔍 Compare Remestemcel-L-Rknd products
A representative set of FDA-listed product records for Remestemcel-L-Rknd — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|
| 💊Kits | ||
| Mesoblast × 12 listings | BLA | View NDC → |
Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Remestemcel-L-Rknd NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Remestemcel-L-Rknd — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Remestemcel-L-Rknd in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Remestemcel-L-Rknd went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Remestemcel-L-Rknd is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Mesoblast is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.