Omidubicel-onlv (Intravenous)

Omidubicel-onlv injection is used to lower the chance of infection and help with the recovery time of white blood cells (like neutrophils) in patients with blood cancer who are scheduled to have an umbilical cord blood transplant after receiving high-dose chemotherapy (myeloablative conditioning).

This medicine must be given only by your doctor or under their close supervision.

It is very important for your doctor to check your or your child's progress during regular visits to ensure this medicine is effective. Blood tests may be needed to monitor for any unwanted effects.

If you are a woman who can get pregnant, your doctor may perform tests to confirm that you are not pregnant before receiving this medicine. Inform your doctor immediately if you think you have become pregnant.

This medicine may cause serious allergic reactions (such as anaphylaxis, angioedema, bronchospasm), which can be life-threatening and require immediate medical attention. Contact your doctor right away if you or your child experience chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, rash, itching, trouble breathing, or unusual tiredness or weakness after using this medicine.

This medicine may cause an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you experience black, tarry stools, blurred vision, colicky or burning stomach pain, constipation, cracked lips, diarrhea, difficulty swallowing, dizziness, facial swelling, fever or chills, headache, loss of appetite, nausea or vomiting, pain in the back of the throat or chest when swallowing, skin rash, slow or fast heartbeat, sores, ulcers, or white spots on the lips, tongue, or inside the mouth, trouble breathing, vomiting blood or material that looks like coffee grounds, or weakness while receiving this medicine.

Contact your doctor right away if you have diarrhea, fever, rash, unexplained weight gain, or yellow eyes. These may be symptoms of serious conditions called graft-versus-host disease or engraftment syndrome.

This medicine may cause secondary cancer (such as post-transplant lymphoproliferative disorder). Contact your doctor right away if you have black, tarry stools, a general feeling of illness, swollen glands, weight loss, or yellow skin and eyes.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (such as HIV, hepatitis B or C) or genetic diseases to people who have received them, although the risk is low. Both human donors and donated blood are tested for viruses to minimize the transmission risk. Discuss any concerns about this risk with your doctor.

In deciding to use a medicine, you and your doctor need to consider the risks versus the benefits. Here are important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how omidubicel-onlv injection affects children younger than 12 years of age. Its safety and effectiveness in this age group have not been established.

Geriatric

Studies conducted so far have not found any specific problems in older adults that would limit the usefulness of omidubicel-onlv injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. You should weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines can also lead to interactions. Discuss with your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works for you. Be sure to tell your doctor about any other medical problems, especially:

• Allergy to antibiotics, history of—Use with caution. May worsen side effects.

• Allergy to bovine products or
• Allergy to dextran 40 or
• Allergy to dimethyl sulfoxide (DMSO) or
• Allergy to gentamicin or
• Allergy to human serum albumin—Should not be used in patients with these allergies.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Agitation
• black, tarry stools
• bloody nose
• bloody urine
• blue lips, fingernails, or skin
• blurred vision
• cold flu-like symptoms
• colicky or burning stomach pain
• coma
• confusion
• constipation
• cough or hoarseness
• cracked lips
• decreased urine output
• depression
• diarrhea
• difficulty in swallowing
• dizziness
• fainting
• fever or chills
• general feeling of illness
• headache
• hostility
• increased blood pressure
• increased thirst
• irritability
• lethargy
• loss of appetite
• lower back or side pain
• muscle twitching
• nausea or vomiting
• nervousness
• pain in the back of the throat or chest when swallowing
• painful or difficult urination
• pounding in the ears
• seizures
• skin rash
• slow or fast heartbeat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• stupor
• swelling of the face, fingers, or lower legs
• swollen glands
• trouble breathing
• unusual tiredness or weakness
• vomiting blood or material that looks like coffee grounds
• weight gain or loss
• yellow skin and eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty swallowing
• pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Omisirge

Available Dosage Forms:

• Suspension

Therapeutic Class: Hematopoietic

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to remain in place for at least 1 to 2 hours.

Your doctor will give you other medicines (eg, allergy medicine, fever medicine, steroid medicine) 30 to 60 minutes before receiving this medicine to prevent unwanted effects (eg, infusion reactions).