Dosage & Administration
THYMOGLOBULIN is intended for intravenous use only.
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Thymoglobulin Prescribing Information
To prevent over-immunosuppression, physicians may wish to decrease the dose of the maintenance immunosuppression regimen during the period of THYMOGLOBULIN use.
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.
THYMOGLOBULIN is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. THYMOGLOBULIN is to be used in conjunction with concomitant immunosuppression.
THYMOGLOBULIN is intended for intravenous use only.
THYMOGLOBULIN for injection: 25 mg anti-thymocyte globulin (rabbit) as a sterile lyophilized powder, in single-dose 10 mL vials for reconstitution.
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.
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
Serious immune-mediated reactions, including anaphylaxis or severe cytokine release syndrome (CRS), have been reported with the use of THYMOGLOBULIN
Fatal anaphylaxis has been reported. If an anaphylactic reaction occurs, terminate the infusion immediately. Provide emergency treatment, such as 0.3 mL to 0.5 mL aqueous epinephrine (1:1000 dilution) subcutaneously and other resuscitative measures including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
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. These infections can be fatal.
Monitor patients carefully and administer appropriate anti-infective treatment when indicated
The following adverse reactions have been identified during postapproval use of THYMOGLOBULIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
IARs may occur following the administration of THYMOGLOBULIN and may occur as soon as the first or second infusion during a single course of THYMOGLOBULIN treatment. Clinical manifestations of IARs have included the following signs and symptoms: fever, chills/rigors, dyspnea, nausea/vomiting, diarrhea, hypotension or hypertension, malaise, rash, urticaria, decreased oxygen saturation, and/or headache. IARs with THYMOGLOBULIN are generally manageable with a reduction in infusion rates and/or with medications
Serious and fatal anaphylactic reactions have been reported. The fatalities occurred in patients who did not receive epinephrine during the event
IARs consistent with cytokine release syndrome (CRS) have been reported. Severe and potentially life-threatening CRS cases have also been reported. Postmarketing reports of severe CRS have included cardiorespiratory dysfunction (including hypotension, acute respiratory distress syndrome, pulmonary edema, myocardial infarction, tachycardia, and/or death).
Transient reversible elevations in aminotransferases without any clinical signs or symptoms have also been reported during THYMOGLOBULIN administration.
Infections, reactivation of infection, febrile neutropenia, and sepsis have been reported after THYMOGLOBULIN administration in combination with multiple immunosuppressive agents, which may be fatal
Malignancies including, but not limited to, lymphoproliferative disorders (LPD) and solid tumors have been reported. These events have been associated with fatal outcome. These adverse reactions were reported with use of a combination of multiple immunosuppressive agents
Coagulopathy has been reported without clinical signs or symptoms of bleeding, and generally resolves within a few days. Cases of disseminated intravascular coagulopathy have occurred secondary to anaphylaxis or infusion-associated reactions.