Generic drug: berotralstat
Brand name: Orladeyo
What is Orladeyo (berotralstat), and how does it work?
- Orladeyo (berotralstat) is a prescription medicine used to prevent attacks of Hereditary Angioedema (HAE) in adults and children 12 years of age and older.
- Orladeyo is not used to treat an acute HAE attack.
- Do not take more than one capsule of Orladeyo a day because extra doses can cause heart rhythm problems.
- It is not known if Orladeyo is safe and effective to treat an acute HAE attack.
- It is not known if Orladeyo is safe and effective in children under 12 years of age.
What are the side effects of Orladeyo?
Taking more than one capsule of Orladeyo a 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 a day. This condition can cause an abnormal heart beat. Do not take more than one capsule of Orladeyo a day.
The most common side effects of Orladeyo include:
Less common side effects include increases in liver function tests. Rarely, some patients had a brief, itchy rash.
These are not all of the possible side effects of Orladeyo. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Orladeyo?
- The recommended dosage of Orladeyo is one 150 mg capsule taken orally once daily with food.
Recommended Dosage In Patients With Hepatic Impairment
- No dosage adjustment of Orladeyo is recommended for patients with mild hepatic impairment (Child-Pugh Class A).
- In patients with moderate or severe hepatic impairment (Child-Pugh B or C), the recommended dosage of Orladeyo is one 110 mg capsule taken orally once daily with food.
Recommended Dosage For Concomitant Use With P-Gp Or BCRP Inhibitors
- In patients with chronic administration of P-gp or BCRP inhibitors (e.g., cyclosporine), the recommended dosage of Orladeyo is one 110 mg capsule taken orally once daily with food.
Dosage Adjustment In Patients With Persistent GI Reactions
- Gastrointestinal (GI) reactions may occur in patients receiving Orladeyo. If GI events persist, a reduced dose of 110 mg once daily with food may be considered.
What drugs interact with Orladeyo?
- This section describes clinically relevant drug interactions with Orladeyo. Drug interaction studies are described elsewhere in the labeling.
Potential For Other Drugs To Affect Orladeyo
P-Gp Or BCRP Inhibitors
- Orladeyo is a P-gp and BCRP substrate. A dose of 110 mg Orladeyo is recommended for patients with chronic administration of P-gp or BCRP inhibitors (e.g., cyclosporine).
- Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (e.g., rifampin, St. John's wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of Orladeyo. The use of P-gp inducers is not recommended with Orladeyo.
Potential For Orladeyo To Affect Other Drugs
CYP2D6 And CYP3A4 Substrates
- Orladeyo at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 (e.g., thioridazine, pimozide) or CYP3A4 (e.g., cyclosporine, fentanyl), appropriate monitoring and dose titration is recommended.
- Orladeyo at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (e.g. digoxin) when co-administering with Orladeyo.
Is Orladeyo safe to use while pregnant or breastfeeding?
- There are insufficient data in pregnant women available to inform drug-related risks with Orladeyo use in pregnancy.
- There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.
- However, when a drug is present in animal milk, it is likely that the drug will be present in human milk.
- AHA News: This Tick Season, Beware the Tiny Bugs That Can Carry Lyme Disease – a Danger to the Heart
- Ticks Can Take a Licking From Really Tough Weather
- Drug Might Help Slow Nearsightedness in Kids
- Does Your Kid Need a Summer Vacation From Smartphones?
- Get in the Swim: Summer Pool Safety Tips
- More Health News »
Orladeyo (berotralstat) is a prescription medicine used to prevent attacks of Hereditary Angioedema (HAE) in adults and children 12 years of age and older. Orladeyo is not used to treat an acute HAE attack. Serious side effects of Orladeyo include heart rhythm problems.
Multimedia: Slideshows, Images & Quizzes
Genetics: 11 Surprising Things Your Genes Say About You
Explore what role DNA plays in your health, love life, and more in this WebMD slideshow.
Picture of Lymphedema
Lymphedema is a build-up of lymph fluid in the body in the fatty tissue of your skin. It can cause swelling and discomfort,...
Picture of Pitting Edema
Observable swelling of body tissues due to fluid accumulation that may be demonstrated by applying pressure to the swollen area...
Family Health History: Genetics, DNA Testing and Your Health
WebMD explains why your doctor asks about your relatives' health conditions and how you can get the information if you don’t know.
Family Health: The Truth About Mail-In DNA Tests
If you're thinking about using an at-home DNA test kit, here are a few things to think about before mailing it in.
Related Disease Conditions
The definition of a genetic disease is a disorder or condition caused by abnormalities in a person's genome. Some types of genetic inheritance include single inheritance, including cystic fibrosis, sickle cell anemia, Marfan syndrome, and hemochromatosis. Other types of genetic diseases include multifactorial inheritance. Still other types of genetic diseases include chromosome abnormalities (for example, Turner syndrome, and Klinefelter syndrome), and mitochondrial inheritance (for example, epilepsy and dementia).
Edema is swelling caused by fluid accumulation in the tissues of the body and occurs most often in the legs, feet, ankles, or hands. Learn about different types, symptoms, causes, and treatment.
Pulmonary edema, or fluid in the lungs, can cause symptoms such as shortness of breath. Learn about causes, diagnosis complications, treatment, and prevention.
Lymphedema is a condition in which one or more extremities become swollen as the result of an impaired flow of the lymphatic system. There are two types of lymphedema: primary and secondary. Filariasis is the most common cause of lymphedema worldwide. In the U.S., breast cancer surgery is the most common cause. Symptoms include swelling of one or more limbs, cracked and thickening skin, and secondary bacterial or fungal infections of the skin. There is no cure for lymphedema.
Hereditary Angioedema (HAE)
Hereditary angioedema or HAE is a genetic disease that causes swelling of the skin and tissues beneath it. Symptoms of HAE include shortness of breath, mood changes, laryngeal edema (a medical emergency), swelling of the hands and feet, muscle aches, and skin tingling. Treatment of HAE includes medication and avoidance of triggers.
What Causes Angioedema?
What is angioedema? Angioedema is a form of swelling that occurs under the skin. Learn what causes angioedema, its signs and symptoms, how doctors diagnose it, when to see a doctor, and ways to treat this condition.
How Is Angioedema Treated?
Learn what medical treatments can help treat your angioedema symptoms and help you manage this condition.
Who Should Get Genetic Counselling?
Genetic counseling is the process that helps you in determining hereditary or genetic (running in your family) problems that might affect you or your family. It is done by a trained professional.
Genetic Testing: Families With Breast Cancer
Breast cancer can be a killer and the decision to get tested to see if a patient is prone to the disease should be discussed with a doctor -- particularly if the woman has a history of breast cancer in her family. Genetic testing can only tell so much about breast cancer risk, however.
Treatment & Diagnosis
Prevention & Wellness
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.