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Nicotinamide (NAM) Technology

Omisirge is the first and only FDA-approved, NAM-modified allogeneic hematopoietic progenitor cell (HPC) therapy for patients 12 years and older with hematologic malignancies in need of transplant

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Donor source cells
are selected

Beneﬁts of CBU as a
donor source

Less stringent HLA-matching requirements¹⁰
Enhanced graft-versus-
leukemia (GvL) effect¹¹
Rapid cell procurement^12,13
No concern over
donor age¹⁴

CD34+ Cells
(Cultured Fraction)

Cells are segregated
into two populations
according to their
expression of the stem
cell marker CD34

CD34- Cells
(Non-cultured Fraction)
Cells are washed, formulated into a
suspension, and then cryopreserved

CD34- Cells
(Non-cultured Fraction)

Cells are washed, formulated into a
suspension, and then cryopreserved

NAM-modiﬁed ex vivo expansion
increases the quantity and enhances
the functionality of HPCs¹⁵

Omisirge NAM-modiﬁed allogeneic
HPC therapy

CD34- Non-Cultured Fraction (NF)
Mature myeloid and lymphoid cells,
including T cells and B cells

CD34+ Cultured Fraction (CF)
Enhanced population of CD34+ HPCs

Find efficacy and safety information for Omisirge

Learn more

references

Kindwall-Keller TL et al. Oncologist. 2017;22(9):1125-1134. doi:10.1634/theoncologist.2017-0009
BeTheMatch.org. How does a patient’s ethnic background affect matching? bethematch.org. Published March 10, 2023.
Fabricius WA et al. Adv Hematol. 2016;2016:5726132. doi:10.1155/2016/5726132
Pidala J et al. Blood. 2014;124(16):2596-2606. doi:https://doi.org/10.1182/blood-2014-05-576041
Horwitz ME et al. J Clin Oncol. 2019;37(5):367-374. doi:10.1200/JCO.18.00053
Giralt S et al. Cancer Treat Res. 2009;144:1-21. doi:10.1007/978-0-387-78580-6_1
Anthias C et al. Biol Blood Marrow Transplant. 2020;26(3):593-599. doi:10.1016/j.bbmt.2019.10.012
BeTheMatch.org You’re a Potential Match. bethematch.org. Published June 2015
Ciurea SO et al. Blood Adv. 2018;2(17):2254-2261. doi:10.1182/bloodadvances.2018021899
Eapen M et al. Lancet Haematol. 2017;4(7):e325-e333. doi:10.1016/S2352-3026(17)30104-7
Eapen M et al. Lancet. 2007;369(9577):1947-1954. doi:10.1016/S0140-6736(07)60915-5
Wang JC et al. Blood. 1997;89(11):3919-3924
Goussetis E et al. Cytotherapy. 2003;5(6):500-508. doi:10.1080/14653240310003602
DeZern AE et al. Blood Adv. 2021;5(5):1360-1368. doi:10.1182/bloodadvances.2020003922
Omisirge (omidubicel-onlv). Prescribing Information. Gamida Cell Ltd.; 2023.

Indication and Usage

Important Safety Information

Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

Important Safety Information

WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE

Infusion reactions: Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine material [see Contraindications, Warnings and Precautions].
Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD [see Warnings and Precautions].
Engraftment Syndrome: Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids [see Warnings and Precautions].
Graft Failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery [see Warnings and Precautions].

Contraindications

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

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Allergic reactions may occur with the infusion of Omisirge. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in Omisirge. Omisirge may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following Omisirge administration.

Infusion Reactions: Infusion reactions occurred following Omisirge infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with Omisirge in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of Omisirge, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after Omisirge administration. When a reaction occurs, pause the infusion and institute supportive care as needed.

Graft-versus-Host Disease: Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with Omisirge. In patients transplanted with Omisirge Grade II-IV acute GvHD was reported in 58% (68/117). Grade III-IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with Omisirge should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops.

Engraftment Syndrome: Engraftment syndrome may occur because Omisirge is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.

Graft Failure: Primary graft failure occurred in 3% (4/117) of patients in Omisirge clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery.

Malignancies of Donor Origin: Two patients treated with Omisirge developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with Omisirge developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.

Transmission of Serious Infections: Transmission of infectious disease may occur because Omisirge is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. Omisirge is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478.

Transmission of Rare Genetic Diseases: Omisirge may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited.

ADVERSE REACTIONS

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

Please see full Prescribing Information, including Boxed Warning.