PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. PANZYGA is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity .
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. (See WARNING and PRECAUTIONS [ 5.4 ], PATIENT COUNSELING INFORMATION [ 17 ]) 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 product 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 DOSAGE and ADMINISTRATION [ 2.3 ], WARNINGS and PRECAUTIONS [ 5.2 , 5.4 ])
PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. PANZYGA is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity .
For intravenous use only.
Solution containing 10% IgG (100 mg/mL) (See How Supplied/Storage and Handling ( 16 )).
With intravenous administration, overdose may lead to fluid overload and hyperviscosity. Patients at risk of complications of fluid overload and hyperviscosity include elderly patients and those with cardiac or renal impairment.
PANZYGA is supplied in 1 g, 2.5 g, 5 g, 10 g, 20 g, and 30 g single-use bottles. The table below shows the details of available presentations of PANZYGA. Carton NDC Number Container NDC Number Size Grams Protein 0069-1011-02 0069-1011-01 10 mL 1 0069-1109-02 0069-1109-01 25 mL 2.5 0069-1224-02 0069-1224-01 50 mL 5 0069-1312-02 0069-1312-01 100 mL 10 0069-1415-02 0069-1415-01 200 mL 20 0069-1558-02 0069-1558-01 300 mL 30 PANZYGA is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), choose a filter size of 0.2-200 microns. Components used in the packaging of PANZYGA are not made with natural rubber latex. Store PANZYGA for 36 months at +2°C to +8°C (36°F to 46°F) from the date of manufacture. Within its shelf-life, the product may be stored at ≤ +25°C (77°F) for up to 12 months. After storage at ≤ +25°C (77°F), either use immediately or discard the product. Do not use after expiration date. Do not freeze. Do not use frozen product. PANZYGA contains no preservatives. The PANZYGA bottle is for single use only. Use promptly any bottle that has been entered or opened, and discard partially used bottles. Dispose of any unused product or waste material in accordance with local requirements.
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL Immune Globulin Intravenous (Human) - ifas, 10% Panzyga 10 mL NDC 0069-1011-02 Carton Panzyga 25 mL NDC 0069-1109-02 Carton Panzyga 50 mL NDC 0069-1224-02 Carton Panzyga 100 mL NDC 0069-1312-02 Carton Panzyga 200 mL NDC 0069-1415-02 Carton Panzyga 300 mL NDC 0069-1558-02 Carton
| Name | UNII | Kind |
|---|---|---|
| HUMAN IMMUNOGLOBULIN G | 66Y330CJHS | ACTIB |
| HUMAN IMMUNOGLOBULIN G | 66Y330CJHS | ACTIB |
| HUMAN IMMUNOGLOBULIN G | 66Y330CJHS | ACTIB |
| HUMAN IMMUNOGLOBULIN G | 66Y330CJHS | ACTIB |
| HUMAN IMMUNOGLOBULIN G | 66Y330CJHS | ACTIB |
| HUMAN IMMUNOGLOBULIN G | 66Y330CJHS | ACTIB |
PANZYGA, Immune Globulin Intravenous (Human) - ifas 10% Liquid Preparation
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. (See WARNING and PRECAUTIONS [ 5.4 ], PATIENT COUNSELING INFORMATION [ 17 ]) 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 product 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 DOSAGE and ADMINISTRATION [ 2.3 ], WARNINGS and PRECAUTIONS [ 5.2 , 5.4 ])
For intravenous use only.
Solution containing 10% IgG (100 mg/mL) (See How Supplied/Storage and Handling ( 16 )).
PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. PANZYGA is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity .
PI: The most common adverse reactions observed at a rate of more than 5% in subjects in clinical trials were: headache, abdominal pain, fever, nausea, and fatigue. Chronic ITP in adults: The most common adverse reactions observed at a rate of more than 5% in subjects in clinical trials were: headache, fever, nausea, vomiting, dizziness, and anemia. CIDP in adults: The most common adverse reactions observed at a rate of more than 5% in subjects in clinical trials were: headache, fever, dermatitis and blood pressure increased. The most serious adverse reaction observed with PANZYGA treatment during clinical trials was aseptic meningitis in one subject.
Clinical studies have not evaluated mixtures of PANZYGA with other drugs and intravenous solutions. It is recommended that PANZYGA is administered separately from other drugs or medications which the patient may be receiving. Do not mix the product. Do not mix PANZYGA with IGIVs from other manufacturers. Passively transferred antibodies in immunoglobulin preparations can confound the results of serological testing, e.g. false positive Treponema pallidum testing might occur. Antibodies in PANZYGA may interfere with the response to live viral vaccines, such as measles, mumps, and rubella. Inform physicians of recent therapy with PANZYGA, so that administration of live viral vaccines, if indicated, can be appropriately delayed for 3 or more months from the time of PANZYGA administration.
