Join expert panelists as they discuss their experience transitioning patients to an oral preventative therapy for HAE, including important considerations to set patients up for treatment success.

Program Information


Sunday, February 25, 2024 │ 12:00 – 12:30 PM ET
Lunch will be offered.

Product Theater
Level 2, Hall D

Walter E. Washington Convention Center
801 Allen Y. Lew Place NW, Washington, DC 20001


HAE Expert Panel

SWilliam R. Lumry, MD  photo

William R. Lumry, MD
UT Southwestern Medical School
Dallas, TX
John T. Anderson, MD  photo

John T. Anderson, MD
AllerVie Health
Birmingham, AL
Michael E. Manning, MD  photo

Michael E. Manning, MD
UA College of Medicine
Phoenix, AZ

Intended for US healthcare professionals only.
The content and opinions expressed are those of the sponsor and/or presenter(s) and are not necessarily those of the AAAAI.


For questions about the program, please contact us at Support@TranscendMedCom.com .

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 full Prescribing Information.


For Colorado prescribers, please see information regarding the Wholesale Acquisition Cost.

For Connecticut prescribers and pharmacists, see information regarding the Average Wholesale Price.

For Vermont prescribers, please see information regarding the Average Wholesale Price.

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