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Berinert (C1 esterase inhibitor human)

Active Ingredient:
C1 esterase inhibitor (human)
Form:
KIT
Brand:
Berinert
Origin:
USA

Berinert (C1 esterase inhibitor human) (C1 esterase inhibitor (human) KIT)

Berinert is a C1 esterase inhibitor (human) concentrate approved by the FDA as an orphan drug for the treatment of hereditary angioedema (HAE). It is administered intravenously and belongs to the therapeutic category of allergy and immunology agents. This plasma-derived replacement therapy addresses the underlying deficiency or dysfunction of C1 esterase inhibitor in HAE patients.

Pack Size

1 KIT in 1 CARTON (63833-825-02) * 10 mL in 1 VIAL (63833-835-01) * 10 mL in 1 VIAL (63833-765-1

Manufacturer / TM Owner

CSL Behring

1
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Indications & Clinical Uses

  • Berinert is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients with C1 esterase inhibitor deficiency or dysfunction. HAE is a rare genetic disorder characterized by recurrent episodes of severe swelling affecting the skin, gastrointestinal tract, and potentially the airway. The drug is used to manage acute angioedema attacks in both pediatric and adult patients. Berinert works by replacing the deficient or dysfunctional C1 esterase inhibitor protein, thereby restoring the normal regulation of contact system activation and preventing excessive bradykinin production. This mechanism helps to rapidly reduce swelling and alleviate symptoms during acute HAE episodes. The patient population includes individuals with Type I HAE (low C1-INH levels), Type II HAE (normal or elevated but dysfunctional C1-INH levels), and Type III HAE variants. Berinert is particularly valuable for patients experiencing acute attacks that pose a risk to airway patency or significantly impact quality of life.

Side Effects

  • Common side effects of Berinert include headache, nausea, and injection site reactions such as pain or erythema. Serious adverse events, though rare, may include thromboembolic complications, hypersensitivity reactions, and anaphylaxis. Patients should be monitored for signs of thrombosis, particularly those with risk factors. Laboratory monitoring may include C1-INH levels and functional assays. Fever and chills have been reported in some patients. Healthcare providers should assess patients for pre-existing thrombotic risk factors before administration. Immediate medical support should be available during infusion to manage potential adverse reactions.

Precautions & Warnings

  • Berinert is contraindicated in patients with known hypersensitivity to C1 esterase inhibitor or any excipients. Caution is warranted in patients with a history of thrombosis or thrombotic risk factors, as C1-INH replacement may increase thrombotic risk. Pregnancy category is not definitively established; use only if clearly needed. Pediatric patients can receive Berinert, with dosing adjusted based on body weight. No specific dose adjustments are required for renal or hepatic impairment, though careful monitoring is recommended. Patients with IgA deficiency may develop anti-IgA antibodies and experience anaphylaxis; screening is advised. Vaccination status should be reviewed prior to administration.

Avoid Interactions

  • No major drug-drug interactions have been formally documented with Berinert. However, concurrent use with other blood products or medications affecting coagulation should be carefully monitored. Patients receiving anticoagulants or antiplatelet agents may have increased thrombotic risk and require closer clinical surveillance. There are no known significant food-drug interactions. Berinert should not be mixed with other medications in the same intravenous line. Healthcare providers should review all concurrent medications and supplements before administration.

Frequently Asked Questions

Berinert is used to treat acute attacks of hereditary angioedema (HAE) in patients with C1 esterase inhibitor deficiency or dysfunction. It rapidly reduces swelling and alleviates symptoms during acute episodes affecting the skin, gastrointestinal tract, or airway. The drug works by replacing the deficient C1 esterase inhibitor protein.

Berinert is administered as an intravenous infusion. The dose is typically based on body weight, with standard dosing of 20 units per kilogram. The infusion is prepared by reconstituting the lyophilized powder with sterile water for injection and is administered slowly over 5-15 minutes.

Common side effects include headache, nausea, injection site reactions (pain, erythema), fever, and chills. Serious but rare adverse events may include thromboembolic complications and hypersensitivity reactions. Most side effects are mild and resolve without intervention.

Berinert is manufactured by CSL Behring, a global biopharmaceutical company specializing in plasma-derived and recombinant therapies.

Yes, Berinert has been designated and approved as an orphan drug by the FDA for the treatment of hereditary angioedema. This designation recognizes its use in treating a rare disease affecting fewer than 200,000 people in the United States.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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