VELPHORO

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 Patient age Daily starting Dose increases or Maximum (years) dose decreases recommended daily dose ≥2 to <6 500 mg 125 or 250 mg 1,250 mg ≥6 to <9 750 mg 125, 250 or 375 mg 2,500 mg ≥9 to <12 1,000 mg 250 or 500 mg 3,000 mg 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.

Summary of the safety profile The current safety profile of Velphoro is based on a total of 778 patients on haemodialysis and 57 patients on peritoneal dialysis, who received sucroferric oxyhydroxide treatment of up to 55 weeks. 36% of the adverse reactions were reported as serious.

The majority of the adverse reactions reported from trials were gastrointestinal disorders, with the most frequently reported adverse reactions being diarrhoea and discoloured faeces (very common). The vast majority of these gastrointestinal disorders occurred early during treatment and abated with time with continued dosing.

No dose-dependent trends were observed in the adverse reaction profile of Velphoro. Tabulated list of adverse reactions Adverse reactions reported from the use of Velphoro at doses from 250 mg iron/day to 3,000 mg iron/day in these patients (n=835) are listed in Table 2.

The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100). 6% of patients in clinical trials. 1% of the patients. Paediatric population In general, the safety profile of Velphoro in paediatric (2 to <18 years of age) and adult patients was comparable.

0%). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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. 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. 1. • Haemochromatosis and any other iron accumulation disorders. 4 Special warnings and precautions for use Peritonitis, gastric and hepatic disorders and gastrointestinal surgery Patients with a recent history of peritonitis (within the last 3 months), significant gastric or hepatic disorders and patients with major gastrointestinal surgery have not been included in clinical studies with Velphoro.

Velphoro treatment should only be used in these patients following careful assessment of benefit/risk. Discoloured stool Sucroferric oxyhydroxide can cause discoloured (black) stool. 5). Information about sucrose and starches (carbohydrates) Velphoro contains sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. It may be harmful to the teeth. Velphoro contains potato starch and pregelatinised maize starch.

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1. • Haemochromatosis and any other iron accumulation disorders.