Ryoncil (remestemcel-L-rknd)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For IV use only.

*Remestemcel-L-rknd is shipped directly to the clinical facility in a liquid nitrogen dry shipper maintained at a temperature of <= -135degreesC. The product must remain frozen as directed until thawed immediately prior to administration. Prior to thawing, verify that the pre-arranged time for the remestemcel-L-rknd administration is still feasible. Patient infusion must occur within 5 hours from the start time of first vials of remestemcel-L-rknd thaw.

*Cryopreserved MSCs are combined with Plasma-Lyte A for administration. Remestemcel-L-rknd and Plasma-Lyte A should be prepared following aseptic technique in a Biological Safety Cabinet (BSC). See Full Prescribing Information for additional instructions for preparation and administration.

*The recommended dosage of remestemcel-L-rknd in pediatric patients 2 months of age or older is 2 x 106 MSC/kg body weight per IV infusion given twice a week for 4 consecutive weeks for a total of 8 infusions. Infusions should be administered at least 3 days apart.

*Assess response 28 +- 2 days after the first dose and administer further treatment as appropriate as described in the table below.

Recommended Treatment Based on Day 28 Response

Response Recommendation Complete Response (CR) No further treatment with remestemcel-L-rknd Partial or Mixed Response Repeat administration of remestemcel-L-rknd once a week for an additional 4 weeks (4 infusions total) No Response Consider alternative treatments Recurrence of GvHD after CR Repeat administration of remestemcel-L-rknd twice a week for an additional 4 consecutive weeks (8 infusions total)

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Myelosuppressives; Immunomodulators/Sodium Iodide I 131

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1)

CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1)

DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1)

There are no moderate interactions for this drug.

Known hypersensitivity to dimethyl sulfoxide (DMSO) or Porcine and Bovine proteins.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common non-laboratory adverse reactions (incidence >=20%) are viral infectious disorders, bacterial infectious disorders, infection - pathogen unspecified, pyrexia, hemorrhage, edema, abdominal pain and hypertension.

More Frequent

• Fever

Less Frequent

• Acute respiratory failure
• Anaphylaxis
• Hypersensitivity drug reaction
• Injection site sequelae
• Pneumatosis cystoides intestinalis

Rare or Very Rare

• Gastroenteritis
• Hypotension

More Frequent

• Acute abdominal pain
• Bacterial infection
• Edema
• Gamma-glutamyl transferase raised
• Hemorrhage
• Hyperbilirubinemia
• Hypertension
• Infection
• Viral infection

Less Frequent

• Arthralgia
• Cardiac arrhythmia
• Cough
• Diarrhea
• Fungal infection
• Skin rash
• Vomiting

No enhanced messaging available.

The safety and effectiveness of remestemcel-L-rknd for treatment of steroid refractory acute graft versus host disease (SR-GvHD) have been established in pediatric patients 2 months of age and older. The use of remestemcel-L-rknd in these age groups is supported by evidence from an adequate and well-controlled trial.

There are no available data for remestemcel-L-rknd use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with remestemcel-L-rknd to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if remestemcel-L-rknd has the potential to be transferred to the fetus. Therefore, remestemcel-L-rknd is not recommended for women who are pregnant. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 10-20%, respectively.

There is no information regarding the presence of remestemcel-L-rknd in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for remestemcel-L-rknd and any potential adverse effects on the breastfed infant from remestemcel-L-rknd or from the underlying maternal condition.

No enhanced messaging available.