Allogeneic regulatory T cell immunotherapy with HSPC and T cells

Allogeneic regulatory T-cell immunotherapy with HSPC and T cells is used in adults with blood cancers who are receiving a matched-donor stem cell transplant after a myeloablative preparative regimen.

This therapy helps restore the blood and immune systems and may lower the chance of developing chronic graft-versus-host disease, a condition in which the donated immune cells attack healthy parts of your body.

This therapy may also be used for purposes not listed in this medication guide.

This therapy is given as an infusion into a vein by a healthcare provider.

You will receive 3 separate infusions. Two infusions will be given on the day of your stem cell transplant. The third infusion will be given 2 to 3 days later.

You will receive other treatment before this therapy to help prepare your body for the transplant. You may also receive other medicines before your infusions to help prevent fever or an allergic reaction.

Your doctor will test your blood and check your progress on a regular basis.

Allogeneic regulatory T-cell immunotherapy with HSPC and T cells can cause graft failure or graft-versus-host disease (GVHD), which may be life-threatening or fatal. Tell your healthcare provider right away if you have a rash, joint pain, diarrhea, or yellowing of the eyes.

This therapy is made from human donor blood cells and may transmit serious infections, even after donor screening and testing. Tell your doctor right away if you have fever, chills, a sore throat, body aches, unusual tiredness, or loss of appetite.

Tell your doctor if you have or ever had health problems or use other medications.

You may need to have a pregnancy test before starting this treatment.

It is not known if this therapy will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Contact Orca Bio at 1-877-290-6722 if you become pregnant after treatment with this therapy.

Ask your doctor if it is safe to breastfeed while using allogeneic regulatory T cell immunotherapy with HSPC and T cells.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

This therapy is made from human donor blood cells. Serious infections may be passed to you even after the donor has been screened and tested. Call your doctor right away if you have signs of infection such as fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

This therapy may increase your risk of developing new cancers, including cancers from donor cells. You should contact Orca Bio at 1-877-290-6722 if you are diagnosed with a new cancer after treatment.

This therapy may cause graft failure or graft-versus-host disease (GVHD), either of which can be life-threatening or fatal. Tell your doctor right away if you have a rash, joint pain, diarrhea, or yellowing of the eyes.

Common side effects of allogeneic regulatory T cell immunotherapy with HSPC and T cells may include:

• skin rash;
• infection;
• swelling;
• nausea, vomiting, diarrhea, stomach pain;
• acute graft-versus-host disease;
• unusual bleeding or bruising;
• inflammation or sores in the mouth or digestive tract; or
• low blood cell counts.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In a medical setting you are not likely to miss a dose.

An overdose of this product is unlikely to occur. However, any overdose in a medical setting would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect this therapy, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.