150 mg hard capsules
berotralstat
What Orladeyo is and what it is used for
Orladeyo is a medicine that contains the active substance berotralstat. It is used to prevent angioedema in adults and adolescents from the age of 12 with hereditary (hereditary) angioedema.
What is hereditary angioedema?
Hereditary angioedema is a disease that can affect several people in the same family. The disease can complicate your daily activities by causing sudden swelling and pain in various parts of the body such as
- hands and feet
- face, eyelids, lips or tongue
- larynx, which can make it difficult to breathe
- genitals
- stomach and intestines.
How Orladeyo works
In hereditary angioedema, the blood contains too little of a protein called a C1 inhibitor, or the protein does not work properly. The result is an excessive amount of enzyme plasma kallikrein, which in turn increases the amount of bradykinin in the blood. Too much bradykinin leads to symptoms of hereditary angioedema. Berotralstat, the active substance in Orladeyo, inhibits the activity of plasma calligraphy and thus reduces the amount of bradykinin. This prevents the swelling and pain that hereditary angioedema can cause.
What you need to know before using Orladeyo
Do not take Orladeyo
- if you are allergic to berotralstat or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Orladeyo
- have moderate or severe hepatic impairment as it may increase the amount of berotralstat in the blood
- has severe renal impairment
- is at risk for a certain heart problem, so-called QT prolongation.
If you get about of hereditary angioedema, you should take your usual emergency medicine without any extra dose of Orladeyo. It is not known whether Orladeyo works as an emergency treatment for hereditary angioedema attacks.
Children and young people
Orladeyo is not recommended for children under 12 years of age as Orladeyo has not been studied in this age group.
Orladeyo has not been studied in adolescents weighing less than 40 kg.
Other drugs and Orladeyo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor before using Orladeyo if you are taking
- thioridazine or pimozide, medicines for mental disorders
- amlodipine, a medicine for high blood pressure or a type of chest pain called angina (angina)
- ciclosporin, a drug for suppressing the immune system, treating serious skin diseases and serious eye or joint inflammation
- dabigatran, a medicine that prevents blood clots
- rifampicin, a medicine for tuberculosis and some other infection
- desipramine, St. John’s wort and other antidepressants, so-called tricyclic antidepressants
- dextromethorphan, a cough suppressant
- digoxin , a drug for heart problems and irregular heartbeats
- fentanyl , a powerful painkiller
- midazolam, a medicine for sleep disorders and for anesthesia
- tolbutamide, a drug to reduce blood sugar
- birth control pills .
Orladeyo may impair the effect of birth control pills , e.g. desogestrel. Women who use only desogestrel as a contraceptive should therefore switch to another effective method of contraception, e.g. barrier method , contraceptive syringes with progesterone or combined oral contraceptives
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Information on the use of Orladeyo during pregnancy and lactation is limited. As a precautionary measure, the use of Orladeyo during pregnancy and lactation should be avoided. Your doctor will talk to you about the benefits and risks of taking this medicine.
Women of childbearing potential must use effective contraception during treatment and for at least 1 month after the last dose. Orladeyo is not recommended for women of childbearing potential not using contraception.
Driving and using machines
Orladeyo has no or negligible effect on the ability to drive and use machines.
How to take Orladeyo
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
The recommended dose for adults and adolescents from 12 years of age weighing 40 kg or more is one capsule once daily.
Orladeyo is not recommended for patients with moderate or severe hepatic impairment. As a precautionary measure, this also applies to patients receiving dialysis.
Method of administration
Take the capsule with food and a glass of water, at the same time each day. The time of day does not matter.
If you take more Orladeyo than you should
Contact your doctor immediately if this happens.
If you forget to take Orladeyo
Do not take a double dose to make up for a forgotten capsule. Take the dose you missed as soon as you remember, but never take more than one dose per day.
If you stop taking Orladeyo
It is important to take this medicine regularly and for as long as 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 product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can occur with the following frequencies:
Very common, may affect more than 1 user in 10:
- headache
- abdominal pain, which includes abdominal discomfort, abdominal pain
- diarrhea and frequent bowel movements.
Common, may affect up to 1 in 10 users:
- vomiting
- heartburn
- intestinal gases
- increased amount of the liver enzymes ALT and AST detected in blood samples
- rash. · · · ·
How to store Orladeyo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is berotral state. Each capsule contains 150 mg of berotralstat (as dihydrochloride).
- The other ingredients are
- pregelatinized starch , crospovidone (type A), colloidal anhydrous silica gel, magnesium stearate, gelatin, titanium dioxide (E 171)
- dyes: indigo carmine (E 132), black iron oxide (E 172), red iron oxide (E 172)
- Inks for labeling: black iron oxide (E 172), potassium hydroxide, shellac, propylene glycol (E 1520).
What the medicine looks like and contents of the pack
Orladeyo capsules have a white opaque body labeled “150” and a light blue opaque body labeled “BCX” (19.4 mm × 6.9 mm). They are packed in plastic/aluminum blister cards, in a box 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 Center, Harcourt Road, DUBLIN 2, D02HW77
Ireland
- Manufacturer
Millmount Healthcare Limited
Block-7, City North Business Campus,
Stamullen,
Co. Meath, K32 YD60
Ireland