Velphoro 500 mg chewable tablets

  • Name:

    Velphoro 500 mg chewable tablets

  • Company:
    info
  • Active Ingredients:

    Sucroferric oxyhydroxide

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/12/20

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Summary of Product Characteristics last updated on medicines.ie: 18/12/2020

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Vifor Pharma UK Limited

Vifor Pharma UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Ferinject (ferric carboxymaltose) Active Ingredients Ferric carboxymaltose
Medicine Name Velphoro 125 mg oral powder in sachet Active Ingredients Sucroferric oxyhydroxide
Medicine Name Velphoro 500 mg chewable tablets Active Ingredients Sucroferric oxyhydroxide
Medicine Name Veltassa (Patiromer) Active Ingredients Patiromer Sorbitex Calcium
Medicine Name Venofer (iron sucrose) Active Ingredients Iron Sucrose
1 - 0 of 5 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 December 2020 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following additions were approved within the SmPC and are highlighted in the blue text below (deleted information is struck out):

4.1       Therapeutic indications

 

Velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate <30 mL/min/1.73 m²) or with CKD on dialysis.

 

 

4.2       Posology and method of administration

Posology

 

Starting dose for adults and adolescents (≥12 years of age)

 

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 for adults and adolescents (≥12 years of age)

 

Serum phosphorus levels must be monitored and the dose of sucroferric oxyhydroxideVelphoro 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) per day.

 

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 (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

 

 

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.

 

Paediatric population <2 years of age

The safety and efficacy of Velphoro in children and adolescents below the age of 18 2 years has not been established. No data are available.

 

 

 

 

 

4.8       Undesirable effects

Paediatric population

 

In general, the safety profile of Velphoro in paediatric (2 to <18 years of age) and adult patients was comparable. The adverse reactions most frequently reported were gastrointestinal disorders including diarrhoea (very common, 16.7%), vomiting (common, 6.1%), gastritis (common, 3.0%) and discoloured faeces (common, 3.0%).

 

 

5.1 Pharmacodynamic Properties

An open label clinical study investigated the efficacy and safety of Velphoro in paediatric patients 2 years of age and older with CKD, and hyperphosphatemia (CKD stages 4-5 (defined by a glomerular filtration rate <30 mL/min/l .73 m²) or with CKD on dialysis). Eighty-five subjects were  randomised to Velphoro  (N=66) or active control calcium acetate arm (N=19) for a 10-week dose titration (Stage 1), followed by a 24-week safety extension (Stage 2). Most patients were ≥12 years of age (66%). Eighty percent of patients were CKD patients on dialysis (67% on haemodialysis and 13% on peritoneal dialysis) and 20% were CKD patients not on dialysis.

 

The limited difference in reduction in mean serum phosphorus level from baseline to the end of Stage 1 in the Velphoro group (N=65) was not statistically significant with -0.120 (0.081) mmol/L (95% CI: -0.282, 0.043) based on the mixed model calculations with actual data showing a mean of 2.08 mmol/L at baseline and 1.91 mmol/L at the end of Stage 1 (reduction by 0.17 mmol/L). The effect was maintained during Stage 2, although some fluctuations in mean effect over time were noticed (0.099 (0.198) mmol/L (95% CI: -0.306, 0.504)).

 

The percentage of subjects with serum phosphorus levels within normal ranges increased from 37% at baseline to 61% at the end of Stage 1, and was 58% at the end of Stage 2, showing the sustainable phosphorus lowering effect of sucroferric oxyhydroxide. Among subjects whose serum phosphorus was above age-related normal ranges at baseline (N=40), serum phosphorus levels showed statistically significant decrease from baseline to the end of Stage 1, with the LS mean (SE) change -0.87 (0.30) mg/dL (95% CI: -1.47, -0.27; p=0.006).

 

The safety profile of Velphoro in paediatric patients was generally comparable to that previously observed in adult patients.

 

The European Medicines Agency has deferred the obligation to submit the results of studies with Velphoro in one or more subsets of the paediatric population in the treatment of hyperphosphataemia (see section 4.2 for information on paediatric use).

 

 

Updated on 18 December 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use

Updated on 18 December 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use

Updated on 7 July 2020 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

VERIFIE investigated real-life long-term safety and effectiveness (up to 3 years) of Velphoro in EU (over 1400 patients). It showed that safety profile was consistent with that observed in the pivotal phase 3 studies. Section 5.1 of the EU SmPC was updated to include “Post-authorisation data” summarizing VERIFIE study results.

Updated on 1 April 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - what the product contains

Updated on 1 April 2019 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2. QUALITATIVE AND QUANTITATIVE COMPOSITION:

Added '(potato starch and pregelatinised maize starch)'

paediatric population:

Added: 'and adolescents'

Hepatic impairment:

removal: 'Generally'

4.4 Special warnings and precautions for use

Information about sucrose and starches (carbohydreates)

substituted 'starches' with 'potato starch and pregelatinised maize starch'.

4.8 Undesirable effects

substituted ADR with adverse reactions.

tabulated list of adverse reactions:

added 'The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).

Description of selected adverse reactions:

removed word 'treatment related' and ' events' added word 'reactions'.

4.9 Overdose

added example '(e.g hypophosphataemia)

6.5 nature and contents of container:

added 'perforated unit-dose' and 'multipack of 90 (3 packs of 30 × 1)'

 

 

Updated on 6 June 2018 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to Section 6.3 Shelf Life - Shelf life after first opening of the bottle changed from 45 days to 90 days

Updated on 24 April 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 22 January 2018 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.2 ( Titration and maintenance) mg in front of 1500 has been removed.

In section 4.2 ( Elderly Population) the number of people that has been administered Velphoro has been changed from 245 to 248.

in section 4.4 ( information about sucrose and starches (carbohydrates)) allergy to gluten or diabetes removed and replaced with diabetes.  Approximately 1.4g of carbohydrates equivalent to 0.116 bread units changed from 0.116 bread units approximately 1.4g of carbohydrates.

in section 4.8 ( tabulated list of adverse reactions) discoloured faeces removed and replaced with faeces discoloured.

in section 5.1 ( clinical efficacy) iron added to 1,000/day and 250/day.

in section 5.2 ( Absorption) iron added to 2,000 mg .

Updated on 22 January 2018 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 January 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 19 September 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to marketing authorisation holder

Updated on 19 September 2016 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • SPC retired pending re-submission

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

6.3 Shelf life

3 years
Shelf life after first opening of the bottle: 45 days

7. MARKETING AUTHORISATION HOLDER

Vifor Fresenius Medical Care Renal Pharma France
100-101 Terrasse Boieldieu
Tour Franklin- La Défense 8
92042 Paris la Défense Cedex
France

10. DATE OF REVISION OF THE TEXT

September 2016.

Updated on 31 October 2015 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.5     Interaction with other medicinal products and other forms of interaction



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 likelevothyroxine 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

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.

Updated on 16 December 2014 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 16 December 2014 PIL

Reasons for updating

  • New PIL for new product