Description
Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq injection is used in matched donor hematopoietic stem cell transplant in patients with blood cancer to improve the blood and immune system and to lower the risk of chronic graft-versus-host disease (cGVHD).
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Tregzi™ in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Tregzi™ in the elderly.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
A doctor or other trained health professional will give you this medicine. It is given through an IV catheter that is placed into one of your veins.
This medicine is made specifically for each patient. It is given only after a matched donor has been identified and after the patient has received cancer treatment before the transplant. Talk with your doctor if you have any concerns about this.
Your doctor will give you other medicines (eg, allergy medicine, fever medicine) 30 minutes before receiving this medicine to prevent unwanted effects.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.
Tell your doctor if you are pregnant. Women who can get pregnant should have a pregnancy test before starting treatment.
Check with your doctor right away if you have black or tarry stools, bloating, dark urine, dry eyes, light-colored stools, mouth sores, nausea, rash with flat lesions or small raised lesions on the skin, stomach pain or burning, vomiting, yellow eyes or skin. These may be symptoms of acute and chronic graft-versus-host disease (GVHD) or graft failure.
This medicine may cause infusion reactions. Check with your doctor right away if you have dizziness, fever or chills, facial swelling, headache, nausea or vomiting, skin rash, trouble breathing, or weakness.
This medicine may cause cancer of donor origin or secondary cancer (eg, post-transplant lymphoproliferative disorder). Check with your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, or yellow skin and eyes.
This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Black or tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- chest pain or tightness
- chills
- cold flu-like symptoms
- cough or hoarseness
- coughing up blood
- dark urine
- difficulty in breathing or swallowing
- dry eyes
- fever
- headache
- increased menstrual flow or vaginal bleeding
- light-colored stools
- lower back or side pain
- mouth sores
- nosebleeds
- painful or difficult urination
- paralysis
- prolonged bleeding from cuts
- rapid weight gain
- rash with flat lesions or small raised lesions on the skin
- sneezing
- sore throat
- stomach pain or burning
- tingling of the hands or feet
- unusual bleeding or bruising
- unusual weight gain or loss
- vomiting
- yellow eyes or skin
Less common
- Pain and fullness in the right upper abdomen or stomach
Incidence not known
- Dizziness
- facial swelling
- nausea
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Cracked lips
- diarrhea
- sores, ulcers, or white spots on the lips, tongue, or inside mouth
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80011923
