(lymphocyte immune globulin, anti-thymocyte globulin [equine])
Advise patients receiving ATGAM that they will be monitored in a facility equipped and staffed with adequate laboratory and supportive medical resources.
Anaphylaxis
Advise the patient that ATGAM may be discontinued and immediate medical attention will be provided if any signs/symptoms of anaphylaxis occur [see Warnings and Precautions (5.1)].
Cytokine Release Syndrome
Advise the patient on the risk of cytokine release syndrome [see Warnings and Precautions (5.2)].
Infusion-Associated Reactions
Advise the patient on the clinical signs associated with infusion-associated reactions [see Warnings and Precautions (5.3)].
Serum Sickness
Advise the patient on the clinical signs associated with serum sickness [see Warnings and Precautions (5.4)].
Transmissible Infectious Agents
Despite screening and testing, products manufactured using components of human blood such as ATGAM may carry a risk of transmitting infectious agents (e.g., viruses). Discuss the risks and benefits of therapy with patients before initiating treatment [see Warnings and Precautions (5.5)].
Infections
Advise the patient to report any signs and symptoms of infection (e.g., fever, sweating, chills, muscle aches, cough, shortness of breath, diarrhea, or stomach pain) [see Warnings and Precautions (5.6)].
Thrombocytopenia and Neutropenia
Advise the patient to report any signs and symptoms of thrombocytopenia and/or neutropenia (e.g., unusual bleeding, bruising, rash of dark red spots under the skin, fever, sweating, chills, muscle aches, cough, shortness of breath, diarrhea, or stomach pain) [see Warnings and Precautions (5.8)].
Hepatic and Renal Function Tests
Advise the patient that monitoring of liver and renal function will occur. Advise the patient of abnormal liver and renal function test results [see Warnings and Precautions (5.9)].
{{section_name_patient}}
{{section_body_html_patient}}
Additional Resources
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.
Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.
Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for a Pfizer medicine or a vaccine.
The submission will be reviewed during our standard business hours.
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information:
Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.