Rethymic allogenic thymocyte-depleted thymus tissue-agdc 22000 mm Implant, 44-count — NDC 72359-001-01 (Billing 72359-0001-01)
This is a package of 44 implants of Rethymic allogenic thymocyte-depleted thymus tissue-agdc 22000 mm Implant from Sumitomo Pharma America, Inc., marketed since Oct 2021 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 72359-001-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72359 labeler · 001 product · 01 package
- Package marketed since
- Oct 8, 2021
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 44 EA per package
- Barcode (UPC)
- 0372359001015
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 082776
- GCN: 51395
- GPI-14 (Medi-Span): 99040010002320
- HICL (First Databank): 047641
- AHFS class code: 26:04.00.00
- RxCUI (RxNorm): 2626464
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 6, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72359-0001-01 You're viewing this Main listing | 11 CONTAINER in 1 BOX / 4 IMPLANT in 1 CONTAINER | 2021-10-08 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rethymic 22000 mmthis 72359-0001-01 | Sumitomo | 44 implants | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Oct 8, 2033 |
Is there a biosimilar for RETHYMIC IMPLANT?
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What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII AAJ75C5376
A sponge made from gelatin derived from animal collagen that absorbs and holds liquid. In medicines, it acts as a carrier or base that helps deliver active ingredients and can be absorbed by the body after use.
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UNII K5DD3J879P
Bovine fetal serum is a protein-rich liquid derived from calf blood. It's used in pharmaceutical manufacturing as a growth medium component during drug development and vaccine production to support cell growth in laboratory processes.
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UNII 5LY4MF66UZ
Gelatin is a protein derived from porcine skin that has been treated with formalin. It's commonly used as a capsule material to hold medicine, and also functions as a binder and gelling agent in various formulations.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE RETHYMIC ® is indicated for immune reconstitution in pediatric patients with congenital athymia. RETHYMIC is indicated for immune reconstitution in pediatric patients with congenital athymia. ( 1 ) Limitations of Use : RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).
Limitations of Use RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION RETHYMIC is administered by a surgical procedure. The recommended dose range is 5,000 to 22,000 mm 2 of RETHYMIC/m 2 recipient body surface area (BSA). (2) Immunosuppressive therapy is recommended for patients receiving RETHYMIC based on disease phenotype and PHA levels. ( 14 )
2.1Dosage RETHYMIC is administered by a surgical procedure. The dosage is determined by the total surface area of the RETHYMIC slices and recipient body surface area (BSA). A RETHYMIC slice is defined as the contents on a single filter membrane; the RETHYMIC slices are variable in size and shape.
The recommended dose range is 5,000 to 22,000 mm 2 of RETHYMIC surface area/m 2 recipient BSA. The manufacturer calculates the dose in advance for the specific patient; the amount of product provided is adjusted at the manufacturing facility to ensure the maximum dose for the patient cannot be exceeded. Up to 42 cultured RETHYMIC slices will be provided for each patient.
At the time of surgery, the manufacturing personnel communicate to the surgical team the portion of the product that represents the minimum dose. Patients with evidence of maternal engraftment or an elevated response to phytohemagglutinin (PHA) should receive RETHYMIC with immunosuppressive medications (Table 2).
2.2Administration Instructions Surgical implantation of RETHYMIC should be done by a qualified surgical team in a single surgical session at a qualified hospital. RETHYMIC should be implanted in the quadriceps muscle in accordance with the instructions provided below. Implantation of RETHYMIC into the quadriceps requires a healthy bed of muscle tissue.
Preparation for the Implantation Procedure: Operating room culture dishes (sterile 100 mm tissue culture dishes) and saline for injection are supplied by the operating room; a sufficient supply of operating room culture dishes and saline must be provided by the hospital for use in the implantation procedure. The product is delivered to the operating room by manufacturing personnel. The recommended dose is determined based on the patient's BSA.
The manufacturer calculates the dose in advance for the specific patient. Manufacturing personnel and the operating room staff confirm that the lot delivered is for the intended recipient. Manufacturing personnel communicate to the surgical team the minimum number of RETHYMIC slices to be implanted to achieve the minimum dose.
The product expiration date and time for the entire lot is labeled on each polystyrene dish (drug product dish). Always handle RETHYMIC slices aseptically. Do not use if there is evidence of contamination.
