Omisirge (omidubicel-onlv)

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For IV use only. Do not irradiate.

Administer by gravity infusion; central venous access is recommended.

Do not use a leukodepleting filter.

Verify patient's identity upon receipt, prior to thaw and prior to infusion. Do not open the metal cassettes until time of thaw.

Omidubicel requires thawing and dilution with 2 infusion solution bags prior to administration. Thawing should only take place immediately prior to use.

The recommended dose of omidubicel is a one-time infusion delivered intwo separate bags.

The thawed and diluted Cultured Fraction (CF) bag must be infused first; the infusion time should not exceed 2 hours from the end of dilution to the end of CF infusion. The thawed and diluted NF bag is infused within 1 hour of safely administering the CF infusion; the infusion time should not exceed 1 hour from the end of dilution to the end of infusion.

The rate of infusion should not exceed a maximum of 10 mL per kg per hour.

Administer under the supervision of a physician experienced in treatment of hematologic malignancies or severe aplastic anemia, incenters with expertise in hematopoietic stem cell transplants.

Premedicate the patient approximately 30 to 60 minutes prior to infusion.

See Full Prescribing Information for additional details and preparation and administration.

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No dosing information is available for this tab.

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There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known sensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Hematological malignancies: The most common adverse reactions(incidence >20%) are infections, GvHD, and infusion andhypersensitivity reactions.

Severe aplastic anemia: The most common adverse reactions (incidence >20%) areinfections, hyperglycemia, skin rash, febrile neutropenia, immunethrombocytopenia, acute kidney injury, acute GvHD, hypertension,hypoxia, and infusion related reactions.

More Frequent

• Hyperbilirubinemia

Less Frequent

• Graft-versus-host disease
• Increased alanine transaminase
• Increased aspartate transaminase
• Infection
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Occlusive vascular disease
• Thrombotic microangiography
• Thrombotic thrombocytopenic purpura

Rare or Very Rare

• Angioedema
• Bronchospastic pulmonary disease
• Engraftment syndrome
• Hypersensitivity drug reaction
• Hypertension
• Myelodysplastic syndrome
• Post-transplant lymphoproliferative disease
• Sepsis

More Frequent

• Disorder of the digestive system
• Pain
• Stomatitis

Less Frequent

• Dysphagia
• Dyspnea
• Fatigue
• Fever

Rare or Very Rare

• Pruritus of skin
• Urticaria
• Vomiting

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The safety and efficacy of omidubicel-onlv have been established in pediatric patients with hematologic malignancy12 years of age and older and in pediatric patients with severe aplastic anemia (SAA) 6 years of age and older.

The use of omidubicel-onlv in pediatric patients with hematologic malignancy was supported by evidence from oneclinical study (Study P0501), which included 2 pediatric patients age 12 to 16 years. The use of omidubicel-onlv inpediatric patients with SAA was supported by evidence from one clinical study (Study 17-H-0091), whichincluded 7 pediatric patients age 6 to 16 years of age.

There are no available data with omidubicel use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with omidubicel-onlv to assess whether it can cause fetal harm when administered to a pregnant woman. In Study 17-H-0091, one patient reported two pregnancies, one at 9months and one at 3.5 years post-transplant. There were no reported birth complications or neonatal concerns.

Omidubicel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In the United States (U.S.) general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

There is no information regarding the presence of omidubicel 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 omidubicel and any potential adverse effects on the breastfed infant from omidubicel or from the underlying maternal condition.

Clinical studies of omidubicel-onlv did not include patients aged 65 and over; therefore, it cannot be determined whether patients 65 years and over respond differently from younger patients.