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Omidubicel-Onlv

FDA Drug Information • Also known as: Omisirge

Brand Names
Omisirge
Dosage Form
KIT
Product Type
CELLULAR THERAPY

⚠ Boxed Warning (Black Box)

WARNING: GRAFT VERSUS HOST DISEASE, INFUSION REACTIONS, AUTOIMMUNE CYTOPENIAS, GRAFT FAILURE, and ENGRAFTMENT SYNDROME Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD [ see Warnings and Precautions (5.1) ]. 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 (4) , Warnings and Precautions (5.2) ]. 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 [see Warnings and Precautions (5.3) ]. Graft failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery [ see Warnings and Precautions (5.4) ]. Engraftment syndrome: Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids [ see Warnings and Precautions (5.6) ]. WARNING: GRAFT VERSUS HOST DISEASE, INFUSION REACTIONS, AUTOIMMUNE CYTOPENIAS, GRAFT FAILURE, and ENGRAFTMENT SYNDROME See full prescribing information for complete boxed warning. Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD. ( 5.1 ) I nfusion 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. ( 4 , 5.2 ) 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. ( 5.3 ) Graft failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. ( 5.4 ) Engraftment syndrome: Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids. ( 5.6 )

Description

11 DESCRIPTION OMISIRGE (omidubicel-onlv) is a cryopreserved nicotinamide modified unrelated allogeneic hematopoietic progenitor cell therapy derived from cord blood consisting of 2 cell fractions; a Cultured Fraction (CF) and a Non-cultured Fraction (NF) which are both derived from the same patient-specific cord blood unit (CBU). 1) The CF is a yellowish suspension consisting of allogeneic, hematopoietic CD34+ progenitor cells. In addition to the CD34+ hematopoietic progenitor cells (HPCs), the CF consists of other cell populations, including more differentiated myelomonocytic cells, dendritic cells and granulocytes. The CF formulation contains a maximum of 35 mg gentamicin. Following manipulation, the cells are washed, formulated into a suspension, and cryopreserved in a patient specific bag in 10% dimethyl sulfoxide (DMSO). The product is thawed and diluted prior to infusion [see Dosage and Administration (2.2) , How Supplied/Storage and Handling (16) ] . The CF contains approximately 2.42 mg of DMSO. The diluted CF contains ≤ 2% DMSO. 2) The NF is a reddish suspension consisting of allogeneic, hematopoietic mature myeloid and lymphoid cells that are washed, formulated into a suspension, and cryopreserved in a patient specific bag in 10% DMSO. In addition to the mature myeloid and lymphoid cells, the NF consists of other cell populations, including more lineage committed hematopoietic cells. The product is thawed and diluted prior to infusion [see Dosage and Administration (2.2) , How Supplied/Storage and Handling (16) ] . The NF contains approximately 1.1 mg of DMSO. The diluted NF contains ≤2% DMSO. Two Infusion Solution bags are also provided for diluting each fraction after thawing, one specifically for the CF and one specifically for the NF. The Infusion Solutions contain 8% w/v HSA and 6.8% w/v Dextran 40 in 0.9% sodium chloride [see Dosage and Administration (2.2) ] . The NF and IS are Released for Shipment (RFS) following full release testing, including...

What Is Omidubicel-Onlv Used For?

1 INDICATIONS AND USAGE OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for the treatment of: 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 infections. ( 1.1 ) adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning. ( 1.2 ) 1.1 Hematologic Malignancies OMISIRGE is indicated for the treatment of 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 infections. 1.2 Severe Aplastic Anemia OMISIRGE is indicated for the treatment of adults and pediatric patients 6 years of age and older with severe aplastic anemia (SAA) following reduced intensity conditioning.

