Atgam
- Generic Name: lymphocyte immune globulin
- Brand Name: Atgam
Atgam (Lymphocyte immune globulin) side effects drug center
Atgam Side Effects Center
What Is Atgam?
Atgam (lymphocyte immune globulin, anti-thymocyte globulin [equine]) Sterile Solution is an immunosuppressant used to treat rejection of a kidney transplant as well as aplastic anemia.
What Are Side Effects of Atgam?
Common side effects of Atgam include:
- fever,
- chills,
- rash,
- itching,
- hives,
- chest/back pain,
- joint pain,
- diarrhea,
- headache,
- nausea,
- vomiting,
- night sweats,
- dizziness,
- shortness of breath,
- low blood pressure (hypotension), and
- pain at the infusion site
Dosage for Atgam
Talk to your doctor about your individual dosage recommendation of Atgam. Atgam must be administered under a doctor's supervision.
What Drugs, Substances, or Supplements Interact with Atgam?
Other drugs may interact with Atgam. Tell your doctor all medications you take.
Atgam During Pregnancy or Breastfeeding
Do not take Atgam if you are pregnant. Exercise caution while taking Atgam and breastfeeding.
Additional Information
Our Atgam (lymphocyte immune globulin, anti-thymocyte globulin [equine]) Sterile Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Atgam Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; chest pain, back pain; swelling of your face, lips, tongue, or throat.
Tell your caregivers right away if you have:
- fast heartbeat, trouble breathing;
- a light-headed feeling, like you might pass out;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin, coughing up blood or vomit that looks like coffee grounds;
- seizure (convulsions); or
- low white blood cell counts--fever, swollen glands, skin sores, rash or itching, muscle or joint pain, feeling very weak or tired.
Common side effects may include:
- fever, chills, night sweats, or other signs of infection;
- blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
- nausea, vomiting, diarrhea;
- pain where the medicine was injected;
- red or itching skin;
- abnormal liver or kidney function tests;
- dizziness, headache, confusion; or
- redness, swelling, warmth, irritation, or tenderness in the veins of your arms or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Atgam (Lymphocyte immune globulin)
Atgam Professional Information
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 entire FDA prescribing information for Atgam (Lymphocyte immune globulin)
&Copy; Atgam Patient Information is supplied by Cerner Multum, Inc. and Atgam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.