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)].
- 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)].