Omisirge

Generic name: Omidubicel-onlv
Dosage form: Customized infusion
Drug class: Miscellaneous uncategorized agents

Usage of Omisirge

Omisirge (omidubicel-onlv) is an infusion made from substantially modified cord blood that may be given to prevent infection in patients with blood cancer undergoing a stem cell transplant.

The correct technical term for Omisirge is nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy.

Omisirge side effects

The most common adverse reactions (incidence > 20%) include infections, GvHD, and infusion reactions.

Contact Gamida Cell at (844)-477-7478 if you are diagnosed with a secondary malignancy after treatment with Omisirge.

Because Omisirge is made using stem cells from umbilical cord blood there is a risk of transmission of infectious disease and rare genetic diseases.

To report side effects, contact Gamida Cell at (844) 477-7478 or FDA at 1-800-FDA-1088.

Before taking Omisirge

There are no human or animal data regarding the use of Omisirge during pregnancy. It should only be used if the potential benefits outweigh the potential risk to the unborn child.

There are no data for the use of omidubicel-onlv during breastfeeding.

Relate drugs

How to use Omisirge

Omisirge is administered via a single intravenous infusion. A patient-specific single dose consists of a Cultured Fraction (CF) and a Non-cultured Fraction (NF). The CF bag is administered first, followed by the NF bag within 1 hour after completion of the CF infusion. Patients receive premedication with an antihistamine, hydrocortisone, and acetaminophen approximately 30 to 60 minutes before receiving Omisirge.

Each Omisirge unit is specific to each patient. There is an approximately 8% risk of a manufacturing failure. If this happens, a second manufacturing attempt may be considered. Additional chemotherapy may be required to cover the delay in making a new product which may increase the risks of adverse events during the preinfusion period.

Warnings

The Omisirge product label carries a Boxed Warning for infusion reactions, graft versus host disease (GvHD), engraftment syndrome, and graft failure. Warnings and precautions associated with this medicine include malignancies of donor origin, the transmission of serious infections, and the transmission of rare genetic diseases.

What other drugs will affect Omisirge

There have been no drug interaction studies performed with Omisurge.

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