Consumer medicine information

Veltassa

Patiromer

BRAND INFORMATION

Brand name

Veltassa

Active ingredient

Patiromer

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Veltassa.

What is in this leaflet

This leaflet answers some common questions about VELTASSA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given VELTASSA against the expected benefits it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What VELTASSA is used for

VELTASSA contains the active ingredient patiromer (as sorbitex calcium).

VELTASSA is used to help remove excessive amounts of potassium from the blood (hyperkalaemia). It works by binding extra potassium in your digestive tract. This increases the amount of potassium excreted and thus lowers potassium levels in your blood.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you take VELTASSA

When you must not take it

Do not take VELTASSA if you have an allergy to patiromer sorbitex calcium or any of the ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips or tongue or other parts of the body
  • rash, itching, or hives on the skin

Do not take it after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well.

Do not take it if the packaging is damaged or shows signs of tampering.

If you are not sure whether you should take VELTASSA, talk to your doctor or pharmacist.

Before you start to take VELTASSA

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • problems swallowing
  • severe stomach and/or bowel problems
  • had major surgery on your stomach and/or bowel
  • high calcium levels in your blood

Do not give this medicine to a child under the age of 18 years. Safety and efficacy of VELTASSA in children below the age of 18 years have not yet been established. Therefore, VELTASSA is not recommended in this age group.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you take VELTASSA.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket, health food shop, naturopath, herbalist or internet.

Veltassa may affect other medicines taken by mouth if they are taken too close together. This can cause you to have too little of other medicines in your body which may affect the way your other medicines work. Therefore, take Veltassa at least 3 hours before or after taking any other medicine by mouth.

Your doctor and pharmacist have more information on medicines to be careful with or avoid when taking VELTASSA.

How to take VELTASSA

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

The recommended dose is:

  • starting dose: 8.4 g patiromer once daily
  • maximum dose: 25.2 g patiromer once daily

Your doctor may adjust the dose during the treatment course depending on the potassium level in your blood.

How to take VELTASSA

Mix VELTASSA with water and stir to a suspension of uniform consistency, as follows:

Measure 80 ml (1/3 cup) of water.

  • Pour half of the water into a glass, then add VELTASSA and stir.
  • Add the remaining half of the water and stir thoroughly. The powder will not dissolve and the mixture will look cloudy.
  • Add more water to the mixture as needed for desired consistency.
  • Drink the mixture immediately. If powder remains in the glass after drinking, add more water, stir and drink immediately. Repeat as needed to ensure the entire dose is taken.

Apple juice or cranberry juice can be used instead of water, if preferred. Other liquids containing high levels of potassium cannot be used.

Take the prepared VELTASSA suspension with or without food and preferably at the same time each day.

Never heat VELTASSA or add it to heated foods or liquids.

Do not take VELTASSA in its dry form.

If you forget to take it

If you have missed a dose, take it as soon as possible on the same day. Do not take a double dose to make up for a forgotten dose. If you miss more than one dose, contact your doctor.

If you stop taking it

Do not stop taking the medicine without your doctor’s approval, as your potassium blood level may increase.

If you take too much (overdose)

Stop taking VELTASSA and talk to your doctor or pharmacist immediately or telephone the Poisons Information Centre on 13 11 26, for advice if you take more VELTASSA than you should.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking VELTASSA.

Do not be alarmed by the following list of side effects, you may not experience any of them.

Tell your doctor if you notice any of the following common side effects and they worry you:

  • constipation
  • diarrhoea
  • abdominal pain
  • wind

Low blood magnesium and/or potassium can occur when taking VELTASSA. Your doctor will check your magnesium and potassium levels during treatment with VELTASSA and may prescribe a supplement if required.

The above list includes the more common side effects.

Tell your doctor as soon as possible if you notice any of the following:

  • nausea
  • vomiting
  • dizziness
  • fast or irregular heartbeats, also called palpitations

The above list includes uncommon side effects that may require medical attention.