Dosage and Administration

2 DOSAGE AND ADMINISTRATION For intravenous use only. Do not irradiate. Do not use a leukodepleting filter. ( 2 ) Verify patient's identity upon receipt, prior to thaw and prior to infusion. ( 2 ) Thawing should only take place immediately prior to use. ( 2 ) Premedicate the patient approximately 30 to 60 minutes prior to infusion. ( 2 ) The recommended dose of OMISIRGE is a one-time infusion delivered in two separate bags. ( 2 ) The CF (Cultured Fraction) bag must be administered FIRST, and infusion should not exceed 2 hours from the end of dilution. Infusion of the NF (Non-cultured) bag should not exceed 1 hour from the end of dilution. ( 2 ) Administration of OMISIRGE should be under the supervision of a physician experienced in treatment of hematologic malignancies or SAA, as appropriate, in centers with expertise in hematopoietic stem cell transplants. ( 2 ) See full prescribing information for details for preparation and administration of OMISIRGE. 2.1 Dose For intravenous use only. The recommended dose of OMISIRGE is a one-time infusion delivered in two separate bags which consists of a Cultured Fraction (CF): a minimum of 8.0 × 10 8 total viable cells of which a minimum of 8.7% is CD34+ cells and a minimum of 9.2 × 10 7 CD34+ cells, and a Non-cultured Fraction (NF): a minimum of 4.0 × 10 8 total viable cells with a minimum of 2.4 × 10 7 CD3+ cells The CF and NF are supplied cryopreserved. OMISIRGE requires thaw and dilution with two infusion solution (IS) bags (one IS bag for the CF, and one IS bag for the NF) prior to administration. Infusion of the NF bag should begin within 1 hour after completion of the CF infusion. For timing of dosing of each fraction, refer to section 2.2 under "Planning prior to OMISIRGE preparation". 2.2 Preparation and Administration Administration of OMISIRGE should be under the supervision of a physician experienced in treatment of hematologic malignancies or SAA, as appropriate, in centers with expertise in hematopoietic stem cell transplants. Preparation Pretreatment Confirm the Release For Infusion Certificate (RFI Certificate) is available for OMISIRGE before starting the conditioning regimen. Before infusion of OMISIRGE, administer as appropriate: For patients with hematologic malignancies, administer a myeloablative conditioning regimen according to institutional guidelines. For patients with SAA, administer a reduced intensity conditioning regimen according to institutional guidelines. Administer prophylactic and supportive therapies [including Granulocyte-Colony Stimulating Factor (G-CSF)] for prevention or treatment of transplant complications (GvHD, infections) according to institutional guidelines. Confirm emergency medications are available prior to infusion and during the recovery period as per institutional guidelines. Premedication for Patients with Hematologic Malignancies Premedicate the patient approximately 30 to 60 minutes prior to OMISIRGE infusion. Premedicate with diphenhydramine 50 mg...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS Hematological malignancies: The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion and hypersensitivity reactions. ( 6.1 ) 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gamida Cell at (844) 477-7478 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hematologic Malignancies The safety of OMISIRGE is based on data from Study P0501 for 52 patients transplanted with OMISIRGE and 56 patients transplanted with umbilical cord blood (UCB) [see Clinical Studies (14) ] . The median duration of follow up for the overall safety population was 14 months (range, 1-19 months). All patients received myeloablative preparative regimens and GvHD prophylaxis with tacrolimus or cyclosporin plus mycophenolate mofetil. Fatal adverse reactions occurred in 17% of patients treated with OMISIRGE, including infection (6%), acute GvHD (6%), veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) (2%), thrombotic thrombocytopenic purpura (TTP)/thrombotic microangiopathy (TMA) (2%), and pulmonary hemorrhage (2%). Fatal adverse reactions occurred in 29% of subjects treated with UCB, including infection/sepsis (11%), respiratory disorders (11%), GvHD (5%), and VOD/SOS (2%). The most common non-laboratory adverse reactions occurring in ≥ 10% of patients in Study P0501 are listed in Table 2 below. The most common Grade 3-5 adverse reactions for patients treated with OMISIRGE, were pain (33%), mucosal inflammation (31%), hypertension (25%), and gastrointestinal toxicity (19%). Table 2: Adverse Reactions in ≥ 10% of Patients with Hematologic Malignancies Following Transplantation with OMISIRGE (N=52) or UCB (N=56) in Study P0501 Adverse Reaction OMISIRGE Any Grade n (%) OMISIRGE Grade 3 or Higher n (%) UCB Any Grade n (%) UCB Grade 3 or Higher n (%) Abbreviation: n: number; UCB: umbilical cord blood. General disorders and administration site conditions - - - - Pain 41(79) 17 (33) 43 (77) 10 (18) Fever 42 (81) 1 (2) 54 (96) 6 (11) Mucosal inflammation 39 (75) 16 (31) 47 (84) 19 (34) Fatigue Fatigue includes asthenia and fatigue. 31(60) 2 (4) 42 (75) 12 (21) Edema 24 (46) 1 (2) 37 (66) 4 (7) Chills 19 (37) 0 32 (57) 0 Gastrointestinal disorders - - - - Gastrointestinal toxicity 40 (77) 10 (19) 48 (86) 19 (34) Vomiting 33 (63) 3 (6) 40 (71) 2 (4) Dysphagia 17 (33) 6 (12) 21 (38) 7 (13) Constipation 12 (23) 0 21 (38) 0 Dyspepsia 12 (23) 0 12 (21) 0 Abdominal distention 10 (19) 0 16 (29) 1 (2) Infections and infestations Infections and infestations were graded according to the BMT-CTN grading system. - - - - Viral infections 39 (75) 4 (8) 45 (80) 15 (27) Bacterial infections 34 (65) 4 (8) 45 (80) 13 (23) Fungal infections 11 (21) 3 (6) 15 (27) 10 (18) Immune System Disorder - - - - Acute Graft versus host disease Acute Graft-versus-host disease was graded according to the Consensus Conference on Acute GvHD grading. 32 (62) 8 (15) 24 (43) 12 (21) Chronic Graft versus host disease Chronic Graft-versus-host disease was graded according to the 2014 NIH consensus criteria. 18 (35) 12 (23) 14 (25) 11 (20) Vascular disorders - - - - Hypertension 29 (56) 13 (25) 37 (66) 21 (38) Hemorrhage Hemorrhage include cystitis hemorrhagic, epistaxis, gastrointestinal hemorrhage, hemorrhage, pulmonary alveolar hemorrhage, subarachnoid hemorrhage, and upper gastrointestinal hemorrhage. 25 (48) 6 (12) 34 (61) 10 (18) Hypotension 16 (31) 2 (4) 19 (34) 5 (9) Psychiatric disorders - - - - Insomnia 24...

Contraindications

4 CONTRAINDICATIONS OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products. Known sensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material. ( 4 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary There are no available data with OMISIRGE use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with OMISIRGE to assess whether it can cause fetal harm when administered to a pregnant woman. In Study 17-H-0091, one patient reported two pregnancies, one at 9 months and one at 3.5 years post-transplant. There were no reported birth complications or neonatal concerns. OMISIRGE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the United States (U.S.) general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING OMISIRGE (NDC 73441-800-04) is shipped in two shipping containers, a liquid nitrogen dry vapor shipper at ≤ -150℃, containing the two cryopreserved cell fractions (CF NDC 73441-100-01 and NF NDC 73441-200-01) and a Chimerism Testing Sample(s) and a refrigerated shipping container at 2-8℃, containing two Infusion Solutions (Infusion Solution for CF NDC 73441-300-01 and Infusion Solution for NF NDC 73441-400-01). OMISIRGE is shipped to the transplant center for a specific patient. The Cryopreserved Cell Fractions OMISIRGE is comprised of two cryopreserved cell fractions, a Cultured Fraction (CF) and a Non-cultured Fraction (NF) each in a separate cryopreserved bag labeled for the specific patient. Each cryopreserved bag is protected by a corresponding transparent overwrap bag and each cryopreserved bag enclosed in its overwrap bag is individually packed in a metal cassette. Both cryopreserved OMISIRGE cell fractions are shipped together in the vapor phase of liquid nitrogen in a liquid nitrogen dry vapor shipper with the Prescribing Information (PI) and a Chimerism Testing Sample(s). At the time of cryopreservation, the CF contains a minimum of 8.0 × 10 8 total viable cells with a minimum of 8.7% CD34+ cells and a minimum of 9.2 × 10 7 CD34+ cells suspended in 20 mL of a cryopreservation solution containing 10% DMSO. See the CoA for the CF for actual cell counts. CoAs are attached to the RFI Certificate available via the Gamida Cell Assist Hospital Portal. Upon cryopreservation, the CF appears white and is frozen at the bottom of the cryopreserved bag. At the time of cryopreservation, the NF contains a minimum of 4.0 × 10 8 total viable cells with a minimum of 2.4 × 10 7 CD3+ cells suspended in 10 mL cryopreservation solution containing 10% DMSO. See the CoA for the NF for actual cell counts. Upon cryopreservation, the NF appears red and is frozen at the bottom of the cryopreserved bag. Match the identity of the patient with the...

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

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