Velphoro 500 mg chewable tablets
*Company:
Vifor Pharma UK LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 01 March 2022
File name
IE Velphoro Chewable Tabs PIL - Feb 2022.pdf
Reasons for updating
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Update to remove previously used common name “mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches”. As per WHO, this term is now obsolete and USAN sucroferric oxyhydroxide should be used instead
Updated on 01 March 2022
File name
IE Velphoro Chewable Tabs SmPC - Feb 2022.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update Product Information in order to remove previously used common name “mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches”. As per WHO, this term is now obsolete and USAN sucroferric oxyhydroxide should be used instead
Updated on 21 January 2022
File name
IE Velphoro Chewable Tabs SmPC - Jan 2022.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
post brexit reporting detailed updated
Updated on 21 January 2022
File name
IE Velphoro Chewable Tabs PIL - Jan 2022.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Ireland
HPRA Pharmacovigilance
Website: www.hpra.ie
United Kingdom (Northern Ireland)
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Updated on 05 February 2021
File name
IE Velphoro Chewable Tabs SmPC - Nov 2020.pdf
Reasons for updating
- 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
Date of Revision amended from December 2020 to November 2020
Updated on 05 February 2021
File name
IE Velphoro Chewable Tabs PIL - Nov 2020.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Date of Revision amended from December 2020 to November 2020
Updated on 18 December 2020
File name
IE Velphoro Chewable Tabs SmPC - Dec 2020.pdf
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.
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4.2 Posology and method of administration |
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Posology
Starting dose for adults and adolescents (≥12 years of age)
The recommended starting dose
Titration and maintenance for adults and adolescents (≥12 years of age)
Serum phosphorus levels must be monitored and the dose of sucroferric oxyhydroxide
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)
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
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
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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%).
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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.
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Updated on 18 December 2020
File name
IE Velphoro Chewable Tabs PIL - Dec 2020.pdf
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
File name
IE Velphoro Chewable Tabs PIL - Dec 2020.pdf
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 07 July 2020
File name
26062020 - Velphoro SPC IE clean.pdf
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 01 April 2019
File name
25032019 Velphoro PIL.pdf
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 01 April 2019
File name
emea-combined-h-2705-en 2019.pdf
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 06 June 2018
File name
200218_Velphoro_SPC_Ireland.docx
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
File name
200218 - Velphoro PIL IRE.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 22 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 January 2018
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 19 January 2018
File name
PIL_16194_787.pdf
Reasons for updating
- New PIL for new product
Updated on 19 January 2018
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 19 September 2016
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 19 September 2016
Reasons for updating
- Change to storage instructions
- Change to marketing authorisation holder
Updated on 31 October 2015
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
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
Updated on 16 December 2014
Reasons for updating
- New PIL for new product