Berinert
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Uses
Berinert is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent patients.
The safety and efficacy of Berinert for prophylactic therapy have not been established.
History
There is currently no drug history available for this drug.
Other Information
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.
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.3 The heavily glycosylated molecule has an apparent molecular weight of 105 kD, of which the carbohydrate chains comprise 26% to 35%.4
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.
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 104 IU of Parvovirus B19 DNA per mL.
The manufacturing process for Berinert includes multiple steps that reduce the risk of virus transmission. The virus inactivation/reduction capacity consists of three steps:
- Pasteurization in aqueous solution at 60°C for 10 hours
- Hydrophobic interaction chromatography
- Virus filtration (also called nanofiltration) by two filters, 20 nm and 15 nm, in series
This was evaluated in a series of in vitro spiking experiments. The total mean cumulative virus inactivation/reduction is shown in Table 5.
| Virus Studied | Pasteurization [log10] |
Hydrophobic Interaction Chromatography [log10] |
Virus Filtration [log10] |
Total Cumulative [log10] |
|---|---|---|---|---|
| HIV-1, Human immunodeficiency virus type 1, a model for HIV-1 and HIV-2 | ||||
| BVDV, Bovine viral diarrhea virus, a model for HCV | ||||
| PRV, Pseudorabies virus, a model for large enveloped DNA viruses | ||||
| WNV, West Nile virus | ||||
| HAV, Hepatitis A virus | ||||
| CPV, Canine parvovirus | ||||
| B19V, Human Parvovirus B19 | ||||
| ND, Not determined | ||||
| NA, Not applicable | ||||
| Enveloped Viruses | ||||
| HIV-1 | ≥6.6 | ≥4.5 | ≥5.1 | ≥16.2 |
| BVDV | ≥9.2 | ≥4.7 | ≥5.3 | ≥19.2 |
| PRV | 6.3 | ≥6.5 | ≥7.1 | ≥19.9 |
| WNV | ≥7.0 | ND | ≥8.0 | ≥15.0 |
| Non-Enveloped Viruses | ||||
| HAV | ≥6.4 | 2.8 | ≥5.3 | ≥14.5 |
| CPV | 1.4 | 6.4 | ≥7.2 | ≥15.0 |
| B19V | 3.9 | ND | ND | NA |
Sources
Berinert Manufacturers
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Csl Behring Gmbh
![Berinert (Human C1-esterase Inhibitor) Kit [Csl Behring Gmbh]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Berinert | Merck Sharp & Dohme Corp.
2.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)Adults and Pediatric Patients 12 Years of Age and Older and Patients Less Than 12 Years of Age who Weigh at least 30 kg
The recommended oral dosage of EMEND capsules, dexamethasone, and a 5-HT3 antagonist in adults and pediatric patients 12 years of age and older and patients less than 12 years of age who weigh at least 30 kg, who can swallow oral capsules, for the prevention of nausea and vomiting associated with administration of HEC or MEC is shown in Table 1 or Table 2, respectively.
In adults only, EMEND for injection (115 mg), a prodrug of aprepitant, may be substituted for EMEND capsules (125 mg), 30 minutes prior to chemotherapy, on Day 1 of the CINV regimen as an intravenous infusion administered over 15 minutes, followed by oral EMEND (80 mg) on Days 2 and 3. See the prescribing information for EMEND for injection.
Table 1: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with HEC Population Day 1 Day 2 Day 3 Day 4 * Administer EMEND capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer EMEND capsules in the morning on Days 2 and 3. † Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone reflects a 50% dosage reduction to account for a drug interaction with EMEND [see Clinical Pharmacology (12.3)]. EMEND capsules* Adults, Pediatric Patients 12 Years and Older, and Pediatric Patients less than 12 Years Who Weigh at least 30 kg 125 mg orally 80 mg orally 80 mg orally none Dexamethasone† Adults 12 mg orally 8 mg orally 8 mg orally 8 mg orally Pediatric Patients 12 Years and Older, and Pediatric Patients less than 12 Years Who Weigh at least 30 kg If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3)]. 5-HT3 antagonist Adults, Pediatric Patients 12 Years and Older, and Pediatric Patients less than 12 Years Who Weigh at least 30 kg See selected 5-HT3 antagonist prescribing information for the recommended dosage none none none Table 2: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with MEC Population Day 1 Day 2 Day 3 * Administer EMEND capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer EMEND capsules in the morning on Days 2 and 3. † Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone reflects a 50% dosage reduction to account for a drug interaction with EMEND [see Clinical Pharmacology (12.3)]. EMEND capsules* Adults,
Pediatric Patients 12 Years and Older, and
Pediatric Patients less than 12 Years Who Weigh at least 30 kg 125 mg orally 80 mg orally 80 mg orally Dexamethasone† Adults 12 mg orally none none Pediatric Patients 12 Years and Older, and
Pediatric Patients less than 12 Years Who Weigh at least 30 kg If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3)]. 5-HT3 antagonist Adults,
Pediatric Patients 12 Years and Older, and
Pediatric Patients less than 12 Years Who Weigh at least 30 kg See the selected 5-HT3 antagonist prescribing information for recommended dosage none none 2.2 Prevention of Postoperative Nausea and Vomiting (PONV)The recommended oral dosage of EMEND capsules in adults is 40 mg within 3 hours prior to induction of anesthesia.
2.3 Administration Instructions Take with or without food. Swallow capsules whole.
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