Remestemcel-L

Remestemcel-L is an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older.

• Remestemcel-L is available under the following different brand names: Ryoncil, remestemcel-L-rknd.

Common side effects of Remestemcel-L include:

• viral infectious disorders
• bacterial infectious disorders 
• infection – pathogen unspecified
• fever
• excessive bleeding
• edema
• abdominal pain
• hypertension

Serious side effects of Remestemcel-L include:

• hypersensitivity and acute infusion reaction symptoms may include fever, breathing, and low blood pressure during or after the remestemcel-L infusion
• transmission of infectious agents
• ectopic tissue formation

Rare side effects of Remestemcel-L include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

Suspension for IV infusion

• 25 x 10^6 MSC/3.8 mL (6.68 x 10^6 MSC/mL) in single-dose 6-mL cryovial
• Cryopreserved MSCs are combined with Plasma-Lyte A

Acute graft versus host disease (aGVHD)

Pediatric dosage

• Premedicate with antihistamine and corticosteroid 30-60 min before dose
• 2 x 10^6 MSC/kg IV twice weekly for 4 consecutive weeks (8 infusions)
• Use actual patient body weight
• Separate infusions by at least 3 days
• Additional treatment based on response at Day 28 (+/- 2 days)
• Complete response: No further treatment
• Partial or Mixed Response: 2 x 10^6 MSC/kg IV once weekly for an additional 4 weeks (4 infusions)
  • No Response: Consider alternative treatments
  • Recurrence of GVHD after complete response: 2 x 10^6 MSC/kg IV twice weekly for 4 consecutive weeks (8 infusions)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Remestemcel-L has no noted severe interactions with any other drugs
• Remestemcel-L has no noted serious interactions with any other drugs
• Remestemcel-L has no noted moderate interactions with any other drugs
• Remestemcel-L has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to dimethyl sulfoxide (DMSO) or porcine and bovine proteins

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Remestemcel-L?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Remestemcel-L?”

Cautions

• Hypersensitivity reactions
  • Hypersensitivity reactions (e.g., anaphylaxis, acute infusion reactions) reported
  • Signs and symptoms (e.g., fever, dyspnea, and hypotension) may occur during or after infusion
  • Reactions may be caused due to DMSO and trace amounts of porcine or bovine proteins in the product
  • Premedication with antihistamines and corticosteroids is recommended
  • Monitor closely for signs and symptoms of hypersensitivity or acute infusion reactions
  • Interrupt infusion if hypersensitivity or infusion reaction occurs
  • Do not administer in patients who experience serious or life-threatening reactions
• Transmission of infectious agents
  • Because the product contains cells from human donors and is manufactured using human, porcine, and bovine-derived reagents, there is a potential for infectious disease transmission
  • Donors are screened and tested for HIV-1 and -2, hepatitis B virus (HBV), hepatitis C virus (HCV), human T-cell leukemia-lymphoma virus (HTLV)-1 and -2, West Nile virus (WNV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), and syphilis (Treponema pallidum)
  • Donors are also screened for Creutzfeldt-Jakob disease (CJD) and communicable disease risks associated with xenotransplantation
  • 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
  • Ectopic tissue formation may occur due to the ability of human MSCs to differentiate into mesenchymal lineage cells such as bone, cartilage, and fat cells

Pregnancy and Lactation

• No data are available regarding use in pregnant patients or from animal reproductive and developmental toxicity studies to assess the risk of fetal harm
• Potential to be transferred to the fetus is not known; therefore, use is not recommended during pregnancy
• Lactation
  • No data are available regarding the presence of remestemcel-L in human milk, its effect on breastfed infants, or milk production
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infants from therapy or the underlying maternal condition