Human C1 Esterase Inhibitor

Kallikrein Inhibitors

Hereditary Angioedemas

<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)

C1 esterase inhibitor (human) 500 UNT Injection

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

Plasma Kallikrein Inhibitor

<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">Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa.</p><p>TAKHZYRO (lanadelumab-flyo) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use.</p><p>Each mL of ready-to-use TAKHZYRO solution contains 150 mg of lanadelumab-flyo, citric acid monohydrate (4.1 mg), L-histidine (7.8 mg), polysorbate 80 (0.1 mg), sodium chloride (5.3 mg), sodium phosphate dibasic dihydrate (5.3 mg), and Water for Injection, USP. The solution has a pH of approximately 6.0.</p></section>

TAKHZYRO

1 ML lanadelumab-flyo 150 MG/ML Prefilled Syringe

1 ML lanadelumab-flyo 150 MG/ML Prefilled Syringe [Takhzyro]

2 ML lanadelumab-flyo 150 MG/ML Injection

2 ML lanadelumab-flyo 150 MG/ML Injection [Takhzyro]

2 ML lanadelumab-flyo 150 MG/ML Prefilled Syringe

2 ML lanadelumab-flyo 150 MG/ML Prefilled Syringe [Takhzyro]

Takhzyro

lanadelumab

lanadelumab-flyo

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.

Report Adverse Event

Prescribing Information

Medication Guide 

Submit MSL Request 

Pharmacy List 

Reimbursement and Coding

Coverage Authorization Request

Coverage Authorization Appeals

Prior Authorization Checklist

Berinert Connect Prescription & Service Request Form

Enroll in Patient Savings Program

About Berinert 

Taking Berinert 

Berinert Connect Patient Support 

Treatment Plan and Therapy Journal

Doctor Discussion Guide

FAQs: HAE

Instructions For Use: HAE

Takhzyro is a monoclonal antibody that controls an overactive enzyme in individuals with hereditary angioedema, a rare genetic immune system disorder. It is prescribed to prevent angioedema attacks in patients aged 2 and above.

Hereditary angioedema leads to elevated bradykinin levels. Takhzyro (lanadelumab-flyo) effectively reduces bradykinin levels, mitigating swelling and associated angioedema symptoms.

Takhzyro injections are FDA-approved for patients aged 2 and older to prevent hereditary angioedema attacks.

Berinert®(C1 esterase inhibitor (human))	Takhzyro®(lanadelumab-flyo)

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 Takhzyro is a monoclonal antibody that controls an overactive enzyme in individuals with hereditary angioedema, a rare genetic immune system disorder. It is prescribed to prevent...
Dosage & Administration
Administration
Intravenous. Learn more.	Subcutaneous. Learn more.
Dosing
Administer 20 International Units per kg body weight.. Learn more.	Adult and pediatric patients 12 years of age and older: administer 300 mg every 2 weeks. 6 to less than 12 years of age: administer 150 mg every 2 weeks. Pediatric patients 2 to less than 6 years of age: administer 150 mg every 4 weeks.. Learn more.
Latin Shorthand
Administer 20 IU/kg BW.. Learn more.	Adult and pediatric patients (≥12 years): 300 mg every 2 weeks. Patients aged 6 to <12 years: 150 mg every 2 weeks. Patients aged 2 to <6 years: 150 mg every 4 weeks.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
Learn more.	$0. Learn more.
Annual Cap
Learn more.	Learn more.
Assistance Expiration
Learn more.	Learn more.
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 common adverse reactions (≥10%) are injection site reactions, upper respiratory infections, headache, rash, dizziness, diarrhea, and myalgia.. Learn more.
Mechanism of Actions (MoA)
Drugs used in Hereditary Angioedema. Learn more.	Drugs used in Hereditary Angioedema. Learn more.
Special Populations

Berinert® Alternatives