Outside the sterile field, manufacturing personnel unpack RETHYMIC from the shipping box. One drug product dish at a time is removed from the drug product box and shipping box. Manufacturing personnel inspect the drug product box and each drug product dish for signs of contamination, damage, spills, or leakage.
If damage to the drug product dishes, leaks, spillage or evidence of contamination is noted, manufacturing personnel will notify the surgical team that the lot cannot be implanted. When the surgical team is ready, manufacturing personnel and surgical staff begin the transfer of drug product to the sterile operative field. Manufacturing personnel carry one drug product dish, which contains up to 4 RETHYMIC slices on up to 2 surgical sponges, with each RETHYMIC slice on a filter membrane, to the surgical staff near the sterile field.
Manufacturing personnel open the drug product dish to expose the RETHYMIC slices. The surgical staff team member uses a pair of forceps to remove individual RETHYMIC slices with their filter membranes from the drug product dish (Figure 1). The surgical team member places each RETHYMIC slice with its filter membrane into a sterile 100 mm tissue culture dish ("operating room culture dish") containing approximately 2 mL preservative-free saline that resides in the sterile field on the instrument table.
This is re… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS RETHYMIC consists of yellow to brown slices of processed thymus tissue with varying thickness and shape. Each drug product dish contains up to 4 RETHYMIC slices that adhere to circular filter membranes on top of surgical sponges in 5 mL of medium. The RETHYMIC slices are variable in size and shape; a RETHYMIC slice is defined as the contents of a single filter membrane.
The dosage is based on the total surface area of the RETHYMIC slices, and the amount administered is calculated based on recipient BSA. The surgeon should implant as many RETHYMIC slices as possible within the recommended dose range of 5,000 to 22,000 mm 2 of RETHYMIC/m 2 recipient BSA. The manufacturer calculates the dose in advance for the specific patient; the amount of product provided is adjusted at the manufacturing facility to ensure the maximum dose for the patient cannot be exceeded.
Up to 42 RETHYMIC slices will be provided for each patient. At the time of surgery, the manufacturing personnel will inform the surgical team of the portion of the product that represents the minimum dose. RETHYMIC consists of yellow to brown slices of processed tissue with varying thickness and shape.
The dosage is determined by the surface area of the RETHYMIC slices and recipient BSA. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Immune reconstitution sufficient to protect from infection is unlikely to develop prior to 6 to 12 months after treatment with RETHYMIC. Given the immunocompromised condition of athymic patients, infection control measures should be followed until the development of thymic function can be established. ( 5.1 ) Monitor and treat patients at risk for the development of graft versus host disease (GVHD).
( 5.2 ) Monitor for the development of autoimmune disorders, including complete blood counts with differential, liver enzymes, serum creatinine, urinalysis, and thyroid function. ( 5.3 ) Pre-existing renal impairment is a risk factor for death. ( 5.4 ) Pre-existing cytomegalovirus infection may result in death prior to the development of thymic function.
( 5.5 ) Monitor for the development of lymphoproliferative disorder (blood cancer). ( 5.6 ) Transmission of infectious diseases may occur because RETHYMIC is derived from human tissue. ( 5.7 ) Immunizations should not be administered in patients who have received RETHYMIC until immune-function criteria have been met.
( 5.8 ) Patients should be tested for anti-HLA antibodies prior to treatment. ( 5.9 )
5.1Infection Control and Immunoprophylaxis Immune reconstitution sufficient to protect from infection is unlikely to develop prior to 6-12 months after treatment with RETHYMIC. Given the immunocompromised condition of athymic patients, follow infection control measures until the development of thymic function is established as measured through flow cytometry. This should include counseling patients and their caregivers on good handwashing practices and minimizing exposure to visitors.
Monitor patients closely for signs of infection, including fever. If a fever develops, assess the patient by blood and other cultures and treat with antimicrobials as clinically indicated. Patients should be maintained on immunoglobulin replacement therapy until all of the following criteria are met: No longer on immunosuppression (at least 10% of CD3 + T cells are naïve in phenotype).
At least 9 months post-treatment. Phytohemagglutinin (PHA) response within normal limits. Normal serum IgA is also desirable but not required.
Two months after stopping immunoglobulin replacement therapy, the IgG trough level should be checked. If the IgG trough level is in the normal range for age, the patient can remain off of immunoglobulin replacement. If the IgG trough level is lower than the normal range for age, immunoglobulin replacement therapy should be restarted and continued for a year before being retested using the above guidelines.