With intravenous administration, overdose may lead to fluid overload and hyperviscosity. Patients at risk of complications of fluid overload and hyperviscosity include elderly patients and those with cardiac or renal impairment.
Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 4% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2; PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus); BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV); MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV); PPV: Porcine Parvovirus, a model for Human Parvovirus B19; n.a.: not applicable; n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ] Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.
Duhem C, Dicato MA, Ries F: Side-effects of intravenous immune globulins. Clin.Exp.Immunol. 1994;97 Suppl 1:79-83. Steinberger BA, Ford SM, Coleman TA: Intravenous immunoglobulin therapy results in post-infusional hyperproteinemia, increased serum viscosity, and pseudohyponatremia. Am.J Hematol. 2003;73:97-100. Dalakas MC: High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994;44:223-226. Go RS, Call TG: Deep venous thrombosis of the arm after intravenous immunoglobulin infusion: case report and literature review of intravenous immunoglobulin-related thrombotic complications. Mayo Clin Proc 2000;75:83-85. Wolberg AS, Kon RH, Monroe DM, et al: Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am.J.Hematol. 2000;65:30-34. Sekul EA, Cupler EJ, Dalakas MC: Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern.Med 1994;121:259-262. Kahwaji J, Barker E, Pepkowitz S, et al: Acute Hemolysis After High-Dose Intravenous Immunoglobulin Therapy in Highly HLA Sensitized Patients. Clin J Am Soc Nephrol 2009;4:1993-1997. Daw Z, Padmore R, Neurath D, et al: Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: A case series analysis. Transfusion 2008;48:1598-1601. Rizk A, Gorson KC, Kenney L, et al: Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001;41:264-268. Radomski KU, Lattner G, Schmidt T, Römisch J: Pathogen Safety of a New Intravenous Immune Globulin 10% Liquid. BioDrugs 2017(2): 125-134
PANZYGA is supplied in 1 g, 2.5 g, 5 g, 10 g, 20 g, and 30 g single-use bottles. The table below shows the details of available presentations of PANZYGA. Carton NDC Number Container NDC Number Size Grams Protein 0069-1011-02 0069-1011-01 10 mL 1 0069-1109-02 0069-1109-01 25 mL 2.5 0069-1224-02 0069-1224-01 50 mL 5 0069-1312-02 0069-1312-01 100 mL 10 0069-1415-02 0069-1415-01 200 mL 20 0069-1558-02 0069-1558-01 300 mL 30 PANZYGA is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), choose a filter size of 0.2-200 microns. Components used in the packaging of PANZYGA are not made with natural rubber latex. Store PANZYGA for 36 months at +2°C to +8°C (36°F to 46°F) from the date of manufacture. Within its shelf-life, the product may be stored at ≤ +25°C (77°F) for up to 12 months. After storage at ≤ +25°C (77°F), either use immediately or discard the product. Do not use after expiration date. Do not freeze. Do not use frozen product. PANZYGA contains no preservatives. The PANZYGA bottle is for single use only. Use promptly any bottle that has been entered or opened, and discard partially used bottles. Dispose of any unused product or waste material in accordance with local requirements.
Inform patients of the signs and symptoms of hypersensitivity reactions including urticaria, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis, and to contact their physicians immediately if allergic symptoms occur. Inform patients to immediately report the signs and symptoms of the following conditions to their physician: Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath, which may suggest kidney problems (see Renal Failure ( 5.2 )) . Symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body (see Thrombosis ( 5.4 )) Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea and vomiting (see Aseptic Meningitis Syndrome ( 5.5 )) Increased heart rate, fatigue, yellowing of skin or eyes and dark-colored urine (see Hemolysis ( 5.6 )) Trouble breathing, chest pain, blue lips or extremities, fever (see TRALI ( 5.7 )) Inform patients that PANZYGA is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses, and theoretically, the CJD agent), and that the risk of infectious agent transmission has been reduced by (a) screening plasma donors for prior exposure to viruses, (b) testing the donated plasma for viral infections and (c) inactivating and/or removing viruses during manufacture. Inform patients that administration of PANZYGA may interfere with the response to live viral vaccines such as measles, mumps and rubella, and to notify their immunizing physician of their therapy with PANZYGA. Manufactured by: Octapharma Pharmazeutika Produktionsges.m.b.H. Oberlaaer Strasse 235 1100 Vienna, Austria Distributed by: Pfizer Labs Division of Pfizer Inc New York, NY 10001
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL Immune Globulin Intravenous (Human) - ifas, 10% Panzyga 10 mL NDC 0069-1011-02 Carton Panzyga 25 mL NDC 0069-1109-02 Carton Panzyga 50 mL NDC 0069-1224-02 Carton Panzyga 100 mL NDC 0069-1312-02 Carton Panzyga 200 mL NDC 0069-1415-02 Carton Panzyga 300 mL NDC 0069-1558-02 Carton
Official SPL XML cached by FDA.report · DailyMed PDF
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