Kallikrein Inhibitors

Human C1 Esterase Inhibitor

Angioedemas, Hereditary

<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">HAEGARDA is a human plasma-derived, purified, pasteurized, lyophilized concentrate of C1-INH to be reconstituted for S.C. administration. HAEGARDA is prepared from large pools of human plasma from U.S. donors. The potency of C1-INH is expressed in International Units (IU), which is related to the current WHO Standard for C1-INH products.</p><p>Reconstituted HAEGARDA has a concentration of 500 IU/mL C1-INH, 65 mg/mL total protein, 10 mg/mL glycine, 8.5 mg/mL sodium chloride and 2.7 mg/mL sodium citrate.</p><div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a><p></p><p class="First"><span class="Underline">C1 Esterase Inhibitor</span></p><p>C1-INH is a soluble, single-chain highly glycosylated protein containing 478 amino acid residues which belongs to the serine protease inhibitor (serpin) family.</p><p>All plasma used in the manufacturing of C1-INH is obtained from U.S. donors and is tested using serological assays for hepatitis B surface antigen and antibodies to HIV-1/2 and HCV. Additionally, the plasma is tested with Nucleic Acid Testing (NAT) for HBV, HCV, HIV-1 and HAV and found to be non-reactive (negative). The plasma is also tested by NAT for Human Parvovirus B19. Only plasma that has passed virus screening is used for production, and the limit for Parvovirus B19 in the fractionation pool is set not to exceed 10<span class="Sup">4</span> IU of Parvovirus B19 DNA per mL.</p><p>The manufacturing process for HAEGARDA includes multiple steps that reduce the risk of virus transmission. The virus inactivation/reduction capacity consists of three steps:</p><ul class="Disc"><li>Pasteurization in aqueous solution at 60°C for 10 hours</li><li>Hydrophobic interaction chromatography</li><li>Virus filtration (also called nanofiltration) by two filters, 20 nm and 15 nm, in series. </li></ul><p>Viral inactivation and reduction were evaluated in a series of in vitro spiking experiments. The total mean cumulative virus inactivation/reduction is shown in Table 2.</p><table width="100%"><caption><span>Table 2. Mean Virus Inactivation/Reductions in HAEGARDA</span></caption><col align="left" valign="middle" width="17%"/><col align="center" valign="middle" width="17%"/><col align="center" valign="middle" width="28%"/><col align="center" valign="middle" width="19%"/><col align="center" valign="middle" width="19%"/><thead><tr class="First Last"><th align="center" class="Lrule Rrule" valign="middle">Virus Studied</th><th align="center" class="Rrule">Pasteurization<br/> [log<span class="Sub">10</span>]</th><th align="center" class="Rrule">Hydrophobic Interaction Chromatography<br/>[log<span class="Sub">10</span>]</th><th align="center" class="Rrule">Virus Filtration<br/>[log<span class="Sub">10</span>]</th><th align="center" class="Rrule">Total Cumulative [log<span class="Sub">10</span>]</th></tr></thead><tfoot><tr class="First"><td align="left" colspan="5">HIV-1, Human immunodeficiency virus type 1, a model for HIV-1 and HIV-2</td></tr><tr><td align="left" colspan="5">BVDV, Bovine viral diarrhea virus, a model for HCV</td></tr><tr><td align="left" colspan="5">PRV, Pseudorabies virus, a model for large enveloped DNA viruses</td></tr><tr><td align="left" colspan="5">WNV, West Nile virus</td></tr><tr><td align="left" colspan="5">HAV, Hepatitis A virus</td></tr><tr><td align="left" colspan="5">CPV, Canine parvovirus</td></tr><tr><td align="left" colspan="5">B19V, Human Parvovirus</td></tr><tr><td align="left" colspan="5">B19ND, Not determined</td></tr><tr class="Last"><td align="left" colspan="5">NA, Not applicable</td></tr></tfoot><tbody><tr class="Botrule First"><td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">Enveloped Viruses</span></td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">HIV-1</td><td align="center" class="Rrule">≥6.6</td><td align="center" class="Rrule">≥4.5</td><td align="center" class="Rrule">≥5.1</td><td align="center" class="Rrule">≥16.2</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">BVDV</td><td align="center" class="Rrule">≥9.2</td><td align="center" class="Rrule">≥4.7</td><td align="center" class="Rrule">≥5.3</td><td align="center" class="Rrule">≥19.2</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">PRV</td><td align="center" class="Rrule">6.3</td><td align="center" class="Rrule">≥6.5</td><td align="center" class="Rrule">≥7.1</td><td align="center" class="Rrule">≥19.9</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">WNV</td><td align="center" class="Rrule">≥7.0</td><td align="center" class="Rrule">ND</td><td align="center" class="Rrule">≥8.0</td><td align="center" class="Rrule">≥15.0</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">Non-Enveloped Viruses</span></td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">HAV</td><td align="center" class="Rrule">≥6.4</td><td align="center" class="Rrule">2.8</td><td align="center" class="Rrule">≥5.3</td><td align="center" class="Rrule">≥14.5</td></tr><tr class="Botrule"><td align="left" class="Lrule Rrule">CPV</td><td align="center" class="Rrule">1.4</td><td align="center" class="Rrule">3.9</td><td align="center" class="Rrule">7.1</td><td align="center" class="Rrule">12.4</td></tr><tr class="Last"><td align="left" class="Lrule Rrule">B19V</td><td align="center" class="Rrule">3.9</td><td align="center" class="Rrule">ND</td><td align="center" class="Rrule">ND</td><td align="center" class="Rrule">NA</td></tr></tbody></table></div></section>

HAEGARDA

C1 esterase inhibitor

C1 esterase inhibitor (human) 2000 UNT Injection

Haegarda

C1 esterase inhibitor (human) 2000 UNT Injection [Haegarda]

C1 esterase inhibitor (human) 3000 UNT Injection

C1 esterase inhibitor (human) 3000 UNT Injection [Haegarda]

C1 esterase inhibitor (human)

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

Haegarda is a synthetic version of a blood protein that regulates swelling in the body. Individuals with Hereditary Angioedema (HAE) lack sufficient levels of this protein, leading to swelling episodes and symptoms like digestive issues and breathing difficulties.

Haegarda is an injectable medication designed to proactively prevent swelling and painful attacks in patients aged 6 and older with Hereditary Angioedema.

It's important to note that Haegarda is not intended for the treatment of acute HAE attacks. If you experience an acute HAE attack, please initiate personalized treatment as advised by your healthcare provider.