Prior to and after treatment with RETHYMIC, patients should be maintained on Pneumocystis jiroveci pneumonia prophylaxis until all of the following criteria are met: No longer on immunosuppression (at least 10% of CD3+ T cells are naïve in phenotype). At least 9 months post-treatment. PHA response within normal limits.
CD4+ T cell count > 200 cells/mm 3 .
5.2Graft versus Host Disease In clinical studies with RETHYMIC, GVHD occurred in 11 (10%) RETHYMIC-treated patients of whom 6 (55%) died. RETHYMIC may cause or exacerbate pre-existing GVHD. Seven patients (7%) experienced autologous GVHD, 3 patients (3%) experienced GVHD due to maternal cells and 1 patient (1%) experienced GVHD due to cells from a prior hematopoietic cell transplant (HCT).
Risk factors for GVHD include atypical complete DiGeorge anomaly phenotype, prior HCT and maternal engraftment. GVHD may manifest as fever, rash, lymphadenopathy, elevated bilirubin and liver enzymes, enteritis, and/or diarrhea. Patients with elevated baseline T cell proliferative response to PHA > 5,000 cpm or > 20-fold over background should receive immunosuppressive therapies to decrease the risk of GVHD (Table 2 and Table 3).
Development of GVHD symptoms should be closely monitored and promptly treated.
5.3Autoimmune Disorders Thirty-seven patients (35%) in the RETHYMIC clinical program experienced autoimmune-r… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (incidence in at least 10% of patients) reported following administration of RETHYMIC were hypertension (high blood pressure), cytokine release syndrome, rash, hypomagnesemia (low magnesium), renal impairment / failure (decrease of kidney function), thrombocytopenia (low platelets), and graft versus host disease. The most common (>10%) adverse events related to RETHYMIC included: hypertension (high blood pressure, 19%), cytokine release syndrome (18%), rash (15%), hypomagnesemia (low magnesium, 16%), renal impairment / failure (decrease of kidney function, 12%), thrombocytopenia (low platelets, 12%), and graft versus host disease, (10%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sumitomo Pharma America at 833-369-9868 or FDA at 1-800-FDA-1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
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 are derived from 10 prospective, single-center, open-label studies, and include 105 patients who were treated with RETHYMIC in these studies and who had at least one year of follow-up.
Table 1 lists the adverse reactions occurring in 105 patients who were treated with RETHYMIC in these studies. Table 1: Adverse Reactions Occurring in at least 5% of Patients Treated with RETHYMIC During Clinical Studies System Organ Class Preferred Term RETHYMIC (N=105) n (%) Number of Patients with Adverse Reactions Reactions which occurred in the 2 years after treatment. 80 (76) Hypertension (high blood pressure) 20 (19) Cytokine release syndrome All events (19/19) of cytokine release syndrome occurred in association with ATG-R treatment.
19 (18) Hypomagnesemia (low magnesium) 17 (16) Rash Rash includes rash, granuloma skin, rash papular, urticaria. 16 (15) Renal impairment / failure Renal impairment / failure includes renal failure and acute kidney injury, proteinuria and blood creatinine increased. (decrease of kidney function) 13 (12) Thrombocytopenia Thrombocytopenia includes thrombocytopenia and Immune thrombocytopenic purpura.
(low platelets) 13 (12) Graft versus host disease GVHD includes GVHD, GVHD-gut, GVHD-skin, Omenn syndrome. 11 (10) Hemolytic anemia Hemolytic anemia includes autoimmune hemolytic anemia, Coombs-positive hemolytic anemia, hemolysis, hemolytic anemia. (low red bloods cells) 9 (9) Neutropenia (low white blood cells) 9 (9) Respiratory distress Respiratory distress includes respiratory distress, hypoxia, respiratory failure.
(difficulty breathing) 8 (8) Proteinuria (protein in urine) 7 (7) Pyrexia (fever) 6 (6) Acidosis Acidosis includes acidosis, renal tubular acidosis and blood bicarbonate decreased. 6 (6) Diarrhea Diarrhea includes diarrhea and hemorrhagic diarrhea. 5 (5) Seizure Seizures include infantile spasms, seizures and febrile convulsion.
