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ATGAM® Patient Counseling Information (lymphocyte immune globulin, anti-thymocyte globulin [equine])

17 PATIENT COUNSELING INFORMATION

Advise patients receiving ATGAM that they will be monitored in a facility equipped and staffed with adequate laboratory and supportive medical resources.

Inform patients that ATGAM may cause serious allergic reactions, infection or abnormal liver or renal function.

Serious Allergic Reactions

  • Advise the patient to discontinue ATGAM and seek immediate medical attention if any signs/symptoms of an allergic or immune reaction occur [see Warnings and Precautions (5.1)].

Skin Testing

  • 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 (5.2)].

Infections

  • Advise the patient to discontinue ATGAM and report any sign/symptoms of leukopenia, thrombocytopenia, or infection (e.g., fever, sweating, chills, muscle aches, cough, shortness of breath, diarrhea or stomach pain) [see Warnings and Precautions (5.1), (5.2), (6)].
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