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. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

High blood pressure, headaches, dizziness, swelling, palpitations.
Diagnosis and management of hypertension, arrhythmias, and tachycardia.
Metabolic syndrome, excess weight, high cholesterol.
Chronic fatigue, insomnia, poor concentration, anxiety.
Respiratory symptoms: colds, flu, sore throat, cough, fever.
Digestive issues: heartburn, bloating, constipation, IBS symptoms.
Chronic conditions: diabetes, thyroid disorders.
Interpretation of lab tests and medical reports, therapy adjustment.
Second opinion and decision-making support.
Cardiovascular disease prevention and metabolic risk reduction.
Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

ORLADEYO 150 mg HARD CAPSULES

Abdullah Alhasan

Nuno Tavares Lopes

Abdullah Alhasan

Nuno Tavares Lopes