Omisirge Side Effects
Generic name: omidubicel
Medically reviewed by Drugs.com. Last updated on Apr 22, 2023.
Note: This document contains side effect information about omidubicel. Some dosage forms listed on this page may not apply to the brand name Omisirge.
Applies to omidubicel: intravenous suspension.
Warning
Intravenous route (Suspension)
Warning: Infusion Reactions, Graft versus Host Disease, Engraftment Syndrome and Graft FailureInfusion 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.Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.Engraftment syndrome: Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.Graft failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Serious side effects of Omisirge
Along with its needed effects, omidubicel (the active ingredient contained in Omisirge) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking omidubicel:
More common
- Agitation
- black, tarry stools
- bloody nose
- bloody urine
- blue lips, fingernails, or skin
- blurred vision
- cold flu-like symptoms
- colicky or burning stomach pain
- coma
- confusion
- constipation
- cough or hoarseness
- cracked lips
- decreased urine output
- depression
- diarrhea
- difficulty in swallowing
- dizziness
- fainting
- fever or chills
- general feeling of illness
- headache
- hostility
- increase blood pressure
- increased thirst
- irritability
- lethargy
- loss of appetite
- lower back or side pain
- muscle twitching
- nausea or vomiting
- nervousness
- pain in the back of throat or chest when swallowing
- painful or difficult urination
- pounding in the ears
- seizures
- skin rash
- slow or fast heartbeat
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stupor
- swelling of the face, fingers, or lower legs
- swollen glands
- trouble breathing
- unusual tiredness or weakness
- vomiting blood or material that looks like coffee grounds
- weight gain or loss
- yellow skin and eyes
Other side effects of Omisirge
Some side effects of omidubicel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
For Healthcare Professionals
Applies to omidubicel: intravenous suspension.
Cardiovascular
Very common (10% or more): Hypertension (25%)[Ref]
Gastrointestinal
Very common (10% or more): Gastrointestinal toxicity (19%), dysphagia (12%)[Ref]
General
The most common adverse reactions (incidence greater than 20%) were infections, GvHD, and infusion reactions.[Ref]
Hematologic
Hemorrhage includes cystitis hemorrhagic, epistaxis, gastrointestinal bleeding, pulmonary alveolar hemorrhage, subarachnoid hemorrhage, and upper gastrointestinal hemorrhage.[Ref]
Very common (10% or more): Hemorrhage (12%)[Ref]
Immunologic
The most common infusion reactions were hypertension, mucosal inflammation, arrythmia, and fatigue. The most common Grade 3 to 4 infusion reaction was hypertension, reported in 6% of the patients.[Ref]
Very common (10% or more): Infusion reactions (any severity: 56%, Grade 3: 17% and 4: 21%), GvHD (acute up to 58%, chronic 35%)
Common (1% to 10%): Primary graft failure[Ref]
Local
Very common (10% or more): Pain (33%), mucosal inflammation (31%)[Ref]
Metabolic
Very common (10% or more): Magnesium decreased (94%), aspartate aminotransferase increased (56%), alanine aminotransferase (56%), alkaline phosphatase increased (42%), magnesium increased (15%)[Ref]
Other
Very common (10% or more): Viral infections (75%), bacterial infections (65%), fungal infections (21%)
Common (1% to 10%): Fatigue, fever[Ref]
Renal
Very common (10% or more): Creatinine increased (50%), renal impairment (12%)[Ref]
Respiratory
Respiratory failure includes acute respiratory distress syndrome, acute respiratory failure, hypoxia, and respiratory failure.[Ref]
Very common (10% or more): Respiratory failure (12%)
Common (1% to 10%): Dyspnea (8%)[Ref]
Hepatic
Very common (10% or more): Bilirubin increased (42%)[Ref]
More about Omisirge (omidubicel)
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- FDA approval history
- Drug class: miscellaneous uncategorized agents
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Patient resources
Professional resources
References
1. Product Information. Omisirge (omidubicel). Gamida Cell Inc.,. 2023.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
