VELPHORO

Posology Starting dose, dose titration and maintenance for paediatric patients 2 to <12 years of age The recommended starting doses for paediatric patients in different age groups are described in Table 1. Table 1 Recommended starting doses and dose titrations for paediatric patients 2 to <12 years of age Patient age (years) Daily starting dose Dose increases or decreases Maximum 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 Serum phosphorus levels must be monitored and the dose of sucroferric oxyhydroxide up or down titrated once per two weeks by adjusting the daily dose as indicated in Table 1 until an acceptable serum phosphorus level is reached, with regular monitoring afterwards.

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

Additional formulation and strength available Velphoro is also available as chewable tablets (500 mg iron) for use in adult and paediatric patients 6 years of age and older. 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. Velphoro oral powder was not studied in adults. For patients 2 to <6 years of age oral powder should be administered as chewable tablet formulation is not appropriate for this age group.

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.

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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. Method of administration Oral use. e. meals with the highest phosphate content. When total number of sachets cannot be equally divided by the number of main meals, rest of the dose should be taken with one or two main meals. The optimal way to give the total daily dose of Velphoro to individual patients should be decided based on their feeding regimens.

Before administration, Velphoro oral powder should be mixed with a small amount of soft food (such as apple sauce) or with non-carbonated beverage or water and taken with meals. g. 2 sachets shall be suspended in minimum 10 mL. The amount of liquid could be increased if total daily fluid intake remains in line with dietary instructions for individual patient.

Patients should take Velphoro oral powder within 30 minutes after being suspended. g. in a microwave) or added to heated food or liquids. The mixture should be stirred vigorously as the powder will not dissolve completely and remain in suspension with a red-brown colour.

If necessary, the suspension should be resuspended right before administration. The prescribed dose of Velphoro oral powder suspended in water as described above, may be administered via an enteral feeding tube >6 FR (French catheter scale).

Follow the manufacturer’s instructions for the feeding tube to administer the medicinal product. To ensure adequate dosing, after administration of the oral suspension, the enteral feeding tube must be flushed with water. 6 for further details.

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.