Veltassa (Powder) Instructions for Use

Marketing Authorization Holder

Vifor Fresenius Medical Care Renal Pharma France (France)

Manufactured By

OM Pharma, S.A. (Portugal)

ATC Code

V03AE09 (Patiromer calcium)

Active Substance

Patiromer (USAN)

Dosage Forms

	Veltassa	Powder for oral suspension 8.4 g: sachets 30, 60 or 90 pcs.
		Powder for oral suspension 16.8 g: sachets 30, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Powder for oral suspension from almost white to light brown in color, with rare white specks; description of the suspension: when mixed with water, it forms a homogeneous suspension from almost white to light brown in color; separation of the suspension is allowed, which is easily eliminated by shaking.

Excipients: xanthan gum.

8.4 mg – sachets made of multilayer combined material (30) – cardboard packs.
8.4 mg – sachets made of multilayer combined material (60) – cardboard packs.
8.4 mg – sachets made of multilayer combined material (90) – cardboard packs.

Powder for oral suspension from almost white to light brown in color, with rare white specks; description of the suspension: when mixed with water, it forms a homogeneous suspension from almost white to light brown in color; separation of the suspension is allowed, which is easily eliminated by shaking.

Excipients: xanthan gum.

16.8 mg – sachets made of multilayer material (30) – cardboard packs.
16.8 mg – sachets made of multilayer material (60) – cardboard packs.
16.8 mg – sachets made of multilayer material (90) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of hyperkalemia

Pharmacotherapeutic Group

Other therapeutic agents; agents for the treatment of hyperkalemia and hyperphosphatemia

Pharmacological Action

Non-absorbable cation-exchange polymer that contains calcium sorbitol counterions. Patiromer increases the excretion of potassium in the feces by binding potassium in the gastrointestinal tract lumen. The binding of potassium reduces the concentration of free potassium in the gastrointestinal tract lumen, thus reducing the serum potassium concentration.

Pharmacokinetics

Patiromer acts by binding potassium in the gastrointestinal tract, so the serum concentration is not relevant to its efficacy. Since Patiromer is insoluble and not absorbed, conducting many classical pharmacokinetic studies is not possible.

Based on the average gastrointestinal transit time, Patiromer is excreted approximately 24-48 hours after oral administration.

Indications

Treatment of hyperkalemia in adults.

ICD codes

Dosage Regimen

The recommended starting dose is 8.4 g of patiromer once daily.

The daily dose can be adjusted at intervals of 1 week or more, based on the serum potassium concentration and the target range. If necessary, the daily dose can be increased or decreased by 8.4 g to achieve the target range, the maximum dose can reach 25.2 g/day. If the serum potassium concentration decreases to a level below the target range, the dose of patiromer should be reduced or discontinued.

The interval between taking patiromer and other orally administered drugs should be at least 3 hours.

The onset of action of patiromer occurs 4-7 hours after administration.

Patiromer does not replace emergency treatment for life-threatening hyperkalemia.

Adverse Reactions

Metabolism common – hypomagnesemia.

Digestive system common – constipation, diarrhea, abdominal pain, flatulence; infrequent – nausea, vomiting.

Contraindications

Hypersensitivity to patiromer and to the excipients of the drug used; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

As a precautionary measure, it is preferable not to use Patiromer during pregnancy.

Due to the minimal systemic exposure of patiromer in a breastfeeding woman, an effect on the breastfed newborn is unlikely. The decision to discontinue breastfeeding or discontinue patiromer therapy should be made taking into account the benefits of breastfeeding for the child and the benefits of therapy for the mother.

Use in Renal Impairment

Data on the use of patiromer in patients with eGFR <15 ml/min/1.73 m² and in patients on dialysis are limited.

Pediatric Use

The safety and efficacy of patiromer in children and adolescents under 18 years of age have not been established to date.

Geriatric Use

There are no specific recommendations for dosing and use of patiromer in elderly patients.

Special Precautions

Serum magnesium concentration should be monitored during treatment and for at least one month after initiation of treatment, and in patients with low serum magnesium concentration, the use of magnesium-containing supplements should be considered.

Patients with a history of intestinal obstruction or major surgical interventions on the digestive system organs, severe gastrointestinal disorders or swallowing disorders were not included in clinical studies. With the use of other potassium-binding drugs, gastrointestinal ischemia, necrosis and/or intestinal perforation have been reported. In patients with past or present severe gastrointestinal disorders, the benefit-risk ratio of using patiromer must be carefully assessed before and during treatment.

Discontinuation of patiromer may lead to an increase in serum potassium concentration, especially if treatment with RAAS inhibitors is continued. Patients should be instructed not to discontinue therapy without prior consultation with their doctor. An increase in serum potassium concentration can occur as early as 2 days after the last dose of patiromer.

Serum potassium concentration should be monitored when clinically indicated, for example, when changing the regimen of drugs that affect serum potassium concentration (e.g., RAAS inhibitors or diuretics), and after titrating the dose of patiromer.

This product contains calcium as part of the counterion complex. Calcium is partially released, and this portion may be absorbed. In patients at risk of developing hypercalcemia, the benefit/risk ratio of using this product must be carefully assessed.

Experience with the use of patiromer in patients with a serum potassium concentration greater than 6.5 mmol/L is limited.

In clinical studies of patiromer, use for more than one year has not been studied.

Effect on ability to drive vehicles and operate machinery

Patiromer has no or negligible influence on the ability to drive vehicles and operate machinery.

Drug Interactions

Patiromer can potentially bind some orally administered drugs used concomitantly with it, which can lead to reduced absorption in the gastrointestinal tract.

Since Patiromer is not absorbed and not metabolized in the body, the effect on other drugs is limited.

As a precaution and based on the data below, the interval between oral administration of patiromer and other drugs should be at least 3 hours.

When used concomitantly with patiromer, a decrease in the bioavailability of ciprofloxacin, levothyroxine and metformin was observed. However, when Patiromer and these drugs were taken 3 hours apart, no interaction was observed.

In vitro studies have shown a potential interaction of patiromer with quinidine.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.