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Thymoglobulin Anti-thymocyte Globulin (Rabbit) 5 mg/mL Injection, Powder, Lyophilized, For Solution — NDC 58468-0080-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Thymoglobulin Anti-thymocyte Globulin (Rabbit) 5 mg/mL Injection, Powder, Lyophilized, For Solution — NDC 58468-0080-1 (Billing 58468-0080-01)

by Genzyme Corporation · 1 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS

This is a package of Thymoglobulin Anti-thymocyte Globulin (Rabbit) 5 mg/mL Injection, Powder, Lyophilized, For Solution from Genzyme Corporation, marketed since Dec 1998 and currently FDA-listed. It is this product's only package size.

NDC 58468-0080-01
🏷️ FDA NDC (as labeled) 58468-0080-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

NDC database record

One package, one record: these facts belong to NDC 58468-0080-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
58468 labeler · 0080 product · 1 package
Package marketed since
Dec 30, 1998
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5846800801 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58468-0080-1
Product NDC 58468-0080
11-digit billing NDC 58468008001
NCPDP billing unit EA — each (per item)
RxCUI 107047, 107050
UNII D7RD81HE4W
Application # BLA103869
SPL Set ID bbd8ab99-552e-4b81-aca4-6b0c7af8b9ae
Established class (EPC) Immunoglobulin G
Mechanism of action Antibody-Surface Protein Interactions
Physiologic effect Lymphocyte Function Alteration; Increased T Lymphocyte Destruction
Chemical class Immunoglobulins
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1998-12-30
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 99402540302120
GCN Seq No 028256
GCN 84010
HICL code 011948
Ingredient (HICL) Anti-Thymocyte Globulin,Rabbit
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2E
Therapeutic class — specific (HIC3) Immunosuppressives
AHFS code 90:28.04.92
AHFS class Polyclonal Antibodies, Miscellaneous
FDB label name THYMOGLOBULIN 25 MG VIAL
FDB brand name Thymoglobulin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 028256
  • GCN: 84010
  • GPI-14 (Medi-Span): 99402540302120
  • HICL (First Databank): 011948
  • AHFS class code: 90:28.04.92
  • RxCUI (RxNorm): 107047
Why two NDCs? The FDA registers this code as 58468-0080-1 — a 5-4-1 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 package segment → 58468-0080-01. 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.

RxNorm drug class

This medicine belongs to the Immunoglobulin G class.

Pharmacologic class Immunoglobulin G
Drug family (ATC) Selective immunosuppressants
How it works Antibody-Surface Protein Interactions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name THYMOGLOBULIN 25 MG VIAL Ingredient Anti-Thymocyte Globulin,Rabbit
📖 What it is MedlinePlus · NLM

Anti-thymocyte globulin is used to prevent or treat kidney transplant rejection (attack of the transplanted organ by the immune system of the person receiving the organ). It is also used to treat aplastic anemia (condition in which the body does not make enough new blood cells). Anti-thymocyte globulin is in a class of medications called Immunosuppressants. It works by decreasing the activity of the immune system.

Read the full MedlinePlus article ↗

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.

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 systemPer mLPer 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.
Medicare Part B allowsASP · J7511 $1,057.791 / J7511 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)58468-0080-1
11-digit billing NDC58468-0080-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ7511
DescriptorLYMPHOCYTE IMMUNE GLOBULIN, ANTITHYMOCYTE GLOBULIN, RABBIT, PARENTERAL, 25MG
Billing units / pkg1 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 25 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$320,488 · 74 claims · $4,330.92 per claim (all NDCs under J7511)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58468-0080-01 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS 1998-12-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Thymoglobulin 5 mg/mLthis 58468-0080-01 Genzyme 1 vial — — 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

🏛️
1999
First FDA approval
May 1999
📍
2026
Currently FDA-listed
27 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

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

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
ThymoglobulinAnti-thymocyte Globulin (Rabbit)
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
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.

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.

  • UNII TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

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.

