VELTASSA Powder for oral suspension Ref.[8679] Active ingredients: Patiromer

Posology

The recommended starting dose is 8.4 g patiromer once daily.

The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. The daily dose may be increased or decreased by 8.4 g as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. If serum potassium falls below the desired range, the dose should be reduced or discontinued.

If a dose is missed, the missed dose should be taken as soon as possible on the same day. The missed dose should not be taken with the next dose.

Administration of Veltassa should be separated by 3 hours from other oral medicinal products (see section 4.5).

The onset of action of Veltassa occurs 4 – 7 hours after administration. It should not replace emergency treatment for life threatening hyperkalaemia.

Patients on dialysis

There is limited data on the use of Veltassa in patients on dialysis. No special dose and administration guidelines were applied to these patients in clinical studies.

Elderly population (≥65 years of age)

No special dose and administration guidelines are recommended for this population.

Paediatric population

The safety and efficacy of Veltassa in children aged under 18 years have not yet been established. No data are available.

Method of administration

Oral use.

Veltassa should be mixed with water and stirred to a suspension of uniform consistency, according to the following steps:

The complete dose should be poured into a glass containing approximately 40 mL of water, then stirred. Another approximately 40 mL of water should be added, and the suspension stirred again thoroughly. The powder will not dissolve. More water may be added to the mixture as needed for desired consistency.

The mixture should be taken within 1 hour of initial suspension. If powder remains in the glass after drinking, more water should be added and the suspension stirred and taken immediately. This may be repeated as needed to ensure the entire dose is administered.

Apple juice or cranberry juice can be used instead of water to prepare the mixture. Other liquids should be avoided as they may contain high amounts of potassium. In general, cranberry juice intake should be limited to moderate amounts (for example less than 400 mL per day) due to its potential interaction with other medicinal products.

Veltassa can be taken with or without food. It should not be heated (e.g. microwaved) or added to heated foods or liquids. It should not be taken in its dry form.

Since excessive doses of Veltassa may result in hypokalaemia, serum potassium levels should be monitored. Patiromer is excreted after approximately 24 to 48 hours, based on average gastrointestinal transit time. If it is determined that medical intervention is required, appropriate measures to restore serum potassium may be considered.

Shelf life: 3 years.

Store and transport refrigerated (2°C–8°C).

Patients may store Veltassa below 25°C for up to 6 months.

For either storage condition, Veltassa should not be used after the expiry date printed on the sachet.

The mixture should be taken within 1 hour of initial suspension.

8.4 g, 16.8 g or 25.2 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.

Pack sizes: boxes of 30, 60 or 90 sachets.

Not all pack sizes may be marketed.

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