SUMMARY CMI

VELPHORO^® 500 mg chewable tablets

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 VELPHORO?

VELPHORO contains 2500 mg of the active substance sucroferric oxyhydroxide which corresponds to 500 mg iron. VELPHORO is used to control the phosphorus levels in the blood of patients with chronic kidney disease (CKD) on dialysis.

For more information, see Section 1. Why am I using VELPHORO? in the full CMI.

2. What should I know before I use VELPHORO?

Do not use if you have ever had an allergic reaction to active substance sucroferric oxyhydroxide or any of the ingredients listed at the end of the CMI. Do not use if you have too much iron or any other problems with the iron levels in your body.

Talk to your doctor or pharmacist 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 VELPHORO? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with VELPHORO and affect how it works.

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 VELPHORO?

• Use as directed by your doctor. Check with your doctor or pharmacist if you are not sure
• Take the tablet during a meal and chew it. DO NOT swallow it whole.

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

5. What should I know while using VELPHORO?

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

6. Are there any side effects?

The most common side effects are diarrhoea, discoloured faeces, nausea, constipation, vomiting, indigestion, abdominal pain, flatulence, and discolouration of teeth and/or tongue. Serious side effects include fatigue and breathlessness.

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

VELPHORO^® 500 mg chewable tablets

Active ingredient(s): Each chewable tablet contains 500 mg iron (equivalent to 2500 mg sucroferric oxyhydroxide)

Consumer Medicine Information (CMI)

This leaflet provides important information about using VELPHORO. 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 VELPHORO.

Where to find information in this leaflet:

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

1. Why am I using VELPHORO?

VELPHORO contains 2500 mg of the active substance sucroferric oxyhydroxide which corresponds to 500 mg iron. VELPHORO belongs to a group of drugs used when the levels of phosphorus in blood are too high (a condition called hyperphosphataemia).

VELPHORO is used to control the phosphorus levels in the blood of patients with chronic kidney disease (CKD) on dialysis. The active ingredient works by binding phosphate from food in the digestive tract. This reduces how much is absorbed and the levels of phosphorus in the 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.

2. What should I know before I use VELPHORO?

Warnings

Do not use VELPHORO if:

• you are allergic to the active substance sucroferric oxyhydroxide, or to any of the other ingredient(s) listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• you are allergic to any other similar medicines

Some of the symptoms of an allergic reaction may include:

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

Do not take this medicine if you have too much iron in your body (haemochromatosis) or any other problems with the iron levels in your body.

Check with your doctor or pharmacist if you:

• have any other medical conditions
• have allergies to any other medicines, foods, preservatives or dyes
• take any medicines for any other condition
• have inflammation of the thin tissue (serous membrane) that lines the inner wall of the abdomen (peritonitis)
• have significant stomach and/or liver disorders
• have had major surgery on your stomach and/or intestines
• have a history of abnormal iron accumulation in your bodily organs (haemochromatosis) or other iron disorders
• have an intolerance to some sugars

Do not take this medicine if you have too much iron in your body (haemochromatosis) or any other problems with the iron levels in your body.

If you are not sure whether you should start taking this medicine, talk to your doctor. 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 or pharmacist if you are pregnant or intend to become pregnant.

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

If you become pregnant while taking this medicine, tell your doctor immediately.

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.

Some medicines may interfere with VELPHORO and affect how it works. These include:

• alendronate (a medicine used to treat or prevent osteoporosis)
• doxycycline (antibiotics to treat infections)
• levothyroxine (a medicine used to treat thyroid problems)

These medicines may be affected by VELPHORO or may affect how well it works. You may need different amounts of your medicines. It is recommended that these drugs should be administrated at least 1 hour before or at least 2 hours after intake of VELPHORO.

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

4. How do I use VELPHORO?

How much to take

• The standard dose for this medicine is one tablet three times a day.
• The usual recommended starting dose is 1,500 mg iron per day (1 tablet, 3 times a day).
• The maximum recommended dose is 3,000 mg iron (2 tablets, 3 times a day).

Your doctor may have prescribed a different dose.

