What is Omisirge?
Omisirge (omidubicel-onlv) is an infusion of substantially modified cord blood that can be administered to help prevent the spread of infection among patients with cancer of the blood who undergo stem cell transplants. The proper technical term for Omisirge is nicotinamide (NAM) modified allogeneic hematopoietic progenitors therapy.
Warnings
Omisirge should not be used in patients who are hypersensitive to dimethyl sulfuroxylate (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.
Omisirge's Omisirge product label includes an enclosed warning regarding infusion reactions such as graft versus host disease (GvHD) as well as engraftment syndrome and graft loss. A few warnings and precautions for the medicine include malignancies that are of donor origin, the transfer of serious infections, and the transfer of genetic disorders.
What exactly is Omisirge being used for?
Omisirge is recommended for use in pediatric and adult patients who are 12 years of age or older and have hematologic malignancies in order to shorten the time required for the recovery of neutrophils and reduce the possibility of infection following the transplantation of stem cells. It is given after myeloablative treatment.
Hismatologic malignancies (blood cancers) result from the abnormal growth of cells within the bone marrow. In this area, stem cells develop into various kinds of blood cells. The most common method of treating blood cancers through stem cell transplantation is done using umbilical cord blood. In preparation for transplantation, patients undergo myeloablative treatment, which is a treatment (such as chemotherapy or radiation) to destroy the patient's stem cells. It may lead to a weakness in the immune system, which increases the likelihood of serious and even fatal infections. Omisirge is a mixture of human alogeneic (donor) stem cells taken from umbilical cord blood. These cells are processed and then cultured using NAM to increase the number and function of the cells targeted. In clinical studies, Omisirge showed faster neutrophil recovery and fewer fungal and bacterial infections when compared with standard cord blood. Gamida Cell Assist provides support for caregivers, patients, and the hospital's transplant team throughout each stage of the process. Omisirge was FDA-approved on April 17, 2023.
Before you take this drug
Your physician will inform you of the potential risks that come with this infusion.
Hypersensitivity Reactions
Inform your doctor immediately of any signs or symptoms of hypersensitivity reactions, such as itching, swelling, wheezing, 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 or lightheadedness.
Graft-versus-Host-Disease
Inform the doctor immediately of any signs or symptoms that suggest graft vs. host disease, such as diarrhea, rash, or a yellowing of the eyes.
Engraftment Syndrome
Inform the doctor immediately of any signs or symptoms that suggest an engraftment disorder, such as the appearance of a rash, fever, or unannounced weight gain.
Graft Failure
Primary failure of the graft, which can be fatal, may occur.
How to take Omisirge?
Omisirge can be administered by intravenous injection. A single dose that is specific to the patient consists of a cultured fraction (CF) and a non-cultured fraction (NF). This CF bag is administered first, followed by an NF bag in the first hour following the completion of the CF infusion. Patients receive a premedication that includes an antihistamine, hydrocortisone, and acetaminophen 30 to 60 minutes prior to receiving Omisirge.
Each Omisirge device is unique to the patient. There is a roughly 8 percent chance of manufacturing error. If this occurs, the possibility of a second attempt at manufacturing might be considered. A second dose of chemotherapy could be needed to make up for the time required to make the new product, which can increase the risk of adverse reactions during the period prior to infusion.
Adverse effects of Osmisirge
The most frequently reported adverse reactions (incidence of more than 20 percent) are illnesses, GvHD, and infusion reactions. Get in touch with Gamida Cell at (844) 477-7478 if you're diagnosed with a second malignancy after treatment with Omisirge. Because Omisirge is a product made from stem cells taken from umbilical cord blood, there is a possibility of transmission of infectious diseases and rare genetic disorders. To report any side reactions, call Gamida Cell at (844) 477-7478 or the FDA at 1-800-FDA-1088.
Interaction with other drugs
There are no studies of drug interactions conducted using Omisurge.
Breastfeeding and pregnancy
There aren't any studies on animals or humans on Omisirge's use in pregnancy. Omisirge should only be used when the potential benefits are greater than the potential risks to the unborn baby. There isn't any data available regarding the use of omidubicel during breastfeeding.
