ATGAM® Adverse Reactions

(lymphocyte immune globulin, anti-thymocyte globulin [equine])

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 allograft rejection and 109 patients with aplastic anemia.

The renal allograft rejection 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
*
Percentages are treatment-emergent all-causality events
†
Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms

Adverse Reaction*,†

ATGAM

Frequency (%)

(N = 476)

Pyrexia

39.5

Chills

26.5

Rash

25.6

Thrombocytopenia

21.6

Leukopenia

17.9

Arthralgia

17.2

Urticaria

9.2

Headache

5.3

Pruritus

4.6

Nausea

4.2

Infection

3.4

Vomiting

3.4

Thrombophlebitis

3.2

Hypertension

2.9

Hypotension

2.9

Diarrhea

2.9

Abdominal pain upper

2.7

Chest pain

2.7

Infusion site pain

2.1

Edema

2.1

Bradycardia

1.5

Back pain

1.5

Lymphadenopathy

1.3

Arteriovenous fistula thrombosis

1.3

Dizziness

1.1

Dyspnea

1.1

Tachycardia

1.1

Liver function test abnormal

1.0

Table 2. Adverse Reactions Occurring in <1% of Patients Who Received ATGAM
*
Percentages are treatment-emergent all-causality events
†
Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms

Adverse Reaction*,†

ATGAM

Frequency (%)

(N = 476)

Convulsion

0.8

Pleural effusion

0.8

Night sweats

0.8

Serum sickness

0.6

Hyperglycemia

0.6

Stomatitis

0.6

Renal function test abnormal

0.6

Herpes simplex

0.4

Agitation

0.4

Hiccups

0.4

Proteinuria

0.4

Asthenia

0.4

Malaise

0.4

Wound dehiscence

0.4

Anaphylactic reaction

0.2

Encephalitis

0.2

Paresthesia

0.2

Renal artery thrombosis

0.2

Iliac vein occlusion

0.2

Laryngospasm

0.2

Pulmonary edema

0.2

Dermatitis allergic

0.2

Periorbital edema

0.2

Toxic epidermal necrolysis

0.2

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ATGAM. 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.

Infections and infestations: Sepsis, Hepatitis viral, Localized infection, Systemic infection (bacterial, viral, fungal).

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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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 allograft rejection and 109 patients with aplastic anemia.

The renal allograft rejection 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
*
Percentages are treatment-emergent all-causality events
†
Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms

Adverse Reaction*,†

ATGAM

Frequency (%)

(N = 476)

Pyrexia

39.5

Chills

26.5

Rash

25.6

Thrombocytopenia

21.6

Leukopenia

17.9

Arthralgia

17.2

Urticaria

9.2

Headache

5.3

Pruritus

4.6

Nausea

4.2

Infection

3.4

Vomiting

3.4

Thrombophlebitis

3.2

Hypertension

2.9

Hypotension

2.9

Diarrhea

2.9

Abdominal pain upper

2.7

Chest pain

2.7

Infusion site pain

2.1

Edema

2.1

Bradycardia

1.5

Back pain

1.5

Lymphadenopathy

1.3

Arteriovenous fistula thrombosis

1.3

Dizziness

1.1

Dyspnea

1.1

Tachycardia

1.1

Liver function test abnormal

1.0

Table 2. Adverse Reactions Occurring in <1% of Patients Who Received ATGAM
*
Percentages are treatment-emergent all-causality events
†
Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms

Adverse Reaction*,†

ATGAM

Frequency (%)

(N = 476)

Convulsion

0.8

Pleural effusion

0.8

Night sweats

0.8

Serum sickness

0.6

Hyperglycemia

0.6

Stomatitis

0.6

Renal function test abnormal

0.6

Herpes simplex

0.4

Agitation

0.4

Hiccups

0.4

Proteinuria

0.4

Asthenia

0.4

Malaise

0.4

Wound dehiscence

0.4

Anaphylactic reaction

0.2

Encephalitis

0.2

Paresthesia

0.2

Renal artery thrombosis

0.2

Iliac vein occlusion

0.2

Laryngospasm

0.2

Pulmonary edema

0.2

Dermatitis allergic

0.2

Periorbital edema

0.2

Toxic epidermal necrolysis

0.2

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ATGAM. 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.

Infections and infestations: Sepsis, Hepatitis viral, Localized infection, Systemic infection (bacterial, viral, fungal).

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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