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.

SUMMARY CMI

Veltassa®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Veltassa?

Veltassa contains the active ingredient patiromer (as sorbitex calcium). Veltassa is used to help remove excessive amounts of potassium from the blood (hyperkalaemia). For more information, see Section 1. Why am I using Veltassa? in the full CMI.

2. What should I know before I use Veltassa?

Do not use if you have ever had an allergic reaction to Veltassa or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Veltassa? in the full CMI.

3. What if I am taking other medicines?

Veltassa may interfere with the absorption of some medicines and reduce their activity if taken together.

A list of these medicines is in Section 3. What if I am taking other medicines? In the full CMI.

4. How do I use Veltassa?

  • The recommended dose is: starting dose: 8.4 g Veltassa (1x8.4 g sachet) once daily; maximum dose: 25.2 g Veltassa (3x8.4 g sachets) once daily. Your doctor may adjust the dose during the treatment course depending on the potassium level in your blood.
  • Mix Veltassa with the recommended liquids or soft foods and stir until it is thoroughly mixed.
  • Take the prepared Veltassa suspension with or without food and preferably at the same time each day.
  • In general, Veltassa should be separated by 3 hours from other oral medicines.

More instructions can be found in Section 4. How do I use Veltassa? In the full CMI.

5. What should I know while using Veltassa?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Veltassa.
Things you should not do
  • Never heat Veltassa or add it to heated foods or liquids.
  • Do not take Veltassa in its dry form.
  • Do not stop taking the medicine without your doctor's approval, as your potassium blood level may increase.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Veltassa affects you.
Drinking alcohol
  • The effect of alcohol on Veltassa has not been formally studied, however, no effect is expected
Looking after your medicine
  • It is recommended to store Veltassa in the refrigerator (at 2°C to 8°C) (Do not store in the freezer).
  • Veltassa may be stored below 25°C for up to 6 months.
  • Protect from heat.

For more information, see Section 5. What should I know while using Veltassa? In the full CMI.

6. Are there any side effects?

Common side effects include: constipation, diarrhoea, abdominal pain, wind. Low blood magnesium and/or potassium can occur when taking Veltassa. Uncommon side effects that may require medical attention include: nausea, vomiting, dizziness, fast or irregular heartbeats, also called palpitations.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? In the full CMI.



FULL CMI

Veltassa®

Active ingredient: patiromer (as sorbitex calcium)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Veltassa. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Veltassa.

Where to find information in this leaflet:

1. Why am I using Veltassa?
2. What should I know before I use Veltassa?
3. What if I am taking other medicines?
4. How do I use Veltassa?
5. What should I know while using Veltassa?
6. Are there any side effects?
7. Product details

1. Why am I using Veltassa?

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.

Veltassa is used to treat high blood potassium levels in adults.

2. What should I know before I use Veltassa?

Warnings

Do not use Veltassa if:

  • you are allergic to patiromer (as sorbitex calcium), or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reactions are 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.
  • the packaging is damaged or shows signs of tampering.
  • It is past the expiry date (EXP) printed on the pack
  • Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

  • have any other medical conditions including severe stomach and/or bowel problems
  • take any medicines for any other condition
  • have problems swallowing
  • had major surgery on your stomach and/or bowel
  • have high calcium levels in your blood.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor can discuss with you the risks and benefits involved.

Use in children

  • 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.

3. What if I am taking other medicines?

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

Take Veltassa at least 3 hours before or after taking any other medicine by mouth. 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. Separation is not needed for certain medicinal products. Check with your doctor or pharmacist to confirm which medicines are impacted.

Examples of medicines that Veltassa may affect if they are taken by mouth at the same time include:

  • telmisartan: a medicine used to treat high blood pressure and heart failure
  • bisoprolol, carvedilol, nebivolol : medications used to treat high blood pressure
  • ciprofloxacin: a medicine to treat bacterial infections
  • levothyroxine: a medicine to treat thyroid hormone deficiency
  • metformin: a medicine to treat diabetes
  • quinidine: a medicine to treat irregular heart rhythm.
  • mycophenolate mofetil: a medication used to lower the body's natural immunity in patients who receive organ transplants
  • thiamine: used to treat or prevent vitamin B1 deficiency

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Veltassa.

4. How do I use Veltassa?

How much to take

  • The recommended starting dose is 8.4 g Veltassa sachet once daily
  • The recommended maximum dose is 25.2 g Veltassa (3x8.4g sachets) once daily
  • Multiple sachets may be required to achieve the required dose
  • Your doctor may adjust the dose during the treatment course depending on the potassium level in your blood.
  • Follow the instructions provided and use Veltassa until your doctor tells you to stop.

When to take Veltassa

  • The prepared Veltassa suspension should be taken with or without food, preferably at the same time each day.

How to take Veltassa

Veltassa should only be mixed with water, other liquids or soft foods (as listed below) and stirred 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.

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.

When using such liquids and soft foods, follow your dietary recommendations on potassium intake. Other liquids containing high levels of potassium cannot be used. Check with your doctor or pharmacist if you are not sure.

Take Veltassa at least 3 hours before or 3 hours after other medicines taken by mouth unless your doctor or pharmacist gives you different advice. See additional information under Section 3. What if I am taking other medicines?

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

Do not take Veltassa in its dry form.

If you forget to take Veltassa

Veltassa should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as possible on the same day. If you missed a day, take the next Veltassa dose at the usual time.

Do not take a double dose to make up for the dose you missed.

  • If you miss more than one dose, contact your doctor.

If you use too much Veltassa

If you think that you have used too much Veltassa, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Veltassa?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using Veltassa.

Things you should not do

  • Never heat Veltassa or add it to heated foods or liquids.
  • Do not take Veltassa in its dry form.
  • Do not stop taking the medicine without your doctor's approval, as your potassium blood level may increase.
  • Do not use Veltassa after the expiry date.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Veltassa affects you.

Looking after your medicine

  • It is recommended to store Veltassa in the refirgerator (at 2°C to 8°C) (Do not store in the freezer).
  • Veltassa may be stored below 25°C for up to 6 months.
  • Protect from heat.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

Discard Veltassa 6 months after taking out of the refrigerator or after expiry date if stored in the refrigerator.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date. The expiry date refers to the last day of that month.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Gastrointestinal disorders:
  • 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.		Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Side effects that may require medical attentionWhat to do
  • nausea
  • vomiting
  • dizziness
  • fast or irregular heartbeats, also called palpitations
Speak to your doctor if you have any of these uncommon side effects as they may require medical attention.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Veltassa contains

Active ingredient
(main ingredient)

patiromer (as 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).
Other ingredients
(inactive ingredients)		Xanthan gum
Potential allergensNone
Does not contain lactose, gluten, starch, gelatin, nut allergens, vegetable oils, cereal, milk proteins, fish oil and/or its derivatives, egg and/or its derivates, dried fruits, fruit flavourings, fruit essences, materials of human or animal origin.

Do not take this medicine if you are allergic to any of these ingredients.

What Veltassa 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.
(8.4 g AUST R 281012
16.8 g AUST R 281014
25.2 g AUST R 281013)

Who distributes Veltassa

Distributed in Australia by:

CSL Seqirus
655 Elizabeth Street,
Melbourne, VIC 3000
Australia
1800 642 865 (Within Australia)

Sponsor

Seqirus Pty Ltd
63 Poplar Rd,
Parkville VIC 3052
Australia

This leaflet was prepared in July 2024.

Published by MIMS October 2024

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