June 26, 2016
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Atgam

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Atgam

PATIENT INFORMATION

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

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].

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].

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].

Healthcare providers should refer to labels.fda.gov or DailyMed for the most updated version of the labeling.

Last reviewed on RxList: 4/11/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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