Kallikrein Inhibitors

Human C1 Esterase Inhibitor

Angioedemas, Hereditary

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">BERINERT is a human plasma-derived, purified, pasteurized, lyophilized concentrate of C1 esterase inhibitor to be reconstituted for intravenous administration. BERINERT is prepared from large pools of human plasma from US donors. The potency of C1 esterase inhibitor is expressed in International Units (IU), which is related to the current WHO Standard for C1 esterase inhibitor products.</p><p>C1 esterase inhibitor is a soluble, single-chain glycoprotein containing 478 amino acid residues organized into three beta-sheets and eight or nine alpha-helices.<span class="Sup">4</span> The heavily glycosylated molecule has an apparent molecular weight of 105 kD, of which the carbohydrate chains comprise 26% to 35%.<span class="Sup">5</span></p><p>Each 500 IU vial of reconstituted BERINERT contains 400-625 IU C1 esterase inhibitor, 50 to 80 mg total protein, 85 to 115 mg glycine, 70 to 100 mg sodium chloride, and 25 to 35 mg sodium citrate.</p><p>All plasma used in the manufacture of BERINERT is obtained from US 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). In addition, 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 BERINERT 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>This was evaluated in a series of in vitro spiking experiments. The total mean cumulative virus inactivation/reduction is shown in Table 2.</p><table width="90%"><caption><span>Table 2. Mean Virus Inactivation/Reductions in BERINERT</span></caption><col align="left" valign="middle" width="18%"/><col align="center" valign="middle" width="18%"/><col align="center" valign="middle" width="28%"/><col align="center" valign="middle" width="18%"/><col align="center" valign="middle" width="18%"/><thead><tr class="First Last"><th align="center" class="Lrule Rrule">Virus Studied</th><th align="center" class="Rrule" valign="bottom">Pasteurization<br/>[log<span class="Sub">10</span>]</th><th align="center" class="Rrule" valign="bottom">Hydrophobic Interaction Chromatography<br/>[log<span class="Sub">10</span>]</th><th align="center" class="Rrule" valign="bottom">Virus Filtration<br/>[log<span class="Sub">10</span>]</th><th align="center" class="Rrule" valign="bottom">Total Cumulative<br/>[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 B19</td></tr><tr><td align="left" colspan="5">ND, 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></section>

Berinert

C1 esterase inhibitor

C1 esterase inhibitor (human) 500 UNT Injection

C1 esterase inhibitor (human)

C1 esterase inhibitor (human) 500 UNT Injection [Berinert]

Bradykinin B2 Receptor Antagonists

Bradykinin B2 Receptor Antagonist

<section class="Section" data-sectioncode="34089-3"><a name="ID58"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First"><a name="ID59"></a>SAJAZIR (icatibant) is a synthetic decapeptide with five non-proteinogenic amino acids. The chemical structure of icatibant acetate is presented in Figure 1.</p><p><span class="Bold">Figure 1 Chemical Structure</span></p><div class="Figure"><img alt="Image" src="e8f64c57-bbfd-44de-8fd9-38d4c4d80638-01.jpg"/></div><p><a name="ID61"></a>Chemical name: D-Arginyl-L-arginyl-L-prolyl-L[(4R)-4-hydroxyprolyl]-glycyl-L[3-(2-thienyl)alanyl]-L-seryl-D-(1,2,3,4-tetrahydroisoquinolin-3-ylcarbonyl)-L[(3aS,7aS)-octahydroindol-2-ylcarbonyl]-L-arginine, acetate salt</p><p>SAJAZIR (icatibant) injection 30 mg/3ml (10 mg/mL) is provided as a sterile, isotonic, and buffered solution of icatibant acetate in a single-dose, prefilled syringe for subcutaneous administration. Each mL of the solution contains 10 mg of icatibant (free base) which is equivalent to 11.38 mg of icatibant acetate. Each prefilled syringe delivers 3 mL of solution equivalent to a 30 mg icatibant dose. The solution is clear and colorless. </p><p>The solution also contains sodium chloride (isotonicity reagent), glacial acetic acid (pH adjuster), sodium hydroxide (pH adjuster) and water for injection with a pH of approximately 5.5. The solution does not contain preservatives.</p><p> </p><p>Pharmacological class: Icatibant is a bradykinin B2 receptor antagonist.</p></section>

SAJAZIR

icatibant

3 ML icatibant 10 MG/ML Prefilled Syringe

Firazyr

3 ML icatibant 10 MG/ML Prefilled Syringe [Firazyr]

Sajazir

3 ML icatibant 10 MG/ML Prefilled Syringe [Sajazir]

Berinert is a synthetic version of a protein naturally found in the bloodstream, which plays a role in regulating swelling within the body. Individuals with hereditary angioedema lack an adequate amount of this protein, which can lead to episodes of swelling and accompanying symptoms like digestive issues or breathing difficulties.

Berinert is prescribed for individuals with hereditary angioedema.

It is employed to manage acute angioedema attacks.

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FAQs: HAE

Instructions For Use: HAE

SAJAZIR (icatibant) injection is a bradykinin B2 receptor antagonist indicated for
treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of
age and older.

Berinert®(C1 esterase inhibitor (human))	Sajazir®(icatibant)

Prescription Only Berinert is a synthetic version of a protein naturally found in the bloodstream, which plays a role in regulating swelling within the body. Individuals with hereditary angioedema...	Prescription Only SAJAZIR (icatibant) injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and...
Dosage & Administration
Administration
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Dosing
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Latin Shorthand
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Financial Assistance
Out-Of-Pocket Costs With Copay Card
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Annual Cap
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Assistance Expiration
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Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
The most serious adverse reaction reported in subjects who received BERINERT was an increase in the severity of pain associated with HAE. •The most common adverse reaction reported in greater than 4% of the subjects and greater than placebo among subjects who received BERINERT in the placebo-controlled clinical trial was dysgeusia.. Learn more.	The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash. . Learn more.
Mechanism of Actions (MoA)
Drugs used in Hereditary Angioedema. Learn more.	Drugs used in Hereditary Angioedema. Learn more.
Special Populations

Berinert® Alternatives