Tell your doctor if you notice anything that is making you feel generally unwell.

Other side effects not listed above are rare and may also occur in some people.

Storage

Store at 2-8°C in the refrigerator.

VELTASSA may be stored below 25°C for up to 6 months.

Protect from heat.

Do not use this medicine after the expiry date, which is stated on the carton or sachet after “EXP”. The expiry date refers to the last day of that month.

Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

Keep VELTASSA out of the sight and reach of children.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

VELTASSA sachets contain an off-white to light-brown powder, with occasional white particles. VELTASSA is available in packs containing 30 sachets.

Not all strengths may be marketed.

Ingredients

The active substance is patiromer sorbitex calcium.

  • Each 8.4 g sachet contains 8.4 g of patiromer (as sorbitex calcium).
  • Each 16.8 g sachet contains 16.8 g of patiromer (as sorbitex calcium).
  • Each 25.2 g sachet contains 25.2 g of patiromer (as sorbitex calcium).

The other ingredient is xanthan gum.

Supplier

VELTASSA is supplied in Australia by:

Vifor Pharma Pty Ltd
Level 9, 140 William Street
Melbourne VIC 3000
Australia
Tel: 1800 202 674

Australian registration number:

8.4 g AUST R 281012

16.8 g AUST R 281014

25.2 g AUST R 281013

This leaflet was prepared in July 2021

Published by MIMS November 2021

BRAND INFORMATION

Brand name

Veltassa

Active ingredient

Patiromer

Schedule

S4

 

1 Name of Medicine

Patiromer sorbitex calcium.

2 Qualitative and Quantitative Composition

Each sachet of Veltassa powder for oral suspension contains 8.4 g, 16.8 g or 25.2 g of patiromer (as sorbitex calcium).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Veltassa powder for oral suspension is an off-white to light-brown powder, with occasional white particles.

4 Clinical Particulars

4.1 Therapeutic Indications

Veltassa is indicated for the treatment of hyperkalaemia in adults.

4.2 Dose and Method of Administration

Dose.

The recommended starting dose of Veltassa is 8.4 g patiromer (as sorbitex calcium) once daily. Take the prepared Veltassa suspension with or without food and preferably at the same time each day.
Adjust the daily dose of Veltassa based on the serum potassium level and the desired target range. The daily dose may be increased at 1-week or longer intervals by increments of 8.4 g, or decreased by 8.4 g, as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. Multiple sachets may be required to achieve the desired dose. If serum potassium falls below the desired range, the dose should be reduced or discontinued.
If a Veltassa dose is missed, the missed dose should be taken as soon as possible on the same day. The missed dose should not be taken with the next dose.
Upon discontinuation of Veltassa, serum potassium levels may rise, especially if renin angiotensin aldosterone system (RAAS) inhibitor treatment is continued (see Section 4.4 Special Warnings and Precautions for Use). Therefore, patients should consult their doctor before discontinuing this medication.
Administer Veltassa at least 3 hours before or 3 hours after other oral medications except those shown to not have a clinically important interaction (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Serum potassium should be monitored when clinically indicated, including after changes are made to medicinal products that affect the serum potassium concentration (e.g. RAAS inhibitors or diuretics) and after the Veltassa dose is titrated (see Section 4.4 Special Warnings and Precautions for Use, Monitoring).
Serum magnesium should be monitored for at least 1 month after initiation of patiromer treatment (see Section 4.4 Special Warnings and Precautions for Use, Monitoring).
Serum calcium should be monitored in patients at risk of hypercalcaemia (see Section 4.4 Special Warnings and Precautions for Use, Monitoring).

Method of administration.

