Omidubicel

Omidubicel is a prescription medication used for the treatment of hematologic malignancies in adults who are planned for umbilical cord blood transplantation following myeloablative conditioning, to reduce neutrophil recovery time and incidence of infection.

• Omidubicel is available under the following different brand names: Omisirge, omidubicel-onlv.

Common side effects of Omidubicel include:

• Not available

Serious side effects of Omidubicel include:

• Hypersensitivity Reactions
• Infusion Reactions
• Graft versus Host Disease
• Engraftment Syndrome
• Graft Failure
• Malignancies of Donor Origin

Rare side effects of Omidubicel include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, Suspension

• Single dose contains:
  • Cultured Fraction (CF): Minimum of 8 x 108 total viable cells (minimum of 8.7% is CD34+ cells [a minimum of 9.2 x 107 CD34+ cells]) suspended in approximately 10% DMSO.
  • Non-cultured Fraction (NF): Minimum of 4 x 108 total viable cells (minimum of 2.4 x 107 CD3+ cells) suspended in approximately 10% DMSO.
  • Each fraction is supplied separately in its cryopreserved bag.
  • Both bags diluted with their respective infusion solution must be infused to achieve the dose

Umbilical Cord Blood Transplantation

Adult and pediatric dosage 

• Single dose contains:
  • Cultured Fraction (CF): Minimum of 8 x 108 total viable cells (minimum of 8.7% is CD34+ cells [a minimum of 9.2 x 107 CD34+ cells]) suspended in approximately 10% dimethyl sulfoxide (DMSO)
  • Non-cultured Fraction (NF): Minimum of 4 x 108 total viable cells (minimum of 2.4 x 107 CD3+ cells) suspended in approximately 10% DMSO.
  • See respective Certificate of Analysis (CoA) for the CF and NF for actual cell counts; the CoAs are attached to RFI Certificate available via Gamida Cell Assist Hospital Portal

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Omidubicel has no noted severe interactions with any other drugs.
• Omidubicel has no noted serious interactions with any other drugs.
• Omidubicel has no noted moderate interactions with any other drugs.
• Omidubicel has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice or health questions or concerns.

Contraindications

• Known sensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine material.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Omidubicel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Omidubicel?”

Cautions

• Infusion reactions occurred following infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity; monitor for signs and symptoms of infusion reactions during and after administration.
• Acute and chronic GVHD, including life-threatening and fatal cases, occurred following treatment; acute GVHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin level.
• Primary graft failure occurred; immunologic rejection is the primary cause of graft failure.
• Engraftment syndrome may occur; monitor 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.
  • Disease may be caused by known or unknown infectious agents.
  • Screen donors for increased risk of infection with human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, West Nile Virus (WNV), transmissible spongiform encephalopathy (TSE) agents, vaccinia, and Zika virus (for umbilical cord blood collected since March 2016)
  • Also screen donors for clinical evidence of sepsis and communicable disease risks associated with xenotransplantation.
  • Test maternal blood samples for HIV types 1 and 2, HTLV types I and II, HBV, HCV, T pallidum, and WNV
  • Testing of maternal and infant donor blood is also performed for evidence of donor infection due to cytomegalovirus.
  • Test results may be found on the container label and/or in accompanying records.
  • Report occurrence of transmitted infection to Gamida Cell at (844) 477-7478
  • These measures do not eliminate the risk of transmitting infectious diseases and disease agents.
• Transmission of rare genetic diseases
  • May transmit rare genetic diseases involving the hematopoietic system.
  • Screen cord blood donors to exclude donors with sickle cell disease, and anemias due to abnormalities in hemoglobin 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.
• Allergic reactions
  • Allergic reactions may occur.
  • Reactions include bronchospasm, wheezing, angioedema, pruritus, and hives.
  • Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA), and bovine material in omidubicel.
  • May also contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero.
  • Monitor patients with a history of allergic reactions to antibiotics for allergic reactions after administering.
• Malignancies of donor origin
  • Two treated patients developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant.
  • PTLD manifests as a lymphoma-like disease favoring non-nodal sites.
• PTLD is usually fatal if not treated.
  • 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.
  • One treated patient developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth year of posttransplant.
  • Natural history is presumed to be the same as that for de novo MDS.
• Monitor life-long secondary malignancies.
  • If a secondary malignancy occurs after treatment, contact Gamida Cell at (844) 477-7478

Pregnancy and Lactation

• No data are available on use in pregnant females.
• No animal reproductive and developmental toxicity studies have been conducted to assess whether it can cause fetal harm when administered to pregnant females.
• Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Verify the pregnancy status of females with reproductive potential.
• Contraception
  • See the prescribing information for medications used for conditioning for information on the need for effective contraception in patients who receive a conditioning regimen.
  • There is insufficient exposure data to provide a recommendation concerning the duration of contraception following treatment.
• Lactation
  • There is no information regarding the presence of omidubicel in human milk, its effect on breastfed infants, and its effects on milk production.