Orladeyo (Berotralstat): Preventing Hereditary Angioedema Attacks
Hereditary angioedema (HAE) is a rare genetic disorder that causes sudden swelling attacks in areas such as the hands, feet, face, and airways. These attacks can be painful, disfiguring, and even life-threatening if the throat or airway is affected.
Orladeyo® (berotralstat) is a once-daily oral medication designed to prevent HAE attacks, offering patients a convenient and effective way to reduce the frequency of swelling episodes.
What Is Orladeyo Used For?
Orladeyo is approved for preventive treatment in adults and pediatric patients (12 years and older) with hereditary angioedema.
- It is not for treating an acute HAE attack, but rather for reducing the number of attacks over time.
- By preventing attacks, Orladeyo can help patients maintain daily activities without the fear of sudden swelling episodes.
How Orladeyo Works
Berotralstat, the active ingredient in Orladeyo, is a plasma kallikrein inhibitor. Its mechanism of action involves:
- Blocking kallikrein activity: Kallikrein is an enzyme that contributes to swelling by producing bradykinin, a protein that increases fluid leakage from blood vessels.
- Reducing bradykinin production: Less bradykinin means reduced swelling and fewer HAE attacks.
By targeting the root cause of HAE attacks, Orladeyo helps patients stay attack-free more consistently.
How Orladeyo Is Administered
- Form: Oral capsules
- Dose: Typically 150 mg once daily, taken with food
- Consistency: Daily intake is important to maintain steady protection
Patients should not split or crush the capsules and should take them at roughly the same time each day to ensure optimal effectiveness.
Benefits of Orladeyo
- Once-daily oral dosing: Convenient and easy to remember compared to injectable options
- Reduces attack frequency: Clinical studies show significant reductions in HAE attacks per month
- Well-tolerated: Most side effects are mild to moderate
- Improved quality of life: Reduces anxiety and disruption associated with unpredictable attacks
Possible Side Effects
Common side effects of Orladeyo include:
- Stomach pain
- Diarrhea
- Nausea
- Heartburn or indigestion
Less common but more serious side effects can include allergic reactions. Any swelling of the face, lips, tongue, or throat during treatment should be treated as an emergency, as these could signal a severe HAE attack.
Precautions and Drug Interactions
- Patients should inform their doctor about all medications they are taking, as Orladeyo can interact with some drugs metabolized by liver enzymes (CYP2D6 and CYP3A4).
- Orladeyo is not a treatment for acute HAE attacks, so patients should have a separate rescue medication available.
- Pregnant or breastfeeding patients should discuss risks and benefits with their healthcare provider.
Monitoring During Treatment
Although Orladeyo is generally safe, healthcare providers may monitor:
- Frequency and severity of HAE attacks
- Any new or worsening gastrointestinal symptoms
- Possible drug interactions if new medications are added
The Bottom Line
Orladeyo (berotralstat) offers a once-daily oral option for preventing hereditary angioedema attacks. By reducing attack frequency and supporting a more predictable daily life, Orladeyo can significantly improve the quality of life for patients with HAE. While it’s important to maintain monitoring and have rescue medications available for breakthrough attacks, Orladeyo represents a modern and convenient approach to managing this rare condition.