Welcome to the 2021 ACAAI Annual Scientific Meeting
Wi-Fi connection brought to you by ORLADEYO® (berotralstat)—the first and only targeted oral prophylactic therapy for hereditary angioedema.1
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 to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
Please see full Prescribing Information.
Reference: 1. ORLADEYO [prescribing information]. Durham, NC: BioCryst Pharmaceuticals Inc.; 2020.
WHAT IS ORLADEYO® (berotralstat)?
ORLADEYO (or-luh-DAY-oh) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in adults and children 12 years of age and older. It is not known if ORLADEYO is safe and effective in children under 12 years of age.
It is not known if ORLADEYO is safe and effective to treat an acute HAE attack, therefore ORLADEYO should not be used to treat an acute HAE attack.
Do not take more than one capsule of ORLADEYO per day because extra doses can cause heart rhythm problems.
IMPORTANT SAFETY INFORMATION
Before taking ORLADEYO, tell your healthcare provider about all of your medical conditions, including if you- have liver problems or are on kidney dialysis.
- are pregnant or planning to become pregnant. It is not known if ORLADEYO can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ORLADEYO passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking ORLADEYO.
Tell your healthcare provider about all of the medicines you take, including other medicines for HAE, prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking ORLADEYO with certain other medicines may affect the way other medicines work and other medicines may affect how ORLADEYO works.
Know the medicines you take and keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What are the possible side effects of ORLADEYO?Taking more than one capsule of ORLADEYO per day may cause serious side effects, including heart rhythm problems. A heart rhythm problem called QT prolongation can happen in people who take more than one capsule of ORLADEYO per day. This condition can cause an abnormal heartbeat. Do not take more than one capsule of ORLADEYO per day.
The most common side effects of ORLADEYO include abdominal pain, vomiting, diarrhea, back pain, and heartburn. These are not all of the possible side effects of ORLADEYO. For more information, ask your healthcare provider or pharmacist.
Talk to your healthcare provider for medical advice about side effects.
You are encouraged to report side effects of prescription drugs to BioCryst Pharmaceuticals, Inc at 1-833-633-2279 or to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088. For more information, please see the full Prescribing Information including the Patient Information.