Manufacturer & labeler

LabelerGenzyme Corporation
FDA applicationBLA103869 (BLA)
Labeler code58468
First marketedDec 1998
Product typeHuman Prescription Drug
Portfolio33 products on file

More NDCs from Genzyme Corporation labeler code 58468

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 60 words ▾

1 INDICATIONS AND USAGE THYMOGLOBULIN is indicated for the prophylaxis and treatment of acute rejection in adult and pediatric patients receiving a kidney transplant in conjunction with concomitant immunosuppression. THYMOGLOBULIN is an immunoglobulin G indicated for the prophylaxis and treatment of acute rejection in adult and pediatric patients receiving a kidney transplant in conjunction with concomitant immunosuppression. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The first dose should be infused over at least 6 hours; doses on subsequent days should be infused over at least 4 hours. ( 2.2 ) Premedication with corticosteroids, acetaminophen, and/or an antihistamine prior to each infusion is recommended. ( 2.2 ) The THYMOGLOBULIN dose should be reduced by one-half if the white blood cell (WBC) count is between 2,000 and 3,000 cells/mm 3 or if the platelet count is between 50,000 and 75,000 cells/mm 3 .

Stopping THYMOGLOBULIN treatment should be considered if the WBC count falls below 2,000 cells/mm 3 or if the platelet count falls below 50,000 cells/mm 3 . ( 2.3 ) Indication Dose Prophylaxis of acute rejection 1.5 mg/kg of body weight administered daily for 4 to 7 days Treatment of acute rejection 1.5 mg/kg of body weight administered daily for 7 to 14 days For complete dosing instructions, see full prescribing information. ( 2 )

2.1Dosing Information For intravenous use only Prophylaxis of Acute Rejection The recommended dosage of THYMOGLOBULIN for prophylaxis of acute rejection in patients receiving a kidney transplant is 1.5 mg/kg of body weight administered daily with the first dose initiated prior to reperfusion of the donor kidney. The usual duration of administration is 4 to 7 days. Treatment of Acute Rejection The recommended dosage of THYMOGLOBULIN for treatment of acute rejection in patients receiving a kidney transplant is 1.5 mg/kg of body weight administered daily for 7 to 14 days.

Dosing for THYMOGLOBULIN is different from dosing for other anti-thymocyte globulin (ATG) products because protein composition and concentrations vary depending on the source of ATG. The prescribing physician must ensure that the dose prescribed is appropriate for the ATG product being administered.

2.2Recommended Dosing Regimen Administer the first dose of THYMOGLOBULIN over a minimum of 6 hours; administer doses on subsequent days over at least 4 hours [see Warnings and Precautions (5.2) ] . Premedicate with corticosteroids, acetaminophen, and/or an antihistamine 1 hour prior to each infusion of THYMOGLOBULIN to reduce the incidence and intensity of infusion-related reactions [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] .

2.3Dose Modifications Monitor patients for adverse reactions during and after infusion. Monitor total white blood cell and platelet counts during and after THYMOGLOBULIN therapy. Reduce the THYMOGLOBULIN dose by one-half if the white blood cell (WBC) count is between 2,000 and 3,000 cells/mm 3 or if the platelet count is between 50,000 and 75,000 cells/mm 3 .

Consider stopping THYMOGLOBULIN treatment if the WBC count falls below 2,000 cells/mm 3 or if the platelet count falls below 50,000 cells/mm 3 .

2.4Recommended Concomitant Medication THYMOGLOBULIN is used with concomitant immunosuppressants. Administer prophylactic antifungal and antibacterial therapy if clinically indicated [see Warnings and Precautions (5.4) ] . Antiviral prophylactic therapy is recommended for patients who are seropositive for cytomegalovirus (CMV) at the time of transplant and for CMV-seronegative patients scheduled to receive a kidney from a CMV-seropositive donor [see Warnings and Precautions (5.4) ].

2.5Instructions for Dilution and Administration Reconstitution After calculating the number of vials needed, using aseptic technique, reconstitute each vial of THYMOGLOBULIN with 5 mL of Sterile Water for Injection, USP (SWFI). Allow THYMOGLOBULIN vials to reach room temperature before reconstituting the lyophilized product. Aseptically remove caps to expose rubber stoppers.

