Omidubicel-onlv (oh-mi-DOO-bi-sel - onlv)

Reduces the risk of infection in patients with blood cancer.

Brand Name(s):

Omisirge CF, Omisirge NF

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. The medicine must be given slowly, so the needle will have to remain in place for at least 1 to 2 hours.
• A nurse or other health provider will give you this medicine.
• Your doctor will give you other medicines (including allergy medicine, fever medicine, steroid medicine) 30 to 60 minutes before receiving this medicine to prevent unwanted effects (including infusion reactions).

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• 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.
• Tell your doctor if you breastfeeding, or if you have a history of allergy to antibiotics (medicine to treat infection).
• This medicine may cause the following problems:
  • Infusion reaction
  • Graft-versus-host-disease
  • Engraftment syndrome
  • Secondary cancer, including post-transplant lymphoproliferative disorder
• This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (including HIV, hepatitis B or C) or genetic diseases to people who have received them, although the risk is low.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, headache, dizziness, lightheadedness, slow or fast heartbeat
• Diarrhea, nausea, vomiting
• Fever, chills, cough, sore throat, body aches
• Muscle or joint pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Skin rash, unusual weight gain, yellow eyes

If you notice other side effects that you think are caused by this medicine, tell your doctor

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