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ATGAM® (lymphocyte immune globulin, anti-thymocyte globulin [equine]) Adverse Reactions

6 ADVERSE REACTIONS

The most clinically significant adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests.

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 clinical practice.

The safety of ATGAM has been evaluated in 367 patients with renal transplant and 109 patients with aplastic anemia.

The renal transplantation and aplastic anemia patients received a similar dosing regimen, and these data were pooled to obtain the frequencies listed in Tables 1 and 2 below.

The most commonly reported adverse reactions (occurring in greater than 10% of patients) are pyrexia, chills, rash, thrombocytopenia, leukopenia and arthralgia.

Table 1. Adverse Reactions Occurring in ≥1% of Patients who Received ATGAM
Adverse Reaction*,ATGAM
Frequency (%)
(N = 476)
*
Percentages are treatment-emergent all-causality events
Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms
Pyrexia39.5
Chills26.5
Rash25.6
Thrombocytopenia21.6
Leukopenia17.9
Arthralgia17.2
Urticaria9.2
Headache5.3
Pruritus4.6
Nausea4.2
Infection3.4
Vomiting3.4
Thrombophlebitis3.2
Hypertension2.9
Hypotension2.9
Diarrhea2.9
Abdominal pain upper2.7
Chest pain2.7
Infusion site pain2.1
Edema2.1
Bradycardia1.5
Back pain1.5
Lymphadenopathy1.3
Arteriovenous fistula thrombosis1.3
Dizziness1.1
Dyspnea1.1
Tachycardia1.1
Liver function test abnormal1.0
Table 2. Adverse Reactions Occurring in <1% of Patients who Received ATGAM
Adverse Reaction*,ATGAM
Frequency (%)
(N = 476)
*
Percentages are treatment-emergent all-causality events
Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms
Convulsion0.8
Pleural effusion0.8
Night sweats0.8
Serum sickness0.6
Hyperglycemia0.6
Stomatitis0.6
Renal function test abnormal0.6
Herpes simplex0.4
Agitation0.4
Hiccups0.4
Proteinuria0.4
Asthenia0.4
Malaise0.4
Wound dehiscence0.4
Anaphylactic reaction0.2
Encephalitis0.2
Paresthesia0.2
Renal artery thrombosis0.2
Iliac vein occlusion0.2
Laryngospasm0.2
Pulmonary edema0.2
Dermatitis allergic0.2
Periorbital edema0.2
Toxic epidermal necrolysis0.2

6.2 Post-Marketing Experience

The following adverse reactions have been identified during post approval use of ATGAM. Because 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.

Infections and infestations: Hepatitis viral, Localized infection, Systemic infection

Blood and lymphatic system disorders: Anemia, Eosinophilia, Granulocytopenia, Hemolysis, Hemolytic anemia, Neutropenia, Pancytopenia

Psychiatric disorders: Confusional state, Disorientation

Nervous system disorders: Dyskinesia, Syncope, Tremor

Cardiac disorders: Cardiac failure congestive

Vascular disorders: Deep vein thrombosis, Vasculitis

Respiratory, thoracic and mediastinal disorders: Apnea, Cough, Epistaxis, Oropharyngeal pain

Gastrointestinal disorders: Abdominal pain, Gastrointestinal hemorrhage, Gastrointestinal perforation, Oral pain

Skin and subcutaneous tissue disorders: Hyperhidrosis

Musculoskeletal and connective tissue disorders: Flank pain, Muscle rigidity, Myalgia, Pain in extremity

Renal and urinary disorders: Kidney enlargement, Kidney rupture, Renal failure acute

Congenital, familial and genetic disorders: Aplasia

General disorders and administration site conditions: Infusion site erythema, Infusion site swelling, Pain

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