5 (5) Of the 105 patients, 29 patients died after receiving RETHYMIC, including 23 deaths in the first year (<365 days) after treatment with RETHYMIC. Causes of death in the first year included 13 deaths due to infection or complications due to infection, 5 deaths due to respiratory failure / hypoxia, 3 deaths due to hemorrhage-related events, and 2 deaths due to cardiorespiratory arrest. Of the 6 patients who died more than 1 year after treatment with RETHYMIC, the deaths were considered unrelated to study treatment: 2 died due to respiratory failure and 1 died due to each of the following: cardiopulmonary arrest, intracranial hemorrhage, infection, and unknown cause.
Severe combined immunodeficiency (SCID) Patients Two patients with SCID were treated in the RETHYMIC clinical program. One patient died two years after receiving RETHYMIC, and… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug interaction studies have been conducted with RETHYMIC. If possible, prolonged use of immunosuppressive therapies, including high-dose corticosteroids, should be avoided.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no clinical data with RETHYMIC in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with RETHYMIC. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
8.2Lactation Risk Summary There is no information regarding the presence of cellular components of RETHYMIC in human milk, the effect breastfeeding may have on RETHYMIC, the effect of being breastfed from a mother who received RETHYMIC as a child, or the effects of RETHYMIC on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for RETHYMIC and potential adverse effects on the breastfed infant from RETHYMIC.
8.3Females and Males of Reproductive Potential No nonclinical or clinical studies were performed to evaluate the effects of RETHYMIC on fertility.
8.4Pediatric Use The efficacy and safety of RETHYMIC have been established in pediatric patients with congenital athymia. The efficacy of RETHYMIC has been established in 95 pediatric patients (median age 9 months [range: 33 days to 3 years], including 65 patients age <1 year, 24 patients age 1 to <2 years, and 6 patients age 2 to <3 years at time of treatment) who were treated with RETHYMIC and included in the analysis of efficacy [ see Clinical Studies (14) ]. The safety of RETHYMIC has been established in 105 pediatric patients (median age 9 months [range: 33 days to 16.9 years] at time of treatment) with congenital athymia who were evaluated for safety following RETHYMIC administration.
The safety population included 65 patients age <1 year, 27 patients age 1 to <2 years, 9 patients age 2 to <3 years, 1 patient age 3 to <6 years, and 3 patients age 13 to 17 years at time of treatment. Within the safety population, survival was similar across age groups. Adverse reactions were reported at similar frequencies across the age groups and were generally of similar types and severities.
8.6Renal Impairment In the clinical studies with RETHYMIC, 10 of 105 patients had impaired renal function at baseline based on elevated screening creatinine [see Warnings and Precautions (5.4) ] . Baseline renal function should be considered when selecting immunosuppressants. Ensure appropriate involvement of a nephrologist in care of patients with renal impairment.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no clinical data with RETHYMIC in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with RETHYMIC. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The efficacy and safety of RETHYMIC have been established in pediatric patients with congenital athymia. The efficacy of RETHYMIC has been established in 95 pediatric patients (median age 9 months [range: 33 days to 3 years], including 65 patients age <1 year, 24 patients age 1 to <2 years, and 6 patients age 2 to <3 years at time of treatment) who were treated with RETHYMIC and included in the analysis of efficacy [ see Clinical Studies (14) ]. The safety of RETHYMIC has been established in 105 pediatric patients (median age 9 months [range: 33 days to 16.9 years] at time of treatment) with congenital athymia who were evaluated for safety following RETHYMIC administration.
The safety population included 65 patients age <1 year, 27 patients age 1 to <2 years, 9 patients age 2 to <3 years, 1 patient age 3 to <6 years, and 3 patients age 13 to 17 years at time of treatment. Within the safety population, survival was similar across age groups. Adverse reactions were reported at similar frequencies across the age groups and were generally of similar types and severities.
🆘 Overdosage ▾
10 OVERDOSAGE The maximum recommended dose is 22,000 mm 2 of RETHYMIC/m 2 recipient body surface area (BSA). Standard clinical care is recommended for patients receiving a dose > 22,000 mm 2 of RETHYMIC/m 2 recipient BSA. The product, as provided, has been adjusted at the manufacturing facility to not exceed the maximum dose based on the patient body surface area.
During clinical development one patient received a dose higher (23,755 mm 2 /m 2 ) than the maximum recommended dose. This patient developed enteritis. A biopsy showed T cell, B cell, and neutrophil infiltration of the gut which resolved after treatment with immunosuppression, 5 months after treatment with RETHYMIC.
