Extended indication Hyperkaliëmie in CHF en CKD in volwassenen.
Therapeutic value No judgement
Registration phase Registered

Product

Active substance Patiromer
Domain Metabolism and Endocrinology
Main indication Metabolic diseases
Extended indication Hyperkaliëmie in CHF en CKD in volwassenen.
Proprietary name Veltassa
Manufacturer Vifor
Route of administration Oral
Therapeutical formulation Powder for oral suspension
Budgetting framework Extramural (GVS)
Additional remarks Patiromer bindt kalium in het maagdarmkanaal. Risico als blijkt dat meer patienten het gebruiken dan verwacht (naast patienten met nierinsufficientie ook patienten met hartfalen).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New medicine
Submission date April 2016
Expected Registration July 2017
Orphan drug No
Registration phase Registered
Additional remarks Geregistreerd in juli 2017, gaat nog beoordeeld worden door het Zorginstituut.

Therapeutic value

Current treatment options De behandeling van eerste keus is intraveneuze toediening van calciumgluconaat.
Therapeutic value No judgement
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 8,4-16,8-25,2 g
Additional remarks Startdosis is 8,4 g, mag worden opgehoogd tot max. 25,2 g per dag.

Expected patient volume per year

Additional remarks Gering aantal patiënten

Expected cost per patient per year

Cost 3,500.00 - 4,000.00
References Fabrikant
Additional remarks Fabrikant (april 2018): €3500 - 4000 pppj.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.