Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
5 WARNINGS AND PRECAUTIONS Malignancies of donor origin: Monitor life-long for secondary malignancies.
In the event that a secondary malignancy occurs after treatment with OMISIRGE, contact Gamida Cell at (844) 477-
( 5.5 ) Transmission of serious infections: Monitor patients closely for serious infections.
( 5.7 ) Transmission of rare genetic diseases: Monitor patients for rare genetic diseases.
( 5.8 ) 5.1 Graft-versus-Host Disease Acute and chronic graft-versus-host disease (GvHD) have occurred following treatment with OMISIRGE [see Adverse Reactions (6.1) ] .
Like all medications, Omisirge can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: