This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use ORLADEYO 150 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Orladeyo 150 mg Hard Capsules

berotralstat

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

What is Orladeyo and what is it used for
What you need to know before you take Orladeyo
How to take Orladeyo
Possible side effects
Storage of Orladeyo
Contents of the pack and other information

1. What is Orladeyo and what is it used for

Orladeyo is a medicinal product that contains the active substance berotralstat. It is used to prevent attacks of hereditary angioedemain adults and adolescents aged 12 years and older with hereditary angioedema.

What is hereditary angioedema

Hereditary angioedema is a disease that is usually inherited. It can limit your daily activities by causing episodes of swelling and pain in different parts of the body, including:

hands and feet
face, eyelids, lips or tongue
larynx, which can make breathing difficult
genitals
stomach and intestine

How Orladeyo works

In hereditary angioedema, the blood does not have enough of a protein called C1 inhibitor or this protein does not work properly. This leads to an excess of the enzyme kallikrein in the plasma, which in turn increases the levels of bradykinin in the bloodstream. Excess bradykinin causes symptoms of hereditary angioedema. Berotralstat, the active substance of Orladeyo, blocks the activity of plasma kallikrein and thus reduces bradykinin. This prevents the swelling and pain that can be caused by hereditary angioedema.

2. What you need to know before you take Orladeyo

Do not take Orladeyo

if you are allergic to berotralstat or any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Orladeyo:

if you have moderate or severe liver impairment that may increase blood levels of berotralstat
if you have severe kidney impairment
if you are at risk of a certain heart rhythm disorder, known as QT interval prolongation

Treat hereditary angioedema attacks with your usual rescue medication without taking additional doses of Orladeyo. It is not known if Orladeyo is effective for the immediate treatment of hereditary angioedema attacks.

Children and adolescents

Orladeyo is not recommended in children under 12 years of age, as it has not been studied in this age group.

Orladeyo has not been studied in adolescents who weigh less than 40 kg.

Other medicines and Orladeyo

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor before taking Orladeyo if you are using:

thioridazine or pimozide, medicines for treating mental disorders
amlodipine, a medicine for treating high blood pressure or a type of chest pain called angina
ciclosporin, a medicine for suppressing the immune system, treating severe skin diseases and severe eye or joint inflammation
dabigatran, a medicine for preventing blood clots
rifampicin, a medicine for treating tuberculosis or other infections
desipramine, hypericum and other medicines for treating depression called tricyclic antidepressants
dextromethorphan, a medicine for relieving cough
digoxin, a medicine for treating heart problems and irregular heart rhythm
fentanyl, a potent pain reliever
midazolam, a medicine for treating sleep disorders and used as an anesthetic
tolutamide, a medicine for reducing blood sugar
oral contraceptives, medicines used for birth control

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicinal product.

There is limited information on the use of Orladeyo during pregnancy and breastfeeding. As a precaution, it is recommended to avoid the use of Orladeyo during pregnancy and breastfeeding. Your doctor will explain the risks and benefits of taking this medicinal product.

Women of childbearing potential must use effective contraceptive methods during treatment and for at least one month after the last dose. It is not recommended to use Orladeyo in women of childbearing potential who are not using contraceptive methods.

Driving and using machines

Orladeyo has no or negligible influence on the ability to drive and use machines.

3. How to take Orladeyo

Follow exactly the administration instructions of this medicinal product given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and adolescents aged 12 years and older who weigh ≥40 kg is one capsule once daily.

It is not recommended to use Orladeyo in patients with moderate or severe liver impairment.

Treatment with Orladeyo should be avoided if you have severe kidney impairment. However, if your doctor considers that treatment with Orladeyo is necessary, you may require additional monitoring, including monitoring of your heart rhythm by tests such as electrocardiogram (ECG, a test that measures the electrical activity of the heart). Treatment with Orladeyo should be avoided if you are on dialysis due to kidney disease.

Method of administration

Take the capsule with food and with a glass of water at the same time every day. You can take it at any time of the day.

If you take more Orladeyo than you should

Contact your doctor immediately.

If you forget to take Orladeyo

Do not take a double dose to make up for a forgotten capsule. Take the forgotten dose as soon as you remember; however, do not take more than one dose per day.

If you stop taking Orladeyo

It is important that you take this medicinal product regularly while your doctor prescribes it. Do not stop taking it without your doctor's approval.

If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.

Side effects may occur with the following frequencies:

Very common, may affect more than 1 in 10 people

headache
stomach pain, including abdominal discomfort, abdominal pain on palpation
diarrhea and frequent bowel movements

Common, may affect up to 1 in 10 people

vomiting
heartburn
gas
blood tests showing an increase in certain liver enzymes called ALT and AST
skin rash

Frequency not known, cannot be estimated from the available data

nausea

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Orladeyo

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orladeyo

The active substance is berotralstat. Each capsule contains 150 mg of berotralstat (as dihydrochloride).
The other ingredients are:

pregelatinized starch, crospovidone (type A), colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide (E 171)
colorants: indigo carmine (E 132), black iron oxide (E 172), red iron oxide (E 172)
edible printing ink: black iron oxide (E 172), potassium hydroxide, shellac, propylene glycol (E 1520)

Appearance of the product and pack size

Orladeyo capsules have a white opaque body with the imprint «150» and a light blue opaque cap with the imprint «BCX» (19.4 mm x 6.9 mm). They are available in plastic/aluminum blisters in a carton with 7 capsules per blister.

Pack size: 28 or 98 hard capsules

Marketing authorization holder and manufacturer

Marketing authorization holder

BioCryst Ireland Limited

Block 4, Harcourt Centre, Harcourt Road, DUBLIN 2, D02HW77

Ireland

Manufacturer

Millmount Healthcare Limited

Block-7, City North Business Campus,

Stamullen,

Co. Meath, K32 YD60

Ireland

Date of last revision of this leaflet: 07/2024

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

fever, chills, fatigue and viral symptoms
cough, sore throat, nasal congestion, breathing discomfort
bronchitis and mild asthma flare-ups
nausea, diarrhoea, abdominal pain, digestive infections
rashes, allergic reactions, redness, insect bites
muscle or joint pain, mild injuries, sprains
headache, dizziness, migraine symptoms
stress-related symptoms, sleep disturbances
questions about test results and treatment plans
management of chronic conditions in stable phases

Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

Advanced Trauma Life Support (ATLS)
Basic and Advanced Cardiac Life Support (BLS/ACLS)
Pediatric Advanced Life Support (PALS)
Prehospital Trauma Life Support (PHTLS)
eFAST and critical care transthoracic echocardiography
aviation medicine

He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.

ORLADEYO 150 mg HARD CAPSULES

Tarek Agami

Abdullah Alhasan

Tarek Agami

Abdullah Alhasan