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Overview: Omisirge is a type of cell therapy that is given as a one-time infusion into a blood vessel. It is used to treat severe aplastic anemia or blood cancer in certain people who will get a stem cell transplant. Common side effects may include infections and a reaction when you get Omisirge. Tell your health care provider right away if you get a fever, chills, tiredness, racing heart, shortness of breath, nausea, vomiting, dizziness, or muscle pain during your infusion or within a few hours of getting Omisirge. Over the next several weeks to months, tell your health care provider right away if you get a rash, unexplained weight gain, unusual bleeding or bruising, or recurrent infections.

Uses

What is Omisirge used for?

Omisirge (omidubicel-onlv) is commonly used to treat certain people with severe aplastic anemia. This medicine is also used for certain people with blood cancer who will get a stem cell transplant. 

Omisirge may also be used for other conditions as determined by your health care provider.

How does Omisirge work (mechanism of action)?

Hematopoietic progenitor cells are also known as stem cells. These cells can be found in blood and your bone marrow and can mature into different blood cells. Stem cells can become red blood cells, white blood cells like neutrophils, and platelets. 

Omisirge provides stem cells from donor cord blood in a changed form. These changed cells are better able to reach your bone marrow, multiply, and make new blood cells. As a result, you are more quickly able to make mature blood cells, such as neutrophils, red blood cells, and platelets.

How is Omisirge supplied (dosage forms)?

Omisirge is available in an injectable form that is given by a health care provider.

How should I store Omisirge?

Omisirge is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Omisirge?

The most common side effects of Omisirge are listed below. These side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Infections 
  • Graft versus host disease (see below)
  • Infusion reactions (see below)
  • Blood disorders (see below)
  • High blood sugar
  • Rash
  • High blood pressure
  • Shortness of breath
  • Kidney problems
  • Allergic reactions (see below)

There may be other side effects of Omisirge that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Omisirge?

While less common, the most serious side effects of Omisirge are described below, along with what to do if they happen.

Severe Allergic Reactions. Omisirge may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Cancer. Omisirge can cause a new cancer, such as a donor-cell derived myelodysplastic syndrome (MDS), to develop. Another cancer of donor origin, called post-transplant lymphoproliferative disease (PTLD), has also occurred. PTLD can be life-threatening if not treated. Your health care provider will likely watch you over your lifetime for possible cancer development. Keep all appointments to have your blood checked. Tell your health care provider about any new symptoms that you may get.

Graft Versus Host Disease (GvHD). Sometimes, after receiving Omisirge, your healthy tissue may be seen as foreign and can be attacked. This condition is called graft versus host disease. Both acute (soon after receiving Omisirge) and chronic (later onset) GvHD may happen and can be life-threatening. You will likely get medicines to help prevent GvHD. Keep all appointments to have your blood checked. If you get any of the following symptoms, call your health care provider right away.

  • Rash
  • Dry eye or whites of your eyes turning yellowish in color
  • Diarrhea

Infusion Reactions. Omisirge can cause reactions that can be serious when it is given to you. Your infusion may need to be slowed or stopped if you have these reactions. Symptoms may start when you get your infusion but may get worse over time. You will likely get medicines to help prevent an infusion reaction. Tell your health care provider right away if you have any of the following symptoms when you get your infusion or within several hours after you get Omisirge. 

  • Fever or chills
  • Tiredness
  • Racing or fast heartbeat
  • Joint or muscle pain
  • Dizziness or lightheadedness
  • Nausea or vomiting
  • Diarrhea

Blood Disorders. Omisirge may cause anemia (low levels of red blood cells), thrombocytopenia (low levels of platelets), or neutropenia (low levels of a type of white blood cell called neutrophils). Low blood levels can be serious or even life-threatening. Low blood cells may happen weeks to months after getting Omisirge. Your blood cell levels may fall after initially rising. Keep all appointments to have your blood checked. Tell your health care provider if you have any of the following symptoms of low blood cells.

  • Unusual weakness or tiredness
  • Fast or abnormal heartbeat
  • Pale or yellowish skin 
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Easy bruising or bleeding
  • Frequent infection or fevers
  • Tiny red, purple, or brown spots on your skin (petechiae)
  • Mouth ulcers or swelling, redness, or bleeding of your gums (gingivitis)

Risk of Infection. Omisirge is made from umbilical cord blood and could give you an infection. Several steps are taken to lower this risk. Donors are screened for increased risk of infection with viruses like HIV and hepatitis B. Omisirge and both maternal and infant donor blood is also tested for mycoplasma. However, infection risk is still a possibility. Tell your health care provider right away if you get any unusual symptoms.

Risk of Rare Genetic Disease. Omisirge is made from umbilical cord blood and could give you a genetic disease that involves blood cells. Cord blood donors are screened for sickle cell anemia and certain other types of anemias caused by genetic problems. However, the ability to rule out rare genetic diseases among donors is very limited. Tell your health care provider right away if you get any unusual symptoms.

Warnings & Precautions

Who should not use Omisirge?

Allergies to Ingredients. People who are allergic to any of the following should not use Omisirge.

Your pharmacist can tell you all of the ingredients in Omisirge.

What should I know about Omisirge before using it?

Omisirge is usually given by a health care provider in a hospital or clinic. It is given as a one-time infusion into a vein (IV).

It is very important to keep all appointments with your health care provider before and after receiving Omisirge. These appointments help your health care provider make sure the treatment is safe and working well for you. Tell your health care provider about any new or worsening symptoms, especially if you get a rash or unexplained weight gain or fever. 

Sometimes Omisirge may not work, and this is called graft failure. Normally, your blood cell levels will increase after getting Omisirge. In some cases, your immune system may reject Omisirge, and this rejection can be life-threatening. Keep all appointments for bloodwork.

What should I tell my health care provider before using Omisirge?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Omisirge is right for you.

In particular, make sure that you discuss if you have ever had an allergic reaction to an antibiotic.

Pregnancy. It is not known if or how Omisirge could affect pregnancy or harm an unborn baby. If you can get pregnant, you should have a test to make sure you are not pregnant before you take the steps needed to receive Omisirge. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Omisirge passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should receive Omisirge while breastfeeding.

How can I get more information about Omisirge?

For more information about Omisirge, you can call the drugmaker at 844-477-7478.

Interactions

Does Omisirge interact with foods or drinks?

There are no known interactions between Omisirge and foods or drinks.

It is unknown if drinking alcohol will affect Omisirge.

Does Omisirge interact with other medicines (drug interactions)?

There are no known interactions between Omisirge and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Omisirge?

If you or someone else has used too much Omisirge, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Omisirge?

Omisirge is usually given by a health care provider in a hospital or clinic. If you miss your appointment to receive Omisirge, call to make another appointment as soon as possible.