Clean stoppers with germicidal or alcohol swab. Aseptically reconstitute each vial of THYMOGLOBULIN lyophilized powder with the 5 mL of SWFI. Rotate vial gently until powder is completely dissolved.

Each reconstituted vial contains 25 mg or 5 mg/mL of THYMOGLOBULIN. Inspect solution for particulate matter after reconstitution. Should some particulate matter remain, continue to ge… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 42 words ▾

3 DOSAGE FORMS AND STRENGTHS THYMOGLOBULIN for injection: 25 mg anti-thymocyte globulin (rabbit) as a sterile lyophilized powder, in single-dose 10 mL vials for reconstitution. Single-dose 10 mL vial containing 25 mg of anti-thymocyte globulin (rabbit) lyophilized, sterile powder. ( 3 )

⛔ Contraindications 74 words ▾

4 CONTRAINDICATIONS THYMOGLOBULIN is contraindicated in patients with history of allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or who have active acute or chronic infections that contraindicate any additional immunosuppression [see Warnings and Precautions (5.2 , 5.4) and Adverse Reactions (6.2) ] . Allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or active acute or chronic infections which contraindicate any additional immunosuppression ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS THYMOGLOBULIN should only be used by physicians experienced in immunosuppressant therapy in transplantation. ( 5.1 ) Hypersensitivity and infusion-related reactions: THYMOGLOBULIN infusion could result in an anaphylactic reaction. Close compliance with the recommended infusion time may reduce the incidence and severity of infusion-related reactions.

( 5.2 ) Cytopenias including anemia, neutropenia, and thrombocytopenia have occurred with THYMOGLOBULIN administration ( 6 ) and require monitoring of blood counts. Adjust dose accordingly to reverse cytopenias. Thrombotic microangiopathy (TMA) has occurred in patients treated with THYMOGLOBULIN for kidney transplantation, particularly when concomitantly administered with calcineurin inhibitors.

( 5.3 ) Infection: Infections and reactivation of infections have been reported. Monitor patients and administer anti-infective prophylaxis. ( 5.4 ) Malignancy: Incidence of malignancies may increase.

( 5.5 ) Immunization with attenuated live vaccines is not recommended for patients who have recently received THYMOGLOBULIN. ( 5.6 ) THYMOGLOBULIN may interfere with rabbit antibody–based immunoassays and with cross-match or panel-reactive antibody cytotoxicity assays. ( 5.7 )

5.1Management of Immunosuppression To prevent over-immunosuppression, physicians may wish to decrease the dose of the maintenance immunosuppression regimen during the period of THYMOGLOBULIN use.

5.2Hypersensitivity and Infusion-Related Reactions Severe hypersensitivity and infusion-related reactions, including fatal anaphylaxis and severe cytokine release syndrome (CRS), have been reported with the use of THYMOGLOBULIN [see Adverse Reactions (6) ] . Severe acute CRS can cause serious cardiorespiratory events and/or death. Close compliance with the recommended dosage and infusion time may reduce the incidence and severity of infusion-related reactions.

Slowing the infusion rate may minimize the risk of infusion-related reactions. If a hypersensitivity or infusion-related reaction occurs, terminate the infusion immediately and provide supportive treatment according to clinical practice.

5.3Cytopenias Cytopenias including anemia, neutropenia, and thrombocytopenia have occurred with THYMOGLOBULIN administration [see Adverse Reactions (6) ] . Monitor blood counts after THYMOGLOBULIN administration. Adjust dose accordingly to reverse cytopenias [see Dosage and Administration (2.3) ] .

Thrombotic microangiopathy (TMA) has occurred in patients treated with THYMOGLOBULIN for kidney transplantation, particularly when concomitantly administered with calcineurin inhibitors.

5.4Infection THYMOGLOBULIN is routinely used in combination with other immunosuppressive agents. Infections (bacterial, fungal, viral and protozoal), reactivation of infection (particularly cytomegalovirus [CMV]) and sepsis have been reported after THYMOGLOBULIN administration in combination with multiple immunosuppressive agents [see Adverse Reactions (6) ] . These infections can be fatal.

