Veltassa (Patiromer) *
Pharmacy Only: Prescription

  • Company:

    Vifor Pharma UK Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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).

 

Patients may store Veltassa below 25°C for up to 6 months.

 

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