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Omisirge (omidubicel-onlv)
omidubicel
Black Box Warnings .
Infusion Reactions
occurred in 47% of patients; can be fatal; monitor patients during and after infusion; signs/symptoms include HTN, mucosal inflammation, dysphagia, dyspnea, vomiting, GI toxicity; D/C tx if severe reaction
Graft vs Host Disease
acute GVHD and chronic GVHD including life-threatening and fatal cases occurred in 58% and 35% of patients, respectively; acute GVHD signs/symptoms include maculopapular rash, GI symptoms, elevated bilirubin; immunosuppressive tx may decr. risk
Engraftment Syndrome
can occur, including fatal; monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in peri-engraftment period; administer corticosteroids promptly; may progress to multiorgan failure, death if untreated
Graft Failure
occurred in 3% of patients; can be fatal; monitor patients for laboratory evidence of hematopoietic recovery
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = omidubicel-onlv
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, prophylactic meds, premeds, and dosing
stem cell therapy, allogeneic HSCT
- [minimum 8x10^8 total viable Cultured Fraction cells IV x1, then minimum 4x10^8 total viable Non-Cultured Fraction cells IV x1]
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = omidubicel-onlv
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, prophylactic meds, premeds, and dosing
stem cell therapy, allogeneic HSCT
- [12 yo and older]
- Dose: minimum 8x10^8 total viable Cultured Fraction cells IV x1, then minimum 4x10^8 total viable Non-Cultured Fraction cells IV x1
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to DMSO
- hypersensitivity to dextran 40
- hypersensitivity to gentamicin
- hypersensitivity to albumin
- hypersensitivity to bovine product
- methylprednisolone prophylactic use, concurrent
- caution: hypersensitivity reaction history to antibiotics
Drug Interactions .
Overview
omidubicel
hematopoietic progenitor cell tx
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- angioedema
- infusion reaction
- graft vs. host disease
- engraftment syndrome
- graft failure
- post-transplant lymphoproliferative disorder
- secondary malignancy
- infectious agent transmission risk
- rare genetic disease transmission risk
- infection
- hepatic veno-occlusive disease
- thrombotic microangiopathy
- hemorrhage
- respiratory failure
Common Reactions
- pain
- mucositis
- HTN
- GI disorder
- hemorrhage
- dysphagia
- renal impairment
- respiratory failure
- dyspnea
- fatigue
- fever
- magnesium decr.
- ALT or AST incr.
- Cr incr.
- bilirubin incr.
- alk phos incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available
Individuals of Reproductive Potential
obtain pregnancy test before tx start
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for omidubicel: other; CYP450: unknown
Excretion: for omidubicel: unknown; Half-life: unknown
Subclass: Stem Cell Therapy
Mechanism of Action
for omidubicel: utilizes nicotinamide to inhibit differentiation and incr. migration, bone marrow homing, and engraftment efficiency of hematopoietic progenitor cells derived from cord blood
Formulary .
No Formulary Selected
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