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What to expect

When you receive TREGZI, your care team will be with you every step of the way

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Who may be involved in your care

Your team may include:

  • Your oncologist, as well as doctors from other specialties
  • Nurses, nurse coordinators, and nurse practitioners who may guide you through your treatment plan and make sure that you understand each step. They can also help you coordinate the logistics and connect you with additional support
  • Physician assistants who may help with treatment
  • Pharmacists who will prepare, dispense, and provide information about the medications you will be taking

Your team may also include a social worker or other counselors who can help you find ways to cope with the emotional aspects that come with having cancer and receiving treatment.

Here’s what happens before, during, and after your
transplant with TREGZI

Your care team will guide you through every step of the process.

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Preparing your new cells

Three different types of cells will be precisely and intentionally selected from your donor cells and prepared for your transplant.

The goal is to administer the cells within 72 hours or less of being collected from the donor so that your transplant can happen as soon as possible.

Take a look at the 3 different cells you’ll receive during your transplant.

Learn more

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Preparing for your infusion

A few days before TREGZI is given, you will receive a course of chemotherapy and/or radiation, called a conditioning regimen. This is done to destroy as many of the cancer cells as possible and to purposefully weaken your immune system so that it accepts the new cells.

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Getting your TREGZI

On transplant day (Day 0), you’ll receive 2 infusions:

  • HSPCs, the starter cells that will grow into the needed red blood cells, white blood cells, and platelets
  • Tregs, the immune system cells that suppress certain actions of the donor cells to help prevent GVHD

2 or 3 days later (Day +2 or +3):
You’ll receive Tcons. These cells will multiply and move through your bloodstream to identify and destroy infected cells and cancer cells that they find.

Getting TREGZI, step-by-step

1

The search for a donor may begin shortly after diagnosis

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2

A healthy donor is found and donor cells are collected

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3

TREGZI is made for your transplant

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4

A few days before TREGZI is given, you will receive a conditioning regimen to prepare your body to accept the new cells

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5

On the first day of transplant, you will receive the first 2 types of your carefully selected donor cells, the HSPCs and the Tregs

About 2 to 3 days later, you’ll receive the third type of donor cells, the Tcons

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After your transplant

Following the transplant, you’ll need to stay either in the hospital or very close by so that you can be monitored.

  • Test tube and clipboard icon
    Blood tests will be performed to:

    • Check that the new cells have successfully moved into your bone marrow and begun producing new, healthy blood and immune cells (called engraftment)
    • Make sure that your organs (kidneys, liver) are working the way they should
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    Additionally, your temperature may be taken, because having a fever can be a sign of infection. You may also be asked about any other side effects that you may be experiencing.

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IMPORTANT SAFETY INFORMATION AND INDICATION

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ISI tray

INDICATION

  • TREGZI is a treatment used in stem cell transplant for adult patients who have blood cancer to rebuild the blood and immune systems and improve survival without chronic graft-versus-host disease (cGVHD).
  • TREGZI is made by selecting certain types of blood cells from a matched donor.

IMPORTANT SAFETY INFORMATION

Before you receive TREGZI, tell your healthcare provider about all your medical conditions, including if you have:

  • Lung or breathing problems
  • Heart problems
  • Liver problems
  • Kidney problems
  • A recent or active infection

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TREGZI can cause serious side effects, including:

  • Graft Failure. Failure to rebuild the blood and/or immune system, which may be fatal, can occur after receiving TREGZI. Your healthcare provider will monitor you closely after TREGZI administration.

  • Graft-Versus-Host Disease (GVHD). Immune reactions from the donor’s cells may occur soon (days) or long (months) after receiving TREGZI. Tell your healthcare provider right away about any signs and symptoms including rash, joint pain, diarrhea, or yellowing of the eyes.
  • Infusion Reactions. Infusion reactions can occur after TREGZI infusion. Tell your healthcare provider right away about any signs and symptoms including fever, chills, flushing, fatigue, shortness of breath, and dizziness/lightheadedness.
  • Secondary Cancer and Cancer from Donor Cells. New cancers can develop after treatment with TREGZI. If you are diagnosed with a new cancer after treatment, contact Orca Bio at 1-877-290-6722.
  • Transfer of Serious Infections. Transfer of serious infectious diseases can occur because TREGZI is made from the human blood cells of a donor. Transfer may occur even though donors are screened and tested for infectious diseases.

The most common side effects of TREGZI include inflammation of the digestive tract, diarrhea, rash, viral infections, infections from an unknown pathogen, abdominal pain, vomiting, nausea, bacterial infections, bleeding, acute graft-versus-host disease (aGVHD), swelling and fungal infections.

These are not all the possible side effects of TREGZI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION

  • TREGZI is a treatment used in stem cell transplant for adult patients who have blood cancer to rebuild the blood and immune systems and improve survival without chronic graft-versus-host disease (cGVHD).
  • TREGZI is made by selecting certain types of blood cells from a matched donor.

Please see accompanying full Prescribing Information including Patient Information.