Allogeneic regulatory t cell immunotherapy, t cells, and hspc
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Dosing in kidney impairment
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Preparation and administration
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Preparation and Administration Preparing Patient for TREGZI Infusion Pretreatment Administer an appropriate myeloablative preparative regimen before infusion of TREGZI. Receipt of TREGZI Do not irradiate. TREGZI is shipped directly to the treatment center in two transport containers [See How Supplied/Storage and Handling ] : A refrigerated cardboard shipping container at 2°C to 8°C (36°F to 46°F), containing the HSPC infusion bag and Treg infusion bag in a single protective carton.
A cardboard box containing: 1) A liquid nitrogen dry vapor shipper at below -125°C (below -193°F), containing the cryopreserved Tcon infusion bag in a protective metal cassette. 2) A protective carton containing the Tcon diluent infusion bag stored at ambient temperature (20°C to 25°C, 68°F to 77°F). Upon receipt of the refrigerated cardboard shipping container containing the HSPC and Treg carton and infusion bags: Match the identity of the patient with the patient identifiers on the carton and infusion bags containing the HSPCs and Tregs.
If the information on the patient-specific label does not match the intended patient, do NOT infuse TREGZI and contact Orca Bio at 1-877-411-6722. Inspect the HSPC and Treg infusion bags for any breaches of bag integrity such as breaks, leaking by the port line seal, or cracks. If an infusion bag is compromised, follow the institutional procedures for handling, storage and disposal and contact Orca Bio at 1-877-411-6722.
Upon receipt of the cardboard box containing the Tcon metal cassette and infusion bag and Tcon diluent carton and infusion bag: Do NOT open the Tcon metal cassette upon receipt. Only open the metal cassette to verify the patient identifiers and inspect the Tcon infusion bag immediately prior to thawing. Match the identity of the patient with the patient identifiers on the metal cassette containing the Tcon infusion bag and carton and infusion bags containing the Tcon diluent.
If the information on the patient-specific label does not match the intended patient, do NOT infuse TREGZI and contact Orca Bio at 1-877-411-6722. Inspect the Tcon diluent infusion bag for any breaches of bag integrity such as breaks, leaking by the port line seal, or cracks. If an infusion bag is compromised, follow the institutional procedures for handling, storage and disposal and contact Orca Bio at 1-877-411-6722.
Premedication Administer diphenhydramine and/or acetaminophen approximately 30 minutes before TREGZI HSPC and Tcon infusions per institutional guidance. The use of corticosteroids as premedication is strongly discouraged. Day 0: Preparation and Administration of TREGZI HSPCs and Tregs Confirm the patient's identity matches the patient identifiers on each of the HSPC and Treg infusion bags.
Do NOT infuse the HSPCs and Tregs if the information on the patient-specific label does not match the intended patient. Central venous catheter access is recommended for TREGZI infusion. Infuse HSPCs (Step 1 of Administration) and Tregs (Step 2 of Administration) promptly after receipt and verification of the expiry date and time listed on the bag label, carton label or Certificate of Analysis (COA).
Infuse HSPCs and Tregs immediately after removal from refrigeration. Do not warm infusion bags prior to infusion. Day 0: Preparation of HSPCs and Tregs for Infusion Remove the HSPC and Treg infusion bags from refrigerated storage immediately prior to infusion. Agitate each infusion bag by inverting or gently massaging to prevent cell clumping.
If visible cell clumping remains, continue to disperse clumps per institutional guidance prior to infusion. Day 0: Administration of HSPCs and Tregs Do NOT use a leukodepleting filter. 3. Prime the tubing with 0.9% sodium chloride. 4. Infuse the entire contents of HSPC infusion bag (Step 1 of Administration) by either gravity or a peristaltic pump at a rate of up to 5 mL/min. 5.
After infusion of the entire contents of the HSPC infusion bag, add approximately 10 mL of 0.9% sodium chloride to the empty infusion bag and administer to the patient at the same infusion rate per institutional guidance. Repeat this process to achieve a total of two rinses. 6. Immediately after infusion of the HSPCs and two rinses on day 0, infuse the entire contents of the Treg infusion bag by either gravity or a peristaltic pump at a rate of up to 5 mL/min. 7.
After infusion of the entire contents of the Treg infusion bag, add approximately 10 mL of 0.9% sodium chloride to the empty infusion bag and administer to the patient at the same infusion rate per institutional guidance. Repeat this process to achieve a total of two rinses. Day +2 to Day +3: Preparation and Administration of TREGZI Tcons Tcons are supplied cryopreserved in an infusion bag that is protected by a corresponding overwrap bag and packed in a metal cassette.
Patient identifiers are found on the cassette and infusion bag labels. Do NOT open the metal cassette until immediately before thawing. Confirm the patient's identity matches the patient identifiers on the Tcon and Tcon diluent infusion bags. Do NOT infuse the Tcons if the information on the patient-specific label does not match the intended patient.
Central venous catheter access is recommended for TREGZI infusion. Infuse Tcons (Step 3a of Administration) after thaw and dilution using the Tcon diluent (Step 3b of Administration) as soon as possible. If the Tcons can not be administered immediately, the Tcon infusion bag must be stored at 2°C to 8°C and infused within 4 hours.
Day +2 to Day +3: Preparation - Thawing of Tcons Preparation of the Tcons for infusion occurs on day +2 to +3 after the start of HSPC infusion on day 0. Refrigerate the Tcon diluent infusion bag at 2°C to 8°C for at least 30 minutes prior to removing the Tcon metal cassette from liquid nitrogen storage. Remove Tcon metal cassette from liquid nitrogen storage.
Open the protective cassette and remove the Tcon infusion bag. Remove the Tcon infusion bag from the overwrap bag. Place Tcon infusion bag in a sterile plastic bag and seal the bag tightly. Place the sealed plastic bag in a 37°C water bath for approximately 1 to 1.5 minutes until the cell suspension is slushy in texture.
Gently massage the Tcon infusion bag during thawing. Remove the sealed bag from the water bath and remove the Tcon infusion bag. Discard outer plastic bag. Wipe down the Tcon infusion bag with 70% isopropanol. Day +2 to Day +3: Preparation - Dilution of Tcons with Tcon Diluent 9. Remove the Tcon diluent infusion bag from refrigeration. 10.
Using a dispensing pin and syringe or transfer set with gravity, over a period of 3 minutes, slowly transfer the contents of the Tcon diluent infusion bag into the Tcon infusion bag. Rock the infusion bag back and forth during transfer to mix. 11. If administering the Tcons immediately, store the Tcon infusion bag at room temperature (18°C to 25°C).
If not administering the Tcons immediately, store the Tcon infusion bag at 2°C to 8°C. 12. Immediately prior to infusion, gently agitate each infusion bag by inverting or gently massaging to prevent cell clumping per institutional guidance. If visible cell clumping remain continue to disperse clumps by gentle massaging per institutional guidance prior to infusion.
Day +2 to Day +3: Administration of Tcons DO NOT use a leukodepleting filter. 13. Prime the tubing with 0.9% sodium chloride. 14. Infuse the entire contents of the Tcon infusion bag by either gravity or a peristaltic pump at a rate of up to 5 mL/min. 15. After infusion of the entire contents of Tcon infusion bag, add approximately 10 mL of 0.9% sodium chloride to the empty infusion bag and administer to the patient at the same infusion rate per institutional guidance.
Repeat this process to achieve a total of two rinses. 16. Treat patients with a single agent calcineurin inhibitor as prophylaxis to decrease the risk of GVHD starting the day after Tcon administration. TREGZI contains human blood cells. Follow universal precautions and local biosafety guidelines for handling and disposal to avoid potential transmission of infectious diseases.
| Component | Dose Regimen | Target Viable Cell Dose Range (Cells per Patient kg) |
|---|---|---|
| Abbreviations: HSPCs, hematopoietic stem and progenitor cells; Tregs, regulatory T cells; Tcons, conventional T cells. | ||
| HSPCs | Intravenous, once, on day 0 | ≥1.0 × 106 |
| Tregs | Intravenous, once, on day 0 immediately after administration of HSPCs | 1.3 × 106 to 3.5 × 106 |
| Tcons | Intravenous, once, on day +2 to +3 (after the start of HSPC infusion on day 0) | 1.3 × 106 to 6.9 × 106 |
| Tcon diluent | Intravenous, once, administered with Tcons drug product on day +2 to +3 (after HSPC infusion on day 0) | 30 mL |
Drug interactions
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- Allogeneic regulatory t cell immunotherapy, t cells, and hspc
Contraindications
None. None ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for allogeneic regulatory t cell immunotherapy, t cells, and hspc. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on TREGZI use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with TREGZI to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if TREGZI has the potential to be transferred to the fetus. TREGZI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Report all pregnancies following treatment with TREGZI to Orca Bio at 1-877-290-6722.
In the United States (U.S.) general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.