Veltassa should only be mixed with water, other liquids or soft foods as listed below, and stirred to a suspension of uniform consistency, according to the following steps:
Measure 80 mL of water. Pour half of the water into a glass, then add Veltassa and stir. Add the remaining half of the water and stir thoroughly. The powder will not dissolve and the mixture will look cloudy. Add more water to the mixture as needed for desired consistency.
Drink the mixture immediately. If powder remains in the glass after drinking, add more water, stir and drink immediately. Repeat as needed to ensure the entire dose is administered.
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.
Other liquids containing high amounts of potassium should be avoided.
Veltassa can be taken with or without food. Veltassa should not be heated (e.g. microwaved) or added to heated foods or liquids. Veltassa should not be taken in its dry form.

4.3 Contraindications

The use of Veltassa is contraindicated in cases of hypersensitivity to patiromer sorbitex calcium or any of its excipients listed in Section 6.1.

4.4 Special Warnings and Precautions for Use

Reversible causes of hyperkalaemia should be excluded and therapy initiated only if the serum potassium remains elevated and uncontrolled with dietary modification.
Treatment needs to be closely supervised or monitored.
There have been no clinical studies related to the use of Veltassa for duration of greater than 1 year. There have been no clinical studies that have examined the impact of Veltassa on patient mortality.

Veltassa should not replace emergency treatment of hyperkalaemia.

The onset of action of Veltassa occurs 4-7 hours after administration. Veltassa could be used in conjunction with other measures to stabilise the myocardium but is not recommended as the sole treatment of patients with hyperkalaemia and ECG changes.

Monitoring.

Serum potassium should be monitored when clinically indicated, including after changes are made to medicinal products that affect the serum potassium concentration (e.g. RAAS inhibitors or diuretics) and after the Veltassa dose is titrated.
Serum magnesium should be monitored for at least 1 month after initiation of patiromer treatment (see also Low magnesium).
Serum calcium should be monitored in patients at risk of hypercalcaemia (also see Information about calcium).

Low magnesium.

In clinical studies, serum magnesium values < 1.4 mg/dL (0.58 mmol/L) occurred in 7.1% of patients treated with patiromer sorbitex calcium, with 0.3% of patients developing a serum magnesium level < 1.0 mg/dL (0.4 mmol/L). Mean decreases in serum magnesium occurred early during patiromer sorbitex calcium use and were 0.118 mg/dL (0.050 mmol/L) one week after initiation, up to a maximum decrease of 0.137 mg/dL (0.06 mmol/L) 4 weeks after initiation of Veltassa. Monitor serum magnesium for at least 1 month after initiation of patiromer sorbitex calcium treatment; continue monitoring if serum magnesium levels decrease. Consider magnesium supplementation in patients who develop low serum magnesium levels on patiromer sorbitex calcium.

Information about calcium.

Veltassa contains calcium as part of the counterion complex. Calcium is partially released some of which may be absorbed (see Section 5 Pharmacological Properties). The benefits and risks of administering this medicinal product should be carefully evaluated in patients at risk of hypercalcaemia. Monitoring serum calcium is recommended in patients at risk for hypercalcemia.

Gastrointestinal disorders.

Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in the clinical studies. Gastrointestinal ischaemia, necrosis and/or intestinal perforation have been reported with other potassium binders. Patients should be monitored carefully such that the benefits and risks of administering Veltassa can be evaluated before and during treatment.

Discontinuing Veltassa.

Veltassa binds potassium. On cessation of this medication, potassium levels will return to pretreatment levels, reflecting the combined effect of the patient's other treatments (e.g. RAAS inhibitors), dietary intake and medical conditions (e.g. CKD). Patients should be instructed not to discontinue therapy without consulting their physicians. In clinical studies, serum potassium increased as early as 2 days after the last patiromer sorbitex calcium dose.

Use in renal impairment.

There is no data on the administration of Veltassa to patients on peritoneal dialysis. Veltassa reduced serum potassium in the 6 patients on haemodialysis included in the drug development program. There is no data on the use with phosphate binders.

Use in the elderly.

