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Important Safety InformationPrescribing Information

About HAE

 
 
 

About HAE

 
 
 

What is hereditary angioedema (HAE) and how is it treated?

HAE is a rare genetic condition that causes repeat episodes of severe swelling in the body, especially the face, arms, legs, airway, and intestinal tract.

Everyone living with HAE experiences their disease differently, but regardless of where you are in your journey, HAE likely affects—or has affected—your life in a number of ways.

— Leah, living with HAE

Treating your HAE

There are 2 types of therapies used to treat HAE.

Rescue therapy

Rescue therapy, or acute therapy, is used to help manage or lessen symptoms when an attack is coming on or has already started.

Preventative therapy

Preventative therapy, or prophylactic therapy, is taken regularly as a way to help stop HAE attacks from happening.

Because treatment with rescue therapy alone is not always enough, people living with HAE often use both types of therapy to manage their disease. Long-term treatment with preventative therapy is the best way to prevent future HAE attacks.

As your life changes, your treatment plan might need to change, too

Making decisions with your healthcare team can lead to better results. As you and your healthcare provider discuss the preventative therapy that‘s right for you, here are some factors to consider:

Injection needle

How it‘s given (injection, infusion, orally)

Lifestyle

How it fits into your lifestyle

Safety

How safe it is

Attack prevention

How well it prevents attacks

Rescue therapy

How it may help reduce the use of rescue therapy

— Daryl, father and caregiver to Le‘ah, a patient

Don‘t be afraid to advocate for yourself to get what you want out of HAE management

Every person‘s experience with HAE is unique. But there‘s no one who understands your experience and what you want better than you.

It‘s important to discuss your unique needs and goals with your healthcare provider, because they‘re what make you, you:

Mother and child illustration

Whether or not you‘re the first in your family with HAE

School-age girl

Age

Elderly couple

Activity level

Logging information

Daily and long-term goals

Adult reading

Personal preferences

C1 esterase inhibitor level

C1 esterase inhibitor level

— Le‘ah, living with HAE

Learn more about why ORLADEYO could be right for you

Ready to start the conversation about ORLADEYO at your next appointment?

Download the discussion guide and use it to talk to your healthcare provider about your satisfaction with your current treatment and if ORLADEYO could be right for you.

Currently taking preventative therapy

Not yet taking preventative therapy

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.