ORLADEYO 150 mg HARD CAPSULES
How to use ORLADEYO 150 mg HARD CAPSULES
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to ORLADEYO 150 mg HARD CAPSULESDosage form: INJECTABLE, 200 mgActive substance:Manufacturer: Csl Behring GmbhPrescription requiredDosage form: INJECTABLE, 1500 IUActive substance: c1-inhibitor, plasma derivedManufacturer: Csl Behring GmbhPrescription requiredDosage form: INJECTABLE, 2000 IUActive substance: c1-inhibitor, plasma derivedManufacturer: Csl Behring GmbhPrescription required
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