The enteritis may have been related to the high dose of RETHYMIC.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action RETHYMIC is intended to reconstitute immunity in patients who are athymic. The proposed mechanism of action involves the migration of recipient T cell progenitors from the bone marrow to the implanted RETHYMIC slices, where they develop into naïve immunocompetent recipient T cells. Evidence of thymic function can be observed with the development of naïve T cells in the peripheral blood; this is unlikely to be observed prior to 6-12 months after treatment with RETHYMIC.
12.2Pharmacodynamics The pharmacodynamic effects of RETHYMIC are not known.
12.3Pharmacokinetics The pharmacokinetic effects of RETHYMIC are not known.
🧬 Mechanism of Action ▾
12.1Mechanism of Action RETHYMIC is intended to reconstitute immunity in patients who are athymic. The proposed mechanism of action involves the migration of recipient T cell progenitors from the bone marrow to the implanted RETHYMIC slices, where they develop into naïve immunocompetent recipient T cells. Evidence of thymic function can be observed with the development of naïve T cells in the peripheral blood; this is unlikely to be observed prior to 6-12 months after treatment with RETHYMIC.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied RETHYMIC, NDC 72359-001-01, contains a single-dose unit, supplied ready for use as slices of processed thymus tissue, in sterile, polystyrene dishes (drug product dishes). Each drug product dish contains up to 4 RETHYMIC slices, adhered to circular filter membranes on top of surgical sponges in 5 mL of medium containing fetal bovine serum. Up to 42 RETHYMIC slices are supplied in a single-dose unit according to the dosage calculated in advance by the manufacturer for the specific patient.
The dosage is determined by the total surface area of the RETHYMIC slices and recipient body surface area (BSA). The recommended dose range is 5,000 to 22,000 mm 2 of RETHYMIC surface area/m 2 recipient BSA. At the time of surgery, the manufacturing personnel communicate to the surgical team the portion of the product that represents the minimum dose.
All drug product dishes are supplied in a polycarbonate container in an insulated shipping box. Storage and Handling Use RETHYMIC prior to the time and date of expiration printed on the polycarbonate container. Store RETHYMIC at room temperature in the polycarbonate container in the insulated shipping box until ready for use.
Do not refrigerate, freeze, agitate, or sterilize RETHYMIC. In the operating room, manufacturing personnel inspect the drug product containers as they are removed from the shipping box. If damage to the drug product dishes, leaks, spillage or evidence of contamination is noted, manufacturing personnel will notify the surgical team that the lot cannot be implanted.
Match the patient's identity with the patient identifiers on the patient label on the polycarbonate container. Do not remove the drug product containers from the polycarbonate container if the information on the patient label does not match the intended patient. Manufacturing personnel record which RETHYMIC slices are used during the surgery.
If any RETHYMIC slices are not administered to the patient, manufacturing personnel return this tissue to the manufacturing facility and dispose of this tissue as biohazardous waste in accordance with local requirements. Manufacturing personnel calculate the total dose that was administered to the patient.
📦 Storage and Handling ▾
Storage and Handling Use RETHYMIC prior to the time and date of expiration printed on the polycarbonate container. Store RETHYMIC at room temperature in the polycarbonate container in the insulated shipping box until ready for use. Do not refrigerate, freeze, agitate, or sterilize RETHYMIC.
In the operating room, manufacturing personnel inspect the drug product containers as they are removed from the shipping box. If damage to the drug product dishes, leaks, spillage or evidence of contamination is noted, manufacturing personnel will notify the surgical team that the lot cannot be implanted. Match the patient's identity with the patient identifiers on the patient label on the polycarbonate container.
Do not remove the drug product containers from the polycarbonate container if the information on the patient label does not match the intended patient. Manufacturing personnel record which RETHYMIC slices are used during the surgery. If any RETHYMIC slices are not administered to the patient, manufacturing personnel return this tissue to the manufacturing facility and dispose of this tissue as biohazardous waste in accordance with local requirements.
Manufacturing personnel calculate the total dose that was administered to the patient.
📋 Description ▾
11 DESCRIPTION RETHYMIC consists of yellow to brown slices of allogeneic processed thymus tissue for administration by surgical implantation. Three to 11 drug product containers, with a total of 10 to 42 RETHYMIC slices, are provided for each patient. Each drug product container provides up to 4 RETHYMIC slices of variable size.
