Anthropometric Measurements as Predictors of Low Birth Weight Among Tanzanian Neonates: A Hospital-Based Study
November 7, 2025
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Brand Name :
Orladeyo
Synonyms :
berotralstat
Class :
Kallikrein Inhibitors
Brand Name :
Orladeyo
Synonyms :
berotralstat
Class :
Kallikrein Inhibitors
Dosage Forms & StrengthsÂ
CapsuleÂ
110mgÂ
150mgÂ
Indicated as prophylaxis of HAE (hereditary angioedema attacks)
150 mg orally each day
Dose Modifications
Hepatic impairment
For severe or moderate Child-Pugh B/C, reduce the dose to 110 mg orally each day
P-gp or BCRP inhibitors
When these are administered for long, like cyclosporine, reduce the dose to 110 mg orally each day
Persistent GI reactions
Reduce the dose to 110 mg orally each day
Dosage Forms & StrengthsÂ
CapsuleÂ
110mgÂ
150mgÂ
Indicated as prophylaxis of HAE (hereditary angioedema attacks) in adolescents over 12 years of age
150 mg orally each day
Dose Modifications
Hepatic impairment
For severe or moderate Child-Pugh B/C, reduce the dose to 110 mg orally each day
P-gp or BCRP inhibitors
When these are administered for long, like cyclosporine, reduce the dose to 110 mg orally each day
Persistent GI reactions
Reduce the dose to 110 mg orally each day
Refer to the adult dosingÂ
berotralstat: they may enhance the serum concentration of glycoprotein IIa Inhibitors
may enhance the serum concentration of BCRP/ABCG2 Inhibitors
may enhance the serum concentration of BCRP/ABCG2 inhibitors
may enhance the serum concentration of P-glycoprotein/ABCB1 Inhibitors
the level of effect of lorlatinib will decrease by MDR1 P-glycoprotein efflux transporter due to berotralsat
when both drugs are combined, there may be a reduced blood level of berotralstat  
It may enhance the effect when combined with tafamidis meglumine
When alprazolam and berotralstat is used together, this leads to reduction in the alprazolam’s metabolism
When encainide is used together with berotralstat, this leads to a rise in the encainide’s metabolism
When berotralstat is used together with adenosine, this leads to enhanced risk or seriousness of QTc prolongation
When berotralstat is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
the metabolism of sulfinpyrazone can be decreased when combined with berotralstat
berotralstat: it may decrease the metabolism of piperazine
berotralstat: it may decrease the metabolism of caroverine
berotralstat: it may increase the risk or severity of QTc prolongation agents
berotralstat: it may increase the risk or severity of QTc prolongation agents
berotralstat: it may increase the risk or severity of QTc prolongation agents
berotralstat: it may increase the risk or severity of QTc prolongation agents
berotralstat: it may increase the risk or severity of QTc prolongation agents
when both drugs are combined, there may be an increased level of serum concentration of etoposide   
when both drugs are combined, there may be an increased the serum concentration of paclitaxel 
when both drugs are combined, there may be a reduced excretion rate of topotecan and result in an elevated level of serum concentration  
when both drugs are combined, there may be an increased effect of abemaciclib by p-glycoprotein -mdr1 efflux transporter  
increase the therapeutic effect of daunorubicin by P-glycoprotein efflux transporter
the level of effect of lenvatinib will increase by MDR1 P-glycoprotein efflux transporter due to berotralstat
increase the therapeutic effect of idarubicin by P-glycoprotein efflux transporter
may increase the anticholinergic effect of anticholinergic agents
the rate of metabolism of tocofersolan may be reduced with berotralstat
the rate of metabolism of dydrogesterone may be reduced
When berotralstat is used together with oliceridine, this leads to enhanced concentration serum of oliceridine
When berotralstat is aided by hesperetin, it elevates concentration serum of berotralstat
Actions and Spectrum:Â
Actions:Â
The primary action of berotralstat is the inhibition of plasma kallikrein, an enzyme involved in the production of bradykinin. Bradykinin is a potent vasodilator and is responsible for the symptoms associated with HAE attacks. By inhibiting plasma kallikrein, berotralstat helps to reduce the production of bradykinin, thereby preventing or reducing the severity and frequency of HAE attacks.
Spectrum:Â
The spectrum of berotralstat’s effects is mainly focused on preventing HAE attacks. It does not provide immediate relief during an acute attack. Instead, it is taken regularly to reduce the frequency and severity of attacks over time. By providing continuous inhibition of plasma kallikrein, berotralstat helps to stabilize bradykinin levels and minimize the risk of sudden and unpredictable swelling episodes.Â
Frequency definedÂ
>10%Â
Abdominal pain (10-23%)Â
Diarrhea (10-15%)Â
Vomiting (10-15%)Â
1-10%Â
Gastroesophageal reflux disease (5-10%)Â
Fatigue (6%)Â
Flatulence (6%)Â
Back pain (2-10%)Â
Headache (9%)Â Â
Frequency not definedÂ
Elevated ALTÂ
Black Box Warning:Â
NoneÂ
Contraindication/Caution:Â
ContraindicationÂ
CautionÂ
Pregnancy consideration:Â Â
Insufficient data are available regarding the usage in pregnant women.Â
Breastfeeding warnings:Â Â
No data is available regarding the excretion of this drug in breast milk. Â
Pregnancy category:Â
Pharmacology:Â
berotralstat is a selective inhibitor of plasma kallikrein, an enzyme involved in the production of bradykinin. By inhibiting plasma kallikrein, berotralstat helps to reduce the production of bradykinin, a potent vasodilator that mediates the symptoms of hereditary angioedema (HAE) attacks.Â
Pharmacodynamics:Â
Pharmacokinetics:Â
AbsorptionÂ
The drug is absorbed systemically.Â
DistributionÂ
The protein-bound is 99%Â
Ratio of blood-to-plasma is 0.92Â
MetabolismÂ
The drug is metabolized by CYP3A4 and CYP2D6Â Â
Elimination and ExcretionÂ
The half-life is 93 hoursÂ
The drug is excreted 9% in urine and 79% in feces
Administration:Â
berotralstat should be taken at approximately the same time each day, with or without food. Follow the specific instructions prescribed by the healthcare professional provides or the medication’s label. The berotralstat tablet should be swallowed whole with water. Do not chew crush, or break before consumption.Â
Patient information leafletÂ
Generic Name: berotralstatÂ
Pronounced: BER-oh-TRAL-stat Â
Why do we use berotralstat?Â
berotralstat prevents hereditary angioedema (HAE) attacks in adults and adolescents aged 12. It helps in the reduction of bradykinin levels, which eases vasodilation.Â
HAE attacks can significantly impact the quality of life of individuals affected by the condition. By reducing the severity and frequency of attacks, berotralstat can help improve overall well-being, minimize HAE’s physical and emotional burden, and enhance daily functioning.Â
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