Berinert

/ Genmedix

Treatment should be initiated under the supervision of a physician experienced in the treatment of C1-esterase inhibitor deficiency.
Adults
Treatment of acute angioedema attacks: 20 IU per kilogram body weight (20 IU/kg b.w.).
Pre-procedure prevention of angioedema attacks: 1000 IU less than 6 hours prior to oral, dental, and upper respiratory tract procedures.
Paediatric Population
Treatment of acute angioedema attacks: 20 IU per kilogram body weight (20 IU/kg b.w.).
Pre-procedure prevention of angioedema attacks: 15 to 30 IU per kilogram body weight (15-30 IU/kg b.w.) less than 6 hours prior to oral, dental, and upper respiratory tract procedures. Dose should be selected taking into account
clinical circumstances (e.g. type of procedure and disease severity).
Method of administration: Berinert is to be reconstituted according to section 6.6. The reconstituted solution should be colourless and clear. The solution is to be administered by slow i.v. injection or infusion (4ml/minute).

Hereditary angioedema type I and II (HAE).
Treatment and pre-procedure (prior to oral, dental, and upper respiratory tract procedures) prevention of acute episodes.

Hypersensitivity to the active substance or to any of the excipients.

In patients with known tendency towards allergies, antihistamines and corticosteroids should be administered prophylactically. If allergic or anaphylactic-type reactions occur, the administration has to be stopped immediately and an appropriate treatment has to be initiated. Patients with laryngeal edema require particularly careful monitoring with emergency treatment in stand-by. Contains up to 486 mg sodium (approximately 21 mmol) per 100 ml solution.
See prescribing information for full details.

Undesired reactions with Berinert are rare.
See prescribing information for full details.

No interaction studies have been performed.

Pregnancy: There are limited amount of data that indicate no increased risk from the use of Berinert in pregnant women. Berinert is a physiological component of human plasma. Therefore, no studies on reproduction and developmental toxicity have been performed in animals and no adverse effects on fertility, pre- and postnatal development are expected in humans.
Therefore, Berinert should be given to a pregnant woman only if clearly needed.
Breastfeeding: It is unknown whether Berinert is excreted in human milk, but due to its high molecular weight, the transfer of Berinert into breast milk seems unlikely. However, breastfeeding is questionable in women suffering from hereditary angioedema. A decision must be made whether to discontinue breastfeeding or to discontinue the Berinert therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

No case of overdose has been reported.