Thymoglobulin Drug Information
Generic name: ANTI-THYMOCYTE GLOBULIN (RABBIT)
Immunoglobulin G [EPC]
Uses of 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.
Dosage & Administration of Thymoglobulin
| 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 |
Side Effects of Thymoglobulin
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 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 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 (N=141) Active Comparator basiliximab (N=137) All Severe/Unknown All Severe/Unknown 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, Escherichia sepsis, Staphylococcal bacteremia. 9 (6%) 5 (4%) 1 (1%) 1 (1%) Lower respiratory tract and lung infections Lower respiratory tract and lung infections group includes: Lower respiratory tract and lung infections, and Pneumonia pseudomonal. 18 (13%) 2 (1%) 16 (12%) 4 (3%) Upper respiratory tract infection 15 (11%) 0 15 (11%) 1 (1%) Nasopharyngitis 7 (5%) 0 9 (7%) 0 Cytomegaloviral infections The collective term "cytomegaloviral infections" includes CMV duodenitis, CMV gastritis, CMV hepatitis, CMV infection, and CMV viremia. 8 (6%) 2 (1%) 21 (18%) 7 (7%) Herpes zoster 7 (5%) 0 2 (2%) 1 (1%) Oral candidiasis 8 (6%) 0 11 (8%) 0 Adverse Drug Reactions Occurring within 24 Hours and Infusion-Related Reactions Adverse reactions occurring during or within 24 hours of infusion in >5% of patients in the THYMOGLOBULIN group are summarized in Table 3. Table 3: Adverse Drug Reactions Adverse reactions that occurred during or within 24 hours of an infusion, and where the incidence was higher in the THYMOGLOBULIN group. Occurring within 24 Hours of Infusion and with >5% Incidence in Patients who Received THYMOGLOBULIN Primary System Organ Class n (%) THYMOGLOBULIN (N=141) Active Comparator basiliximab (N=137) Constipation 47 (33%) 23 (17%) Anemia 35 (25%) 19 (14%) Hyperkalemia 33 (23%) 18 (13%) Hypertension 25 (18%) 19 (14%) Leukopenia and White blood cell count decreased 29 (21%) 0 Pyrexia 18 (13%) 3 (2%) Vomiting 17 (12%) 14 (10%) Thrombocytopenia 13 (9%) 1 (1%) Abdominal pain 11 (8%) 6 (4%) Anxiety 10 (7%) 2 (2%) Hyperphosphatemia 10 (7%) 2 (2%) Tachycardia 10 (7%) 5 (4%) Acidosis 9 (6%) 8 (6%) Diarrhea 9 (6%) 1 (1%) Hypokalemia 9 (6%) 4 (3%) Infusion-related reactions Adverse reactions that occurred within 24 hours after the completion of the THYMOGLOBULIN administration and are considered as possible infusion related reactions (IARs) include the following: anxiety, confusional state, agitation, restlessness, headache, lethargy, dizziness, decreased sensitivity, fast heart rate, myocardial infarction, elevated blood pressure, decreased blood pressure, cough, throat irritation, reduced oxygen supply to tissues, shortness of breath, pulmonary edema, pain in mouth and throat, diarrhea, upper abdominal pain, abdominal tenderness, abdominal discomfort, nausea, pruritus, rash, joint pain, fever, chills, lack of energy, localized edema, malaise, and chest pain. Serum sickness was reported in 6 of 405 patients enrolled across completed studies where patients had been treated with THYMOGLOBULIN for the prophylaxis of acute rejection in patients receiving a kidney transplant.
Anaphylactic shock was reported in 2 of 405 patients enrolled across completed studies. Treatment of acute rejection In the US Phase 3 randomized controlled clinical trial (n=163; Study 3) comparing the efficacy and safety of THYMOGLOBULIN and Active Comparator in the treatment of acute rejection in kidney transplant patients, adverse reactions occurring at least 5% more frequently in the THYMOGLOBULIN group than in the Active Comparator group are shown in Table 4. Malignancies were reported in 3 patients who received THYMOGLOBULIN and in 3 patients who received Active Comparator during the one-year follow-up period. These included two cases of post-transplant lymphoproliferative disease (PTLD) in the THYMOGLOBULIN group and two cases of PTLD in the Active Comparator group.
Table 4: Adverse Reactions Treatment-emergent adverse events/reactions (TEAE) are summarized. Reported More Frequently (incidence ≥5%) Following THYMOGLOBULIN versus Active Comparator Anti-thymocyte globulin equine (ATG-E) Frequently Reported Events THYMOGLOBULIN n=82 Active Comparator n=81 Chills 47 (57%) 35 (43%) Leukopenia 47 (57%) 24 (30%) Headache 33 (40%) 28 (35%) Abdominal pain 31 (38%) 22 (27%) Hypertension 30 (37%) 23 (28%) Nausea 30 (37%) 23 (28%) Dyspnea 23 (28%) 16 (20%) Hyperkalemia 22 (27%) 15 (19%) Myalgia 16 (20%) 10 (12%) Insomnia 16 (20%) 10 (12%) Hypotension 13 (16%) 6 (7%) Rash 11 (13%) 6 (7%) Sweating 11 (13%) 4 (5%) Malaise 11 (13%) 3 (4%) Acne 10 (12%) 4 (5%) Overdose 5 (6%) 0 Treatment-emergent thrombocytopenia was reported in 30 (37%) of patients following THYMOGLOBULIN infusion and in 36 (44%) of patients following Active Comparator infusion. Infections occurring more frequently in the THYMOGLOBULIN group during the 3-month follow-up are summarized in Table 5. No significant differences were seen between the THYMOGLOBULIN and Active Comparator groups for all types of infections.
