VELPHORO® CHEWABLE TABLETS 500MG [SIN14727P]

Product Info

VELPHORO® CHEWABLE TABLETS 500MG

[SIN14727P]

4.1 Therapeutic Indications
Velphoro is indicated for the control of serum phosphorus levels in adult patients with end-stage renal disease (ESRD) on haemodialysis or peritoneal dialysis.

4.2 Posology and Method of Administration
Velphoro is for oral administration only.

Posology

Starting Dose
The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day administered as 1 tablet (500 mg iron) 3 times daily with meals.

Titration and Maintenance
Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in increments of 500 mg iron (1 tablet) per day as needed every 1–2 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. In case of hypophosphatemia occurring during the titration and maintenance phase, Velphoro should be down titrated to achieve appropriate serum phosphorus levels.

Based on clinical studies, on average patients required 1,500 mg iron to 2,000 mg iron (3 to 4 tablets) a day to control serum phosphorus level.

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).

Special Populations

Paediatric Population
The safety and efficacy of Velphoro in children below the age of 18 years has not been established.

Elderly population (≥ 65 years of age)
Of the total number of subjects in two active-controlled clinical studies of Velphoro (n = 835), 29.7 % (n = 248) were aged 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Renal Impairment
Velphoro is indicated for the control of serum phosphorus levels in adult ESRD patients on haemodialysis or peritoneal dialysis. There is no clinical data available with Velphoro in patients with earlier stages of renal impairment.

Hepatic Impairment
Patients with severe hepatic impairment were excluded from participating in clinical studies with Velphoro. However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in the clinical studies with Velphoro. See further information in section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of Administration
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.

4.3 Contraindications
The use of the drug is contraindicated in patients with:

• Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Haemochromatosis and any other iron accumulation disorders.