Of the total number of subjects exposed to Veltassa in clinical studies, 1307 (61.2%) were aged 65 and over, while 500 (23.4%) were aged 75 and over. No special dose and administration guidelines were applied to seniors in these studies.

Paediatric use.

There is no data on the safety and efficacy of Veltassa in children aged under 18 years.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Effect of patiromer on other medicinal products.

Patiromer sorbitex calcium has the potential to bind some oral co-administered drugs, which could decrease their gastrointestinal absorption and result in a loss of efficacy when taken close to the time Veltassa is administered. As patiromer is not absorbed or metabolised by the body, interactions with other medicinal products outside of the gastrointestinal tract are not expected.
Table 1 and Table 2 show the medicinal products tested for interactions with Veltassa and recommendations for administration of these medicinal products with Veltassa. For oral medicinal products not listed, administration of patiromer should be separated by at least 3 hours as a precautionary measure.
Physicians should consider monitoring medicines with a narrow therapeutic index when starting Veltassa.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no data on the effect of Veltassa on fertility in humans.
Male and female fertility were unaffected in rats at oral doses of patiromer up to 5 g/kg/day, 10 times higher than the maximum recommended human dose on a g/kg basis (assuming 50 kg patient body weight).
(Category B1)
There are no data from the use of Veltassa in pregnant women. Veltassa is not absorbed systemically following oral administration and maternal use is not expected to result in fetal risk.
No adverse effects on embryofetal development were observed in rats and rabbits receiving oral doses of patiromer of up to 6 and 3 g/kg/day, respectively (12 and 6 times, respectively, the maximum recommended human dose on a g/kg basis).
 There are no data from the use of Veltassa in breastfeeding women. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to patiromer is negligible.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The current safety profile of Veltassa is based on both post marketing experience, and a total of 2135 patients from clinical trials. This includes 1838 patients with hyperkalaemia from treatment studies, 266 patients at risk of hyperkalaemia from prevention studies and 31 patients with hyperkalaemia from pharmacology studies.

Clinical trials experience.

The majority of the adverse drug reactions reported from trials were hypomagnesaemia and gastrointestinal disorders, with the most frequently reported adverse events being constipation, diarrhoea, abdominal pain, nausea, flatulence, and vomiting (see Table 3). Gastrointestinal disorder reactions were generally mild to moderate in nature, did not appear to be dose related, generally resolved spontaneously or with treatment, and none were reported as serious.

Undesirable effects from post-marketing reporting.

As part of the continuing post-marketing surveillance of Veltassa, the following additional adverse reaction has been observed. See Table 4.

Laboratory abnormalities.

Approximately 4.7% of patients in clinical trials developed hypokalaemia with a serum potassium value < 3.5 mEq/L.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Doses of Veltassa in excess of 50.4 g patiromer per day have not been tested. Since excessive doses of Veltassa may result in hypokalaemia, serum potassium levels should be monitored. If it is determined that medical intervention is required, appropriate measures to restore serum potassium may be considered.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Patiromer sorbitex calcium is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol complex as a counterion.
Veltassa increases faecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels.

Pharmacodynamic effects.

Patiromer has been shown to bind potassium in vitro and in vivo in experimental animal models.
In a Phase 1 study in healthy adult subjects (6 to 8 subjects per group), patiromer (2.52 g to 50.4 g per day) administered three times a day for 8 days caused a dose-dependent increase in faecal potassium excretion compared with placebo. A corresponding dose-dependent decrease in urinary potassium excretion with no change in serum potassium was also observed. Compared to placebo, patiromer doses of 25.2 and 50.4 g per day significantly decreased mean daily urinary potassium excretion. Daily urinary calcium excretion increased from baseline by 73 mg/day at the 25.2 g dose of patiromer.
In a Phase 1, open-label, multiple-dose crossover study in 12 healthy subjects, 25.2 g of patiromer per day was administered orally as a once daily, twice daily or thrice daily regimen for 6 days in a randomly assigned order. A significant increase in mean daily faecal potassium excretion and concomitant decrease in mean daily urinary potassium excretion were observed during the treatment periods for all three dosing regimens. The mean increase in faecal potassium excretion ranged from 1283 to 1550 mg/day, and the mean decrease in urinary potassium excretion ranged from 1438 to 1534 mg/day across the three dosing regimens. No significant differences were observed among the dosing regimens with respect to mean daily faecal potassium and urinary potassium excretion. This was true for the overall comparison among the three dosing regimens, as well as for the pairwise comparisons. Daily urinary calcium excretion increased from baseline by 53 mg/day, 66 mg/day and 73 mg/day for once daily, twice daily and thrice daily regimens, respectively.
In an open-label, uncontrolled study, 25 patients with hyperkalaemia (mean baseline serum potassium of 5.9 mEq/L) and chronic kidney disease were given a controlled potassium diet for 3 days, followed by 16.8 g patiromer daily (as two divided doses) for 2 days while the controlled diet was continued. A statistically significant reduction in serum potassium (0.2 mEq/L) was observed at 7 hours after the first dose. Serum potassium levels continued to decline during the 48-hour treatment period (-0.8 mEq/L at 48 hours after the first dose). Potassium levels remained stable for 24 hours after the last dose, then rose during the 4-day observation period following discontinuation of patiromer sorbitex calcium (see Figure 1).

Clinical trials.

The safety and efficacy of Veltassa were demonstrated in a two-part, single-blind randomised withdrawal study that evaluated Veltassa in hyperkalaemic patients with CKD on stable doses of at least one RAAS inhibitor (i.e. angiotensin-converting enzyme inhibitor [ACEI], angiotensin II receptor blocker [ARB], or mineralocorticoid receptor antagonist [MRA]).
In Part A, 243 patients were treated with Veltassa for 4 weeks. Patients with a baseline serum potassium of 5.1 mEq/L to < 5.5 mEq/L received a starting Veltassa dose of 8.4 g patiromer per day (as a divided dose) and patients with a baseline serum potassium of 5.5 mEq/L to < 6.5 mEq/L received a starting Veltassa dose of 16.8 g per day (as a divided dose). The dose of Veltassa was titrated, as needed, based on the serum potassium level, assessed starting on Day 3 and then at weekly visits (Weeks 1, 2 and 3) to the end of the 4-week treatment period, with the aim of maintaining serum potassium in the target range (3.8 mEq/L to < 5.1 mEq/L). The mean daily doses of Veltassa were 13 g and 21 g in patients with serum potassium of 5.1 to < 5.5 mEq/L and 5.5 to < 6.5 mEq/L, respectively.
The mean age of patients was 64 years, 58% of patients were men, and 98% were Caucasian. Approximately 97% of patients had hypertension, 57% had type 2 diabetes, and 42% had heart failure.
Mean serum potassium levels were 5.58 mEq/L at baseline and the mean (SE) change in serum potassium from Part A Baseline to Part A Week 4 was -1.01 (0.031) mEq/L (see Figure 2); this mean reduction in serum potassium was statistically significant (p < 0.001). For the Part A secondary outcome, 76% (95% CI: 70%, 81%) of patients had a serum potassium in the target range of 3.8 mEq/L to < 5.1 mEq/L at Part A Week 4.
In Part B, 107 patients with a Part A baseline serum potassium of 5.5 mEq/L to < 6.5 mEq/L and whose serum potassium was in the target range (3.8 mEq/L to < 5.1 mEq/L) at Part A Week 4 and still receiving RAAS inhibitor medication were randomised to continue Veltassa or to receive placebo for 8 weeks to evaluate the effect of withdrawing Veltassa on serum potassium. In patients randomised to Veltassa, the mean daily dose was 21 g at the start of Part B and during Part B.
The Part B primary endpoint was the change in serum potassium from Part B baseline to the earliest visit at which the patient's serum potassium was first outside of the range of 3.8 to < 5.5 mEq/L or to Part B Week 4 if the patient's serum potassium remained in the range. In Part B, serum potassium rose by 0.72 mEq/L in patients on placebo relative to no change in patients who remained on Veltassa (p < 0.001).
More placebo patients (91% [95% CI: 83%, 99%]) developed a serum potassium ≥ 5.1 mEq/L at any time during Part B than Veltassa patients (43% [95% CI: 30%, 56%]), p < 0.001. More placebo patients (60% [95% CI: 47%, 74%]) developed a serum potassium ≥ 5.5 mEq/L at any time during Part B than Veltassa patients (15% [95% CI: 6%, 24%]), p < 0.001.
Fifty-two percent (52%) of subjects receiving placebo discontinued RAAS inhibitor medication because of recurrent hyperkalaemia compared with 5% of subjects treated with Veltassa.
The effect of treatment with Veltassa for up to 52 weeks was evaluated in an open-label study of 304 hyperkalaemic patients with CKD and type 2 diabetes mellitus on stable doses of a RAAS inhibitor. Decreases in serum potassium with Veltassa treatment were maintained over 1 year of chronic treatment with a low incidence of hypokalaemia and the majority of subjects reaching and maintaining target serum potassium levels. In patients with a baseline serum potassium of > 5.0 to 5.5 mEq/L who received an initial dose of 8.4 g Veltassa per day (as a divided dose), the mean daily dose was 14 g; in those with a baseline serum potassium of > 5.5 to < 6.0 mEq/L who received an initial dose of 16.8 g Veltassa per day (as a divided dose), the mean daily dose was 20 g during the entire study (see Figure 3).
After stopping Veltassa, significant increases in least squares mean serum potassium levels were seen by day 3 post-treatment. Patients remained on all RAAS inhibitors for 28 days after discontinuation of Veltassa treatment, during which time the increase in serum potassium remained statistically significant.

