VELPHORO Chewable tablet Ref.[7693] Active ingredients: Sucroferric oxyhydroxide

Posology

Starting dose for adults and adolescents (≥12 years of age)

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

Titration and maintenance for adults and adolescents (≥12 years of age)

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 for adults and adolescents (≥12 years of age)

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

Starting dose, titration and maintenance for paediatric patients (2 to <12 years of age)

Velphoro is also available as 125 mg oral powder in sachet for use in paediatric patients 2 to <12 years of age. The choice of the formulation depends on patient’s age, preference, characteristics and compliance. When transitioning between formulations, the same recommended dose should be used. Recommended starting doses and dose titrations of Velphoro for paediatric patients 2 to <12 years of age are shown in the Table 1.

Table 1. Recommended starting doses and dose titrations for paediatric patients 2 to <12 years of age:

For patients 2 to <6 years of age oral powder should be administered, as the chewable tablet formulation is not appropriate for this age group.

For patients 6 to <12 years of age Velphoro chewable tablets may be prescribed instead of or in combination with Velphoro oral powder in case the daily dose is 1,000 mg iron (2 chewable tablets) or more.

Serum phosphorus levels must be monitored and the dose of sucroferric oxyhydroxide up or down titrated in increments per day every 2–4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards.

Paediatric population <2 years of age

The safety and efficacy of Velphoro in children below the age of 2 years has not 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.

Any instances of overdose of Velphoro (e.g. hypophosphataemia) should be treated by standard clinical practice.

3 years.

Shelf life after first opening of the bottle: 90 days.

Store in the original package in order to protect from moisture.

High density polyethylene (HDPE) bottle with child-resistant polypropylene closure and foil induction seal, containing a molecular sieve desiccant and cotton. Pack sizes of 30 or 90 chewable tablets.

Child-resistant aluminium/aluminium perforated unit-dose blister, each blister containing 6 chewable tablets. Pack sizes of 30 × 1 or multipack of 90 (3 packs of 30 × 1) chewable tablets.

Not all pack sizes may be marketed.

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