May 26, 2016
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Atgam

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Atgam

Side Effects
Interactions

SIDE EFFECTS

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

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

Table 2: Adverse Reactions Occurring in < 1% of Patients who Received ATGAM

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

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

Read the Atgam (lymphocyte immune globulin) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Previously masked reactions to ATGAM may appear when the dose of corticosteroids and other immunosuppressants is being reduced.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/11/2016

Side Effects
Interactions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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