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TREGZI allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq Kit

by Orca Biosystems Inc. · 1 KIT in 1 CARTON (85866-223-04) * 100 mL in 1 BAG (85866-124-01) * 1 BAG in 1 CARTRIDGE (85866-126-02) / 15 mL in 1 BAG (85866-126-01) * 1 BAG in 1 CARTON (85866-127-02) / 30 mL in 1 BAG (85866-127-01) * 100 mL in 1 BAG (85866-125-01)

NDC 85866-0223-04

🏷️ FDA NDC (as labeled) 85866-223-04 billing pads the product segment with a zero

Brand On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 85866-223-04

Product NDC 85866-223

11-digit billing NDC 85866022304

NCPDP billing unit EA — each (per item)

RxCUI 2747373, 2747379

Application # BLA125868

SPL Set ID 2157e11b-87c3-4d54-a225-81b341e4e21a

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-06-30

Dosage form KIT

Why two NDCs? The FDA registers this code as 85866-223-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 85866-0223-04. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerOrca Biosystems Inc.

FDA applicationBLA125868 (BLA)

Labeler code85866

First marketedJun 2026

Product typeCellular Therapy

🔎 All NDCs from Orca Biosystems Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Tregzithis 85866-0223-04	Orca	1 kit	—	—	FDA listed	—

About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️

2026

On the market since

Jun 2026

📍

2026

Currently FDA-listed

listed with the FDA

🧬

Biosimilars

see Purple Book

🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?

Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
85866-0223-04 You're viewing this	1 KIT in 1 CARTON (85866-223-04) * 100 mL in 1 BAG (85866-124-01) * 1 BAG in 1 CARTRIDGE (85866-126-02) / 15 mL in 1 BAG (85866-126-01) * 1 BAG in 1 CARTON (85866-127-02) / 30 mL in 1 BAG (85866-127-01) * 100 mL in 1 BAG (85866-125-01)	2026-06-30	Active

🧭 About this NDC listing & data coverage

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 85866-223-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 85866-0223-04, written without dashes as 85866022304. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 85866-0223-04, the first segment (85866) is the labeler code FDA assigned to Orca Biosystems Inc.; the middle segment (0223) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Orca Biosystems Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Orca Biosystems Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 95 words ▾

1 INDICATIONS AND USAGE TREGZI is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival, in the treatment of adults with hematological malignancies. TREGZI™ is an allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cells and T cells indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGVHD)-free survival, in the treatment of adults with hematological malignancies.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intravenous use only . ( 2.1 ) Verify patient's identity prior to infusion. ( 2.2 ) TREGZI is provided as 4 separate infusion bags (HSPCs, Tregs, Tcons, and Tcon diluent).

( 2.1 ) Administer an appropriate myeloablative preparative regimen before infusion of TREGZI. ( 2.2 ) DO NOT use a leukodepleting filter. ( 2.2 ) See Full Prescribing Information for instructions on receipt, preparation, and administration of TREGZI ( 2.2 , 16 )

2.1Dose For intravenous use only. A single dose of TREGZI consists of hematopoetic stem and progenitor cells (HSPCs), regulatory T cells (Tregs), conventional T cells (Tcons), and Tcon diluent provided in 4 separate infusion bags labeled for the specific patient. Each patient-specific infusion bag of TREGZI contains a batch-dependent concentration of allogeneic cells (see Table 1 ).

Patient-specific dose information can be found within the Certificate of Analysis (COA). Table 1 TREGZI Route of Administration, Dose Regimen, and Target Dose Range 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 × 10 6 Tregs Intravenous, once, on day 0 immediately after administration of HSPCs 1.3 × 10 6 to 3.5 × 10 6 Tcons Intravenous, once, on day +2 to +3 (after the start of HSPC infusion on day 0) 1.3 × 10 6 to 6.9 × 10 6 Tcon diluent Intravenous, once, administered with Tcons drug product on day +2 to +3 (after HSPC infusion on day 0) 30 mL

2.2Preparation 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 (16) ] : 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 (1) Tcon metal cassette and infusion bag and (2) 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 (1) metal cassette containing the Tcon infusion bag and (2) 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 Admin…

💊 Dosage Forms and Strengths ~2 min read ▾

3 DOSAGE FORMS AND STRENGTHS TREGZI is a cell suspension for intravenous infusion. TREGZI is provided in separate infusion bags labeled for the specific patient. Each single-dose, patient-specific infusion bag of TREGZI contains a batch-dependent concentration of allogeneic cells as described in Table 2.

Patient-specific dose information can be found within the COA. Table 2 TREGZI Cell Components and Diluent Cell Component Target Viable Cell Dose Range (Cells per Patient kg) Excipients Appearance Container and Approximate Fill Volume Component Identifying Information Abbreviations: DMSO, dimethyl sulfoxide; HSA, human serum albumin; HSPCs, hematopoietic stem and progenitor cells; MEI, multiple electrolytes injection; Tcons, conventional T cells; Tregs, regulatory T cells. HSPCs ≥1.0 × 10 6 MEI, Type 1 HSA Clear to opaque liquid Color = off-white, white, yellow, orange, to red Fill volume: approximately 100 mL Orange colored label specifying "Step 1 of Administration" Tregs 1.3 × 10 6 to 3.5 × 10 6 MEI, Type 1 HSA Clear to opaque liquid Color = off-white, white, yellow, orange, to red Fill volume: approximately 100 mL Light blue colored label specifying "Step 2 of Administration" Tcons 1.3 × 10 6 to 6.9 × 10 6 MEI, Type 1, HSA, DMSO Hetastarch (6% hetastarch in 0.9% sodium chloride injection added at 30.5% (v/v)).

Clear to opaque liquid Color = off-white, white, yellow, orange, to red Fill volume: approximately 15 mL Dark blue colored label specifying "Step 3a of Administration" Diluent Tcon Diluent Not Applicable MEI Type 1, HSA Clear Color: Colorless to yellow Fill volume: approximately 38 mL Tan label specifying "Step 3b of Administration" Dosage form(s): TREGZI is a suspension for intravenous infusion. TREGZI is provided in separate infusion bags labeled for the specific patient. A single dose of TREGZI consists of: A minimum dose of HSPCs of 1.0 × 10 6 viable cells per patient kilogram.

A dose of Tregs of 1.3 × 10 6 to 3.5 × 10 6 viable cells per patient kilogram. A dose of Tcons of 1.3 × 10 6 to 6.9 × 10 6 viable cells per patient kilogram. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Graft Failure: Monitor patients closely for laboratory evidence of hematopoietic recovery. ( 5.1 ) Graft-Versus-Host Disease (GVHD): Treat patients with a single agent calcineurin inhibitor as prophylaxis to decrease the risk of GVHD. Monitor for signs and symptoms of GVHD.

( 5.2 ) Infusion Reactions: Monitor patients for signs and symptoms of infusion reactions during and after TREGZI administration. When a reaction occurs, pause the infusion and institute supportive care as needed. ( 5.3 ) Secondary Malignancies and Malignancies of Donor Origin: Monitor for secondary malignancies and malignancies of donor origin.

( 5.4 ) Transmission of Infectious Agents: Monitor patients closely for serious infections. ( 5.5 )

5.1Graft Failure Graft failure has occurred after TREGZI administration [see Adverse Reactions (6.1) ]. Screen TREGZI recipients for antidonor antibodies that may prevent engraftment. Monitor patients closely for laboratory evidence of hematopoietic recovery.

5.2Graft-Versus-Host Disease Acute and chronic Graft-Versus-Host disease (GVHD), including life-threatening and fatal cases, occurred following treatment with TREGZI [see Adverse Reactions (6.1) ] . Acute GVHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Chronic GVHD may include skin rash, mouth sores, dry eyes, liver inflammation, and development of scar tissue in the skin and joints and damage to the lungs.

Treat patients with a single agent calcineurin inhibitor as prophylaxis to decrease the risk of GVHD. Monitor for signs and symptoms of GVHD, and treat if GVHD develops.

5.3Infusion Reactions Infusion reactions (IRs) may occur during or following treatment with TREGZI. Serious hypersensitivity reactions including anaphylaxis may occur due to DMSO, human serum albumin (HSA), Dextran or murine protein present in TREGZI. IRs may begin within minutes of the start of TREGZI infusion, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion.

Monitor patients for signs and symptoms of IRs during and after TREGZI administration. When a reaction occurs, pause the infusion and institute supportive care as needed. Premedicate patients with antipyretics and histamine antagonists prior to infusion to reduce the incidence and intensity of infusion reactions.

5.4Secondary Malignancies and Malignancies of Donor Origin Secondary malignancies and malignancies of donor origin may occur following treatment with TREGZI [see Adverse Reactions (6.1) ] . Development of secondary malignancies, including posttransplantation lymphoproliferative disorder (PTLD) may occur many years after transplantation. PTLD manifests as a lymphoma-like disease favoring non-nodal sites.

PTLD is usually fatal if not treated. Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. No patient treated with TREGZI has developed PTLD.

Monitor for malignancies of donor origin and secondary malignancies. Contact Orca Bio at 1-877-290-6722 if any patient is diagnosed with a secondary malignancy or a malignancy of donor origin.

5.5Transmission of Infectious Agents Transmission of serious infectious or communicable disease or agents may occur with TREGZI treatment as it is derived from human donor blood and manufactured using animal-derived reagents. Risks of transmission of infectious agents may occur despite screening or testing of donors. Risks of transmission of serious infections include, but are not limited to, human immunodeficiency virus, human T cell lymphotropic virus (HTLV)-1 and -2, hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, Trypanosoma cruzi, West Nile virus (WNV), cytomegalovirus, transmissible spongiform encephalopathy agents and vaccinia.

Monitor patients for signs and symptoms of infections, perform tests for infectious agents and treat as clinically indicated.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥20%) were mucositis, diarrhea, rash, viral infections, infections - pathogen unspecified, abdominal pain, vomiting, nausea, bacterial infections, hemorrhage, aGVHD, edema, and fungal infections. ( 6.1 ) The most common Grade 3-4 laboratory abnormalities (≥ 20%) are lymphocyte count decreased, platelet count decreased, leukocyte count decreased, neutrophil count decreased, and hemoglobin decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Orca Bio at 1-877-290-6722 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflects exposure to TREGZI in one clinical study (Precision-T Study) which enrolled patients with advanced hematologic malignancies eligible for HLA-matched allogeneic stem cell transplantation following myeloablative preparative regimen.

The study treated 88 patients with TREGZI and 94 patients with standard of care (SoC) unmanipulated graft. The patients were followed for a duration of 24 months [see Clinical Studies (14) ]. Serious adverse reactions within the first 100 days occurred in 25 patients (28%) treated with TREGZI including bacterial infections (n=12; 14%), pyrexia (n=4; 5%), venooclusive liver disease (n=3; 3%), and viral infections (n=3; 3%).

Fatal adverse reactions occurred in 3 patients (3%). Non-relapse deaths at 12 months occurred in 3/88 (3.4%) patients in the TREGZI group and in 11/94 (11.7%) patients in the SoC control group [see Clinical Studies (14) ]. In the TREGZI treated safety population, the most common (greater than or equal to 10%) Grade 3 or 4 nonlaboratory adverse reactions were mucositis (28%), bacterial infection (18%), infection – pathogen unspecified (18%), and viral infection (14%).

Table 3 summarizes the most common nonlaboratory adverse reactions occurring in ≥10% patients treated with TREGZI or unmanipulated allograft control group in Precision-T Study. Table 3 Adverse Reactions occurring in ≥10% of patients treated with TREGZI or unmanipulated allograft control arm in Precision-T Study Adverse Reactions TREGZI (N = 88) SoC Control (N=94 ) All Grades % Grade 3 or Higher % All Grades % Grade 3 or Higher % Infections and infestations Infections and infestations were calculated for the first 2 years after transplantation.

Abbreviations: GVHD, Graft-Versus-Host disease. Viral infections 51 14 47 19 Infections - pathogen unspecified 45 18 56 30 Bacterial infections 40 18 38 16 Fungal infections 20 3 18 0 Gastrointestinal disorders Diarrhea includes multiple related terms 69 1 79 6 Abdominal pain 45 0 54 1 Vomiting 44 1 35 0 Nausea 41 1 44 2 Immune system disorders Acute graft-versus-host disease Acute GVHD graded by MAGIC standardization criteria (Harris 2016) as determined by an independent review committee; calculated for the first year after transplantation.

38 6 46 15 General disorders and administration site conditions Mucositis 85 28 88 37 Edema 30 0 38 3 Respiratory, thoracic and mediastinal disorders Pneumonia 5 5 17 15 Skin and Subcutaneous Tissue Disorders Rash 65 0 55 0 Vascular Disorders Hemorrhage 39 6 33 1 Other clinically important adverse reactions that occurred in less than 10% of patients treated with TREGZI include the following: Hepatobiliary disorders: veno-occlusive liver disease 3% in TREGZI group and 2% in control group. Immune system disorders: moderate to severe chronic Graft-versus-host disease (GVHD) 13% in TREGZI group and 41% in control group as per International NIH Chronic GVHD Diagnosis and Staging.

Injury, poisoning, and procedural complications: Secondary graft failure 1% in TREGZI group and 0% in control group. Table 4 summarizes the mos…

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation Risk Summary There are no available data on the presence of TREGZI in human milk, the effect on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TREGZI and any potential adverse effects on the breastfed infant from TREGZI or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Pregnancy Testing Females of reproductive potential should have a pregnancy test prior to starting the conditioning regimen for TREGZI. Contraception There are insufficient exposure data to provide a recommendation concerning the duration of contraception following treatment with TREGZI. See the prescribing information of selected myeloablative regimens for recommendations on use of contraception.

Infertility There are no data on the effect of TREGZI on fertility.

8.4Pediatric Use Safety and efficacy of TREGZI in pediatric patients have not been established.

8.5Geriatric Use Although Precision-T Study did not include any patients aged 65 years and older, some patients over 65 years of age participated in other TREGZI studies using a myeloablative or reduced intensity conditioning (RIC) regimen. However, the number of patients was inadequate to allow subgroup analysis to support recommendations in the geriatric population.

🤰 Pregnancy 116 words ▾

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and efficacy of TREGZI in pediatric patients have not been established.

🧓 Geriatric Use 55 words ▾

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action TREGZI is isolated from the mobilized peripheral blood of a donor HLA-matched to the recipient, and administered after appropriate cytoreductive conditioning. TREGZI contains purified regulatory T cells (Tregs) and conventional T cells (Tcons). The exact mechanism by which Tregs exert their effects is not fully understood.

Tregs are administered prior to Tcons to control GVHD and promote immune reconstitution. Nonclinical studies have shown that Tregs suppress Tcon activation and proliferation in secondary lymphoid organs and GVHD target organs, and improve immune reconstitution without compromising graft-versus-tumor (GVT) effects of Tcons. The immunosuppressive activity of Tregs occurs through various immunoregulatory mechanisms, which help preserve immune function and decrease severity of GVHD.

Tcons are administered approximately two days later to accelerate immune reconstitution, characterized by the complete or partial restoration of peripheral blood T-cell counts. Immune reconstitution is thought to result in graft-versus-infection and graft-versus-leukemia effects. TREGZI also contains allogeneic hematopoietic stem and progenitor cells (HSPCs).

HSPCs home to the bone marrow, engraft, self-renew, proliferate, and differentiate into all mature blood cells. The mature cells are released from the bone marrow, circulate in the blood stream, and migrate to tissue sites, restoring blood counts and hematopoietic function.

12.2Pharmacodynamics No studies have been conducted to evaluate the pharmacodynamics of TREGZI.

12.3Pharmacokinetics No studies have been conducted to evaluate the pharmacokinetics of TREGZI.

🧬 Mechanism of Action 198 words ▾

📦 How Supplied / Storage and Handling ~3 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING TREGZI (NDC-85866-223-04) is provided as a single dose and intended for use by a single patient. TREGZI is provided in two transport containers: A refrigerated shipping container at 2°C to 8°C (36°F to 46°F), containing the HSPC infusion bag (NDC 85866-124-01) and Treg infusion bag (NDC 85866-125-01) in a single protective carton (NDC 85866-123-02). A cardboard box containing: 1) A liquid nitrogen dry vapor shipper at below -125°C (below -193°F) , containing the cryopreserved Tcon infusion bag (NDC 85866-126-01) in a protective metal cassette (NDC 85866-126-02).

The prescribing information is also included in the shipper. 2) A protective carton (NDC 85866-127-02) at ambient temperature (20°C to 25°C, 68°F to 77°F) containing the Tcon diluent infusion bag (NDC 85866-127-01). Table 6 TREGZI National Drug Codes (NDCs) Bag (Container) and Carton (Package) Name NDC TREGZI (all components, located on Certificate of Analysis) NDC 85866-223-04 HSPC Infusion Bag Label NDC 85866-124-01 Treg Infusion Bag Label NDC 85866-125-01 Tcon Infusion Bag Label NDC 85866-126-01 Tcon Diluent Infusion Bag Label NDC 85866-127-01 Carton for Treg and HSPC NDC 85866-123-02 Cassette Label for Tcon NDC 85866-126-02 Carton for Tcon Diluent NDC 85866-127-02 Refrigerated TREGZI HSPCs and Tregs The HSPCs and Tregs are shipped at 2°C to 8°C (36°F to 46°F).

The HSPCs and Tregs are in separate infusion bags labeled for a specific patient. The HSPC and Treg infusion bags are provided together in one protective carton, also labeled for a specific patient. The HSPCs are provided ready-to-infuse in an 150 mL infusion bag with an orange-colored label specifying "Step 1 of Administration" (NDC 85866-124-01).

The Tregs are provided ready-to-infuse in an 150 mL infusion bag with a light blue-colored label specifying "Step 2 of Administration" (NDC 85866-125-01). Match the identity of the patient with the patient-specific identifiers on the infusion bag and carton labels upon receipt. Store the Tregs and HSPCs in refrigerated storage at 2°C to 8°C (36°F to 46°F) until the time of use [see Dosage and Administration (2.2) ] .

Per institutional guidelines, Tregs and HSPCs may be kept in shipping container or moved to refrigerated storage up to the expiry time. Do not freeze. Cryopreserved TREGZI Tcons The Tcons are shipped frozen in vapor phase of liquid nitrogen at below -125°C (below -193°F).

The Tcon infusion bag is contained in an overwrap bag packed in a protective metal cassette. Both the Tcon infusion bag and cassette are labeled for a specific patient. The infusion bag label can not be observed when packaged in the protective metal cassette.

Do NOT open the Tcon metal cassette upon receipt. Only open the metal cassette immediately prior to thawing. The Tcons are provided in a 50 mL infusion bag with a dark blue-colored label specifying "Step 3a of Administration" (NDC 85866-126-01).

The Tcons must be thawed and diluted with the Tcon diluent prior to infusion (see Preparation and Administration (2.2) ] . Match the identity of the patient with the patient-specific identifiers on the cassette label upon receipt. Do NOT open the cassette.

Store the frozen Tcons in the vapor phase of liquid nitrogen (below -125°C (below -193°F)) in a temperature-controlled system or in the provided dry shipper. The Tcon label includes an expiry date and time corresponding to 7 days from the time of completion of the first apheresis collection used to manufacture the product. Immediately prior to thawing, open the cassette and match the identity of the patient with the patient-specific identifiers on the infusion bag.

Once thawed and diluted, Tcons should be administered as soon as possible but within 4 hours when stored at 2°C to 8°C (36°F to 46°F). TREGZI Tcon diluent The Tcon diluent is shipped at ambient temperature (20°C to 25°C, 68°F to 77°F). The Tcon diluent infusion bag is packaged in a protective carton.

Both the infusion bag and carton are la…

📦 Storage and Handling ~2 min read ▾

Refrigerated TREGZI HSPCs and Tregs The HSPCs and Tregs are shipped at 2°C to 8°C (36°F to 46°F). The HSPCs and Tregs are in separate infusion bags labeled for a specific patient. The HSPC and Treg infusion bags are provided together in one protective carton, also labeled for a specific patient.

The HSPCs are provided ready-to-infuse in an 150 mL infusion bag with an orange-colored label specifying "Step 1 of Administration" (NDC 85866-124-01). The Tregs are provided ready-to-infuse in an 150 mL infusion bag with a light blue-colored label specifying "Step 2 of Administration" (NDC 85866-125-01). Match the identity of the patient with the patient-specific identifiers on the infusion bag and carton labels upon receipt.

Store the Tregs and HSPCs in refrigerated storage at 2°C to 8°C (36°F to 46°F) until the time of use [see Dosage and Administration (2.2) ] . Per institutional guidelines, Tregs and HSPCs may be kept in shipping container or moved to refrigerated storage up to the expiry time. Do not freeze.

Cryopreserved TREGZI Tcons The Tcons are shipped frozen in vapor phase of liquid nitrogen at below -125°C (below -193°F). The Tcon infusion bag is contained in an overwrap bag packed in a protective metal cassette. Both the Tcon infusion bag and cassette are labeled for a specific patient.

The infusion bag label can not be observed when packaged in the protective metal cassette. Do NOT open the Tcon metal cassette upon receipt. Only open the metal cassette immediately prior to thawing.

The Tcons are provided in a 50 mL infusion bag with a dark blue-colored label specifying "Step 3a of Administration" (NDC 85866-126-01). The Tcons must be thawed and diluted with the Tcon diluent prior to infusion (see Preparation and Administration (2.2) ] . Match the identity of the patient with the patient-specific identifiers on the cassette label upon receipt.

Do NOT open the cassette. Store the frozen Tcons in the vapor phase of liquid nitrogen (below -125°C (below -193°F)) in a temperature-controlled system or in the provided dry shipper. The Tcon label includes an expiry date and time corresponding to 7 days from the time of completion of the first apheresis collection used to manufacture the product.

Immediately prior to thawing, open the cassette and match the identity of the patient with the patient-specific identifiers on the infusion bag. Once thawed and diluted, Tcons should be administered as soon as possible but within 4 hours when stored at 2°C to 8°C (36°F to 46°F). TREGZI Tcon diluent The Tcon diluent is shipped at ambient temperature (20°C to 25°C, 68°F to 77°F).

The Tcon diluent infusion bag is packaged in a protective carton. Both the infusion bag and carton are labeled for a specific patient. Do NOT directly infuse the Tcon diluent into the patient.

The Tcon diluent is provided in an 50 mL infusion bag with a tan label specifying "Step 3b of Administration" (NDC 85866-127-01). Store the Tcon diluent at room temperature (18°C to 25°C, 64°F to 77°F). Add the Tcon diluent to the Tcon infusion bag prior to infusion (see Preparation and Administration (2.2) ] .

Refrigerate the Tcon diluent at 2°C to 8°C (36°F to 46°F) for 30 minutes prior to use.

📋 Description ~2 min read ▾

11 DESCRIPTION TREGZI (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) is an allogeneic hematopoietic stem cell and T-cell immunotherapy isolated from the mobilized peripheral blood of an 8/8 HLA-matched related or unrelated donor and is donor- and recipient-specific. TREGZI is composed of individual cell suspensions for intravenous infusion of 1) purified hematopoietic stem and progenitor cells (HSPCs), 2) regulatory T cells (Tregs), and 3) conventional T cells (Tcons). In addition, 4) a chemically defined diluent is provided to dilute the Tcons before infusion.

HSPCs (CD34+ cells) are formulated in approximately 100 mL of Multiple Electrolytes Injection (MEI), Type 1 and 2% (w/v) human serum albumin (HSA) and filled into an infusion bag. In addition to the HSPCs cells, other cell populations present may include lymphocytes, erythrocytes, and platelets. The HSPCs contain less than 50 × 10 3 T cells per kg.

The cell suspension appears off-white, white, yellow, orange, to red in color. The HSPC infusion bag is supplied in a carton with the Treg infusion bag. Tregs (CD4+CD25+CD127-/low cells) are formulated in approximately 100 mL of MEI, Type 1 and 2% (w/v) HSA and filled into an infusion bag.

