Omisirge

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

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 4, 2023.

What is 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.

Who should not receive Omisirge?

Omisirge is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.

What is Omisirge used to treat?

Omisirge is indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies to reduce the time to neutrophil recovery and the risk of infection following stem cell transplantation. It is given following myeloablative conditioning.

Hematologic malignancies (blood cancers) are caused by abnormal cell growth in the bone marrow, where stem cells form into different types of blood cells. A common treatment for blood cancers is stem cell transplantation from umbilical cord blood. In preparation for transplantation, patients undergo myeloablative conditioning which is a course of treatment (such as radiation or chemotherapy) to remove a patient's stem cells. It can cause a weakening of the immune system, increasing the risk of severe and potentially fatal infections.

Omisirge is composed of human allogeneic (donor) stem cells from umbilical cord blood that are processed and cultured with NAM to enhance the number and functionality of the targeted cells. In clinical trials, Omisirge showed faster neutrophil recovery and reduced bacterial and fungal infections as compared to standard cord blood.

Gamida Cell Assist provides support to patients, caregivers, and the hospital’s transplant team at each step of the process.

Omisirge was FDA-approved on Apr 17, 2023.

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.

Before taking this medicine

Your doctor will advise you of the following risks associated with this infusion.

Hypersensitivity Reactions

Report immediately any signs and symptoms of hypersensitivity reactions including wheezing, swelling, itching, or hives.

Infusion Reactions

Report immediately any signs and symptoms of infusion reactions including fever, chills, fatigue, tachycardia, hypoxia, severe nausea, severe vomiting, diarrhea, muscle pain, joint pain, low blood pressure, high blood pressure, or dizziness/lightheadedness.

Graft-versus-Host-Disease

Report immediately any signs and symptoms suggestive of graft vs host disease, including rash, diarrhea, or yellowing of the eyes.

Engraftment Syndrome

Report immediately any signs and symptoms suggestive of engraftment syndrome including fever, rash, or unexplained weight gain.

Graft Failure

Primary graft failure, which may be fatal, can occur.

How is Omisirge administered?

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.

What are the side effects of Omisirge?

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.

What other drugs will affect Omisirge?

There have been no drug interaction studies performed with Omisurge.

Pregnancy and breastfeeding

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.

What are the ingredients in Omisirge

Omisirge is manufactured from umbilical cord blood using a laboratory process called proprietary nicotinamide (NAM) technology to enhance and expand the number of progenitor cells.

Manufacturer

Omisirge is manufactured by Gamida Cell Inc. and is made in their fully licensed GMP manufacturing facility in Kiryat Gat, Israel. Time to delivery to U.S. transplant centers is within 30 days after the start of manufacturing.

Further information

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

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