The incidence of CMV infection was the same in both groups. Viral prophylaxis was by the center's discretion during antibody treatment, but all centers used ganciclovir infusion during treatment. Table 5: Infections THYMOGLOBULIN n=82 Active Comparator ATG-E n=81 Body System No. of Patients (%) Total Reports No. of Patients (%) Total Reports Body as a Whole 30 36 22 29 Infection 25 26 19 21 Other 14 15 11 12 CMV 11 11 9 9 Sepsis 10 10 7 7 Digestive 5 5 3 3 Gastrointestinal moniliasis 4 4 1 1 Gastritis 1 1 0 0 Skin 4 4 0 0 Herpes simplex 4 4 0 0 Adverse reactions occurring during or within 24 hours of infusion in at least 5% of patients in the THYMOGLOBULIN group are listed in Table 6. Table 6: Adverse Reactions* Occurring within 24 Hours of Infusion and with >5% Incidence in THYMOGLOBULIN Patients Adverse Reaction THYMOGLOBULIN (N=82) Active Comparator ATG-E (N=81) * Treatment-emergent adverse events that occurred during or within 24 hours of an infusion are summarized.
Chills 45 (55%) 28 (35%) Leukopenia 40 (49%) 10 (12%) Fever 38 (46%) 39 (48%) Nausea 24 (29%) 17 (21%) Thrombocytopenia 24 (29%) 30 (37%) Headache 22 (27%) 22 (27%) Hypertension 22 (27%) 16 (20%) Pain 21 (26%) 19 (24%) Tachycardia 19 (23%) 16 (20%) Diarrhea 16 (20%) 15 (19%) Peripheral edema 16 (20%) 13 (16%) Vomiting 16 (20%) 12 (15%) Abdominal pain 14 (17%) 13 (16%) Hyperkalemia 14 (17%) 12 (15%) Arthralgia 12 (15%) 11 (14%) Constipation 12 (15%) 16 (20%) Dyspnea 12 (15%) 11 (14%) Asthenia 11 (13%) 11 (14%) Leukocytosis 11 (13%) 9 (11%) Anemia 10 (12%) 11 (14%) Back pain 10 (12%) 8 (10%) Hypokalemia 10 (12%) 7 (9%) Insomnia 10 (12%) 4 (5%) Lung disorder 10 (12%) 6 (7%) Myalgia 9 (11%) 7 (9%) Dyspepsia 8 (10%) 6 (7%) Hypotension 8 (10%) 2 (3%) Acidosis 7 (9%) 4 (5%) Chest pain 7 (9%) 7 (9%) Malaise 7 (9%) 3 (4%) Anxiety 6 (7%) 8 (10%) Anorexia 5 (6%) 1 (1%) Cough increased 6 (7%) 8 (10%) Rash 6 (7%) 4 (5%) Edema 5 (6%) 12 (15%) Hypophosphatemia 5 (6%) 3 (4%) Itchiness 5 (6%) 4 (5%) Sweating 5 (6%) 4 (5%) Treatment-emergent serum sickness was reported in 2 (2%) of patients following THYMOGLOBULIN infusion and in no patients following Active Comparator infusion.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of THYMOGLOBULIN. Because these adverse 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. Hepatobiliary disorders: Hepatic dysfunction including transient reversible elevations in aminotransferases without any clinical signs or symptoms, hepatic failure, hyperbilirubinemia. Blood and lymphatic system disorders: Febrile neutropenia, coagulopathy without clinical signs or symptoms of bleeding, disseminated intravascular coagulopathy, anemia including hemolytic anemia, thrombotic microangiopathy.
Immune system disorders: Hypersensitivity reactions including anaphylaxis, CRS.
Warnings & Cautions for Thymoglobulin
Management of Immunosuppression To prevent over-immunosuppression, physicians may wish to decrease the
dose of the maintenance immunosuppression regimen during the period of THYMOGLOBULIN use.
Hypersensitivity 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 . 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.
Cytopenias Cytopenias including anemia, neutropenia, and thrombocytopenia have occurred with
THYMOGLOBULIN administration . Monitors blood counts after THYMOGLOBULIN administration. Adjust dose accordingly to reverse cytopenias .
Infection
THYMOGLOBULIN is routinely used in combination with other immunosuppressive agents. Infections (bacterial, fungal, viral and protozoal), reactivation of infection (particularly cytomegalovirus ) 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 .
Malignancy Malignancies with fatal outcomes have been reported in patients treated with
THYMOGLOBULIN. Use of immunosuppressive agents, including THYMOGLOBULIN, may increase the risk of malignancies, including lymphoma or lymphoproliferative disorders.
Immunizations
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.
Laboratory 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.
Drug Interactions with Thymoglobulin
No drug interaction studies have been performed. THYMOGLOBULIN can stimulate the production of antibodies that cross-react with rabbit immune globulins .
Pregnancy Safety for Thymoglobulin
Pregnancy 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 of Thymoglobulin
Pediatric 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.
Contraindications for 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 . Allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or active acute or chronic infections which contraindicate any additional immunosuppression
Overdosage Information for Thymoglobulin
overdosage may result in leukopenia (including lymphopenia and neutropenia) and/ or thrombocytopenia, which can be managed with dose reduction .
Clinical Studies of Thymoglobulin
Prophylaxis 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, graft loss, 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%) 0.02 BPAR 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 THYMOGLOBULIN (N=114) Active Comparator daclizumab (N=116) Difference Two-sided 95% confidence intervals of difference between treatment groups (THYMOGLOBULIN – Active Comparator) are based on normal approximation of binomial distribution. (95% CI) BPAR= biopsy-proven acute rejection; CI=confidence interval 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. A patient can be counted in more than one category with the exception of lost to follow-up. Composite endpoint 29 (25%) 39 (34%) -9% (-19.9% to 3.6%) BPAR 12 (11%) 24 (21%) -10% (-19.4% to -0.9%) Graft loss 17 (15%) 13 (11%) – Death 5 (4%) 4 (3%) – Lost to follow-up Lost to follow-up is defined as not having BPAR (Grade I–III), GL, or death within 12 months post-transplantation, and last visit date was prior to the lower bound of 12 month window (12 months ± 30 days post-transplantation). 2 (2%) 3 (3%) – In Study 2, patients received either THYMOGLOBULIN (n=114) 1.25 mg/kg daily for a total of 8 doses (Day 0 to Day 7) or Active Comparator (n=116) 1 mg/kg (maximum dose 100 mg) on Days 0, 14, 28, 42, and 56. For both treatment groups, the first induction treatment was initiated prior to the beginning of the surgical procedure.
All patients received triple maintenance immunosuppression (tacrolimus, mycophenolate mofetil, and corticosteroids) throughout the 12 months of the study. Recipient disease characteristics were balanced between the 2 treatment groups, including similar distribution of prior transplant, degree of sensitization and number of HLA mismatches. The number of patients having prior transplants was 163 of 230 (71%). Overall, the mean percentage of pretransplant PRA was 35% and the historical peak was 72%. The number of patients having a higher level of sensitization with PRA >20% was similar in the THYMOGLOBULIN (55%) and Active Comparator (58%) groups.
The mean number of HLA mismatches was evenly distributed across the 2 treatment groups.
Treatment of Acute Rejection in Patients Receiving a Kidney Transplant Study 3
A controlled, double-blind, multicenter, randomized clinical trial comparing THYMOGLOBULIN and Active Comparator was conducted at 28 US transplant centers in renal transplant patients (n=163) with biopsy-proven Banff Grade II (moderate), Grade III (severe), or steroid-resistant Grade I (mild) acute graft rejection. This clinical trial met the non-inferiority criteria for THYMOGLOBULIN relative to Active Comparator in reversing acute rejection episodes with a 20% non-inferiority margin. The overall weighted estimate of the treatment difference (THYMOGLOBULIN – Active Comparator success rate) was 11% with a lower 95% confidence bound of 0.07%. Therefore, THYMOGLOBULIN was not inferior to Active Comparator in reversing acute rejection episodes.
In the study, patients were randomized to receive 7 to 14 days of THYMOGLOBULIN (1.5 mg/kg/day) or Active Comparator (15 mg/kg/day). For the entire study, the two treatment groups were comparable with respect to donor and recipient characteristics. In Table 9, successful treatment is presented as those patients whose serum creatinine levels (14 days from the diagnosis of rejection) returned to baseline and whose graft was functioning on Day 30 after the end of therapy. Table 9: Treatment of Acute Rejection – Response to Study Treatment by Rejection Severity Success/n Total Thymoglobulin Active Comparator ATG-E Rejection Severity: Mild 9/10 (90%) 5/8 (63%) Moderate 44/58 (76%) 41/58 (71%) Severe 11/14 (72%) 8/14 (57%) Overall 64/82 (78%) 54/80 (68%) Weighted estimate of difference (Thymoglobulin – Active Comparator ) 11% Lower one-sided 95% confidence bound 0.07% p Value under null hypothesis (Cochran-Mantel-Haenszel test) 0.061 There were no statistically significant differences between the two treatments with respect to serum creatinine levels 30 days after treatment relative to baseline, improvement rate in post-treatment histology, one-year post-rejection Kaplan-Meier patient survival (THYMOGLOBULIN 93%, n=82 and Active Comparator 96%, n=80), Day 30 post-rejection graft survival and one-year post-rejection graft survival (THYMOGLOBULIN 83%, n=82; Active Comparator 75%, n=80).
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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