Presentation and Status in Health Basket
90 X 500 mg
Starting dose: The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day, divided across the meals of the day. Velphoro is for oral administration only and must be taken with meals.
Patients receiving Velphoro should adhere to their prescribed diets.
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 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 mg-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.
Paediatric population: The safety and efficacy of Velphoro in children below the age of 18 years has not yet been established. No data are available.
Elderly population (≥65 years of age): Velphoro has been administered to over 245 seniors (≥65 years of age) according to the approved dosing regimen. Of the total number of subjects in clinical studies of 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: 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 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 Velphoro. However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in the clinical studies with Velphoro.
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. Tablets must be chewed and not swallowed whole; tablets may be crushed.
Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).
Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.
Hypersensitivity to the active substance or to any of the excipients.
Haemochromatosis and any other iron accumulation disorders.
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 should only be used in these patients following careful assessment of benefit/risk.
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 medicine. May be harmful to the teeth.
Velphoro contains starches. Patients with allergy to gluten or diabetics should take notice that one tablet of Velphoro is equivalent to 0.116 bread units (equivalent to approximately 1.4 g of carbohydrates).
Discoloured stool: Velphoro can cause discoloured (black) stool. Discoloured (black) stool may visually mask gastrointestinal bleeding.
The majority of the adverse drug reactions (ADRs) reported from trials were gastrointestinal disorders, with the most frequently reported ADRs 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 ADR profile of Velphoro.
See prescribing information for full details.
Velphoro is almost not absorbed from the gastrointestinal tract. Although the potential for interactions with medicinal products seems low, for concomitant treatment with medicinal products with a narrow therapeutic window, the clinical effect and adverse events should be monitored, on initiation or dose adjustment of either Velphoro or the concomitant medicinal product, or the physician should consider measuring blood levels. When administering any medicinal product that is already known to interact with iron (like alendronate and doxycycline) or has the potential to interact with Velphoro based only on in vitro studies like levothyroxine, the medicinal product should be administered at least one hour before or two hours after Velphoro.
In vitro studies with the following active substances did not show any relevant interaction: acetylsalicylic acid, cephalexin, cinacalcet, ciprofloxacin, clopidogrel, enalapril, hydrochlorothiazide, metformin, metoprolol, nifedipine, pioglitazone and quinidine.
Drug-drug interaction studies have only been performed in healthy volunteers. They have been conducted in healthy human male and female subjects with losartan, furosemide, digoxin, warfarin, and omeprazole. Concomitant administration of Velphoro did not affect the bioavailability of these
medicinal products as measured by the area under the curve (AUC).
Data from clinical studies have shown that Velphoro does not affect the lipid lowering effects of HMG-CoA reductase inhibitors (e.g., atorvastatin and simvastatin). In addition, post-hoc analyses from clinical studies demonstrated no impact of Velphoro on iPTH lowering effect of oral Vitamin D analogues. Vitamin D and 1,25-dihydroxy Vitamin D levels remained unchanged.
Velphoro does not affect guaiac based (Haemoccult) or immunological based (iColo Rectal and Hexagon Obti) faecal occult blood tests.
Pregnancy and Lactation
Pregnancy: There are no available clinical data from the use of sucroferric oxyhydroxide on exposed human pregnancies.
Reproductive and developmental toxicity studies in animals revealed no risk with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Velphoro should only be used by pregnant women if clearly needed following careful assessment of benefit/risk.
Breast-feeding: There are no available clinical data from the use of Velphoro in breast-feeding women. Since absorption of iron from Velphoro is minimal, excretion of iron from Velphoro in breast milk is unlikely. A decision on whether to continue breast-feeding or to continue therapy with Velphoro should be made taking into account the benefit of breast-feeding to the child and the benefit of Velphoro therapy to the mother.
Any instances of overdose of Velphoro should be treated by standard clinical practice.
Sucrose and starches (carbohydrates): Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Patients with allergy to gluten or diabetics should take notice that one tablet of Velphoro is equivalent to 0.116 bread units.
Shelf life: 36 months. Shelf life after first opening of the bottle: 90 days