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Infusion RatesCIDPDosing and administrationInfusion rate chartInfusion rate calculatorPIDosing and administrationInfusion rate chartInfusion rate calculatorcITPDosing and administrationInfusion rate chartInfusion rate calculatorEfficacyEfficacyCIDPStudy designINCAT responder ratesSupporting efficacy endpointsRescue dosingPatient profilesPIStudy designsPrimary endpoint, supporting efficacy endpoints, and safety assessmentsPatient profilescITPStudy design, primary endpoint, and supporting efficacy endpointsSafety & TolerabilitySafety & TolerabilityCIDPPIcITPSupportSupportMaterialsVideosCIDP Warranty ProgramPfizer PANZYGA Co-Pay Program for patientsPfizer IGuideTMIg Companion patient mobile appFrequently asked questionsRequest a representative
Prescribing Information, including BOXED WARNINGIndicationsImportant Safety Information
EfficacycITPAdult patients with cITP receiving PANZYGA in a clinical study demonstrated a rise in platelet count and decrease in hemorrhages when compared with baseline1 Study design

A prospective, open-label, noncontrolled, multicenter, phase 3 study evaluated the efficacy, safety, and tolerability of PANZYGA in patients with cITP aged 18 to 72 years at a maximum infusion rate of 8 mg/kg/min.

Of the 36 patients included in the full analysis, 29 patients responded to PANZYGA with an increase in platelet count within 7 days of treatment.

 Primary endpoint

Patients treated with PANZYGA achieved a rise in platelet count.

81% (n=29 [95% CI, 64%-92%]) experienced a rise in platelet count (≥50 x 109/L) within 7 days after the first infusion. Supporting efficacy endpoints

Assessments included: response rate, maximum platelet count, time to response, duration of response, and regression of hemorrhages in patients with bleeding at baseline.

Patients treated with PANZYGA demonstrated a response in platelet count within 7 days, with a median duration of 14 days.

  • Median time to response was 2 days (range: 1-4 days), with a median duration of 14 days (range: 1-20 days)


Patients treated with PANZYGA experienced a decrease in hemorrhages.

  • Among 36 patients, 64% (n=23) had bleeding at baseline compared to 14% (n=5) at day 7
Reference:Panzyga. Prescribing information. Octapharma USA Inc.; 2021.Efficacy cITP dosing and infusion rates for PANZYGA See details Loading cITP safety and tolerability data for PANZYGA Review data Loading

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INDICATIONS 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.
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE IMPORTANT SAFETY INFORMATION
  • Thrombosis may occur with immune globulin intravenous (IGIV) products, including PANZYGA. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IGIV products, including PANZYGA. Patients predisposed to renal dysfunction include those with a degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. PANZYGA does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer PANZYGA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. [see Full Prescribing Information, Warnings and Precautions (5.2, 5.4)]
 Contraindications 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. Adverse Reactions 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 (>5% study 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. 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. PANZYGA® is a registered trademark of Octapharma AG. Please click here for Full Prescribing Information, including BOXED WARNING. Helix ImageINDICATIONS 
AND USAGEPANZYGA (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.