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Orladeyo (berotralstat) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to prevent attacks of hereditary angioedema (HAE) in adults and children ages 2 and older.
Orladeyo is a plasma kallikrein inhibitor. Plasma kallikrein is a protein involved in swelling. Orladeyo blocks this protein and lowers the production of bradykinin.
Bradykinin can make blood vessels leak fluid and cause swelling. Orladeyo helps prevent HAE attacks. It is not used to treat a sudden HAE attack.
Doctors prescribe Orladeyo when adults and children ages 2 and older need preventive treatment for HAE attacks.
Orladeyo is taken by mouth with food. Adults and children ages 12 and older take capsules. Children ages 2 to under 12 take oral pellets.
Do not chew or crush the oral pellets. This can damage the coating and make them taste bitter.
Pour the full packet directly into the mouth and swallow it right away with a nonacidic liquid, such as water or milk. You may also sprinkle the full packet over 1 tablespoon (15 milliliters) of soft, non-acidic food and eat it right away.
Throw away the pellets if they are not eaten within 10 minutes after being sprinkled over food. Eat a meal just before or just after taking the pellets.
For adults and children ages 12 and older, the recommended dose is 150 milligrams once daily with food.
For children ages 2 to under 12, the dose is based on body weight:
For people ages 12 and older with moderate or severe liver problems, the recommended dose is 110 milligrams once daily with food. Orladeyo should be avoided in children ages 2 to under 12 who have moderate or severe liver problems.
For people ages 12 and older who have ongoing stomach-related side effects, a doctor may consider lowering the dose to 110 milligrams once daily with food.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In a 24-week study of adults and children ages 12 and older, the most common side effects of Orladeyo occurred in about 10 percent to 23 percent of people. These include:
Orladeyo can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
BioCryst Pharmaceuticals, the manufacturer of Orladeyo, offers Empower Patient Services. Eligible people with commercial insurance may pay as little as $0 for treatment.
Empower Patient Services also offers support from a dedicated clinical team, help getting started and staying on treatment, insurance navigation, and coordination of prescription refills and shipments.
To learn more, visit the Empower Patient Services website or call 866-536-7693.
Tell your doctor if you are allergic to berotralstat or any of Orladeyo’s ingredients.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Before starting Orladeyo, tell your doctor if you have liver or kidney problems.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Orladeyo, talk with your doctor about the risks and benefits.
These answers are fact-checked by our editorial staff.
How effective is Orladeyo for HAE?
In a 24-week study of adults and children ages 12 and older with type 1 or type 2 HAE, people taking Orladeyo 150 milligrams once daily had 1.31 attacks per 28 days. People taking placebo (an inactive treatment) had 2.35 attacks per 28 days. This was a 44.2 percent reduction in attack rate compared with placebo.
In the same study, 58 percent of people taking Orladeyo 150 milligrams had their attack rate reduced by at least half. This happened in 25 percent of people taking placebo.
How long does Orladeyo take to work for HAE?
The study does not provide an exact number of days. Reductions in HAE attacks were seen during the first month of treatment and continued through 24 weeks.
How do you take Orladeyo oral pellets for HAE?
Take Orladeyo oral pellets once daily with food. Pour the full packet directly into your mouth and swallow it right away with a non-acidic liquid, such as water or milk. You can also sprinkle the full packet over 1 tablespoon (15 milliliters) of soft, non-acidic food and eat it right away.
Do not chew or crush the pellets. Do not mix them with acidic foods, such as yogurt or applesauce. Throw the pellets away if they are not eaten within 10 minutes after being sprinkled over food.
Eat a meal just before or just after taking the dose.
On myHAEteam, people share their experiences with HAE, get advice, and find support from others who understand.
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