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Overview: Tregzi is used to prevent certain problems in people with blood cancer who need a stem cell transplant. It contains cells from a donor and is specific to each person who receives it. Common side effects may include mouth sores, diarrhea, rash, infections, stomach pain, nausea, or vomiting. Tregzi is given as an infusion into a vein. Tell your health care provider right away if you have a fever, chills, tiredness, trouble breathing, or feel dizzy during your infusion or afterward.

Uses

What is Tregzi used for?

Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) is commonly used to lower the risk of chronic graft versus host disease (cGvHD) in certain people with blood cancer who are getting a stem cell transplant. It also helps restore the immune system and the body’s ability to form blood cells, which can help manage the blood cancer.

Navigating Blood Cancer: What to Know About Tregzi for Donor Stem Cell Transplant

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

How does Tregzi work (mechanism of action)?

People with blood cancer may need a stem cell transplant to help their body make new blood cells. Rarely, the transplant can lead to chronic graft versus host disease, where the stem cells from a donor (the “graft”) attack the healthy cells of the person who received the transplant (“the host”). 

Tregzi is specific to each person who receives it. It contains immune cells (T cells) and stem cells (hematopoietic stem and progenitor cells, or HSPCs) that are provided by a donor. These cells are purified and tested for germs before use.

The T cells in Tregzi help prevent the donated stem cells from attacking the host’s healthy cells, preserve and restore the immune system, and prevent or reduce the symptoms of cGvHD. The HSPCs in Tregzi help the body make new blood cells. Compared to a traditional stem cell transplant, Tregzi may increase the likelihood of staying alive without cGvHD.

How is Tregzi supplied (dosage forms)?

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

How should I store Tregzi?

Tregzi 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 Tregzi?

The most common side effects of Tregzi are listed below. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of Tregzi 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 Tregzi?

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

Severe Allergic Reactions. Tregzi 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

Graft Versus Host Disease (GvHD). Sometimes, after receiving Tregzi, the donated cells may see your healthy tissue as foreign and attack it. This condition is called graft versus host disease (GvHD), and it can be life-threatening. It may happen soon after receiving Tregzi (acute) or later (chronic). You will likely get medicine to help prevent GvHD. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms.

  • Rash
  • Joint pain
  • Diarrhea 
  • Dry eyes or the whites of your eyes turning yellow
  • Mouth sores

Infusion Reactions. Tregzi 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. Tell your health care provider right away if you have any of the following symptoms when you get your infusion and afterward.

  • Fever or chills
  • Redness of your face and neck
  • Tiredness
  • Shortness of breath
  • Feeling dizzy or lightheaded

Cancer. Tregzi can cause a new cancer or cause a previously treated cancer to come back. Some of these cancers can be life-threatening if not treated. Keep all appointments to have your blood checked. Tell your health care provider about any new symptoms that you may get. If you are diagnosed with a new cancer, call the Tregzi drugmaker at 877-411-6722.

Risk of Infection. The process to make Tregzi involves the use of human blood. It is possible that the blood may carry germs that can cause infections. While steps are taken to reduce this risk, there is still a small chance you could get an infection. Some infections may not cause symptoms. Keep all appointments after taking Tregzi, so your health care provider can check your health. Talk with your health care provider if you think you have an infection or have any new or unusual symptoms.

Warnings & Precautions

Who should not use Tregzi?

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

  • Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq
  • Dextran
  • Dimethyl sulfoxide (DMSO) 
  • Human serum albumin (HSA)
  • Rodent (mouse or rat) products
  • Tregzi
  • Any of the ingredients in the specific product dispensed

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

What should I know about Tregzi before using it?

Tregzi is usually given by a health care provider in a hospital or clinic. It is given as an infusion into a vein (IV).

Before receiving Tregzi, you will need to have chemotherapy. Your health care provider may also give you certain medicines before your Tregzi dose. Talk with your health care provider about what steps you will need to take before receiving Tregzi.

It is very important to keep all appointments with your health care provider before and after receiving Tregzi. 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. 

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

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

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 Tregzi is right for you.

In particular, make sure that you discuss any of the following.

Pregnancy. It is not known if or how Tregzi could affect pregnancy or harm a fetus. If you can get pregnant, you should have a test to make sure you are not pregnant before taking the steps needed to receive Tregzi. Ask your health care provider if you should use birth control before or after receiving Tregzi. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Tregzi 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 Tregzi while breastfeeding.

How can I get more information about Tregzi?

For more information about Tregzi, you can visit the drugmaker’s website at www.orcabio.com or call them at 877-290-6722.

Interactions

Does Tregzi interact with foods or drinks?

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

It is unknown if drinking alcohol will affect Tregzi, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Tregzi interact with other medicines (drug interactions)?

There are no known interactions between Tregzi 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 Tregzi?

If you or someone else has used too much Tregzi, 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 Tregzi?

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