Monitor patients carefully and administer appropriate anti-infective treatment when indicated [see Dosage and Administration (2.4) ] .

5.5Malignancy Malignancies with fatal outcomes have been reported in patients treated with THYMOGLOBULIN [see Adverse Reactions (6) ]. Use of immunosuppressive agents, including THYMOGLOBULIN, may increase the risk of malignancies, including lymphoma or lymphoproliferative disorders.

5.6Immunizations The safety of immunization with attenuated live vaccines following THYMOGLOBULIN therapy has not been studied; therefore, immunization with attenuated live vaccines is not recommended for patients who have recently received THYMOGLOBULIN.

5.7Laboratory Tests THYMOGLOBULIN may interfere with rabbit antibody–based immunoassays and with cross-match or panel-reactive antibody cytotoxicity assays. THYMOGLOBULIN has not been shown to interfere with any routine clinical laboratory tests that do not use immunoglobulins.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions and laboratory abnormalities (incidence >5% higher than comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased potassium levels in the blood, low counts of platelets and white blood cells. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-633-1610 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 most common adverse reactions and laboratory abnormalities (incidence >5% higher than comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased potassium levels in the blood, and low counts of platelets and white blood cells.

Prophylaxis of Acute Rejection The safety of THYMOGLOBULIN compared to Active Comparator for the prophylaxis of acute rejection in patients receiving a kidney transplant were evaluated in a randomized, open-label, international, multicenter trial in patients receiving solitary kidneys from deceased donors (n=278; Study 1). Table 1: Adverse Reactions Adverse reactions are treatment emergent adverse events (TEAE) reported as related to the study agent in at least 1 patient. and Laboratory Abnormalities Reported More Frequently (incidence Number (percentage) is shown regardless of causal relationship. >5%) Following THYMOGLOBULIN versus Active Comparator basiliximab Adverse Reaction [n (%) ] THYMOGLOBULIN (N=141) Active Comparator (N=137) Urinary tract infection 55 (39%) 36 (26%) Pyrexia 39 (28%) 25 (18%) Headache 26 (18%) 17 (12%) Hyperlipidemia 21 (15%) 9 (7%) Anxiety 20 (14%) 12 (9%) Chills 13 (9%) 5 (4%) Laboratory Abnormalities Hyperkalemia: blood potassium ≥5.5 mmol/L; Leukopenia: WBC <3000 cells/mm 3 .

Thrombocytopenia: platelet count <75,000 cells/mm 3 . Hyperkalemia 81 (57%) 70 (51%) Leukopenia 89 (63%) 20 (15%) Thrombocytopenia 23 (16%) 7 (5%) Malignancies Six patients in the THYMOGLOBULIN group developed malignancies (Epstein-Barr virus-induced lymphoma of the cavum, Epstein-Barr virus-positive large B-cell lung lymphoma, Epstein-Barr virus-induced lymphoma of the brain, squamous cell carcinoma, renal cancer, and recurrent basal cell carcinoma). In the Active Comparator group, 1 patient developed renal cancer.

Infections Infections occurred in 76% of THYMOGLOBULIN-treated patients (severe in 23%), and in 63% of Active Comparator-treated patients (severe in 15%). Infections occurring in ≥5% of the patients in either treatment group during the 12-month follow-up are summarized in Table 2. Urinary tract infection was the most frequent type of infection, and was reported as severe in 9% of THYMOGLOBULIN-treated patients and in 2% of Active Comparator-treated patients.

