Orladeyo 150 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the patient
Introduction
Package leaflet: information for the patient
Orladeyo 150 mg hard capsules
berotralstat
This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Orladeyo is and what it is used for
- What you need to know before taking Orladeyo
- How to take Orladeyo
- Possible side effects
- How to store Orladeyo
- Contents of the pack and other information
1. What Orladeyo is and what it is used for
Orladeyo is a medicine that contains the active substance berotralstat. It is used to prevent attacks of angioedema in 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 may 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 may make breathing difficult
- genitals
- stomach and intestines
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 excessive levels of the enzyme plasma kallikrein, which in turn increases levels of bradykinin in the bloodstream. Excess bradykinin causes symptoms of hereditary angioedema. Berotralstat, the active substance in Orladeyo, blocks the activity of plasma kallikrein and thereby reduces bradykinin levels. This helps prevent the swelling and pain caused by hereditary angioedema.
2. What you need to know before taking Orladeyo
Do not take Orladeyo
- if you are allergic to berotralstat or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting Orladeyo:
- if you have moderate or severe liver impairment, which may increase blood levels of berotralstat
- if you have severe renal impairment
- if you are at risk of a certain heart rhythm abnormality known as QT interval prolongation
Treat attacks of hereditary angioedema with your usual rescue medication without taking additional doses of Orladeyo. It is unknown whether Orladeyo is effective for the immediate treatment of hereditary angioedema attacks.
Children and adolescents
Orladeyo is not recommended for children under 12 years of age, as it has not been studied in this age group.
Orladeyo has not been studied in adolescents weighing less than 40 kg.
Other medicines and Orladeyo
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor before taking Orladeyo if you are using:
- thioridazine or pimozide, medicines used to treat mental disorders
- amlodipine, a medicine used to treat high blood pressure or a type of chest pain called angina
- cyclosporine, a medicine used to suppress the immune system, treat serious skin diseases, or severe inflammation of the eyes or joints
- dabigatran, a medicine used to prevent blood clots
- rifampicin, a medicine used to treat tuberculosis or other infections
- desipramine, St. John’s wort, and other medicines used to treat depression known as tricyclic antidepressants
- dextromethorphan, a medicine used to relieve cough
- digoxin, a medicine used to treat heart problems and irregular heartbeat
- fentanyl, a strong painkiller
- midazolam, a medicine used to treat sleep disorders and as an anesthetic
- tolbutamide, a medicine used to lower blood sugar
- oral contraceptives, medicines used for birth control
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Limited information is available on the use of Orladeyo during pregnancy and breastfeeding. As a precautionary measure, it is preferable to avoid using Orladeyo during pregnancy and breastfeeding. Your doctor will explain the risks and benefits of taking this medicine.
Women of childbearing potential must use effective contraceptive methods during treatment and for at least one month after the last dose. The use of Orladeyo is not recommended in women of childbearing potential who are not using contraceptive methods.
Driving and use of machines
The influence of Orladeyo on the ability to drive and operate machinery is none or negligible.
3. How to take Orladeyo
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If 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.
Orladeyo is not recommended for use 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 treatment with Orladeyo to be necessary, additional monitoring may be required, including monitoring of heart rhythm using tests such as the 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.
How to take
Take the capsule with food and a glass of water at the same time every day. You may take it at any time of 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 missed 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 medicine regularly as long as your doctor prescribes it. Do not stop taking it without your doctor's approval.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects may occur with the following frequencies:
Very common: may affect more than 1 in 10 people
- headache
- stomach pain, including abdominal discomfort (intestinal discomfort), abdominal tenderness on palpation
- diarrhoea and frequent bowel movements
Common: may affect up to 1 in 10 people
- vomiting
- heartburn
- gas
- blood tests showing increased levels of liver enzymes known as ALT and AST
- skin rash
Frequency not known: cannot be estimated from the available data
- nausea
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Orladeyo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. 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).
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The other components are:
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pregelatinized starch, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, gelatin, titanium dioxide (E 171)
-
colourants: indigo carmine (E 132), black iron oxide (E 172), red iron oxide (E 172)
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edible printing ink: black iron oxide (E 172), potassium hydroxide, shellac, propylene glycol (E 1520)
Appearance of the product and contents of the pack
Orladeyo capsules have an opaque white body printed with "150" and an opaque light blue cap printed with "BCX" (19.4 mm x 6.9 mm). They are supplied in plastic/aluminum blisters in a carton containing 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 the most recent revision of this leaflet:
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.