OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell
therapy derived from cord blood indicated for the treatment of:
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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.
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Adults and pediatric patients 6 years and older with severe aplastic
anemia (SAA) following reduced intensity conditioning.
IMPORTANT SAFETY INFORMATION
WARNING: GRAFT VERSUS HOST DISEASE, INFUSION REACTIONS, AUTOIMMUNE
CYTOPENIAS, GRAFT FAILURE, and ENGRAFTMENT SYNDROME
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Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of
immunosuppressive therapy may decrease the risk of GvHD
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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
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Autoimmune cytopenias: Autoimmune cytopenias have occurred following
treatment of severe aplastic anemia. Monitor blood counts prior to and
after infusion. Manage cytopenias according to local institutional
guidelines
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Graft failure: Graft failure may be fatal. Monitor patients for
laboratory evidence of hematopoietic recovery
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Engraftment syndrome: Engraftment syndrome may be fatal. Treat
engraftment syndrome promptly with corticosteroids
CONTRAINDICATIONS
OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl
sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine
material.
WARNINGS AND PRECAUTIONS
Graft-versus-Host Disease
Acute and chronic graft-versus-host disease (GvHD) have occurred
following treatment with OMISIRGE. Acute GvHD manifests as maculopapular
rash, gastrointestinal symptoms, and elevated bilirubin. Chronic GvHD
manifests as skin rash, oral symptoms, ocular dryness, transaminase
elevations, gastrointestinal symptoms, or serositis.
Patients treated with OMISIRGE should receive immunosuppressive drugs to
decrease the risk of GvHD, and be monitored for signs and symptoms of GvHD,
and treated if GvHD develops.
Hypersensitivity and Infusion-Related Reactions
Hypersensitivity and infusion-related reactions have occurred with
OMISIRGE administration. 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.
Signs and symptoms of hypersensitivity reactions may include bronchospasm,
wheezing, angioedema, pruritus, hives, fever, and hypotension during or
after OMISIRGE infusion.
Infusion-related 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.
Premedicate patients with antipyretics, histamine antagonists, and
corticosteroids and monitor closely for signs and symptoms of
hypersensitivity and infusion-related reactions. When a reaction occurs,
pause the infusion and institute supportive care as needed.
Autoimmune Cytopenias
Autoimmune cytopenias (AICs) have occurred with OMISIRGE administration in
patients with SAA. AIC is characterized by thrombocytopenia, anemia, and
neutropenia, alone or in combination, occurring weeks to months
post-transplant, often after initial hematopoietic recovery. Risk factors
for post-transplant AIC include younger age, ATG-containing conditioning,
underlying SAA, and delayed T cell chimerism. Monitor blood counts prior to
and after OMISIRGE infusion. Manage cytopenias according to local
institutional guidelines.
Graft Failure
Graft failure has occurred with OMISIRGE administration. 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. Patients should be monitored for laboratory evidence of
hematopoietic recovery.
Malignancies of Donor Origin
Malignancy of donor origin, including post-transplant lymphoproliferative
disorder (PTLD), has occurred with OMISIRGE administration. 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. A donor-cell
derived myelodysplastic syndrome (MDS) has occurred with OMISIRGE
administration. The natural history is presumed to be the same as that for
de novo MDS. Monitor life-long for secondary malignancies. In the event that
a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.
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.
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
with human immunodeficiency virus (HIV), human T-cell lymphotropic virus
(HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV),
T pallidum
, West Nile virus (WNV), transmissible spongiform encephalopathy (TSE)
agents, vaccinia, and Zika virus [for umbilical cord blood (UCB)
collected between March 2016 and 20 May 2024]. Donors are also screened
for clinical evidence of sepsis and communicable disease risks
associated with xenotransplantation. Maternal blood samples are tested
for HIV types 1 and 2, HTLV types I and II, HBV, HCV,
T pallidum
, and WNV. 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. These
measures do not totally eliminate the risk of transmitting these or
other transmissible infectious diseases and disease agents. Testing of
maternal and infant donor blood is also performed for evidence of donor
infection due to cytomegalovirus (CMV).
Test results may be found on the container label and/or in accompanying
records.
Product manufacturing includes bovine-derived reagents. While 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. Final sterility test results may not be available at the time of
use, but Quality Assurance (QA) 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. Report the occurrence of
transmitted rare genetic disease to Gamida Cell at (844) 477-7478.
ADVERSE REACTIONS
Hematological malignancies: The most common adverse reactions (incidence
> 20%) are infections, GvHD, and infusion and hypersensitivity reactions.
SAA: The most common adverse reactions (incidence > 20%) are infections,
hyperglycemia, skin rash, febrile neutropenia, immune thrombocytopenia,
acute kidney injury, acute GvHD, hypertension, hypoxia, and infusion related
reactions.
Please see full
Prescribing Information
, including Boxed Warning.
