Generic name: berotralstat [ BER-oh-TRAL-stat ]
Drug class: Hereditary angioedema agents
What is Orladeyo?
Orladeyo is used to prevent attacks of hereditary angioedema (HAE) in adults and children at least 12 years old.
Orladeyo is not for use in treating an HAE attack that has already begun.
It is not known if Orladeyo is safe and effective in children under 12 years of age.
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Taking Orladeyo with certain other medicines may affect the way other medicines work and other medicines may affect how berotralstat works.
Before taking this medicine
To make sure Orladeyo is safe for you, tell your doctor if you have ever had:
kidney disease (or if you are on dialysis); or
heart rhythm problems.
Tell your doctor if you are pregnant or breastfeeding.
Orladeyo is not approved for use by anyone younger than 12 years old.
How should I take Orladeyo?
Use Orladeyo exactly as prescribed by your doctor. Follow all directions on your prescription label and use the medicines exactly as directed.Follow all directions on your prescription label and read all medication guides or instruction sheets.
The recommended dosage of Orladeyo is one 150 mg capsule taken orally once daily with food.
Follow your doctor's dosing instructions very carefully. Taking too much of this medicine can cause serious heart rhythm problems.
Store at room temperature away from moisture and heat. Keep each capsule in the blister pack until you are ready to take a pill. Each carton contains a tamper evident seal. Do not use Orladeyo if the tamper evident seal is broken or missing.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Orladeyo?
Do not share this medicine with another person, even if they have HAE.
Orladeyo side effects
Get emergency medical help if you have signs of an allergic reaction to Orladeyo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Common Orladeyo side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Orladeyo?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may interact with berotralstat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
How effective is Orladeyo for HAE?
In research studies that led to approval, Orladeyo significantly reduced HAE attacks at 6 months (24 weeks) time and led to a sustained reduction through 48 weeks. For patients in the studies, HAE attacks declined from an average of 2.9 attacks per month to 1 attack per month after about one year of treatment.
Is Orladeyo an orphan drug?
Orladeyo (berotralstat) is an orphan drug. The US Food and Drug Administration (FDA) granted Orladeyo orphan drug designation in November 2017 for the treatment of C1-inhibitor-dependent angioedema (including prevention and treatment of attacks).
Orladeyp is a plasma kallikrein inhibitor, which was approved by the FDA in 2020 for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Orladeyp is marketed by BioCryst Pharmaceuticals, which has marketing exclusivity for this drug until December 2027.
Orphan drugs are drugs that are used to treat orphan or rare diseases. The FDAs orphan drug designation process provides companies with various incentives to develop therapeutics for the treatment of rare disease.
How does Orladeyo work?
Orladeyo (berotralstat) works by blocking the action of a protein in your blood called kallikrein. High kallikrein activity in people with hereditary angioedema (HAE) increases bradykinin, a chemical that leads to pain and swelling. Orladeyo is a once-daily oral, prescription medicine used to prevent attacks of HAE in adults and children 12 years and older.
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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Orladeyo only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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