Thymoglobulin 5 mg/mL
Anti-thymocyte Globulin (Rabbit) · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Genzyme Corporation
Thymoglobulin is a injection, powder, lyophilized, for solution containing anti-thymocyte globulin (rabbit) at 5 mg/mL, taken intravenous. Manufactured by Genzyme Corporation.
Key Facts
- Brand Name
- Thymoglobulin
- Generic Name
- Anti-thymocyte Globulin (Rabbit)
- NDC Code (Product)
58468-0080- Manufacturer
- Genzyme Corporation
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA103869
- Drug Class
- Immunoglobulin G [EPC]
- Marketing Start
- 12/30/1998
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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 ) 2.1 Dosing 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 reperfus…
Contraindications
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 )
Drug Interactions
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) ] .
Adverse Reactions
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. 6.1 Clinical 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 acut…
Frequently Asked Questions
What is Thymoglobulin used for?
Thymoglobulin contains Anti-thymocyte Globulin (Rabbit). It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Thymoglobulin a controlled substance?
Thymoglobulin is not classified as a controlled substance by the DEA.
What is the generic name for Thymoglobulin?
The generic name for Thymoglobulin is Anti-thymocyte Globulin (Rabbit). There are no other listed brand versions of Anti-thymocyte Globulin (Rabbit).
What is the NDC code for Thymoglobulin 5 mg/mL?
The NDC (National Drug Code) for Thymoglobulin 5 mg/mL is 58468-0080, listed by Genzyme Corporation.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)