CMV infections were reported more frequently in the Active Comparator group, with an incidence of 6% (severe in 1%) in THYMOGLOBULIN-treated patients and of 18% (severe in 7%) in Active Comparator-treated patients. Patients who were CMV-positive at the time of transplant, as well as CMV-negative recipients of transplants from CMV-positive donors, were required to receive antiviral prophylaxis for 3 months after transplant. Table 2: Infections Reported in ≥5% of Study Patients Infection THYMOGLOBULIN All (N=141) THYMOGLOBULIN Severe/Unknown (N=141) Active Comparator basiliximab All (N=137) Active Comparator Severe/Unknown (N=137) Urinary tract infections Urinary tract infection group includes: Urinary tract infections, Urinary tract infection fungal, Urinary tract infection bacterial, Bacterial pyelonephritis, Urosepsis.

59 (42%) 12 (9%) 39 (29%) 3 (2%) Sepsis Sepsis group includes: Sepsis, Escher… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 29 words ▾

7 DRUG INTERACTIONS No drug interaction studies have been performed. THYMOGLOBULIN can stimulate the production of antibodies that cross-react with rabbit immune globulins [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations 181 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Animal reproduction studies have not been conducted with THYMOGLOBULIN. It is also not known whether THYMOGLOBULIN can cause fetal harm. THYMOGLOBULIN should be given to a pregnant woman only if the benefit outweighs the risk.

8.2Lactation Risk Summary THYMOGLOBULIN has not been studied in nursing women. It is not known whether this drug is excreted in human milk. Because other immunoglobulins are excreted in human milk, breastfeeding should be discontinued during THYMOGLOBULIN therapy.

8.3Females and Males of Reproductive Potential Contraception Females There is a lack of information on the risks associated with the administration of THYMOGLOBULIN during pregnancy. Therefore, effective contraception is recommended during and for a minimum of 3 months after treatment.

8.4Pediatric Use The safety and effectiveness of THYMOGLOBULIN in pediatric patients have been established in pediatric patients for the prophylaxis and treatment of acute rejection. The use of THYMOGLOBULIN in pediatric patients was supported by extrapolation of adult data from Study 1, Study 2 and Study 3 [see Adverse Reactions (6) and Clinical Studies (14) ].

🤰 Pregnancy 39 words ▾

8.1Pregnancy Risk Summary Animal reproduction studies have not been conducted with THYMOGLOBULIN. It is also not known whether THYMOGLOBULIN can cause fetal harm. THYMOGLOBULIN should be given to a pregnant woman only if the benefit outweighs the risk.

🧒 Pediatric Use 57 words ▾

8.4Pediatric Use The safety and effectiveness of THYMOGLOBULIN in pediatric patients have been established in pediatric patients for the prophylaxis and treatment of acute rejection. The use of THYMOGLOBULIN in pediatric patients was supported by extrapolation of adult data from Study 1, Study 2 and Study 3 [see Adverse Reactions (6) and Clinical Studies (14) ].

🆘 Overdosage 31 words ▾

10 OVERDOSAGE THYMOGLOBULIN overdosage may result in leukopenia (including lymphopenia and neutropenia) and/ or thrombocytopenia, which can be managed with dose reduction [see Dosage and Administration (2.1 , 2.3) ] .

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action by which polyclonal antilymphocyte preparations suppress immune responses is not fully understood. Possible mechanisms by which THYMOGLOBULIN may induce immunosuppression in vivo include: T-cell clearance from the circulation and modulation of T-cell activation, homing, and cytotoxic activities. THYMOGLOBULIN includes antibodies against T-cell markers such as CD2, CD3, CD4, CD8, CD11a, CD18, CD25, CD44, CD45, HLA-DR, HLA Class I heavy chains, and ß2 micro-globulin.

In vitro , THYMOGLOBULIN (concentrations >0.1 mg/mL) mediates T-cell suppressive effects via inhibition of proliferative responses to several mitogens. In patients, T-cell depletion is usually observed within a day after initiating THYMOGLOBULIN therapy. THYMOGLOBULIN has not been shown to be effective for treating antibody-mediated (humoral) rejections.

