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Thymoglobulin (Anti-Thymocyte Globulin (Rabbit)) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials

US Phase 3 Study

Thymoglobulin adverse events are generally manageable or reversible. In the US Phase 3 controlled clinical trial (n=163) comparing the efficacy and safety of Thymoglobulin and Atgam, there were no significant differences in clinically significant adverse events between the two treatment groups (Table 2). Malignancies were reported in 3 patients who received Thymoglobulin and in 3 patients who received Atgam during the one-year follow-up period. These included two post-transplant lymphoproliferative diseases (PTLDs) in the Thymoglobulin group and two PTLDs in the Atgam group.


Table 2. Frequently Reported and Significant Adverse Events 1   
Preferred Term   Thymoglobulin
n=82
Atgam
n=81
p Value 2     
    No. of    
Patients
    (%)         No. of    
Patients
    (%)    
Frequently Reported Events  
  Fever  52 (63.4) 51 (63.0) 1.0
  Chills  47 (57.3) 35 (43.2) 0.086
  Leukopenia  47 (57.3) 24 (29.6) <0.001
  Pain    38 (46.3) 35 (43.2) 0.753
  Headache  33 (40.2) 28 (34.6) 0.518
  Abdominal pain  31 (37.8) 22 (27.2) 0.181
  Diarrhea  30 (36.6) 26 (32.1) 0.622
  Hypertension  30 (36.6) 23 (28.4) 0.316
  Nausea  30 (36.6) 23 (28.4) 0.316
  Thrombocytopenia  30 (36.6) 36 (44.4) 0.341
  Peripheral edema  28 (34.1) 28 (34.6) 1.0
  Dyspnea  23 (28.0) 16 (19.8) 0.271
  Asthenia 22 (26.8) 26 (32.1) 0.495
  Hyperkalemia 22 (26.8) 15 (18.5) 0.262
  Tachycardia 22 (26.8) 19 (23.5) 0.719
Significant Events 3
  Leukopenia 47 (57.3) 24 (29.6) <0.001
  Malaise 11 (13.4) 3 (3.7) 0.047
  Dizziness 7 (8.5) 20 (24.7) 0.006

1 Treatment Emergent Adverse Events (TEAE) are summarized. Frequently reported adverse events are those reported by more than 25% of patients in a treatment group; significant adverse events are those where the incidence rate differed between treatment groups by a significance level of ≤0.05.
2 p Value comparing treatment groups using Fisher's exact test.
3 statistically significant differences in the AEs.

Infections occurring in both treatment groups during the 3-month follow-up are summarized in Table 3. No significant differences were seen between the Thymoglobulin and Atgam groups for all types of infections, and the incidence of cytomegalovirus (CMV) infection was equivalent in both groups. (Viral prophylaxis was by the center's discretion during antibody treatment, but all centers used gancyclovir infusion during treatment.)




Table 3. Infections
BODY SYSTEM
Preferred Term  
Thymoglobulin
n=82  
Atgam
n=81  
  p Value 1     
    No. of     
Patients
    (%)         Total    
Reports
    No. of    
Patients
    (%)         Total    
Reports
BODY AS A WHOLE  30 (36.6) 36 22 (27.2) 29 0.240
  Infection  25 (30.5) 26 19 (23.5) 21 0.378
    Other  14 (17.1) 15 11 (13.6) 12 0.665
    CMV  11 (13.4) 11 9 (11.1) 9 0.812
  Sepsis  10 (12.2) 10 7 (9.6) 7 0.610
  Moniliasis  0 (0.0) 0 1 (1.2) 1 0.497 
DIGESTIVE  5 (6.1) 5 3 (3.7) 3 0.720

  Gastrointestinal moniliasis 

4 (4.9) 4 1 (1.2) 1 0.367
  Oral moniliasis  3 (3.7) 0 2 (2.5) 1 0.497
  Gastritis  1 (1.2) 1 0 (0.0) 0 1.000
RESPIRATORY  0 (0.0) 0 1 (1.2) 1 0.497
  Pneumonia  0 (0.0) 0 1 (1.2) 1 0.497
SKIN 4 (4.9) 4 0 (0.0) 0 0.120
  Herpes simplex  4 (4.9) 4 0 (0.0) 0 0.120
UROGENITAL  15 (18.3) 15 22 (29.2) 22 0.195
  Urinary tract infection  15 (18.3) 15 21 (25.9) 21 0.262
  Vaginitis  0 (0.0) 0 1 (1.2) 1 0.497
NOT SPECIFIED  0 (0.0) 0 2 (2.5) 2 0.245

1 p Value comparing treatment groups using Fisher's exact test.

Post-marketing Experience

The following adverse reactions have been identified during post approval 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.

Infusion-Associated Reactions and Immune System Disorders

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 infusion-associated reactions IARs have included some of the following signs and symptoms: fever, chills/rigors, dyspnea, nausea/vomiting, diarrhea, hypotension or hypertension, malaise, rash, and/or headache. IARs with Thymoglobulin are generally manageable with a reduction in infusion rates and/or with medications (See PRECAUTIONS ). Serious and fatal anaphylactic reactions have been reported (See WARNINGS ). 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 have also been reported. Post-marketing reports of severe CRS have included cardiorespiratory dysfunction (including hypotension, acute respiratory distress syndrome, pulmonary edema, myocardial infarction, tachycardia, and/or death).

During post-marketing surveillance, reactions such as fever, rash, arthralgia, and/or myalgia, indicating possible serum sickness, have been reported. Serum sickness tends to occur 5 to 15 days after onset of Thymoglobulin therapy. Symptoms are manageable with corticosteroid treatment. 

Adverse Events Due to Immunosuppression

Infections, reactivation of infection, and sepsis have been reported after Thymoglobulin administration in combination with multiple immunosuppressive agents (See WARNINGS   and PRECAUTIONS ). Malignancies including, but not limited to post-transplant lymphoproliferative disorder (PTLD) and other lymphomas as well as solid tumors have been reported (See PRECAUTIONS ). These adverse events were reported with use of a combination of multiple immunosuppressive agents.



REPORTS OF SUSPECTED THYMOGLOBULIN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Thymoglobulin. The information is not vetted and should not be considered as verified clinical evidence.

Possible Thymoglobulin side effects / adverse reactions in 33 year old female

Reported by a physician from Japan on 2011-10-04

Patient: 33 year old female

Reactions: Sepsis

Adverse event resulted in: death

Suspect drug(s):
Thymoglobulin



Possible Thymoglobulin side effects / adverse reactions in 27 year old male

Reported by a physician from Japan on 2011-10-04

Patient: 27 year old male

Reactions: Lymphoma

Adverse event resulted in: death

Suspect drug(s):
Thymoglobulin



Possible Thymoglobulin side effects / adverse reactions in 73 year old male

Reported by a pharmacist from United States on 2011-10-07

Patient: 73 year old male

Reactions: Refusal of Treatment by Patient, Collagen-Vascular Disease, Lung Infection, Pulmonary Embolism, Coma, Pulmonary Haemosiderosis, Organising Pneumonia, Lung Disorder, Multifocal Micronodular Pneumocyte Hyperplasia, Interstitial Lung Disease, Cardiopulmonary Failure, Pneumothorax, Cardiac Failure Congestive

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Thymoglobulin



See index of all Thymoglobulin side effect reports >>

Drug label data at the top of this Page last updated: 2008-11-10

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