Immunologic Deficiency Syndromes

<section class="Section" data-sectioncode="34089-3"><a name="DESCRIPTION"></a><a name="section-11"></a><h1>11 DESCRIPTION</h1>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 90% monomers and dimers, and not more than 3% 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: IgG1 is 65%, IgG2 is 28%, IgG3 is 3% and IgG4 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 (<a href="#Table4">Table 4</a>). 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). <a href="#Table4">Table 4</a> shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log10 reduction factor (LRF).<a name="Table4"></a>Table 4: Virus Reduction by PANZYGA Manufacturing Process<div class="Figure"><img alt="Image File" src="img0001.jpg"/></div> 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. [<a href="#REFERENCES">10</a>] 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. </section>

Panzyga

immune globulin intravenous (human) - ifas

10 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection

10 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]

25 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection

25 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]

50 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection

50 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]

100 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection

100 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]

200 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection

200 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]

300 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection

300 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]

immunoglobulin G

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Report Adverse Event 

Prescribing Information 

Submit MSL Request 

Pharmacy List 

Formulary Coverage 

Billing & Coding Guide 

Coverage Authorization Request 

Coverage Authorization Appeals

Letter of Medical Necessity

Panzyga Enrollment Form

Panzyga Enrollment Form - Spanish 

Enroll in Patient Savings Program 

Co-Pay Claim Form 

Pfizer Pledge Warranty Program - CIDP 

Other HCP Resources 

Other HCP Resources: Videos

App Download 

Instructions For Use: Primary Humoral Immunodeficiency (PI)

Instructions For Use: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Instructions For Use: Chronic Immune Thrombocytopenia (cITP)