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Velphoro

Velphoro Dosage/Direction for Use

sucroferric oxyhydroxide

Manufacturer:

Vifor Fresenius Medical Care Renal Pharma

Distributor:

Fresenius Kabi
Full Prescribing Info
Dosage/Direction for Use
Starting dose: The recommended starting dose of Sucroferric Oxyhydroxide (Velphoro) is 1,500 mg iron (3 tablets) per day, divided across the meals of the day. Sucroferric Oxyhydroxide (Velphoro) is for oral administration only and must be taken with meals.
Patients receiving Sucroferric Oxyhydroxide (Velphoro) should adhere to their prescribed diets.
Titration and maintenance: Serum phosphorus levels must be monitored and the dose of Sucroferric Oxyhydroxide (Velphoro) 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 Sucroferric Oxyhydroxide (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) per day.
Pediatric population: The safety and efficacy of Sucroferric Oxyhydroxide (Velphoro) in children below the age of 18 years has not yet been established. No data are available.
Elderly population (≥65 years of age): Sucroferric Oxyhydroxide (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 (Velphoro), 29.7 % were aged 65 and over, while 8.7 % were aged 75 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.
Renal impairment: Sucroferric Oxyhydroxide (Velphoro) is indicated for the control of serum phosphorus levels in adult CKD patients on HD or PD. There is no clinical data available with Sucroferric Oxyhydroxide (Velphoro) in patients with earlier stages of renal impairment.
Hepatic impairment: Generally, patients with severe hepatic impairment were excluded from participating in clinical studies with Sucroferric Oxyhydroxide (Velphoro). However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in the clinical studies with Sucroferric Oxyhydroxide (Velphoro).
Method of administration: Oral use.
Sucroferric Oxyhydroxide (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 and not swallowed whole; tablets may be crushed.
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