Omidubicel Dosage

Medically reviewed by Drugs.com. Last updated on Feb 13, 2024.

Usual Adult Dose for Blood Cell Transplantation

This is a cell suspension for intravenous infusion only. A single dose consists of:

• Cultured Fraction (CF): A minimum of 8.0 x 10(8) total viable cells of which a minimum of 8.7% is CD34+ cells and a minimum of 9.2 x 10(7) CD34+ cells, and
• Non-cultured Fraction (NF): A minimum of 4.0 x 10(8) total viable cells with a minimum of 2.4 x 10(7) CD3+ cells.
• FIRST, administer the Cultured Fraction (CF) IV, this should not exceed 2 hours from the end of the dilution.
• Infuse the Non-cultured (NF) bag. Infusion should not exceed 1 hour from the end of dilution.

Comments:

• Administration should always be under supervision of a physician experienced in the treatment of hematologic malignancies, in centers with expertise in hematopoietic stem cell transplants.
• Verify patient's identity prior to thaw and prior to infusion.

Use: Umbilical cord blood transplantation in patients with hematologic malignancies

Usual Pediatric Dose for Blood Cell Transplantation

This is a cell suspension for intravenous infusion only. A single dose consists of:

• Cultured Fraction (CF): A minimum of 8.0 x 10(8) total viable cells of which a minimum of 8.7% is CD34+ cells and a minimum of 9.2 x 10(7) CD34+ cells, and
• Non-cultured Fraction (NF): A minimum of 4.0 x 10(8) total viable cells with a minimum of 2.4 x 10(7) CD3+ cells.
• FIRST, administer the Cultured Fraction (CF) IV, this should not exceed 2 hours from the end of the dilution.
• Infuse the Non-cultured (NF) bag. Infusion should not exceed 1 hour from the end of dilution.

Comments:

• Administration should always be under supervision of a physician experienced in the treatment of hematologic malignancies, in centers with expertise in hematopoietic stem cell transplants.
• Verify patient's identity prior to thaw and prior to infusion.

Use: Umbilical cord blood transplantation in children 12 years and older with hematologic malignancies

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING(S):

• Infusion Reactions: Infusion reactions may be fatal. Monitor patients during infusion and discontinue if severe reactions occur. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine material.
• Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk.
• Engraftment syndrome: Engraftment syndrome may be fatal. Treat promptly with corticosteroids.
• Graft failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.

CONTRAINDICATIONS:

• Known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine material

Safety and efficacy have not been established in patients younger than 12 years old.

To report suspected adverse reactions, contact Gamida Cell at (844) 477-7478 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For intravenous infusion only
• Administration should always be under supervision of a physician experienced in the treatment of hematologic malignancies, in centers with expertise in hematopoietic stem cell transplants.
• Do not use a leukodepleting filter.
• Verify patient's identity upon receipt, prior to thaw and prior to infusion. The patient identity should match the identifiers on the CF and NF metal cassettes, the CF and NF bags, and the respective infusion solution for CF and NF bags. DO NOT infuse if the information on the patient-specific labels does not match the intended patient.
• Do not open the metal cassettes until time of thaw.
• Thawing should be immediately prior to use.
• Premedicate the patient 30 to 60 minutes before the infusion.
• Administer prophylactic and supportive therapies for prevention or treatment of transplant complications according to institutional guidelines.
• Confirm availability of emergency medications prior to infusion and during the recovery period as per institutional guidelines.

Storage requirements:

• Store the cryopreserved CF and NF labeled bags frozen in the vapor phase of liquid nitrogen (-150C) in a temperature-controlled system. DO NOT OPEN the metal cassettes until the time of thaw (immediately prior to use).
• Use closed containers when transporting the bags within the facility.
• Store the infusion solution bags in a 2C to 8C refrigerated storage unit until the time of thaw of the CF and NF bags.

Reconstitution/preparation techniques:

• Read the US FDA-approved patient labeling for further patient preparation, premedication, receipt, preparation, and administration instructions.

Monitoring:

• Monitor the patient for hypersensitivity or infusion-related reactions, during and after the infusion.
• The infusion rate should be reduced if the fluid load is not tolerated.
• Stop the infusion in the event of a hypersensitivity reaction or a moderate to severe infusion reaction.
• Administer appropriate medical therapy as needed.
• Monitor for graft failure, GvHD, infections, and other post-transplants complications according to institutional guidelines.

Patient advice:

• Read the Patient Information and Instructions for Use.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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