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Berinert Generic Name & Formulations
Legal Class
Rx
General Description
C1 esterase inhibitor (human) 500 IU; per vial; freeze-dried pwd for IV inj after reconstitution; preservative-free.
Pharmacological Class
C1 inhibitor.
How Supplied
Single-use vial—1 (w. supplies)
Manufacturer
Generic Availability
NO
Berinert Indications
Indications
Treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adult and pediatric patients.
Limitations of Use
Safety and efficacy for prophylactic therapy have not been established.
Berinert Dosage and Administration
Adults and Children
Give 20 IU/kg by slow IV inj at a rate of approx. 4mL/min. Do not administer doses <20 IU/kg.
Berinert Contraindications
Not Applicable
Berinert Boxed Warnings
Not Applicable
Berinert Warnings/Precautions
Warnings/Precautions
Discontinue immediately if hypersensitivity reactions are suspected. Have epinephrine inj available. Monitor patients with known risk factors for thromboembolic events (eg, indwelling venous catheter/access device, history of thrombosis, atherosclerosis, morbid obesity, immobility). Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Pregnancy. Nursing mothers.
Berinert Pharmacokinetics
See Literature
Berinert Interactions
Interactions
Risk of thrombotic events with concomitant oral contraceptives or certain androgens.
Berinert Adverse Reactions
Adverse Reactions
Dysgeusia, increased severity of pain; hypersensitivity reactions, thromboembolic events.
Berinert Clinical Trials
See Literature
Berinert Note
Notes
To report infections that may have been transmitted by Berinert, call the CSL Behring Pharmacovigilance Department at (866) 915-6958.
Berinert Patient Counseling
See Literature
