Is Omidubicel approved by the FDA?

Yes, Omidubicel, marketed under the brand name Omisirge, is FDA approved. The FDA granted approval on April 17, 2023, for use in adults and children aged 12 years and older with certain types of blood cancer undergoing stem cell transplantation. This medication aids in the recovery of white blood cells and reduces the risk of infections.

Administration

Omidubicel is administered as an infusion into a vein by a healthcare provider in a medical setting. The treatment is divided into two main components:

1. Cultured Fraction (CF): A minimum of 8.0 x 10^8 total viable cells, with at least 8.7% being CD34+ cells and a minimum of 9.2 x 10^7 CD34+ cells. The CF should be administered intravenously, and the infusion should not exceed 2 hours from the end of dilution.
2. Non-cultured Fraction (NF): A minimum of 4.0 x 10^8 total viable cells, with at least 2.4 x 10^7 CD3+ cells. The NF should be infused within 1 hour from the end of dilution.

Side Effects

Common Side Effects

• Infections
• Graft-versus-host disease (GVHD)
• Dizziness
• Nausea
• Light-headedness
• Itching
• Sweating
• Headache
• Chest tightness
• Back pain
• Trouble breathing
• Swelling in the face

Serious Side Effects

• Allergic reactions (hives, difficulty breathing, swelling of face, lips, tongue, or throat)
• Infections (flu symptoms, cough, night sweats, neck stiffness, confusion, vision problems)
• Graft-versus-host disease (GVHD) symptoms (rash, diarrhea, yellow skin or eyes)
• Graft entrapment syndrome or graft failure (unexplained fever, rash, difficulty breathing, weight gain)

Warnings and Precautions

• Allergies: Omidubicel should not be used if you are allergic to dimethyl sulfoxide (DMSO), dextran 40, gentamicin, human serum albumin, or bovine products.
• Other Medical Conditions: Inform your doctor if you have a history of antibiotic allergies or kidney disease.
• Pregnancy and Breastfeeding: A negative pregnancy test may be required before starting treatment. Discuss with your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Drug Interactions

Omidubicel can interact with other medications, including prescription and over-the-counter drugs, vitamins, and herbal products. Inform your doctor about all medications you are taking to avoid potential interactions.

Conclusion

Omidubicel (Omisirge) received FDA approval on April 17, 2023, for use in adults and children aged 12 years and older undergoing stem cell transplantation for certain types of blood cancer. This medication plays a critical role in promoting white blood cell recovery and reducing infection risks in these patients.

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