Patients with HAE are likely struggling with disease and treatment burden^1,2

Self-administration challenges, needle fatigue, and other issues may be weighing patients down¹

In a study of 75 adults living with hereditary angioedema (HAE), approximately 90% of patients say they have learned to tolerate difficult aspects of their treatment, while 75% of patients say they try not to think about the demanding nature of their treatment.¹

With the treatment landscape changing, you can talk with your patients about their satisfaction with their current therapy and what approach might best meet their needs.

Prophylactic therapy should be determined based on individual considerations^2,3:

Disease-related factors
(physical, emotional, quality of life)

Treatment-related factors
(route of administration, side effects, availability/supply)

Patient preference
(lifestyle, dosing schedule, flexibility)

Shared decision making empowers patients to play a more active role in treatment decisions and be more compliant with their treatment, leading to better overall outcomes.⁴

Research shows there is a strong patient demand for an oral prophylactic therapy⁵

Data from a study of 75 patients with HAE demonstrate the preference for an oral preventative therapy.⁵

of the 48 patients on a prophylactic therapy would prefer an oral treatment if one were available even though they are satisfied with their current prophylactic therapy⁵

of the 48 patients on a prophylactic therapy agree that an oral prophylactic therapy would better fit their lives vs an injectable HAE medication⁵

Learn about an oral option your patients have hoped for

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) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine).

Berotralstat is a substrate of P-gp and BCRP. 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 full Prescribing Information.

References: 1. Radojicic, C, Riedl MA, Craig TJ, et al. Patient perspectives on the treatment burden of injectable medication for hereditary angioedema. Allergy Asthma Proc. 2021;42(3):S4-S10. doi:10.2500/aap.2021.42.210025. 2. Busse PJ, Christiansen SC, Riedl MA, et al. US HAEA Medical Advisory Board 2020 Guidelines for the Management of Hereditary Angioedema. J Allergy Clin Immunol Pract. 2021;9(1):132-150.e3. doi:10.1016/j.jaip.2020.08.046. 3. Maurer M, Magerl M, Ansotegui I, et al. The international WAO/EAACI guideline for the management of hereditary angioedema—the 2017 revision and update. Allergy. 2018;73(8):1575-1596. doi:10.1111/all.13384. 4. Banerji A, Anderson J, Johnston DT. Optimal management of hereditary angioedema: shared decision-making. J Asthma Allergy. 2021;14:119-125. doi:10.2147/JAA.S284029. 5. Geba D, Sani JM, Gascon M, Hahn R, Aggarwal K, Rosselli J. Hereditary angioedema patients would prefer newer-generation oral prophylaxis. J Drug Assess. 2021;10(1):51-56. doi:10.1080/21556660.2020.1863699.

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.

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.

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

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.

Patients with HAE are likely struggling with disease and treatment burden^1,2

Self-administration challenges, needle fatigue, and other issues may be weighing patients down¹

Prophylactic therapy should be determined based on individual considerations^2,3:

Disease-related factors
(physical, emotional, quality of life)

Treatment-related factors
(route of administration, side effects, availability/supply)

Patient preference
(lifestyle, dosing schedule, flexibility)

Research shows there is a strong patient demand for an oral prophylactic therapy⁵

The content on this website is intended for US healthcare professionals.

I am a healthcare professional

You are now leaving this site.

Patients with HAE are likely struggling with disease and treatment burden1,2

Self-administration challenges, needle fatigue, and other issues may be weighing patients down1

Prophylactic therapy should be determined based on individual considerations2,3:

Disease-related factors (physical, emotional, quality of life)

Treatment-related factors (route of administration, side effects, availability/supply)

Patient preference (lifestyle, dosing schedule, flexibility)

Research shows there is a strong patient demand for an oral prophylactic therapy5

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION AND IMPORTANT SAFETY INFORMATION Click to expand and close

INDICATION

IMPORTANT SAFETY INFORMATION

The content on this website is intended for US healthcare professionals.

I am a healthcare professional

You are now leaving this site.

Patients with HAE are likely struggling with disease and treatment burden^1,2

Self-administration challenges, needle fatigue, and other issues may be weighing patients down¹

Prophylactic therapy should be determined based on individual considerations^2,3:

Disease-related factors
(physical, emotional, quality of life)

Treatment-related factors
(route of administration, side effects, availability/supply)

Patient preference
(lifestyle, dosing schedule, flexibility)

Research shows there is a strong patient demand for an oral prophylactic therapy⁵

INDICATION AND IMPORTANT SAFETY INFORMATION