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">GAMMAPLEX 5% is a ready-to-use sterile solution of polyclonal human Immunoglobulin G for intravenous administration that contains sorbitol, glycine and polysorbate 80 as stabilizers. Specifically, GAMMAPLEX 5% contains approximately 5 g normal human immunoglobulin and 5 g D-sorbitol in 100 mL of buffer solution containing: 0.6 g glycine, 0.2 g sodium acetate, 0.3 g sodium chloride and about 5 mg polysorbate 80. Immunoglobulin G purity is &gt;95%, the pH is in the range of 4.8 to 5.1, and osmolality is not less than 240 mOsmol/kg (typically 420 to 500 mOsmol/kg). The distribution of the four IgG subclasses is approximately 64% IgG1, 30% IgG2, 5% IgG3, and 1% IgG4. The content of IgA is lower than 10 micrograms/mL. The anti-D and anti-A/anti-B hemagglutinin content of the drug product is strictly controlled to specification. GAMMAPLEX 5% contains no reducing carbohydrate stabilizers (e.g. sucrose, maltose) and no preservative.</p><p>GAMMAPLEX 5% is prepared from large pools of human plasma by a combination of cold ethanol fractionation and ion exchange chromatography. Fab functions tested include antigen binding activity, and Fc functions tested include complement activation and rubella antibody-mediated hemolysis.</p><p>GAMMAPLEX 5% is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma.</p><p>All plasma donations are screened for antibody to HIV-1/2 and hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) that undergo nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), HCV, hepatitis A virus (HAV) and parvovirus B19.</p><p>Further testing is carried out on the manufacturing pools for HBsAg, and antibody to HIV-1/2; HCV and parvovirus B19 are also tested by NAT, with the limit for B19 set to not exceed 10<span class="Sup">4</span> IU B19 DNA per mL plasma.</p><p>There are three processing steps specifically designed to remove or inactivate viruses:</p><p>1) Solvent/Detergent treatment is targeted to enveloped viruses;</p><p>2) A virus filtration step designed to remove small viruses including non-enveloped viruses, on a size exclusion basis; and</p><p>3) The terminal low pH incubation step is identified as contributing to the overall viral clearance capacity for enveloped and non-enveloped viruses.</p><p>The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other.</p><p>In addition, each step was validated to provide robust virus reduction. The table below presents the contribution of each process step to virus reduction and the overall process reduction.</p><a name="Table5"></a><table width="80%"><caption><span>Table 5: Viral Reduction by Process Step</span></caption><col align="left" valign="top" width="10%"/><col align="left" valign="top" width="20%"/><col align="left" valign="top" width="14%"/><col align="left" valign="top" width="12%"/><col align="left" valign="top" width="12%"/><col align="left" valign="top" width="17%"/><col align="left" valign="top" width="15%"/><thead><tr class="Botrule First"><th align="left" class="Lrule Rrule" rowspan="2" valign="middle">Virus</th><th align="left" class="Rrule" rowspan="2" valign="middle">Type<br/>(Envelope/Genome)</th><th align="left" class="Rrule" rowspan="2" valign="middle">Size<br/>(nm)</th><th align="center" class="Rrule" colspan="3">Process Log<span class="Sub">10</span> Reduction of Virus (LRV) over manufacturing step</th><th align="left" class="Rrule"></th></tr><tr class="Botrule Last"><th align="left" class="Rrule" valign="middle">Solvent Detergent</th><th align="left" class="Rrule" valign="middle">20 nm filtration</th><th align="left" class="Rrule" valign="middle">Terminal low pH/elevated temperature incubation</th><th align="left" class="Rrule" valign="middle">Total LRV</th></tr></thead><tfoot><tr class="First"><td align="left" valign="top">HIV:</td><td align="left" colspan="6" valign="top">Human immunodeficiency virus</td></tr><tr><td align="left" valign="top">SIN:</td><td align="left" colspan="6" valign="top">Sindbis virus, model for hepatitis C virus (HCV)</td></tr><tr><td align="left" valign="top">WNV:</td><td align="left" colspan="6" valign="top">West Nile Virus</td></tr><tr><td align="left" valign="top">BVDV:</td><td align="left" colspan="6" valign="top">Bovine viral diarrhea virus, model for HCV</td></tr><tr><td align="left" valign="top">IBR:</td><td align="left" colspan="6" valign="top">Infectious bovine rhinotracheitis, bovine herpes virus model for enveloped DNA viruses including hepatitis B</td></tr><tr><td align="left" valign="top">HAV:</td><td align="left" colspan="6" valign="top">Hepatitis A virus</td></tr><tr><td align="left" valign="top">EMC:</td><td