Follow the instructions provided and use VELPHORO until your doctor or pharmacist tells you to stop. Your doctor may adjust the dose during the treatment course depending on the phosphorus level in your blood.

If you take the wrong dose, VELPHORO may not work as well, and your problem may not improve.

If you do not understand the instructions, ask your doctor or pharmacist for help. Ask your doctor or pharmacist if you are unsure of the correct dose for you.

When to take VELPHORO

Take your medicine during or immediately after a meal, at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

If you take it on an empty stomach, it may cause stomach upset.

The amount of tablets taken per day should be divided across the three largest meals of the day.

How to take VELPHORO

VELPHORO chewable tablets should only be taken by mouth.

Take the tablet during a meal and chew it. DO NOT swallow it whole.

If necessary, the tablet may be crushed to make this easier for you.

No additional fluid above the amount usually taken due to your kidney disease is required.

Additional information for the blister pack:

• Separate the blister pack at perforations.
• Peel back the paper foil at the corner.
• Push the tablet through the aluminium foil.

Continue taking your medicine for as long as your doctor tells you.

This medicine helps to control your condition but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take VELPHORO

VELPHORO should be used regularly at the same time each day to have the best effect.

If you miss your dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.

If you use too much VELPHORO

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

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor or pharmacist, 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 VELPHORO?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking VELPHORO.

Tell any doctor or pharmacist, dentist, or pharmacist you visit that you are using VELPHORO.

Keep all of your doctor's appointments so that your progress can be checked

Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

If you become pregnant while taking this medicine, tell your doctor immediately.

Things you should not do

• Do not stop using this medicine suddenly or lower your dose without checking with your doctor or pharmacist. If you stop taking it suddenly, your condition may worsen.
• Do not take this medicine to treat any other complaints unless your doctor tells you to.
• Do not give your medicine to anyone else, even if they have the same condition as you.

Driving or using machines

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

It is unlikely that this medicine will affect your ability to drive or to operate tools or machines. Ask your doctor if you are not sure.

Looking after your medicine

• Store below 30°C
• Store in the original container

Follow the instructions on 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 windowsills.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

When to discard your medicine

Do not take this medicine after the expiry date printed on the pack or 90 days after opening (whichever is earlier) or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Getting rid of any unwanted medicine

If your doctor tells you to stop taking this medicine or the expiry date has passed, take it to any pharmacy for safe disposal.

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.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

Serious side effects

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

This includes any other possible side effects not listed here that 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 or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What VELPHORO contains

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

What VELPHORO looks like

VELPHORO chewable tablets are brown, circular, bi-planar tablets embossed with PA500 on one side.

The tablets are packed in high density polyethylene bottles with a child resistant polypropylene cap and a foil induction seal, or in child resistant aluminium blister packs.

VELPHORO is available in packs containing 30 or 90 chewable tablets.

Australian Registration Numbers:

AUST R 216701 (blister pack)

AUST R 216702 (bottle pack)

Who distributes VELPHORO

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 January 2024.

Published by MIMS May 2024

1 Name of Medicine

Sucroferric oxyhydroxide.

2 Qualitative and Quantitative Composition

Each Velphoro chewable tablet contains 500 mg iron, equivalent to 2500 mg sucroferric oxyhydroxide.
The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose and 700 mg starches.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Velphoro chewable tablets are brown, round, flat-faced, chewable tablets embossed with PA500 on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Velphoro is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease (CKD) on dialysis.

4.2 Dose and Method of Administration

Tablets must be taken with meals, chewed and not swallowed whole. The tablets may be crushed as an aid to chewing.
Patients receiving Velphoro should adhere to their prescribed diets.

Starting dose.

Titration and maintenance.

Maximum tolerated daily dose.

Paediatric population.

Elderly.

Renal impairment.

Hepatic impairment.

Method of administration.

4.3 Contraindications

The use of the drug is contraindicated in patients with:
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 List of Excipients.
Haemochromatosis and any other iron accumulation disorders.