In addition to the Tregs, other cell populations present may include T cells, NK cells, B cells, monocytes, granulocytes, and erythrocytes. The cell suspension appears off-white, white, yellow, orange, to red in color. The HSPC infusion bag is supplied in a carton with the Treg infusion bag.

Tcons (CD3+ cells) are formulated in approximately 15 mL of MEI, 3% to 4% (w/v) HSA, 7.5% DMSO, and Hetastarch (6% hetastarch in 0.9% sodium chloride injection added at 30.5% (v/v)), filled into an infusion bag, cryopreserved in a protective metal cassette. In addition to T cells, other cell populations present may include HSPCs, erythrocytes, and other lymphocytes. The cell suspension appears off-white, white, yellow, orange, to red in color.

The Tcon diluent contains approximately 38 mL of MEI and 2% (w/v) HSA and is filled into an infusion bag. The Tcon diluent appears colorless to yellow. The Tcon diluent is completely transferred to the Tcon infusion bag prior to Tcon infusion [see Preparation and Administration (2.2) ] .

The HSPC, Treg and Tcon suspensions must pass a rapid microbial detection test prior to administration. Complete sterility test results are available approximately 14-days post-administration. The Tcon diluent must pass a sterility test before release for shipment.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Discuss the following with the patient receiving TREGZI. Each TREGZI unit is specific to each patient. The course of therapy for TREGZI is three cell components for infusion, which is provided by the manufacturer as 4 separate infusion bags comprising the HSPCs, Tregs, Tcons, and Tcon diluent.

Two infusions, HSPCs and Tregs, will take place on day 0 and one infusion, Tcons, on day +2 to +3 (after the start of HSPC infusion on day 0). Prior to treatment, advise patients of the following: Graft Failure Advise patients that primary graft failure, which may be fatal, can occur [see Warnings and Precautions (5.1) ] . Graft-Versus-Host Disease Treat patients with a single agent calcineurin inhibitor as prophylaxis to decrease the risk of GVHD.

Monitor for signs and symptoms of GVHD, and treat if GVHD develops. Report immediately any signs and symptoms suggestive of GVHD, including rash, joint pain, diarrhea, or yellowing of the eyes [see Warnings and Precautions (5.2) ]. Infusion Reactions Report immediately any signs and symptoms of Infusion reactions that occur within 24 hours of infusion of TREGZI including fever, chills, flushing, fatigue, shortness of breath, and dizziness/lightheadedness [see Warnings and Precautions (5.3) ] .

Secondary Malignancies and Malignancies of Donor Origin Advise patients of the need to contact Orca Bio at 1-877-290-6722 if they are diagnosed with a secondary malignancy or malignancies of donor origin after treatment with TREGZI [see Warnings and Precautions (5.4) . Transmission of Infectious Agents Advise patients of the risk of transmission of infectious disease [see Warnings and Precautions (5.5)] . Manufactured by: Orca Biosystems, Inc.

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Glossary — plain-language definitions of medical terms used in this label:

immunosuppressive: Describes something that lowers the activity of the immune system.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diarrhea: Loose, watery bowel movements that happen more often than normal.

diluent: The liquid used to dissolve or thin a medicine before it is given.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dosage form: The physical form a medicine comes in, such as a tablet, capsule, liquid, patch, or injection.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

encephalopathy: Any condition that affects how the brain works, causing confusion, memory problems, or changes in alertness.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

maculopapular rash: A common rash made up of flat red patches mixed with small raised bumps.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

mucositis: Painful swelling and sores in the moist lining of the mouth, throat, or digestive tract.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutrophil: A type of white blood cell that is one of the body's main defenders against infection.

pathogen: Any germ, such as a bacterium, virus, or fungus, that can cause disease.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

pyrexia: A raised body temperature; a fever.

reconstitution: Mixing a powdered medicine with a liquid to prepare it for use, following the label's directions.

relapse: The return of a cancer after a period of improvement or disappearance.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

secondary malignancy: A new, different cancer that develops later, sometimes following earlier treatment.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

subgroup analysis: A closer look at results within a smaller part of a study, such as one age or sex, to see if the effect differs.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

TREGZI allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq Kit

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