Orladeyo (berotralstat)

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What is Orladeyo (berotralstat) for?

Orladeyo (berotralstat) is a plasma kallikrein inhibitor indicated for the prevention of hereditary angioedema (HAE) attacks in adults and children 12 years of age and older.^[1]

Because it is not known if Orladeyo (berotralstat) is safe and effective to treat an acute HAE attack, it should not be used to treat an acute HAE attack.^[1]

It is available in capsule form containing 150 or 110 mg of berotralstat.^[1]

How does Orladeyo (berotralstat) work?

HAE is a rare genetic disease that causes swelling under the skin. It can develop when there is too little of a certain protein in the body named C1 inhibitor. Because of this, the protein plasma kallikrein gets activated, which in its turn activates bradykinin. This protein causes tiny blood vessels to push fluids into the tissues surrounding them, which leads to sudden swelling.^[2]

Berotralstat works by decreasing the activity plasma kallikrein. Thereby it can prevent attacks in patients with HAE.^[2]

Where has Orladeyo (berotralstat) been approved?

Orladeyo (berotralstat) was approved for the prevention of HAE attacks by:

• The Food and Drug Administration (FDA), USA on December 3, 2020.^[3]
• The Pharmaceuticals and Medical Devices Agency (PMDA), Japan on January 22, 2021.^[4]
• The European Medicines Agency (EMA) on April 30, 2021.^[5]

It is the first oral drug that is not a steroid that has been approved for this indication.^[3]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Orladeyo (berotralstat) taken?

The standard dosage is:^[1]

• One 150 mg capsule taken orally once daily with food

The recommended dosage for patients who have liver problems or are on kidney dialysis is different: patients should take one 110 mg capsule per day with food.^[1]

Warning: do not take more than one capsule of Orladeyo a day because extra doses can cause heart rhythm problems.

Complete information about Orladeyo (berotralstat) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Orladeyo (berotralstat)?

Common adverse reactions

The most common side effects (≥20% of patients) listed in the prescribing information include:^[1]

• Belly (abdominal) pain
• Vomiting
• Diarrhea
• Back pain
• Heartburn

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Heart rhythm problems (QT prolongation)

Use in a specific population

Orladeyo (berotralstat) can cause fetal harm when administered to a pregnant woman; it is advised to avoid pregnancies and breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Orladeyo (berotralstat) [PDF] BioCryst Pharmaceuticals, Dec 2020

2. Overview of Epidemiology, Pathophysiology, and Disease Progression in Hereditary Angioedema
AJMC, Lumry WR, cited on Dec 9 2020

3. Orladeyo Set to Launch by Year’s End if Approved, BioCryst Says
Angioedema news article, cited on Dec 9, 2020

4. BioCryst Announces Approval of ORLADEYO™ (berotralstat) in Japan for the Prophylactic Treatment of Hereditary Angioedema
Globe Newswire, Jan 22, 2021

4. Orladeyo product information
EMA, Apr 2021