12.3Pharmacokinetics After an intravenous dose of 1.25 to 1.5 mg/kg/day (over 4 hours for 7–11 days) 4–8 hours post infusion, THYMOGLOBULIN levels were on average 21.5 mcg/mL (10–40 mcg/mL) with a half-life of 2–3 days after the first dose, and 87 mcg/mL (23–170 mcg/mL) after the last dose. During the THYMOGLOBULIN Phase 3 randomized trial for the treatment of acute rejection, of the 108 of 163 patients evaluated, anti-rabbit antibodies developed in 68% of the THYMOGLOBULIN-treated patients, and anti-horse antibodies developed in 78% of the Active Comparator-treated patients.

No controlled studies have been conducted to study the effect of anti-rabbit antibodies on repeat use of THYMOGLOBULIN. However, to ensure that T-cell depletion is achieved upon retreatment with THYMOGLOBULIN, monitoring the lymphocyte count is recommended. T-cell counts based on data collected from a limited number of patients (n=12) in this study, are presented in the chart below.

These data were collected using flow cytometry (FACSCAN, Becton-Dickinson). chart

🧬 Mechanism of Action 117 words ▾

12.1Mechanism of Action The mechanism of action by which polyclonal antilymphocyte preparations suppress immune responses is not fully understood. Possible mechanisms by which THYMOGLOBULIN may induce immunosuppression in vivo include: T-cell clearance from the circulation and modulation of T-cell activation, homing, and cytotoxic activities. THYMOGLOBULIN includes antibodies against T-cell markers such as CD2, CD3, CD4, CD8, CD11a, CD18, CD25, CD44, CD45, HLA-DR, HLA Class I heavy chains, and ß2 micro-globulin.

In vitro , THYMOGLOBULIN (concentrations >0.1 mg/mL) mediates T-cell suppressive effects via inhibition of proliferative responses to several mitogens. In patients, T-cell depletion is usually observed within a day after initiating THYMOGLOBULIN therapy. THYMOGLOBULIN has not been shown to be effective for treating antibody-mediated (humoral) rejections.

📦 How Supplied / Storage and Handling 144 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied THYMOGLOBULIN is supplied as a single-dose clear glass 10 mL vial containing 25 mg of lyophilized (solid) THYMOGLOBULIN. Each carton contains one THYMOGLOBULIN vial (NDC 58468-0080-1).

16.2Storage and Handling Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze.

Do not use after the expiration date indicated on the label. Reconstituted THYMOGLOBULIN is physically and chemically stable for up to 24 hours at room temperature; however, room temperature storage is not recommended. As THYMOGLOBULIN contains no preservatives, reconstituted product should be used immediately.

Infusion solutions of THYMOGLOBULIN must be used immediately. Any unused drug remaining after infusion must be discarded.

16.1How Supplied THYMOGLOBULIN is supplied as a single-dose clear glass 10 mL vial containing 25 mg of lyophilized (solid) THYMOGLOBULIN. Each carton contains one THYMOGLOBULIN vial (NDC 58468-0080-1).

📦 Storage and Handling 81 words ▾

16.2Storage and Handling Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze.

Do not use after the expiration date indicated on the label. Reconstituted THYMOGLOBULIN is physically and chemically stable for up to 24 hours at room temperature; however, room temperature storage is not recommended. As THYMOGLOBULIN contains no preservatives, reconstituted product should be used immediately.

Infusion solutions of THYMOGLOBULIN must be used immediately. Any unused drug remaining after infusion must be discarded.

📋 Description 209 words ▾

11 DESCRIPTION THYMOGLOBULIN ® (anti-thymocyte globulin [rabbit]) is a purified, pasteurized, immunoglobulin G, obtained by immunization of rabbits with human thymocytes. This immunosuppressive product contains cytotoxic antibodies directed against antigens expressed on human T-lymphocytes. THYMOGLOBULIN is a sterile, lyophilized powder for intravenous administration after reconstitution with sterile Water for Injection, USP (SWFI).

Each single-dose 10 mL vial contains 25 mg of anti-thymocyte globulin (rabbit), 50 mg glycine, 50 mg mannitol and 10 mg sodium chloride. After reconstitution with 5 mL SWFI, each vial of reconstituted product contains approximately 5 mg/mL of THYMOGLOBULIN, of which >90% is rabbit gamma immune globulin (IgG). The reconstituted solution has a pH of 6.5 to 7.2.