The total dose, based on the number of slices administered to the patient, is 5,000 to 22,000 mm 2 of RETHYMIC/m 2 recipient BSA. Thymus tissue is obtained from donors less than or equal to 9 months of age undergoing cardiac surgery. This thymus tissue is aseptically processed and cultured for 12 to 21 days to produce RETHYMIC slices.
Each product lot is manufactured from a single unrelated donor and one product lot treats a single patient. The manufacturing process preserves the thymic epithelial cells and tissue structure and depletes most of the donor thymocytes from the tissue. These RETHYMIC slices are then surgically implanted into patients with congenital athymia.
The product manufacture uses reagents derived from animal materials. The surgical sponge used during culturing is porcine-derived. Fetal bovine serum is a component in the culture medium used to culture the thymus slices and RETHYMIC is formulated in media that is supplemented with fetal bovine serum.
Therefore, bovine- and porcine-derived proteins will be present in RETHYMIC. These animal-derived reagents are tested for animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma before use.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients and/or their caregivers that: Immune reconstitution sufficient to protect from infection usually develops between 6-12 months after treatment with RETHYMIC, but for some patients elevated naïve T cell numbers are not observed until 2 years after treatment. Strict infection control measures should be observed until the healthcare provider confirms that immune function has been reconstituted through the evaluation of blood using flow cytometry and the criteria for the discontinuation of immunoglobulin replacement therapy and Pneumocystis jiroveci pneumonia prophylaxis have been met.
Patients and caregivers should follow good handwashing practices, minimize contact with others, and immediately report signs and symptoms of infection to their healthcare provider [see Warnings and Precautions (5.1) ]. Congenital athymia alters the immune response to vaccines. Instruct patients and/or their caregivers to notify their healthcare professional to evaluate the immune status of RETHYMIC recipients prior to receiving vaccinations [see Warnings and Precautions (5.8) ].
Immunosuppression should be administered in patients with elevated T cell response, maternal engraftment, or oligoclonal T cell expansion and autoreactive T cells manifested by rash, lymphadenopathy and/or diarrhea. Inform patients and/or their caregivers on risks associated with short-term and long-term use of immunosuppression and refer them to review the risks of the specific immunosuppressants prescribed with their physician. Congenital athymia is associated with a wide spectrum of genetic anomalies.
Instruct patients and/or their caregiver to consult with a clinical geneticist prior to receiving RETHYMIC. Advise patients and/or their caregivers of the following risks : Graft versus Host Disease [see Warnings and Precautions (5.2) ] Autoimmune Disorders (patient's immune (defense) system mistakenly attacks patient's body) [see Warnings and Precautions (5.3) ] Renal Impairment (decrease of kidney function) [see Warnings and Precautions (5.4) ] Cytomegalovirus Infection [see Warnings and Precautions (5.5) ] Malignancy ( Cancer) [see Warnings and Precautions (5.6) ] Transmission of Serious Infections and Transmissible Infectious Diseases [see Warnings and Precautions (5.7) ]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetic effects of RETHYMIC are not known.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics The pharmacodynamic effects of RETHYMIC are not known.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The efficacy of RETHYMIC was evaluated in 10 prospective, single-center, open-label studies that enrolled a total of 105 patients, including 95 patients in the primary efficacy analysis. The demographics and baseline characteristics of the patients enrolled in the clinical studies were similar across studies. Across the efficacy population, 59% were male; 70% were White, 22% were Black, 4% were Asian/Pacific Islander; 2% were American Indian/Alaskan Native; and 2% were multi-race.
The median (range) age at the time of treatment was 9 months (1-36). The diagnosis of congenital athymia was based on flow cytometry documenting fewer than 50 naïve T cells/mm 3 (CD45RA + , CD62L + ) in the peripheral blood or less than 5% of total T cells being naïve in phenotype in 91/95 patients (range 0-98 naïve T cells/mm 3 ). In addition to congenital athymia, patients also had complete DiGeorge syndrome (cDGS; also referred to as complete DiGeorge anomaly (cDGA)) if they also met at least one of the following criteria: congenital heart defect, hypoparathyroidism (or hypocalcemia requiring calcium replacement), 22q11 hemizygosity, 10p13 hemizygosity, CHARGE (coloboma, heart defect, choanal atresia, growth and development retardation, genital hypoplasia, ear defects including deafness) syndrome, or CHD7 mutation.
