C1 Esterase Inhibitor: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: July 14, 2025🚩 Report this page

C1 Esterase Inhibitor

Active ingredient

Sold as HAEGARDA · BERINERT 500 · BERINERT 1500

CA Health Canada

Drug class: -
Availability: See label
Routes: Intravenous, Subcutaneous
Markets covered: 1
Products on record: 4

Overview

C1 Esterase Inhibitor is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	4	July 14, 2025

CACanada· Health Canada

4 products

Uses

CAOfficial regulatory label· revised July 14, 2025[1]

BERINERT 500 / BERINERT 1500 (reduced volume) commonly referred as BERINERT (C1 Esterase Inhibitor, Human) is indicated for: • The treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) of moderate to severe intensity in pediatric and adult patients.
The safety and efficacy of BERINERT for prophylactic therapy has not been established. 1 Pediatrics Pediatrics (3-16 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of BERINERT in pediatric patients has been established.
Therefore, Health Canada has authorized an indication for pediatric use. 3 Pediatrics. 2 Geriatrics Geriatrics (65 and above): The safety and efficacy of BERINERT in the geriatric population have not been evaluated in controlled clinical studies.
However, based on registry data the safety profile observed in the geriatric population was similar to that observed in the younger populations studied. 4 Geriatrics.

Sources & citations

[1]Health Canada (DPD) · 02352575 · revised July 14, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised July 14, 2025[1]

1 Adverse Reaction Overview The most serious adverse reaction reported in subjects in clinical studies who received BERINERT is an increase in the severity of pain associated with HAE. The most common adverse reactions that have been reported in greater than 4% of the subjects who received BERINERT are HAE, headache, dysgeusia, abdominal pain, nausea, muscle spasms, pain, diarrhea, and vomiting.
BERINERT® 500 / BERINERT® 1500, C1 Esterase Inhibitor, Human Page 11 of 42 The other common adverse reactions that have been reported in 1% to 4 % of the subjects who received BERINERT are back pain, edema peripheral, abdominal distension and upper respiratory tract infection, including nasopharyngitis.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Placebo-Controlled Pivotal Study In a pivotal Phase III clinical study, 124 subjects experiencing an acute moderate to severe abdominal or facial HAE attack were treated with BERINERT (either a 10 IU per kg body weight dose, 20 IU per kg body weight dose), or placebo (physiological saline solution).
Table 3, Table 4, and Table 5 list the associated Adverse Events (AEs) that occurred in more than 4% of the subjects up to 4 hours, 72 hours and 9 days respectively after the end of a BERINERT infusion, irrespective of causality. , adverse reactions).
† The following abdominal symptoms were identified in the protocol as associated with HAE abdominal attacks: abdominal pain, bloating, cramps, nausea, vomiting, and diarrhea. , adverse reactions). † If a subject experienced no relief or insufficient relief of symptoms within 4 hours after infusion, investigators had the option to administer a blinded second infusion (“rescue” treatment) of BERINERT (20 IU/kg for the placebo group or 10 IU/kg for the 10 IU/kg group), or placebo (for the 20 IU/kg group).
‡ Adverse reactions following either initial treatment and/or blinded “rescue” treatment. Because more subjects in the placebo randomization group than in the BERINERT randomization group received rescue treatment, the median observation period in this analysis for subjects randomized to placebo was slightly longer than for subjects randomized to receive BERINERT.
6 *Symptoms were considered to be related to the underlying disease. Any increase in intensity or new occurrence of these symptoms after study medication administration was considered to be an ARs. Open-Label Extension Study In a supportive Phase III extension study, 57 subjects with 1085 acute moderate to severe abdominal, facial, peripheral, and laryngeal HAE attacks received a 20 IU/kg body weight dose of BERINERT.
Table 6 lists the associated AEs that occurred in the safety analysis of the open-labeled extension study in ≥2 BERINERT® 500 / BERINERT® 1500, C1 Esterase Inhibitor, Human Page 13 of 42 subjects or associated with ≥5 attacks during infusion, within 24 hours or 72 hours after the end of a BERINERT infusion.
1%) Abdominal discomfort 0 (0) 1 […]

CAOfficial regulatory label· Warnings and precautions· revised July 14, 2025[1]

Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. This product is prepared from large pools of human plasma. Thus, there is a possibility it may contain causative agents of viral or other undetermined diseases. General BERINERT is made from human plasma and may contain pathogens such as viruses and, theoretically, the agent responsible for the Creutzfeldt-Jakob disease (CJD).
The risk that such products will transmit an infectious agent has been reduced by implementing stringent measures to reduce the risk of contamination by pathogens (for more information please see 13 PHARMACEUTICAL INFORMATION, subsection Viral Inactivation).
The current manufacturing process includes multiple steps that reduce the risk of viral transmission. Since February 22, 2001 (date of licensure of the current product formulation), no proven case of virus transmission has been attributed to BERINERT.
The manufacturing process of the BERINERT drug substance up to and including the virus filtration step is identical for BERINERT 500 and BERINERT 1500. Despite these measures, human plasma-derived products may still potentially transmit diseases.
There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician to have been possibly transmitted by this product should be reported by the latter or another healthcare provider to CSL Behring at 1-866-773-7721.
The physician or healthcare provider should discuss the risks and benefits of this product with the patient. Cardiovascular Thrombotic events have been reported at the recommended dose of C1 Esterase Inhibitor (Human) products, including BERINERT, following treatment of HAE attacks.
Thrombotic events also have been reported when used off-label and at higher than labeled doses. Patients with known risk factors for thrombotic events should be monitored closely. BERINERT® 500 / BERINERT® 1500, C1 Esterase Inhibitor, Human Page 10 of 42 Sensitivity/Resistance As with any pharmaceutical agent, allergic reactions may occur.
g. hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) occur, immediately discontinue the administration of BERINERT and take appropriate measures as required. 1 Pregnant Women Animal reproduction studies have not been conducted with BERINERT.

This is not medical advice. Consult a qualified healthcare professional.