Orladeyo
Pronunciation: or-luh-DAY-oh
Generic name: berotralstat [ BER-oh-TRAL-stat ]
Dosage form: capsules (150 mg, 110 mg)
Drug class: Hereditary angioedema agents
What is Orladeyo?
Orladeyo is a treatment for hereditary angioedema (HAE) to help reduce the number of angioedema attacks in adults and children at least 12 years old. Orladeyo works by blocking a protein called kallikrein which results in a reduction of swelling and inflammation in hereditary angioedema. Orlando capsules are taken once daily.
Hereditary angioedema is a rare and potentially life-threatening genetic disorder that causes an attack of rapid swelling in the face, throat, arms, legs or around the abdomen. Orladeyo is not used for treating an HAE attack that has already begun.
In people with hereditary angioedema, overactive kallikrein increases levels of bradykinin, a protein that causes blood vessels to widen and leak. This leads to the swelling and inflammation of angioedema attacks. By inhibiting kallikrein, Orladeyo reduces the frequency of angioedema attacks.
Orladeyo mechanism of action is as a plasma kallikrein inhibitor, it binds to plasma kallikrein which decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE. Orladeyo (berotralstat) is from a group of medicines called kallikrein inhibitors.
Orladeyo side effects
Common Orladeyo side effects may include stomach pain, heartburn, vomiting, diarrhea, or back pain, these side effects can occur in 10% or more patients.
Get emergency medical help if you have signs of an allergic reaction to this medicine with symptoms of hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Taking more than one capsule a day may cause serious side effects of heart rhythm problems. QT prolongation is a heart rhythm problem that can happen in people who take more than one capsule a day. This condition can cause an abnormal heartbeat. Do not take more than one capsule a day.
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.
Warnings
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.
An increase in QT prolongation can occur at dosages higher than the recommended 150 mg once daily dosage. Additional doses or doses of this medicine higher than 150 mg once daily are not recommended.
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 this medicine is safe for you, tell your doctor if you have ever had:
- liver disease;
- 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?
The recommended dosage of Orladeyo is one 150 mg capsule taken orally once daily with food.
Use Orladeyo exactly as prescribed by your doctor. Follow all directions on your prescription label and use the medicines exactly as directed.
Follow your doctor's dosing instructions very carefully. Taking too much of this medicine can cause serious heart rhythm problems.
Orladeyo Dosing Information
Recommended Dosage: One capsule (150 mg) taken orally once daily with food.
Comments: Dosage should be adjusted in patients with moderate or severe hepatic impairment and patients with persistent gastrointestinal reactions.
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.
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.
P-gp inducers: Avoid P-gp inducers use with Orladeyo.
CYP2D6, CYP3A4 or P-gp Substrates: Appropriately monitor or dose titrate narrow therapeutic index drugs that are predominantly metabolized by CYP2D6, CYP3A4 or are P-gp substrates when co-administered with Orladeyo.
Not all possible interactions are listed here. Click on the link below to check for interaction with this medication.
Orladeyo Package Insert
Review the Orladeyo Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.
Storage
Store at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
Ingredients
Active ingredient: berotralstat dihydrochloride
Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and pregelatinized starch.
Manufacturer
BioCryst Pharmaceuticals, Inc., Durham, NC 27703
Popular FAQ
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.
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.
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.
References
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Further information
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