Human red blood cells are used in the manufacturing process to deplete cross-reactive antibodies to non–T-cell antigens. The manufacturing process is validated to remove or inactivate potential exogenous viruses. All human red blood cells are from U.S.-registered or FDA-licensed blood banks.

A virus removal step (nanofiltration, using a 20 nm filter) and a viral inactivation step (pasteurization, i.e., heat treatment of active ingredient at 60°C/10 hr) are performed for each lot. Each THYMOGLOBULIN lot is released following potency testing (lymphocytotoxicity and anti-CD2 binding inhibition), and cross-reactive antibody testing (hemagglutination, platelet agglutination, and fibroblast toxicity assays on every lot).

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients receiving THYMOGLOBULIN that they will be monitored by a physician experienced in immunosuppressive therapy for the management of kidney transplant patients [see Warnings and Precautions (5.1) ] . Hypersensitivity and Infusion-Related Reactions Advise patients of the signs and symptoms of infusion-related reactions (flu-like symptoms, e.g., fever, chills, nausea, muscle or joint pain) and the need to take premedications as prescribed. Determine if the patient has known allergies to rabbits or rabbit proteins.

Determine if the patient has had significant exposure to rabbits [see Warnings and Precautions (5.2) and Adverse Reactions (6.2) ] . Cytopenias Inform patients of the increased risk of thrombotic microangiopathy (TMA). TMA is a severe condition characterized by the formation of microscopic blood clots in small blood vessels, leading to organ damage, most commonly the kidneys [see Warnings and Precautions (5.3) ] .

Infections Inform patients of the increased risk of infection while taking immunosuppressive therapy. Instruct patients to immediately report signs or symptoms of infection and to take prophylactic anti-infectives as prescribed [see Warnings and Precautions (5.4) and Adverse Reactions (6.2) ] . Malignancies Inform patients of the increased risk of malignancies, especially skin cancer, while taking immunosuppressive therapy.

Instruct patients to limit exposure to sunlight and UV light by wearing protective clothing and using sunscreen with a high protection factor [see Warnings and Precautions (5.5) and Adverse Reactions (6.2) ] . Immunizations Advise patients that they should not receive immunizations with live viral vaccines if they have been recently treated with THYMOGLOBULIN [see Warnings and Precautions (5.6) ] .

🧬 Pharmacokinetics 157 words ▾

12.3Pharmacokinetics After an intravenous dose of 1.25 to 1.5 mg/kg/day (over 4 hours for 7–11 days) 4–8 hours post infusion, THYMOGLOBULIN levels were on average 21.5 mcg/mL (10–40 mcg/mL) with a half-life of 2–3 days after the first dose, and 87 mcg/mL (23–170 mcg/mL) after the last dose. During the THYMOGLOBULIN Phase 3 randomized trial for the treatment of acute rejection, of the 108 of 163 patients evaluated, anti-rabbit antibodies developed in 68% of the THYMOGLOBULIN-treated patients, and anti-horse antibodies developed in 78% of the Active Comparator-treated patients.

No controlled studies have been conducted to study the effect of anti-rabbit antibodies on repeat use of THYMOGLOBULIN. However, to ensure that T-cell depletion is achieved upon retreatment with THYMOGLOBULIN, monitoring the lymphocyte count is recommended. T-cell counts based on data collected from a limited number of patients (n=12) in this study, are presented in the chart below.

These data were collected using flow cytometry (FACSCAN, Becton-Dickinson). chart

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Prophylaxis of Acute Rejection in Patients Receiving a Kidney Transplant Study 1 (NCT00235300) THYMOGLOBULIN was evaluated in an open-label, randomized, active-controlled study in kidney transplant patients (n=278) at increased risk of acute rejection or delayed graft function. The treatment failure rate within 12 months post-transplantation was statistically significantly lower in the THYMOGLOBULIN group than in the Active Comparator group (25% vs 38%; p=0.02), based on the composite endpoint (biopsy-proven acute rejection [BPAR], graft loss [GL], or death, with "lost to follow-up" considered as a treatment failure).