4.4 Special Warnings and Precautions for Use

Patients with a recent history (of 3 months) of peritonitis, significant gastric or hepatic disorders, and patients with major gastrointestinal surgery have not been included in clinical studies with Velphoro. Velphoro should only be used in these patients following careful assessment of benefit/ risk.
One tablet of Velphoro is equivalent to approximately 1.4 g of carbohydrates.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Drug-drug interaction studies have been conducted in healthy male and female subjects with losartan, furosemide, digoxin, warfarin, and omeprazole. Concomitant administration of Velphoro did not affect the bioavailability of these drugs as measured by the area under the curve (AUC).
Data from clinical studies have shown that Velphoro does not affect the lipid lowering effects of HMG-CoA reductase inhibitors (e.g. atorvastatin and simvastatin).
In vitro studies showed significant drug interaction (adsorption by Velphoro) with paricalcitol and doxercalciferol. However, data from clinical studies demonstrated no impact of Velphoro on iPTH lowering effect of oral vitamin D analogues. Serum vitamin D and 1,25-dihydroxy vitamin D levels remained unchanged.
In vitro studies showed significant drug interaction (adsorption by Velphoro) with alendronate, doxycycline and levothyroxine. No clinical data is available at present. It is recommended that these drugs should be administrated at least 1 hour before or at least 2 hours after intake of Velphoro.
In vitro studies with the following drugs did not show any relevant interaction: acetylsalicylic acid, cephalexin, cinacalcet, ciprofloxacin, clopidogrel, enalapril, hydrochlorothiazide, metformin, metoprolol, nifedipine, pioglitazone and quinidine. However, clinical data are not available at present.
Concomitant treatment with antacids containing aluminium, magnesium or calcium and oral iron therapies as well as phosphate binders has not been investigated.
When administering any medicinal product that is known to interact with iron, the medicinal product should be administered at least one hour before or two hours after Velphoro.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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 safety of Velphoro has been investigated in 2 active controlled clinical studies: a 6 week dose finding study and a safety and efficacy study of up to 55 weeks. A total of 778 patients on haemodialysis and 57 patients on peritoneal dialysis were treated with treatment duration of up to 55 weeks. Velphoro had a similar adverse drug reaction (ADR) profile to sevelamer and no dose dependent trends were observed.
Table 1 reports the most common adverse events occurring in at least 5% of patients in either group.
Adverse drug reactions reported from the use of Velphoro at doses from 250 mg iron/day to 3000 mg iron/day in these patients (n = 835) are summarised in Table 2.

Postmarketing experience.

Reporting suspected adverse reactions.

4.9 Overdose

No case of overdose with Velphoro has been reported. Since the absorption of iron from Velphoro is low, the risk of systemic iron toxicity is negligible. Any instances of overdose (e.g. hypophosphataemia) due to phosphate binder overdose should be treated by standard clinical practice.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Post-authorisation data.

5.2 Pharmacokinetic Properties

Velphoro works by binding phosphate in the GI tract and thus the serum concentration is not relevant for its efficacy. Due to the insolubility and degradation characteristics of Velphoro, no classical pharmacokinetic studies can be carried out, e.g. determination of the distribution volume, area under the curve, mean residence time, etc.
In two phase 1 studies, it was concluded that the potential for iron overload is minimal and no dose dependent effects were observed in healthy volunteers. The sucrose and starch components of Velphoro can be digested to glucose and fructose, and maltose and glucose, respectively. These compounds can be absorbed in the blood.

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The chewable tablets also contain the following inactive ingredients; woodberry flavour, neohesperidin-dihydrochalcone, magnesium stearate and colloidal anhydrous silica.

6.2 Incompatibilities

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

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.
Shelf life after first opening of the bottle: 90 days.

6.4 Special Precautions for Storage

Store below 30°C.
Store in the original package in order to protect from moisture.

6.5 Nature and Contents of Container

The tablets are supplied in high density polyethylene (HDPE) bottle with child-resistant closure and foil induction seal, containing a molecular sieve desiccant and cotton. Pack sizes of 30 or 90 chewable tablets.
The tablets are supplied in blister, each blister containing 6 chewable tablets. Pack sizes of 30 or 90 chewable tablets.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Sucroferric oxyhydroxide is a brown amorphous powder, which is odourless, slightly sweet and practically insoluble in water.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes