IMPORTANT SAFETY INFORMATION AND INDICATION
IMPORTANT SAFETY INFORMATION AND INDICATION AND USAGE
PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin and in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
Warnings and Precautions
Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.
Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving PANZYGA.
Aseptic meningitis syndrome may occur in patients receiving PANZYGA, especially with high doses or rapid infusion.
Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to PANZYGA treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.
Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).
Monitor blood pressure prior to, during, and following PANZYGA infusion.
Carefully consider the relative risks and benefits before prescribing the high dose regimen (for cITP) in patients at increased risk of volume overload.
PANZYGA is made from human plasma and may contain infectious agents, e.g. viruses and theoretically, the Creutzfeldt-Jakob disease agent.
PI – The most common adverse reactions (≥5% study subjects) were headache, nausea, fever, fatigue, and abdominal pain.
cITP in adults – The most common adverse reactions (≥5% study subjects) were headache, fever, nausea, vomiting, dizziness, and anemia.
CIDP in adults – The most common adverse reactions reported in greater than 5% of subjects were: headache, fever, dermatitis, and blood pressure increase.
The risk information provided here is not comprehensive; see Full Prescribing Information and Boxed Warning for PANZYGA.
INDICATION AND USAGE
PANZYGA (Immune Globulin Intravenous [Human] - ifas) is indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older; this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies; chronic immune thrombocytopenia (cITP) in adults to raise platelet counts to control or prevent bleeding; and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment.
You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
Please click here for Full Prescribing Information, including BOXED WARNING.