Antigen Neutralization

Human Immunoglobulin G

Immunologic Deficiency Syndromes

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">PRIVIGEN is a ready-to-use, sterile, 10% protein liquid preparation of polyvalent human immunoglobulin G (IgG) for intravenous administration. PRIVIGEN has a purity of at least 98% IgG, consisting primarily of monomers. The balance consists of IgG dimers (≤12%), small amounts of fragments and polymers, and albumin. PRIVIGEN contains ≤25 mcg/mL IgA. The IgG subclass distribution is similar to that of normal human plasma. PRIVIGEN has an osmolality of approximately 320 mOsmol/kg (range: 240 to 440) and a pH of 4.8 (range: 4.6 to 5.0).</p><p>PRIVIGEN contains approximately 250 mmol/L (range: 210 to 290) of L-proline (a nonessential amino acid) as a stabilizer and trace amounts of sodium. PRIVIGEN contains no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative.</p><p>PRIVIGEN is prepared from large pools of human plasma by a combination of cold ethanol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). PRIVIGEN does not activate the complement system or prekallikrein in an unspecific manner.</p><p>To specifically reduce blood group A and B antibodies (isoagglutinins A and B) the manufacturing process for PRIVIGEN includes an immunoaffinity chromatography step.</p><p>All plasma units used in the manufacture of PRIVIGEN have been tested and approved for manufacture using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to HCV and HIV-1/2 as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1 and found to be nonreactive (negative). In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passed virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 10<span class="Sup">4</span> IU of B19V DNA per mL.</p><p>The manufacturing process for PRIVIGEN includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.</p><p>These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses.</p><p>Table 6 shows the virus clearance during the manufacturing process for PRIVIGEN, expressed as the mean log<span class="Sub">10</span> reduction factor (LRF).</p><table width="90%"><caption><span>Table 6. Virus Inactivation/Removal in PRIVIGEN<a class="Sup" href="#footnote-6" name="footnote-reference-6">*</a></span></caption><col align="left" valign="top" width="28%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><col align="center" valign="top" width="12%"/><thead><tr class="First Last"><th align="left" class="Lrule Rrule"></th><th align="left" class="Rrule">HIV-1</th><th align="left" class="Rrule">PRV</th><th align="left" class="Rrule">BVDV</th><th align="left" class="Rrule">WNV</th><th align="left" class="Rrule">EMCV</th><th align="left" class="Rrule">MVM</th></tr></thead><tfoot><tr class="First Last"><td align="left" colspan="7">HIV-1, human immunodeficiency virus type 1, a model for HIV-1 and HIV-2; PRV, pseudorabies virus, a nonspecific model for large enveloped DNA viruses (eg, herpes virus); BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; WNV, West Nile virus; EMCV, encephalomyocarditis virus, a model for hepatitis A virus; MVM, minute virus of mice, a model for a small highly resistant non-enveloped DNA virus (eg, parvovirus); LRF, log<span class="Sub">10</span> reduction factor; nt, not tested.</td></tr><tr><td align="left" colspan="7"><dl class="Footnote"><dt><a href="#footnote-reference-6" name="footnote-6">*</a></dt><dd>The virus clearance of human parvovirus B19 was investigated experimentally at the pH 4 incubation step. The estimated LRF obtained was ≥5.6.</dd></dl></td></tr></tfoot><tbody><tr class="Botrule First"><td align="left" class="Lrule Rrule" colspan="7"><span class="Bold">Virus property</span></td></tr><tr><td align="left" class="Lrule Rrule">Genome</td><td align="center" class="Rrule">RNA</td><td align="center" class="Rrule">DNA</td><td align="center" class="Rrule">RNA</td><td align="center" class="Rrule">RNA</td><td align="center" class="Rrule">RNA</td><td align="center" class="Rrule">DNA</td></tr><tr><td align="left" class="Lrule Rrule">Envelope</td><td align="center" class="Rrule">Yes</td><td align="center" class="Rrule">Yes</td><td align="center" class="Rrule">Yes</td><td align="center" class="Rrule">Yes</td><td align="center" class="Rrule">No</td><td align="center" class="Rrule">No</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">Size (nm)</td><td align="center" class="Rrule">80-100</td><td align="center" class="Rrule">120-200</td><td align="center" class="Rrule">50-70</td><td align="center" class="Rrule">50-70</td><td align="center" class="Rrule">25-30</td><td align="center" class="Rrule">18-24</td></tr><tr><td align="left" class="Lrule Rrule"><span class="Bold">Manufacturing step</span></td><td align="center" class="Rrule" colspan="6"><span class="Bold">Mean LRF </span></td></tr><tr><td align="left" class="Lrule Rrule Toprule">pH 4 incubation</td><td align="center" class="Rrule Toprule">≥5.6</td><td align="center" class="Rrule Toprule">≥6.1</td><td align="center" class="Rrule Toprule">4.6</td><td align="center" class="Rrule Toprule">≥7.8</td><td align="center" class="Rrule Toprule">nt</td><td align="center" class="Rrule Toprule">nt</td></tr><tr><td align="left" class="Lrule Rrule">Depth filtration</td><td align="center" class="Rrule">≥6.7</td><td align="center" class="Rrule">≥5.7</td><td align="center" class="Rrule">3.5±0.2</td><td align="center" class="Rrule">3.0±0.4</td><td align="center" class="Rrule">5.7±0.2</td><td align="center" class="Rrule">3.7±0.3</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">Virus filtration</td><td align="center" class="Rrule">≥4.7</td><td align="center" class="Rrule">≥5.8</td><td align="center" class="Rrule">≥4.6</td><td align="center" class="Rrule">≥6.8</td><td align="center" class="Rrule">≥6.3</td><td align="center" class="Rrule">≥6.5</td></tr><tr class="Last"><td align="left" class="Lrule Rrule"><span class="Bold">Overall reduction (log<span class="Sub">10</span> units)</span></td><td align="center" class="Rrule"><span class="Bold">≥17.0</span></td><td align="center" class="Rrule"><span class="Bold">≥17.6</span></td><td align="center" class="Rrule"><span class="Bold">≥12.7</span></td><td align="center" class="Rrule"><span class="Bold">≥17.6</span></td><td align="center" class="Rrule"><span class="Bold">≥12.0</span></td><td align="center" class="Rrule"><span class="Bold">≥10.2</span></td></tr></tbody></table></section>

Privigen

immunoglobulin G, human

50 ML immunoglobulin G, human 100 MG/ML Injection

100 ML immunoglobulin G, human 100 MG/ML Injection

200 ML immunoglobulin G, human 100 MG/ML Injection

100 ML immunoglobulin G, human 100 MG/ML Injection [Privigen]

200 ML immunoglobulin G, human 100 MG/ML Injection [Privigen]

50 ML immunoglobulin G, human 100 MG/ML Injection [Privigen]

400 ML immunoglobulin G, human 100 MG/ML Injection

400 ML immunoglobulin G, human 100 MG/ML Injection [Privigen]

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

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Prescribing Information 

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Pharmacy List 

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