The safety of ORLADEYO^® is supported by data from patients across 2 clinical studies¹

In APeX-2 (part 1), the most common^a treatment-emergent adverse reactions were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease (GERD)¹

ORLADEYO® APeX-2 study adverse reaction summary

^a≥10% and higher than placebo.¹
^bIncludes abdominal pain, abdominal discomfort, abdominal tenderness, and upper abdominal pain.¹
^cIncludes diarrhea and frequent bowel movements.¹

No patients in the ORLADEYO 150 mg dose group and 1 patient in the ORLADEYO 110 mg dose group discontinued treatment due to a gastrointestinal (GI) adverse reaction in APeX-2 part 1¹
Findings from the open-label, long-term safety study, APeX-S (interim safety population, n=227), support the data observed in APeX-2 (part 1)¹
No new types of side effects were seen in those who continued ORLADEYO for 96 weeks³
- One patient receiving ORLADEYO 150 mg discontinued treatment due to a GI abdominal adverse reaction in APeX-2 part 3³

GI adverse reactions generally occurred early after initiation of treatment, became less frequent with time, and typically self-resolved¹

Abbreviation: TEAE, treatment-emergent adverse event.

If GI reactions persist, a reduced dosage of 110 mg once daily with food may be considered¹

Setting expectations with patients regarding possible adverse reactions can help ensure a strong start.⁵

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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. ORLADEYO [prescribing information]. Durham, NC: BioCryst Pharmaceuticals Inc.; 2022. 2. Data on file, BioCryst Pharmaceuticals Inc. 3. Kiani S, Jacobs J, Desai B, et al. Durable reduction in hereditary angioedema (HAE) attack rates with berotralstat over 24 months: results from the phase 3 APeX-2 study. Presented at: European Academy of Allergy and Clinical Immunology Hybrid Congress; July 10-12, 2021; Madrid, Spain and Krakow, Poland. 4. Johnston D, Lumry WR, Banerji A, et al. Gastrointestinal adverse events observed with berotralstat (BCX7353) treatment for hereditary angioedema are primarily mild, self-limited, and diminish with time on treatment. Poster presented at: American Academy of Allergy, Asthma and Immunology Annual Meeting; March 13-16, 2020; Philadelphia, PA. 5. 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.

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.

The safety of ORLADEYO^® is supported by data from patients across 2 clinical studies¹

In APeX-2 (part 1), the most common^a treatment-emergent adverse reactions were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease (GERD)¹

GI adverse reactions generally occurred early after initiation of treatment, became less frequent with time, and typically self-resolved¹

Set treatment expectations

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The safety of ORLADEYO® is supported by data from patients across 2 clinical studies1

In APeX-2 (part 1), the most commona treatment-emergent adverse reactions were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease (GERD)1

GI adverse reactions generally occurred early after initiation of treatment, became less frequent with time, and typically self-resolved1

Set treatment expectations

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.

The safety of ORLADEYO^® is supported by data from patients across 2 clinical studies¹

In APeX-2 (part 1), the most common^a treatment-emergent adverse reactions were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease (GERD)¹

GI adverse reactions generally occurred early after initiation of treatment, became less frequent with time, and typically self-resolved¹

INDICATION AND IMPORTANT SAFETY INFORMATION