Omisirge

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

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 14, 2024.

What is Omisirge?

Omisirge (full biological name omidubicel-onlv) is an individualized infusion that may be given to adults and children aged 12 and older with blood cancer undergoing a stem cell transplant to quicken their neutrophil recovery rate and lessen their risk of infection.

• Omisirge is made from substantially modified donor cord blood.
• Omisirge is given following myeloablative conditioning (this is high-dose chemotherapy or radiation that kills cells in the bone marrow, including cancer cells before the stem cell transplant).
• Myeloablative conditioning can weaken the immune system, increasing the risk of severe and potentially fatal infections.

Omisirge is made from the stem cells of donor umbilical cord blood which have been specially treated with nicotinamide (NAM) to boost their number and functionality. This enhanced cord blood helps patients recover faster after a stem cell transplant and reduces the risk of infections compared to untreated cord blood. The correct technical term for Omisirge is nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy.

• Appropriate cord blood units are selected using the Omisirge search filter in MatchSource.
• A Gamida Cell Search Optimization Specialist can help your healthcare provider identify the appropriate CBU for Omisirge.
• Gamida Cell Assist provides support to patients, caregivers, and the hospital’s transplant team at each step of the process.

Omisirge gained FDA approval on April 17, 2023.

Omisirge side effects

The most common side effects of Omisirge include:

• infections
• graft versus host disease
• infusion reactions.

Serious warnings and side effects

Omisirge carries a Boxed Warning for infusion reactions, graft versus host disease (GvHD), engraftment syndrome, and graft failure.

Infusion reactions, some of which have been fatal, have occurred during or following an Omisirge infusion; 47% of patients in clinical trials experienced one. Your healthcare provider will consider premedicating you before your infusion with acetaminophen, antihistamines, and/or corticosteroids to reduce your risk of these reactions. Most reactions begin within minutes of the start of the infusion. Your healthcare provider will also monitor you throughout the infusion.

• You should not receive Omisirge if you are allergic to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine material.
• Tell your healthcare provider right away if you experience any of the following signs or symptoms: your gums feel inflamed, you have difficulty swallowing, fever, chills, fatigue, fast heart rate, shortness of breath, severe nausea, severe vomiting, diarrhea, muscle pain, joint pain, low blood pressure, high blood pressure, or dizziness/lightheadedness.

Graft-versus-Host-Disease. This is a serious complication that has been reported following Omisirge treatment where the donor cells perceive the recipient's tissues as foreign and initiate an immune response against them. Tell your healthcare provider immediately if you experience any signs and symptoms suggestive of graft vs host disease, including rash, diarrhea, or yellowing of the eyes.

Engraftment Syndrome. This is associated with neutrophil recovery after Omisirge administration because Omisirge is derived from umbilical cord blood. Tell your healthcare provider right away if you develop an
unexplained fever, rash, headache, breathing problems, cough, or weight gain because corticosteroids may be needed.

Primary graft failure. This is when the new stem cells do not make the white blood cells, red blood cells, or platelets that you need. This may be fatal.

Allergic reactions. These may occur with Omisirge administration. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA), or bovine material contained in Omisirge. Omisirge may also contain residual antibiotics if the cord blood donor was exposed to antibiotics while inside the mother. If you have a history of allergic reactions to antibiotics, your healthcare provider should monitor you during the infusion. Tell your healthcare provider right away if you develop any breathing difficulties, tightening of your airways, wheezing, itch, or hives.

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

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

See the Omisirge Prescribing Information for a full list of side effects. To report side effects, contact Gamida Cell at (844) 477-7478 or the FDA at 1-800-FDA-1088.

Before taking this medicine

Do not receive Omisirge if you are allergic to omidubicel-onlv, Omisirge, DMSO, gentamicin, Dextran 40, human serum albumin (HSA), or bovine material.

Tell your healthcare provider about all your medical conditions, including if you:

• have allergies to antibiotics
• have had infusion reactions before
• have experienced graft versus host disease before
• have an infection
• have a genetic disorder
• are pregnant or planning to become pregnant
• are breastfeeding.

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 risks to the unborn child.

There are no data regarding the use of Omisirge during breastfeeding.

How is Omisirge administered?

Omisirge is administered via a one-off intravenous infusion.

• Omisirge is made especially for you. Each treatment course consists of one infusion and that infusion is tailor-made for you.
• Each 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.

Warning: 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.

Related/similar drugs

cisplatin, Platinol, omidubicel

What other drugs will affect Omisirge?

There have been no drug interaction studies performed with Omisurge.

Omisirge ingredients

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.

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

• A Cultured Fraction: At the time of cryopreservation, the CF contains a minimum of 8.0 × 10⁸ total viable cells with a minimum of 8.7% CD34+ cells and a minimum of 9.2 × 10⁷ CD34+ cells suspended in approximately 10% DMSO.
• A Non-cultured Fraction: At the time of cryopreservation, the NF contains a minimum of 4.0 × 10⁸ total viable cells with a minimum of 2.4 × 10⁷ CD3+ cells suspended in approximately 10% DMSO.

Each fraction is supplied separately in its own cryopreserved bag.

• Both bags diluted with their respective IS must be infused to achieve the dose of Omisirge.

Who makes Omisirge?

Gamida Cell Inc. manufactures Omisirge.

• Omisirge 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.

Medical Disclaimer