align="left" colspan="6" valign="top">Encephalomyocarditis, model for HAV</td></tr><tr><td align="left" valign="top">CPV:</td><td align="left" colspan="6" valign="top">Canine parvovirus, model for human parvovirus B19</td></tr><tr><td align="left" valign="top">NA:</td><td align="left" colspan="6" valign="top">Not applicable, solvent detergent step is limited to the inactivation of enveloped viruses</td></tr><tr><td align="left" valign="top">I:</td><td align="left" colspan="6" valign="top">Inactivation by the product intermediate precluded the accurate estimation of the removal of these viruses by the filtration step</td></tr><tr><td align="left" valign="top">NT:</td><td align="left" colspan="6" valign="top">Not tested</td></tr><tr class="Last"><td align="left" valign="top">B19:</td><td align="left" colspan="6" valign="top">Viral clearance of human parvovirus B19 was investigated experimentally at the 20 nm filtration step. The estimated Log reduction Factor obtained was 6.0</td></tr></tfoot><tbody><tr class="Botrule First"><td align="left" class="Lrule Rrule">HIV</td><td align="left" class="Rrule">Env/RNA</td><td align="left" class="Rrule">80-100</td><td align="left" class="Rrule">&gt;6.8</td><td align="left" class="Rrule">I</td><td align="left" class="Rrule">&gt;6.1</td><td align="left" class="Rrule">&gt;12.9</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">SIN</td><td align="left" class="Rrule">Env/RNA</td><td align="left" class="Rrule">70</td><td align="left" class="Rrule">&gt;6.7</td><td align="left" class="Rrule">6.2</td><td align="left" class="Rrule">&gt;7.3</td><td align="left" class="Rrule">&gt;20.2</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">WNV</td><td align="left" class="Rrule">Env/RNA</td><td align="left" class="Rrule">50</td><td align="left" class="Rrule">&gt;6.4</td><td align="left" class="Rrule">I</td><td align="left" class="Rrule">NT</td><td align="left" class="Rrule">&gt;6.4</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">BVDV</td><td align="left" class="Rrule">Env/RNA</td><td align="left" class="Rrule">40-60</td><td align="left" class="Rrule">&gt;5.6</td><td align="left" class="Rrule">I</td><td align="left" class="Rrule">&gt;6.1</td><td align="left" class="Rrule">&gt;11.7</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">IBR</td><td align="left" class="Rrule">Env/DNA</td><td align="left" class="Rrule">200</td><td align="left" class="Rrule">&gt;5.0</td><td align="left" class="Rrule">I</td><td align="left" class="Rrule">&gt;6.3</td><td align="left" class="Rrule">&gt;11.3</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">HAV</td><td align="left" class="Rrule">Non-Env/RNA</td><td align="left" class="Rrule">30</td><td align="left" class="Rrule">NA</td><td align="left" class="Rrule">&gt;4.8</td><td align="left" class="Rrule">0.9</td><td align="left" class="Rrule">&gt;4.8</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">EMC</td><td align="left" class="Rrule">Non-Env/RNA</td><td align="left" class="Rrule">30</td><td align="left" class="Rrule">NA</td><td align="left" class="Rrule">&gt;4.8</td><td align="left" class="Rrule">1.6</td><td align="left" class="Rrule">&gt;6.4</td></tr><tr class="Last"><td align="left" class="Lrule Rrule">CPV</td><td align="left" class="Rrule">Non-Env/RNA</td><td align="left" class="Rrule">18-24</td><td align="left" class="Rrule">NA</td><td align="left" class="Rrule">3.2</td><td align="left" class="Rrule">1.1</td><td align="left" class="Rrule">4.3</td></tr></tbody></table></section>

Gammaplex

immunoglobulin G, human

100 ML immunoglobulin G, human 50 MG/ML Injection

200 ML immunoglobulin G, human 50 MG/ML Injection

400 ML immunoglobulin G, human 50 MG/ML Injection

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

200 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex]

400 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex]

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 

Reimbursement Information 

Get Benefits Investigation Support 

Coverage Authorization Request 

Coverage Authorization Appeals 

Enroll in patient savings program (  no program offered ) 

About Gammaplex 10%

About Gammaplex 5% 

Patient Stories - Gammaplex 10 % 

Instructions for Use (Gammaplex 10 %) : Idiopathic Thrombocytopenic Purpura (ITP)

Instructions for Use (Gammaplex 10 %) : Primary Humoral Immunodeficiency  (PI)

Instructions for Use ( Gammaplex 5 %): Idiopathic Thrombocytopenic Purpura (ITP)

Instructions for Use ( Gammplex 5%) : Primary Humoral Immunodeficiency  (PI) - Adults 

Instructions for Use (Gammaplex 5%): Primary Humoral Immunodeficiency (PI) - Pediatrics

Submit MSL Request 