Omidubicel-onlv Injection

Omidubicel-onlv injection may cause serious life-threatening reactions during infusion such as bronchospasm (difficulty breathing), wheezing, hives, itching and angioedema (sudden swelling deep under the skin around the eyes, lips, hands feet or genitals that may be life-threatening). Your doctor will monitor you carefully during and following infusion. The risk of a reaction may be higher in patients with an allergy to dimethylsulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, bovine (cattle) products, or antibiotics. Make sure you tell your doctor if you have an allergy to any of these substances. Your doctor will probably tell you not to receive omidubicel-onlv.

Omidubicel-onlv injection may cause Graft-vs-Host disease (GvHD; a condition in which the donor-supplied organ, tissues or cells attack the organ recipient) which can be fatal. You will be given medications to prevent GvHD from occurring. Tell your doctor if you experience any of the following symptoms: maculopapular rash (a rash with flat discolored patches and small raised bumps that may appear anywhere on the body and be itchy), diarrhea, nausea, abdominal cramping, loss of appetite, yellowing of the skin or whites of the eyes, and extreme tiredness.

Omidubicel-onlv injection may cause engraftment syndrome (an inflammatory condition that occurs after stem cell transplant that causes fever, rash, weight gain, pulmonary edema (fluid in the lungs), and confusion). Tell your doctor if you experience any of the following symptoms: fever, rash, difficulty breathing or shortness of breath or shallow breathing, cough, or weight gain.

Omidubicel-onlv injection may cause graft failure (failure to show signs of lasting cell production following cell transplant usually due to immune rejection) which can be fatal. Your doctor will monitor you closely.

Keep all appointments with your doctor and the laboratory.

Omidubicel-onlv injection is used to aid in the success of an umbilical cord transplant in patients with hematological malignancies (blood cancers).Omidubicel-onlv injection is in a class of medications called nicotinamide modified allogenic hematopoietic progenitor cell therapies. It works by infusing (placing) healthy blood-forming stem cells from a matched donor into a patient.

Omidubicel-onlv injection comes as a suspension (liquid) for infusion to be given intravenously (into the vein) by a doctor or a nurse at a healthcare facility specialized in umbilical cord transplant. You will be given medications prior to receiving omidubicel-onlv injection to reduce risk of adverse effects. Your doctor will monitor you closely during and after the infusion. Omidubicel-only injection is prepared by the manufacturer specifically for the patient. It is given as a single dose.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving omidubicel-onlv injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You may be required to have a negative pregnancy test before receiving omidubicel-onlv injection.
• do not have any vaccinations without talking to your doctor.
• you should know that receiving omidubicel-onlv injection has caused cancer, infectious diseases or genetic disorders that come from the donor cells used to manufacture omidubicel-onlv injection. You will be monitored closely during and after omidubicel-onlv infusion. Talk to your doctor about the risks of receiving omidubicel-onlv injection.

Unless your doctor tells you otherwise, continue your normal diet.

Omidubicel-onlv injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain
• inflammation of mucosa such as gums, inside of cheeks, nostils, lips
• nausea, vomiting, diarrhea, loss of appetitie
• difficulty swallowing or shortness of breath

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• unexplained bleeding such as nose bleeds, blood in urine, coughing up blood, vomiting blood
• fever, extreme tiredness, productive cough, muscle aches, painful urination
• difficulty urinating or low urine stream, swelling or weight gain, weakness, loss of appetite

Omidubicel-onlv injection may cause other side effects. Call your doctor if you have any unusual problems while or after receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Omiserge ^®