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)].
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)].
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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Pfizer Safety
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
Pfizer Safety Reporting Site*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.