Information for Healthcare Professionals about Panzyga® 10% | Panzyga (Immune Globulin Intravenous (Human) – ifas 10%) is FDA approved for the treatment of PI in patients over 2 years old, cITP in adults and CIDP in adults.

For Treatment of PI, cITP in Adults, or CIDP in Adults

Panzyga is
FDA-Approved
for Treatment of:

Primary humoral immunodeficiency (PI) in patients 2 years of age and older
Chronic immune thrombocytopenia (cITP) in adults to raise platelet counts to control or prevent bleeding
Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment

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Clinical Studies

Intravenous Immunoglobulin 10% in Children with Primary Immunodeficiency Diseases

Assessed the safety and efficacy of Panzyga in preventing serious bacterial infections (SBIs) in predominantly antibody-deficient children with PI disease, finding it effective, well tolerated, and safe for both children and adolescents during 12-15 months of treatment.¹

Efficacy and Safety of Human Intravenous Immunoglobulin 10% (Panzyga) in Patients with Primary Immunodeficiency Diseases

Analyzed the efficacy and safety of Panzyga in preventing serious bacterial infections (SBIs) in patients with PI, finding that its use with antibody-deficient PI patients was associated with a low rate of adverse events (AEs) and was effective in preventing SBIs.²

Pharmacokinetics of a Novel Human Intravenous Immunoglobulin 10% in Patients with Primary Immunodeficiency Diseases

Investigated the pharmacokinetics of Panzyga in patients aged 2-75 years with CVID or X-linked agammaglobulinaemia, finding its pharmacokinetic properties similar to those of other commercial preparations and that 3- or 4-weekly administration achieved sufficient concentrations of IgG/IgG subclasses/specific antibodies needed to prevent serious bacterial infections.³

Efficacy and Safety of a New Intravenous Immunoglobulin (Panzyga) in Chronic Immune Thrombocytopenia

Assessed the efficacy and safety of Panzyga, a novel human normal IVIg 10%, in adult patients with chronic ITP, finding it well tolerated even at a high infusion speed, inducing a rapid platelet count increase, thus decreasing rate and severity of bleeding events.⁴

ProCID Trial of Panzyga for CIDP

The Progress in Chronic Inflammatory Demyelinating polyneuropathy (ProCID) dose-ranging study investigated the efficacy, tolerability, and safety of a standard loading dose of Panzyga followed by 3 alternative maintenance dosing levels, finding that the 1.0 and 2.0 g/kg dosing levels were efficacious and well tolerated as maintenance treatment for CIDP in adults.⁵

ProCID Study Design

A closer look at study design and protocol of the ProCID randomized, multicenter, phase III study of intravenous immunoglobulin 10% in adult patients with chronic inflammatory demyelinating polyradiculoneuropathy.⁶

Physician Support Materials

Fast Facts: Panzyga for Treatment of PI & cITP

A handy reference overview of the safety, tolerability, and efficacy of Panzyga used in the treatment of PI and cITP, along with recommended dosing and administration rates for both disease states.

Fast Facts: Panzyga for Treatment of CIDP

A handy reference overview of the safety, tolerability, and efficacy of a standard loading dose and two FDA-approved maintenance dosing options for Panzyga used in the treatment of CIDP in adults.

Panzyga Infusion Guide

For help calculating the appropriate infusion rate for loading and maintenance dosing for your patients with PI, cITP, and CIDP.

Keep Me Updated on Panzyga

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References:

Ochs HD, Melamed I, Borte M, et al. Intravenous immunoglobulin 10% in children with primary immunodeficiency diseases. Immunotherapy. 2018 Oct;10(14):1193-1202. doi:10.2217/imt-2018-0074
Borte M, Melamed IR, Pulka G, et al. Efficacy and safety of human intravenous immunoglobulin 10% (Panzyga^®) in patients with primary immunodeficiency diseases: a two-stage, multicenter, prospective, open-label study. J Clin Immunol. 2017;37(6):603-612. doi:10.1007/s10875-017-0424-4
Melamed IR, Borte M, Trawnicek L, et al. Pharmacokinetics of a novel human intravenous immunoglobulin 10% in patients with primary immunodeficiency diseases: analysis of a phase III, multicentre, prospective, open-label study. Eur J Pharm Sci. 2018;118:80-86. doi:10.1016/j.ejps.2018.03.007
Arbach O, Taumberger AB, Wietek S, Cervinek L, Salama A. Efficacy and safety of a new intravenous immunoglobulin (Panzyga^®) in chronic immune thrombocytopenia. Transfus Med. 2019;29(1):48-54. doi:10.1111/tme.12573
Cornblath DR, van Doorn PA, Hartung HP, et al. Randomized trial of three IVIg doses for treating chronic inflammatory demyelinating polyneuropathy. Brain. 2022 Apr 29;145(3):887-896. doi:10.1093/brain/awab422
Cornblath DR, Hartung HP, Katzberg HD, Merkies ISJ, van Doorn PA. A randomised, multi-centre phase III study of 3 different doses of intravenous immunoglobulin 10% in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ProCID trial): study design and protocol. J Peripher Nerv System. 2018;23:108-114. doi:10.1111/jns.12267

Indications and Important Safety Information for Panzyga^® Immune Globulin Intravenous (Human) – ifas 10% Liquid Preparation

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

Please click here for Full Prescribing Information, including BOXED WARNING.

Indications and Important Safety Information for Panzyga^® Immune Globulin Intravenous (Human) – ifas 10% Liquid Preparation

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

Please click here for Full Prescribing Information, including BOXED WARNING.

Thrombosis may occur with immune globulin intravenous (IVIg) 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 IVIg 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 IVIg 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)]

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.

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 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.

Please click here for Full Prescribing Information, including BOXED WARNING.