Veltassa (Patiromer)

  • Name:

    Veltassa (Patiromer)

  • Company:
    info
  • Active Ingredients:

    Patiromer Sorbitex Calcium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/05/20

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Summary of Product Characteristics last updated on medicines.ie: 25/11/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Vifor Pharma UK Limited

Vifor Pharma UK Limited

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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
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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 25 November 2020 SPC

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 SPC

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 PIL

Reasons for updating

  • New PIL for new product