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What Is Orladeyo?

Orladeyo is a prescription medication containing berotralstat, a plasma kallikrein inhibitor used to prevent attacks of hereditary angioedema. It is approved for adults and children aged two years and older. Hereditary angioedema is a genetic disorder that causes recurring episodes of swelling affecting the skin, digestive tract, or airways. Orladeyo is available as oral capsules for patients aged 12 years and older and oral pellets for children aged two through 11 years. It is taken daily and is not intended to treat an acute angioedema attack.

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What Is Orladeyo?

Orladeyo is a prescription medication containing berotralstat, a plasma kallikrein inhibitor used to prevent attacks of hereditary angioedema. It is approved for adults and children aged two years and older. Hereditary angioedema is a genetic disorder that causes recurring episodes of swelling affecting the skin, digestive tract, or airways. Orladeyo is available as oral capsules for patients aged 12 years and older and oral pellets for children aged two through 11 years. It is taken daily and is not intended to treat an acute angioedema attack.

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How Does Orladeyo Work?

Orladeyo blocks plasma kallikrein, an enzyme involved in producing bradykinin. Bradykinin increases blood vessel permeability and contributes to swelling during hereditary angioedema attacks. In people with certain hereditary deficiencies or dysfunction of C1 inhibitor, excessive activation of this pathway can cause unpredictable swelling episodes. By reducing plasma kallikrein activity, berotralstat helps lower the frequency of attacks. It does not act quickly enough to reverse a sudden attack, so patients still need access to prescribed on-demand treatment.

Who Can Receive Orladeyo Treatment?

Orladeyo is approved for the prevention of hereditary angioedema attacks in adults and pediatric patients aged two years and older. The treatment is intended for patients with a confirmed diagnosis who need ongoing attack prevention. Clinicians consider age, body weight, liver function, other medications, and attack frequency before prescribing it. Children younger than 12 years use oral pellets with weight-based dosing, while patients aged 12 years and older use capsules. Orladeyo is not approved for immediate treatment of acute swelling attacks or for other unrelated forms of angioedema.

How Should Orladeyo Be Taken?

Orladeyo is taken orally once daily with food. Adults and children aged 12 years and older generally take a 150 mg capsule daily. Children aged two through 11 years receive oral pellets in a weight-based dose according to the prescribing instructions. The pellets can be swallowed with an appropriate non-acidic liquid or mixed with suitable soft, non-acidic food. They should not be chewed or crushed. Dosage adjustments or avoidance may be necessary with certain liver conditions and medication interactions. Patients should not take more than one dose daily.

What Are the Side Effects and Warnings of Orladeyo?

Common adverse effects include abdominal pain, vomiting, diarrhea, back pain, and heartburn. Liver enzyme elevations and skin reactions have also been reported. Taking more than the recommended daily dose can increase the risk of QT interval prolongation, a heart rhythm abnormality. Drug interactions can affect berotralstat exposure, and some patients with liver impairment require additional precautions. Orladeyo must not replace emergency treatment for sudden hereditary angioedema attacks, particularly those involving the throat or breathing.

Common Questions About Orladeyo

Is Orladeyo used for hereditary angioedema?

Yes. Orladeyo is approved to prevent hereditary angioedema attacks in adults and children aged two years and older.

Can Orladeyo stop an active swelling attack?

No. Orladeyo is a preventive treatment and should not be used to treat an acute hereditary angioedema attack. Patients need prescribed rescue treatment.

Can children take Orladeyo?

Yes. Children aged two through 11 years can receive weight-based oral pellets, while patients aged 12 years and older use the capsule formulation.

How often is Orladeyo taken?

Orladeyo is taken once daily with food. The prescribed formulation and dose depend on age, body weight, and other clinical considerations.

References

Berotralstat. LiverTox. https://www.ncbi.nlm.nih.gov/books/NBK605175/. Date Accessed October 22, 2026.

Berotralstat. MedlinePlus. https://medlineplus.gov/druginfo/meds/a626011.html. Date Accessed October 22, 2026.

Berotralstat. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/Berotralstat. Date Accessed October 22, 2026.

DailyMed - ORLADEYO (berotralstat hydrochloride) capsules and oral pellets. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3527ece1-e7e0-40b1-b0c5-6baeb0deabeb. Date Accessed October 22, 2026.

Orladeyo. European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/EPAR/orladeyo. Date Accessed October 22, 2026.