Immunologic Deficiency Syndromes

<section class="Section" data-sectioncode="34089-3"><a name="AS110"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>ASCENIV is a purified, sterile, ready-to-use preparation of concentrated human immunoglobulin G (IgG) antibodies. The product is a clear to opalescent liquid, which is colorless to pale yellow. The distribution of IgG subclasses is similar to that of normal plasma. The active ingredient is human immunoglobulin purified from source human plasma and processed using a modified classical Cohn Method 6 / Oncley Method 9 fractionation procedure. ASCENIV contains 100 ± 10 mg/mL protein, of which not less than 96% is human immunoglobulin obtained from source human plasma. It is formulated in water for injection containing 0.100-0.140 M sodium chloride, 0.20-0.29 M glycine, 0.15–0.25% polysorbate 80, with pH 4.0–4.6. ASCENIV contains ≤ 200 µg/mL of IgA.Each plasma donation used for the manufacture of ASCENIV is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, each plasma unit must test negative and/or non-reactive for HIV RNA, HCV RNA, HBV DNA, Hepatitis A Virus (HAV) RNA, and Parvovirus B19 (B19 virus) DNA as determined by Nucleic Acid Amplification Testing (NAT) of plasma minipools. NATs for HIV, HAV, HBV, HCV and B19 virus DNA are also performed on a sample of the manufacturing pool. The limit for B19 virus DNA in a manufacturing pool is set not to exceed 10 4 IU/mL and all other NAT results must be negative. The manufacturing process of ASCENIV employs three steps to remove/inactivate adventitious viruses to minimize the risk of virus transmission. The steps are "Precipitation and removal of fraction III" during cold ethanol fractionation, classical "solvent/detergent treatment" and "35 nm virus filtration." In compliance with current guidelines, the steps have been separately validated in a series of in vitro experiments for their capacity to inactivate or remove both enveloped and nonenveloped viruses.Precipitation and removal of fraction III removes both enveloped and non-enveloped viruses, solvent/detergent treatment represents a virus inactivation step for enveloped viruses, and 35 nm virus filtration removes both enveloped and non-enveloped viruses by size exclusion. In addition to the steps above, low pH during several steps of the production process contributes to virus inactivation. The results of virus validation studies for ASCENIV are shown in <a href="#table3">Table 3</a>, expressed as log 10 reduction factors. <a name="table3"></a><table class="Noautorules" width="750"><caption>Table 3: Virus Validation Data for ASCENIV</caption><col align="left" width="19%"/><col align="center" width="9%"/><col align="center" width="9%"/><col align="center" width="9%"/><col align="center" width="9%"/><col align="center" width="9%"/><col align="center" width="9%"/><col align="center" width="9%"/><col align="center" width="9%"/><col align="center" width="9%"/><tfoot><tr><td align="left" colspan="10">*without depth filtration -- not done values below 1 log 10 are considered as insignificant and are not used for total clearance; HIV, human immunodeficiency virus; BVDV, Bovine viral diarrhea virus, model virus for HCV; SinV, Sindbis virus, model virus for HCV; WNV, West Nile virus; PRV, Pseudorabies virus, model virus for herpes viruses and Hepatitis B virus; MEV, Murine encephalomyelitis virus, model virus for hepatitis A virus; BPV, Bovine parvovirus, model virus for human B19 virus; PPV, Porcine parvovirus, model virus for human B19 virus; SV40, Simian virus 40, model virus for highly resistant non- enveloped viruses. </td></tr></tfoot><tbody class="Headless"><tr><td align="left"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="9">Virus Reduction (log 10) </td></tr><tr><td align="left" class="Lrule Rrule Toprule" rowspan="2">Virus Type Family</td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="5">Enveloped Viruses</td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="4">Non-enveloped Viruses</td></tr><tr><td align="center" class="Botrule Lrule Rrule Toprule">Retro</td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3">Flavi</td><td align="center" class="Botrule Lrule Rrule Toprule">Herpes</td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2">Parvo</td><td align="center" class="Botrule Lrule Rrule Toprule">Picorna</td><td align="center" class="Botrule Lrule Rrule Toprule">Polyoma</td></tr><tr><td align="left" class="Botrule Lrule Rrule Toprule">Step / Test Virus</td><td align="center" class="Botrule Lrule Rrule Toprule">HIV</td><td align="center" class="Botrule Lrule Rrule Toprule">BVDV</td><td align="center" class="Botrule Lrule Rrule Toprule">SinV</td><td align="center" class="Botrule Lrule Rrule Toprule">WNV</td><td align="center" class="Botrule Lrule Rrule Toprule">PRV</td><td align="center" class="Botrule Lrule Rrule Toprule">PPV</td><td align="center" class="Botrule Lrule Rrule Toprule">BPV</td><td align="center" class="Botrule Lrule Rrule Toprule">MEV</td><td align="center" class="Botrule Lrule Rrule Toprule">SV40</td></tr><tr><td align="left" class="Botrule Lrule Rrule Toprule">Precipitation and Removal of Fraction III and Depth Filtration </td><td align="center" class="Botrule Lrule Rrule Toprule">-</td><td align="center" class="Botrule Lrule Rrule Toprule">1.87 *</td><td align="center" class="Botrule Lrule Rrule Toprule">-</td><td align="center" class="Botrule Lrule Rrule Toprule">-</td><td align="center" class="Botrule Lrule Rrule Toprule">-</td><td align="center" class="Botrule Lrule Rrule Toprule">4.00</td><td align="center" class="Botrule Lrule Rrule Toprule">-</td><td align="center" class="Botrule Lrule Rrule Toprule">5.29</td><td align="center" class="Botrule Lrule Rrule Toprule">2.00 *</td></tr><tr><td align="left" class="Botrule Lrule Rrule Toprule">TnBP/Triton X-100 Treatment </td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 4.43</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 5.04</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 7.11</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 4.96</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 4.01</td><td align="center" class="Botrule Lrule Rrule Toprule">-</td><td align="center" class="Botrule Lrule Rrule Toprule">-</td><td align="center" class="Botrule Lrule Rrule Toprule">-</td><td align="center" class="Botrule Lrule Rrule Toprule">-</td></tr><tr><td align="left" class="Botrule Lrule Rrule Toprule">35 nm Virus Filtration </td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 5.19</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 4.88</td><td align="center" class="Botrule Lrule Rrule Toprule">-</td><td align="center" class="Botrule Lrule Rrule Toprule">-</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 4.64</td><td align="center" class="Botrule Lrule Rrule Toprule">&lt; 1.0</td><td align="center" class="Botrule Lrule Rrule Toprule">6.18</td><td align="center" class="Botrule Lrule Rrule Toprule">&lt; 1.0</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 5.02</td></tr><tr><td align="left" class="Botrule Lrule Rrule Toprule">Total Clearance</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 9.62</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 11.79</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 7.11</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 4.96</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 8.65</td><td align="center" class="Botrule Lrule Rrule Toprule">4.00</td><td align="center" class="Botrule Lrule Rrule Toprule">6.18</td><td align="center" class="Botrule Lrule Rrule Toprule">5.29</td><td align="center" class="Botrule Lrule Rrule Toprule">&gt; 7.02</td></tr></tbody></table></section>

ASCENIV

immune globulin intravenous (human) - slra

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

Asceniv

50 ML immune globulin intravenous (human) - slra 100 MG/ML Injection [Asceniv]

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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Instructions For Use: Primary Immunodeficiency