Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: BioCryst Ireland Limited, Block 4, Harcourt Centre, Harcourt Road, DUBLIN 2, D02HW77, Ireland
Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
The recommended dose for adults and adolescents aged 12 years and older weighing ≥ 40 kg is 150 mg berotralstat once daily.
If a dose of berotralstat is missed, the patient should take the forgotten dose as soon as possible without exceeding one dose per day.
Orladeyo is not intended for treatment of acute HAE attacks (see section 4.4).
No dose adjustment is required for patients above 65 years of age (see sections 4.4 and 5.2).
No dose adjustment is required for patients with mild or moderate renal impairment. In patients with severe renal impairment, it is preferable to avoid the use of berotralstat. If treatment is required, appropriate monitoring (e.g. ECGs) should be considered (see section 4.4).
There are no available clinical data for the use of berotralstat in patients with end stage renal disease (ESRD) requiring haemodialysis. As a precautionary measure, it is preferable to avoid the use of berotralstat in patients with ESRD (see section 5.2).
No dose adjustment is required for patients with mild hepatic impairment. Use of berotralstat in patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) should be avoided (see section 5.2).
The safety and efficacy of berotralstat in children under 12 years of age have not yet been established. No data are available.
Orladeyo is for oral use. The capsule can be taken at any time of the day, with food (see section 5.2).
No case of overdose has been reported in clinical studies. There is no available information to identify potential signs and symptoms of overdose. If symptoms should occur, symptomatic treatment is recommended. There is no antidote available.
3 years.
This medicinal product does not require any special storage conditions.
PCTFE/PVC-Alu blisters in a carton with 7 capsules per blister.
Pack size: 28 or 98 hard capsules.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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