Omidubicel

Omidubicel is used in adults and children who are at least 12 years old with a specific type of blood cancer who are receiving a type of stem cell transplant. It helps to increase the recovery of white blood cells and reduce the risk of infections.

Omidubicel may also be used for other reasons that are not mentioned in this medication guide.

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 reactions. 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.

Some side effects may happen 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 serious condition called graft-versus-host disease (GVHD) may happen with omidubicel. Tell your doctor right away if you have a rash, diarrhea, or yellow skin or eyes.

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

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.

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

Some side effects may happen during the injection. Tell your medical caregiver if you feel dizzy, nauseous, 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, including serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.

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

Another serious disease called graft entrapment syndrome or graft failure can also happen 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-headedness, itchiness, sweating, 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.

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

In a medical setting, you are unlikely to miss a dose.

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

Follow your doctor's instructions about any limits on food, drinks, or activities.

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