Veltassa (Patiromer)
*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 18 June 2024
File name
PIL_Veltassa_EU 1171179_001-11.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
CCDS v4.0 : Revisions based on analysis of patiromer (Veltassa) pooled database: Undesirable Effects and Special Warnings and Precautions for Use sections were updated based on safety set of Veltassa pooled database, comprising 2135 subjects treated with patiromer.
CCDS V5.0: Inclusion of the Adverse Drug Reaction (ADR) ”Hypersensitivity” under the system organ class Immune System Disorders with frequency “not known” based on the analysis of the post-marketing data.
Updated on 18 June 2024
File name
spC_Veltassa_EU 1171179_001-11.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
CCDS v4.0 : Revisions based on analysis of patiromer (Veltassa) pooled database: Undesirable Effects and Special Warnings and Precautions for Use sections were updated based on safety set of Veltassa pooled database, comprising 2135 subjects treated with patiromer.
CCDS V5.0: Inclusion of the Adverse Drug Reaction (ADR) ”Hypersensitivity” under the system organ class Immune System Disorders with frequency “not known” based on the analysis of the post-marketing data.
Updated on 14 March 2024
File name
RoI and NI patiromer PIL Jan 2024.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 23 January 2024
File name
RoI and NI patiromer SPC January 2024.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 8 - Marketing authorisation number(s)
- 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
extended use of patiromer for paediatric patients and new strength (1g)
Updated on 23 January 2024
File name
RoI and NI patiromer SPC January 2024.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 8 - Marketing authorisation number(s)
- 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
extended use of patiromer to paediatric patients and introduced 1g strength
Updated on 25 November 2022
File name
PTR IE SPC November 2022.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 November 2022
File name
PTR IE PIL November 2022.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 22 July 2022
File name
PTR IE PIL July 2022.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 22 July 2022
File name
PTR IE SPC July 2022.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 July 2022
File name
PTR GB PIL July 2022.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
- Introduction of new pack/pack size
Updated on 21 July 2022
File name
PTR GB SPC July 2022.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 March 2022
File name
veltassa IE PIL March 2022.pdf
Reasons for updating
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
You can use water or the following liquids or soft foods to prepare the mixture by following the same steps as described above: apple juice, cranberry juice, pineapple juice, orange juice, grape juice, pear juice, apricot nectar, peach nectar, yoghurt, milk, thickener, apple sauce, vanilla and chocolate pudding.
When using such liquids and soft foods, follow your dietary recommendations on potassium intake. Check with your doctor or pharmacist if you are not sure.
Updated on 04 March 2022
File name
Veltassa IE SPC March 2022.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The following liquids or soft foods can be used instead of water to prepare the mixture by following the same steps as described above: Apple juice, cranberry juice, pineapple juice, orange juice, grape juice, pear juice, apricot nectar, peach nectar, yoghurt, milk, thickener, apple sauce, vanilla and chocolate pudding.The potassium content of liquids or soft foods used to prepare the mixture should be considered as part of the dietary recommendations on potassium intake for each individual patient.’
Updated on 21 January 2022
File name
Veltassa IE PIL December 2021.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 06 December 2021
File name
Veltassa IE SPC December 2021.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Reporting details to include both HPRA and MHRA. MHRA details added for reporting of Northern Ireland cases.
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 27 October 2021
File name
Veltassa IE SPC October 2021.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
Reporting details updated to include for Northern Ireland MHRA reporting details, as this SPC covers Republic of Ireland and now Northern Ireland as well.
Updated on 23 April 2021
File name
Veltassa IE SPC October 2020.docx.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
From November 2020 to Octover 2020
Updated on 23 April 2021
File name
Veltassa IE PIL October 2020.pdf
Reasons for updating
- Change to date of revision
Free text change information supplied by the pharmaceutical company
From June 2019 to October 2020
Updated on 25 November 2020
File name
Veltassa IE SPC November 2020 - clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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5.1 Pharmacodynamic properties |
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The ability of patiromer to enable concomitant spironolactone treatment in patients with resistant hypertension and CKD was further investigated in a randomised, double-blind, placebo-controlled study over 12 weeks. Normokalaemic patients initiated spironolactone at 25 mg QD together with their randomised treatment (patiromer 8.4 g QD or placebo). Patiromer/placebo was titrated weekly (up to 25.2 g QD) to maintain serum potassium ≥4.0 mEq/L and ≤5.1 mEq/L. At week 3 or after, spironolactone dose was increased to 50 mg QD for subjects with systolic blood pressure ≥120 mmHg and serum potassium ≤5.1 mEq/L. Of the 295 randomized patients receiving study treatment (patiromer 147; placebo 148), mean age was 68.1 years, 51.9% were men, 98.3% were Caucasian, and mean eGFR was 35.73 mL/min/1.73m2. At randomization, mean baseline serum potassium values were 4.74 mEq/L for patiromer and 4.69 mEq/L for placebo. The primary efficacy endpoint, the proportion of subjects remaining on spironolactone at Week 12, was significantly higher (p<0.0001) in the patiromer group (85.7%) compared to the placebo group (66.2%). Significantly more patients received spironolactone 50 mg/day (69.4% versus 51.4%). Overall, patients in the patiromer group remained on spironolactone 7.1 days longer (95% CI 2.2–12.0; p=0.0045) compared to the placebo group and received significantly higher cumulative doses of spironolactone (2942.3 (SE 80.1) mg vs 2580.7 (SE 95.8) mg, p=0.0021). There were also significantly fewer patients in the patiromer group with serum potassium values ≥5.5 mEq/L (35.4% vs. 64.2%, p<0.001). At Week 12, the mean systolic blood pressure had decreased by 11.0 mmHg (SD 15.34) in the spironolactone + placebo group and by 11.3 mmHg (SD 14.11) in the spironolactone + patiromer group. These decreases from baseline were statistically significant within each treatment group (p<0.0001), but not statistically significant between the groups.
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6.4 Special precautions for storage |
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Store and transport refrigerated (2°C – 8°C).
If stored at room temperature (below 25°C), Veltassa should be used within 6 months of being taken out of the refrigerator. |
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Updated on 18 May 2020
File name
Veltassa IE SmPC June 2019.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 May 2020
File name
Veltassa IE PIL June 2019.pdf
Reasons for updating
- New PIL for new product