The individual elements of the composite endpoint were BPAR (13% vs 21%), GL (8% vs 10%), and death (4% vs 4%) for the THYMOGLOBULIN and Active Comparator groups, respectively (Table 7). Table 7: Prophylaxis of Acute Rejection – Treatment Failure within 12 Months (Study 1) Parameter THYMOGLOBULIN (N=141) Active Comparator basiliximab (N=137) Difference Two-sided 95% confidence intervals of difference between treatment groups (THYMOGLOBULIN – Active Comparator) are based on normal approximation of binomial distribution.

(95% CI) P-value P-value obtained by comparison of treatment groups using Fisher's exact test. BPAR= biopsy-proven acute rejection; CI=confidence interval Composite endpoint 35/141 (25%) 52/137 (38%) -13% (-23.9% to -2.3%)

0.02BPAR 18/141 (13%) 29/137 (21%) -8% (-17.2% to 0.4%) – Graft loss 11/141 (8%) 13/137 (10%) – – Death 6/141 (4%) 6/137 (4%) – – Lost to follow-up Lost to follow-up is defined as not having BPAR, GL, or death within 12 months after transplantation, and last visit date was prior to the lower bound of 12-month window (12 months ± 30 days after transplantation). 7/141 (5%) 11/137 (8%) – – The composite endpoint is defined as the occurrence of any of the following: BPAR (Grade I–III), graft loss, death, or lost to follow-up.

Except for patients counted as "lost to follow-up," a patient can be counted in more than one category for the individual components (BPAR, graft loss, death). In Study 1, patients received either THYMOGLOBULIN (n=141) 1.5 mg/kg daily for a total of 5 doses (Day 0 to Day 4) or Active Comparator (n=137) 2 doses of 20 mg each (Day 0, Day 4). For both treatment groups, the first induction treatment was initiated prior to the reperfusion of the kidney.

All patients received triple maintenance immunosuppression (cyclosporine, mycophenolate mofetil, and corticosteroids) throughout the 12 months of the study. Recipient disease characteristics were balanced between the 2 treatment groups with similar distribution of prior transplant, degree of sensitization and number of mismatched human leukocyte antigens (HLA). Overall, the mean percentage of pretransplant panel-reactive antibody (PRA) was 6% and the historical peak was 14%.

The number of patients having a higher level of sensitization with PRA >20% was similar in the THYMOGLOBULIN (9%) and Active Comparator (10%) groups. The mean number of mismatched HLAs was evenly distributed across the 2 treatment groups. Study 2 (NCT00682292) THYMOGLOBULIN was evaluated in an open-label, parallel-arm, randomized, active-controlled, investigator-sponsored study in kidney transplant patients (n=230) at higher immunological risk of rejection.

The noninferiority of THYMOGLOBULIN to Active Comparator was achieved with treatment failure rates of 25% versus 34%, with an estimated treatment group difference (THYMOGLOBULIN – Active Comparator) of -9% (95% CI: -19.9% to 3.6%), based on the composite endpoint (BPAR, GL, or death, with lost to follow-up considered as a treatment failure) in the 12 months after transplantation. The individual elements of the composite endpoint were BPAR (11% vs 21%), GL (15% vs 11%), and death (4% vs 3%) for the THYMOGLOBULIN and Active Comparator groups, respectively (Table 8).

Table 8: Prophylaxis of Acute Rejection – Treatment Failure within 12 Months (Study 2) Parameter THYMOGLOB… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.3 ) 6/2026

📄 Package Label / Principal Display Panel 41 words ▾

PRINCIPAL DISPLAY PANEL - 25 mg Vial Carton NDC 58468-0080-1 Rx only Thymoglobulin ® Anti-thymocyte Globulin (Rabbit) 25 mg per vial For Injection For Intravenous Infusion One single-dose vial Discard unused portion sanofi Principal Display Panel - 25 mg Vial Carton

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

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← 58468-0070-01 · Genzyme 58468-0131-02 · Genzyme →
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