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Important Safety InformationPrescribing Information

Help your patients live without compromise.

ORLADEYO® is the only targeted preventative therapy for hereditary angioedema (HAE) to combine attack prevention AND oral administration.1

Rob, an ORLADEYO patient on treatment
since 2021

Capsule not actual size

 

ORLADEYO demonstrated significant HAE attack rate reduction over 24 weeks1

  • APeX-2 part 1 was a double-blind, placebo-controlled study (N=121)1,a
  • Patients treated with ORLADEYO 150 mg saw an attack rate reduction from 3.06 to 1.31 attacks per month2
  • Patients receiving placebo saw a reduction from 2.91 to 2.35 attacks per month2

ORLADEYO offers significant and sustained attack prevention, with results seen within the first 4 weeks and maintained over 96 weeks.1,3

aThe percent reduction in attack rate was greater with ORLADEYO 150 mg (n=40) relative to placebo (n=39) regardless of attack rate during the run-in period.1

ATTACK RATE REDUCTION FROM BASELINE AT 96 WEEKS3,b

aThe percent reduction in attack rate was greater with ORLADEYO 150 mg (n=40) relative to placebo (n=39) regardless of attack rate during the run-in period.1

bDue to study design, investigator-confirmed attack rates were reported only during the first 48 weeks, while patient-reported attack rates were reported during weeks 49 to 96. For consistency across the entire 96 weeks, only patient-reported attack rates are reported. For analysis purposes, 1 month was defined as 4 weeks of treatment.3

cAdjusted patient-reported attack rates were defined as the total number of adjusted patient-reported HAE attacks experienced in a period, adjusted for the length of a month (defined as 28 days) and the number of days during that period.3

aThe percent reduction in attack rate was greater with ORLADEYO 150 mg (n=40) relative to placebo (n=39) regardless of attack rate during the run-in period.1

Bill Lumry, HAE specialist physician and ORLADEYO prescriber, and hypothetical HAE patient

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Real experiences of switching

Hear about a patient‘s experience switching to ORLADEYO from another prophylaxis.

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“I think there‘s a misperception among other healthcare providers that ORLADEYO is not effective because it‘s an oral medication. I like to inform them about the efficacy of ORLADEYO; I think that information is reassuring.”

– Patricia Stewart, MD
   a prescriber of ORLADEYO

To date, no studies to evaluate ORLADEYO against an active comparator have been conducted.

About HAE
About HAE
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HAE resources
Resources
References: 1. ORLADEYO [prescribing information]. Durham, NC: BioCryst Pharmaceuticals Inc.; 2023. 2. Zuraw B, Lumry WR, Johnston DT, et al. Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: a randomized, double-blind, placebo-controlled phase 3 trial. J Allergy Clin Immunol. 2021;148(1):164-172.e9. doi:10.1016/j.jaci2020.10.015 3. Kiani-Alikhan S, Gower R, Craig T, et al; on behalf of the APeX-2 investigators. Once-daily oral berotralstat for long-term prophylaxis of hereditary angioedema: the open-label extension of the APeX-2 randomized trial. J Allergy Clin Immunol Pract. 2023;12(3):733-743.e10. doi:1016/j.jaip.2023.12.019

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

ORLADEYO® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

Limitations of use

The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.

IMPORTANT SAFETY INFORMATION

An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent.

The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C).

Berotralstat is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein. P-gp inducers (eg, rifampin, St. John‘s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO.

ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO.

The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established.

There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.

To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information.