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FDA-approved for children 2 months and older with acute graft-versus-host disease (acute GvHD) who did not get better with steroids

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Treating acute GvHD in children

Doctors usually treat acute GvHD with steroids. For many children, they help. But for about half, they don’t work well enough. When this happens, it’s called steroid-refractory acute GvHD.

Indication and Important Safety Information for RYONCIL® (remestemcel-L-rknd)
What is Ryoncil?

RYONCIL is a prescription medicine used to treat a condition called steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older.

Who should not receive Ryoncil?

Do not receive Ryoncil if you are allergic to DMSO or porcine and bovine proteins (e.g., pigs or cows).

Ryoncil is not recommended if you are pregnant. Talk to your doctor about the risks and benefits of breastfeeding during Ryoncil treatment.

What are the possible serious side effects?
  • Allergic reactions. Serious allergic reactions, including anaphylaxis, can happen during or after infusion. Tell your doctor or nurse right away if you experience signs of an allergic reaction, including fever, rash, hives, low blood sugar, or breathing problems.
  • Infections. Ryoncil is made from human cells using materials from humans and porcine and bovine sources (e.g., pigs, cows). Although all donors and materials are carefully screened and tested, these measures cannot completely eliminate potential risk of transmission of infectious disease.
  • Unusual tissue growth. There is a theoretical risk that Ryoncil could cause growth of tissue in other places, such as bone, cartilage, or fat.
What are the most common side effects?

The most common side effects include infections, fever, bleeding, swelling, stomach pain, high blood pressure, vomiting, irregular heartbeat, diarrhea, rash, joint pain, low blood pressure, cough, and trouble breathing.

What should I tell my doctor before receiving Ryoncil?

Tell your doctor about all your medical conditions, allergies, and if you are pregnant or breastfeeding.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.

For additional information, see full Prescribing Information.

Indication and Important Safety Information for RYONCIL® (remestemcel-L-rknd)
What is Ryoncil?

RYONCIL is a prescription medicine used to treat a condition called steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older.

Who should not receive Ryoncil?

Do not receive Ryoncil if you are allergic to DMSO or porcine and bovine proteins (e.g., pigs or cows).

Ryoncil is not recommended if you are pregnant. Talk to your doctor about the risks and benefits of breastfeeding during Ryoncil treatment.

What are the possible serious side effects?
  • Allergic reactions. Serious allergic reactions, including anaphylaxis, can happen during or after infusion. Tell your doctor or nurse right away if you experience signs of an allergic reaction, including fever, rash, hives, low blood sugar, or breathing problems.
  • Infections. Ryoncil is made from human cells using materials from humans and porcine and bovine sources (e.g., pigs, cows). Although all donors and materials are carefully screened and tested, these measures cannot completely eliminate potential risk of transmission of infectious disease.
  • Unusual tissue growth. There is a theoretical risk that Ryoncil could cause growth of tissue in other places, such as bone, cartilage, or fat.
What are the most common side effects?

The most common side effects include infections, fever, bleeding, swelling, stomach pain, high blood pressure, vomiting, irregular heartbeat, diarrhea, rash, joint pain, low blood pressure, cough, and trouble breathing.

What should I tell my doctor before receiving Ryoncil?

Tell your doctor about all your medical conditions, allergies, and if you are pregnant or breastfeeding.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.

For additional information, see full Prescribing Information.