Pronunciation:

oh-mi-DOO-bi-sel - onlv

Brand Names:

• Omisirge

Dosage Forms:

• Suspension

Warnings:

Warning: Infusion Reactions, Graft versus Host Disease, Engraftment Syndrome and Graft FailureInfusion reactions: Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine material.Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.Engraftment syndrome: Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.Graft failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery .

Classifications:

Therapeutic—

Hematopoietic

Uses of This Medicine:

Omidubicel-onlv injection is used to reduce the risk of infection and white blood cell (eg, neutrophil) recovery time in patients with blood cancer who have a planned umbilical cord blood transplantation after receiving high-dose chemotherapy (myeloablative conditioning).

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of omidubicel-onlv injection in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omidubicel-onlv injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to antibiotics, history of—Use with caution. May cause side effects to become worse.

• 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 conditions.

Proper Use of This Medicine:

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).

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Tell your doctor right away think you have become pregnant.

This medicine may cause serious allergic reactions (eg, anaphylaxis, angioedema, bronchospasm), which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have a 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 infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have black, tarry stools, blurred vision, colicky or burning stomach pain, constipation, cracked lips, diarrhea, difficulty in swallowing, dizziness, facial swelling, fever or chills, headache, loss of appetite, nausea or vomiting, pain in the back of 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 you are receiving this medicine.

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

This medicine may cause secondary cancer (eg, post-transplant lymphoproliferative disorder). Check with your doctor right away if you have black, tarry stools, 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 (eg, HIV, hepatitis B or C) or genetic diseases to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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

increase 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 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.