Veltassa (Patiromer) * Pharmacy Only: Prescription
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 25 November 2022
File name
6380b01fa26b2.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
6380aee35dcba.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 22 July 2022
File name
62da8123d849f.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 22 July 2022
File name
62da806f2211b.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
62d9806c3855e.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
62d97fea26203.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_1646405583.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_1646405440.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_1642792576.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_1638803459.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_1635327776.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_1619172669.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_1619172620.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_1606321599.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
5.1 Pharmacodynamic properties |
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.
|
6.4 Special precautions for storage |
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. |
|
Updated on 18 May 2020
File name
Veltassa IE SmPC June 2019_1589795190.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_1589795134.pdf
Reasons for updating
- New PIL for new product