Posology : מינונים

4.2    Posology and method of administration

Posology
Starting dose

The recommended starting dose is 1,500 mg iron (3 tablets) per day, divided across the meals of the day.

Titration and maintenance

Serum phosphorus levels must be monitored and the dose of Sucroferric oxyhydroxide up or down titrated in increments of 500 mg iron (1 tablet) per day every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards.

In clinical practice, treatment will be based on the need to control serum phosphorus levels, though patients who respond to Velphoro therapy usually achieve optimal serum phosphorus levels at doses of 1,500 -2,000 mg iron per day (3 to 4 tablets).

If one or more doses are missed, the normal dose of the medicinal product should be resumed with the next meal.


Maximum tolerated daily dose

The maximum recommended dose is 3,000 mg iron (6 tablets).

Paediatric population
The safety and efficacy of Velphoro in children and adolescents below the age of 18 years has not yet been established. No data are available.


Renal impairment
Velphoro is indicated for the control of serum phosphorus levels in adult CKD patients on HD or PD.
There is no clinical data available in patients with earlier stages of renal impairment.

Hepatic impairment

Patients with severe hepatic impairment were excluded from participating in clinical studies with sucroferric oxyhydroxide. However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in the clinical studies with sucroferric oxyhydroxide. See further information in section 4.4.

Elderly population (≥65 years of age)
Velphoro has been administered to over 248 seniors (≥65 years of age) according to the approved dosing regimen. Of the total number of subjects in clinical studies of sucroferric oxyhydroxide, 29.7% were aged 65 years and over, while 8.7% were aged 75 years and over. No special dose and administration guidelines were applied to seniors in these studies and the dosing schedules were not associated with any significant concerns.

Method of administration

Oral use.
Velphoro is a chewable tablet that must be taken with meals. In order to maximise the adsorption of dietary phosphate, the total daily dose should be divided across the meals of the day. Patients are not required to drink more fluid than they normally would and should adhere to their prescribed diets.
Tablets must be chewed or crushed; tablets must not be swallowed whole.