Omidubicel

Generic name: omidubicel [ OH-mi-DOO-bi-sel ]
Brand name: Omisirge
Dosage form: intravenous suspension (onlv)
Drug class: Miscellaneous uncategorized agents

Medically reviewed by Drugs.com on Feb 13, 2024. Written by Cerner Multum.

What is omidubicel?

Omidubicel is used in adults and children at least 12 years old with a certain type of blood cancer receiving a type of stem cell transplant to help increase white blood cells recovery and decrease the risk of infections.

Omidubicel may also be used for purposes not listed in this medication guide.

Omidubicel side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.

A deadly condition called graft-versus-host disease (GVHD) may occur with omidubicel. You may receive medicines to suppress the immune system to lower the risk of GVHD. Tell your doctor right away if you have a rash, diarrhea, or yellow skin or eyes.

Another fatal disease called graft entrapment syndrome or graft failure can also occur with the use of omidubicel. Tell your doctor right away if you have unexplained fever, rash, difficulty breathing, or weight gain.

Common side effects of omidubicel may include:

• infections;

• graft-versus-host disease; or

• dizziness, nausea, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

A fatal condition called graft-versus-host disease (GVHD) may occur with omidubicel. Tell your doctor right away if you have a rash, diarrhea, or yellow skin or eyes.

Another fatal disease called graft entrapment syndrome or graft failure can also occur with the use of omidubicel. Tell your doctor right away if you have unexplained fever, rash, difficulty breathing, or weight gain.

Before taking this medicine

You should not use omidubicel if you are allergic to dimethyl sulfoxide (DMSO), dextran 40, gentamicin, human serum albumin, or bovine products.

Tell your doctor if you have or have ever had:

• an antibiotic allergy; or

• kidney disease.

You may need to have a negative pregnancy test before starting this treatment.

Tell your doctor if you are pregnant or breastfeeding.

How is omidubicel given?

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Omidubicel is given as an infusion into a vein. A healthcare provider will give you this injection in a medical setting.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.

Using omidubicel may increase your risk of developing cancer and some rare genetic diseases. Ask your doctor about your individual risk.

Your blood will need to be tested often.

Omidubicel dosing information

Usual Adult Dose for Blood Cell Transplantation:

This is a cell suspension for intravenous infusion only. A single dose consists of:
-Cultured Fraction (CF): A minimum of 8.0 x 10(8) total viable cells of which a minimum of 8.7% is CD34+ cells and a minimum of 9.2 x 10(7) CD34+ cells, and
-Non-cultured Fraction (NF): A minimum of 4.0 x 10(8) total viable cells with a minimum of 2.4 x 10(7) CD3+ cells.
--- FIRST, administer the Cultured Fraction (CF) IV, this should not exceed 2 hours from the end of the dilution.
---Infuse the Non-cultured (NF) bag. Infusion should not exceed 1 hour from the end of dilution.

Comments:
-Administration should always be under supervision of a physician experienced in the treatment of hematologic malignancies, in centers with expertise in hematopoietic stem cell transplants.
-Verify patient's identity prior to thaw and prior to infusion.

Use: Umbilical cord blood transplantation in patients with hematologic malignancies

Usual Pediatric Dose for Blood Cell Transplantation:

This is a cell suspension for intravenous infusion only. A single dose consists of:
-Cultured Fraction (CF): A minimum of 8.0 x 10(8) total viable cells of which a minimum of 8.7% is CD34+ cells and a minimum of 9.2 x 10(7) CD34+ cells, and
-Non-cultured Fraction (NF): A minimum of 4.0 x 10(8) total viable cells with a minimum of 2.4 x 10(7) CD3+ cells.
---FIRST, administer the Cultured Fraction (CF) IV, this should not exceed 2 hours from the end of the dilution.
---Infuse the Non-cultured (NF) bag. Infusion should not exceed 1 hour from the end of dilution.

Comments:
-Administration should always be under supervision of a physician experienced in the treatment of hematologic malignancies, in centers with expertise in hematopoietic stem cell transplants.
-Verify patient's identity prior to thaw and prior to infusion.

Use: Umbilical cord blood transplantation in children 12 years and older with hematologic malignancies

What happens if I miss a dose?

In a medical setting you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving omidubicel?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect omidubicel?

Other drugs may affect omidubicel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2024 Cerner Multum, Inc. Version: 1.01.