Effect of food.

In an open-label study (RLY5016-401 - Tourmaline), 114 patients with hyperkalaemia were randomized to patiromer once daily with food or without food. Serum potassium at the end of treatment, the change from baseline in serum potassium, and the mean dose of patiromer were similar between groups.

5.2 Pharmacokinetic Properties

Veltassa works by binding potassium in the gastrointestinal tract and thus the serum drug concentration is not relevant for its efficacy. Due to the insolubility and non-absorptive characteristics of Veltassa, many classical pharmacokinetic studies cannot be carried out.

5.3 Preclinical Safety Data

In radio-labelled ADME studies in rats and dogs, patiromer was not systemically absorbed and was excreted in the faeces. Quantitative whole-body autoradiography analysis in rats demonstrated that radioactivity was limited to the gastrointestinal tract, with no detectable level of radioactivity in any other tissues or organs.

Genotoxicity.

Patiromer was not genotoxic in the bacterial reverse mutation test (Ames assay), in vitro chromosomal aberration assay (Chinese Hamster Ovary cells) or rat micronucleus test.

Carcinogenicity.

Carcinogenicity studies with Veltassa have not been performed.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each sachet also contains Xanthan gum.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
Please see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2 to 8°C. (Refrigerate. Do not freeze.)
Veltassa may be stored below 25°C for up to 6 months.
Do not use Veltassa past the expiry date printed on the sachet.
Protect from heat.

6.5 Nature and Contents of Container

Veltassa powder for oral suspension is available in Al laminated with PE/paper sachets.
Pack size: carton boxes containing 30 sachets.
Not all strengths may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Patiromer sorbitex calcium is a crosslinked polymer of calcium, hydrolyzed divinylbenzene- Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes. The molecular weight of a 100 micrometre patiromer sorbitex calcium bead, calculated using an experimentally derived value for density and the theoretical calculated value for volume, is estimated to be 5.6 x 1017 g/mol.

Chemical structure.


Empirical formula: C613H765F114O399Ca57.

CAS number.

1415477-49-4.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes