ORLADEYO Film-coated granules in sachet Ref.[116874] Active ingredients: Berotralstat

Posology

The recommended dose for children aged 2 to less than 12 years is weight based and provided in Table 1.

Table 1. Recommended dose for children aged 2 to less than 12 years:

The recommended dose for adolescents aged 12 years and older with a body weight less than 40 kg is one 108 mg sachet of Orladeyo granules once daily.

For adolescents aged 12 years and older with a body weight ≥40 kg, reference should be made to the Summary of Product Characteristics for Orladeyo capsules.

Consideration should be given to discontinuing treatment in patients with normal C1 esterase inhibitor HAE (nC1-INH) who have shown insufficient reduction in attacks after 3 months of treatment (see sections 4.4 and 5.1).

Missed doses

If a dose of Orladeyo 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).

Special populations

Renal impairment

No dose adjustment is required for patients with mild or moderate renal impairment. In patients with severe renal impairment, it is preferrable 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).

Hepatic impairment

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).

Paediatric population

The safety and efficacy of Orladeyo in children under 2 years of age have not been established. No data are available.

Method of administration

Oral use.

Each sachet is for single use only.

Each sachet of film-coated granules should be taken at approximately the same time each day with a meal (see section 5.2).

The film-coated granules should be swallowed whole. To avoid a bitter aftertaste, patients should not chew or crush the granules.

Orladeyo film-coated granules can be administered in one of the following ways:

• The entire contents of one sachet should be poured directly into the mouth and swallowed immediately with non-acidic liquid (water or milk).
• The entire contents of one sachet should be sprinkled over approximately one tablespoon (15 mL) of soft, non-acidic food and consumed immediately. Food should be at or below room temperature. Examples of soft, non-acidic foods include chocolate pudding, mashed potatoes, creamed corn, and pureed peas or bananas.

Acidic foods such as yoghurt and applesauce should not be used because they can dissolve the taste-masking coating and result in a bitter taste. All of the granules should be taken within 10 minutes of being sprinkled over food to prevent the taste-masking coating from dissolving.

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.

2 years.

This medicinal product does not require any special storage conditions.

PET/AL/PE foil laminate sachets.

Pack size: 28 sachets (each carton contains 4 wallets with 7 sachets each).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.