Across the efficacy population, 93 patients (98%) were diagnosed with cDGS, and the most common DiGeorge gene mutations or syndromic associations were Chromosome 22q11.2 deletion (36 patients; 38%) and CHARGE syndrome (23 patients; 24%). There were 35 patients with missing or no identified genetic mutations. Two (2%) patients had FOXN1 deficiency, and 1 patient (1%) had a TBX variant.
There were 50 (53%) patients with typical cDGS; these patients had congenital athymia with the absence of a T cell-related rash. There were 42 (44%) patients diagnosed with atypical cDGS; these patients may have had a rash, lymphadenopathy, or oligoclonal T cells. Patients who did not have congenital athymia (e.g.
SCID) and patients with prior transplants, including thymus and HCT, were excluded from the efficacy analysis population. The baseline demographics and disease characteristics were similar in the safety population. Patients with heart surgery anticipated within 4 weeks prior to, or 3 months after, the planned RETHYMIC treatment date, patients with human immunodeficiency virus (HIV) infection, and patients who were not considered good surgical candidates were excluded from study participation.
Patients in the efficacy population received RETHYMIC in a single surgical procedure at a dose of 4,900 to 24,000 mm 2 of RETHYMIC / recipient BSA in m 2 . Patients were assigned to receive immunosuppressive therapy prior to and/or after treatment according to their disease phenotype and pre-RETHYMIC PHA response. Table 2 summarizes the criteria used to administer immunosuppression.
Table 3 summarizes the specific immunosuppressant dosing used in RETHYMIC clinical studies. No patients were retreated with RETHYMIC. Table 2: Summary of Treatment Assignment to Immunosuppression During Clinical Studies Complete DiGeorge Anomaly Phenotype Phytohemagglutinin (PHA) Response Values for PHA response are reported from Duke University Medical Center and may not be comparable to values reported at other clinical laboratories.
A patient background value (cells without stimulus) of less than 5,000 cpm was required to consider PHA test results valid. A normal control value of > 75,000 cpm was also required during clinical studies. Immunosuppression Used During Clinical Studies with RETHYMIC Abbreviations: ATG-R: anti-thymocyte globulin [rabbit] (Thymoglobulin); cpm: counts per minute; MMF: mycophenylate mofetil; PHA: phytohemagglutinin Typical < 5,000 cpm or < 20-fold response to PHA over background None Typical ≥ 5,000 cpm and < 50,000 cpm or Evidence of maternal engraftment ATG-R Methylprednisolone Typical ≥ 50,000 cpm ATG-R Methylprednisolone Cyclosp… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 22,000 mm Container Label NDC 72359–001–02 allogeneic processed thymus tissue–agdc RETHYMIC Dosage for entire lot is 5000 – 22,000 mm^2 RETHYMIC /m^2 recipient body surface area. Handle aseptically. Do not agitate or sterilize.
Formulated in media that is supplemented with fetal bovine serum. Preservative Free. Store at room temperature.
Do not freeze or refrigerate. Lot # GMP–423 Container 1 of 11 Expiration: 13JUN2023 Contains up to 4 slices of RETHYMIC adhered to filter membranes on top of surgical sponges in 5 mL of media. For intended recipient only.
Rx Only. For administration by surgical implantation. See package insert for full prescribing information and instructions for administration.
Manufactured for Sumitomo Pharma America, Inc. Marlborough, MA 01752 Telephone: 1–833–369–9868 Lic. #: 2368 PRINCIPAL DISPLAY PANEL - 22,000 mm Container Label
PRINCIPAL DISPLAY PANEL - 22,000 mm Container Box Label NDC 72359–001–01 allogeneic processed thymus tissue–agdc RETHYMIC Dosage for entire lot is 5000 – 22,000 mm^2 RETHYMIC /m^2 recipient body surface area. This entire lot contains 22,000 mm^2 RETHYMIC. Formulated in media that is supplemented with fetal bovine serum.
Preservative free. Handle aseptically. Do not agitate or sterilize.
Store at room temperature. Do not freeze or refrigerate. Lot # GMP–423 Expiration: 13JUN2023 Manufactured for Sumitomo Pharma America, Inc.
Marlborough, MA 01752 Telephone: 1–833–369–9868 Lic. #: 2368 PRINCIPAL DISPLAY PANEL - 22,000 mm Container Box Label
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