ATGAM® Medication Guide

(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.

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)].

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Medication Guide

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.

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)].

Medication Guide

Health Professional Information

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