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Important Safety InformationPrescribing Information

HAE attack prevention should be

You deserve “AND” with ORLADEYO®

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

Capsule not actual size

Kharri, an ORLADEYO patient
on treatment since 2021

HAE attack prevention should be

You deserve “AND” with ORLADEYO®

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

Capsule not actual size

 

Capsule not actual size

Kharri, taking ORLADEYO
since 2020

ORLADEYO offers proven long-term HAE control combined with the simplicity of a pill

In a 3-part study of 120 adolescents and adults living with HAE, 40 were given ORLADEYO 150 mg, 41 were given ORLADEYO 110 mg, and 39 received placebo.

  • People taking ORLADEYO 150 mg for 6 months (part 1) had a decrease in average attack rate from 3.1 to 1.3 attacks per month
  • Those receiving placebo had a decrease from 2.9 to 2.4 attacks per month

aAt 2 years, average attack rate was lowered by 91% compared with pretreatment for the 21 people who completed the full 2 years of treatment with ORLADEYO 150 mg.

— Rochelle, taking ORLADEYO since 2022

The unique stories of real people living with HAE show
that the outcomes are clear: ORLADEYO works, the
results last, and it‘s easy to take.

Individual results may vary

Witness the change for yourself.

The unique stories of real people living with HAE show
that the outcomes are clear: ORLADEYO works, the
results last, and it‘s easy to take.

Individual results may vary

Witness the change for yourself.

Getting started with ORLADEYO®
Getting started
Finding support
Support
Tools and resources
Tools and resources

INDICATION AND IMPORTANT SAFETY INFORMATION

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.