"The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
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].
- 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].
- 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.
Additional Atgam Information
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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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