Consumer medicine information

Velphoro

Sucroferric oxyhydroxide

BRAND INFORMATION

Brand name

Velphoro

Active ingredient

Sucroferric oxyhydroxide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Velphoro.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about VELPHORO.

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 taking this medicine against the benefits they expect it will have for you.

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

Keep this leaflet. You may need to read it again.

WHAT VELPHORO IS USED FOR

VELPHORO is used to control the phosphorus levels in the blood of patients with chronic kidney disease (CKD) on dialysis.

It contains 2.5 g of the active substance sucroferric oxyhydroxide which corresponds to 500 mg iron.

This medicine belongs to a group of drugs used when the levels of phosphorus in blood are too high (a condition called hyperphosphataemia).

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.

BEFORE YOU TAKE VELPHORO

When you must not take it

Do not take this medicine if you have an allergy to:

  • the active substance sucroferric oxyhydroxide, or to any of the other ingredient(s) listed at the end of this leaflet
  • 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.

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.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

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

Tell your doctor or pharmacist before taking VELPHORO if you have:

  • inflammation of the thin tissue (serous membrane) that lines the inner wall of the abdomen (peritonitis),
  • significant stomach and/or liver disorders,
  • had major surgery on your stomach and/or intestines,
  • a history of abnormal iron accumulation in your bodily organs (haemochromatosis) or other iron disorders
  • an intolerance to some sugars

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor will 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 start taking VELPHORO.

Taking other medicines

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

Some medicines and VELPHORO may interfere with each other. 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.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE VELPHORO

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

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 adjust the dose during the treatment course depending on the phosphorus level in your blood.

Your doctor may have prescribed a different dose.

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.

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

How to take it

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.

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

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.

When to take VELPHORO

Take your medicine 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.

Take your medicine during or immediately after a meal, at about the same time each day. If you take it on an empty stomach, it may cause stomach upset.

How long to take VELPHORO

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 it

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 that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much VELPHORO. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

WHILE YOU ARE TAKING VELPHORO

Things you must do

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

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

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

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.

Things you must not do

Do not take VELPHORO 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.

Do not stop taking your medicine or lower the dosage without checking with your doctor or pharmacist. If you stop taking it suddenly, your condition may worsen.

Things to be careful of

Be careful driving or operating machinery 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.

SIDE EFFECTS

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

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

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

Ask your doctor or pharmacist to answer any questions you may have.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported in patients taking VELPHORO:

Very common (may affect more than 1 in 10 people): diarrhoea, discoloured faeces*.

Common (may affect up to 1 in 10 people): nausea, constipation, vomiting, indigestion, abdominal pain, flatulence, discolouration of teeth and/or tongue.

Uncommon (may affect up to 1 in 100 people): abdominal distension (bloating), gastritis, abdominal discomfort, difficulty swallowing, gastro-oesophageal reflux disorder (GORD), fatigue, itching skin, rash, headache, shortness of breath.

*As is often seen with oral iron preparations, discoloured (black) stools may occur very commonly in patients taking VELPHORO®. This may visually hide gastrointestinal bleeding. If you also have symptoms like increasing fatigue and breathlessness contact your doctor immediately.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

AFTER TAKING VELPHORO

Storage

Keep your medicine in the original container. If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 30°C.

Shelf life after first opening the bottle: 90 days

Do not store VELPHORO or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

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

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.

Ingredients

Active ingredients:

  • 2.5 g sucroferric oxyhydroxide (equivalent to 500 mg iron)

The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose and 700 mg starches.

Inactive ingredients:

  • woodberry flavour
  • neohesperidin dihydrochalcone
  • magnesium stearate
  • silica (colloidal, anhydrous)

Sponsor

Vifor Pharma Pty Ltd
655 Elizabeth Street
Melbourne
VIC 3000, Australia
Tel: 1800 202 674

Australian Registration Number:

AUST R 216701
AUST R 216702

This leaflet was prepared in September 2023

Published by MIMS November 2023

BRAND INFORMATION

Brand name

Velphoro

Active ingredient

Sucroferric oxyhydroxide

Schedule

S4

 

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.

The recommended starting dose of Velphoro is 1500 mg iron per day (3 tablets). Velphoro is for oral administration only and must be taken with meals.

Titration and maintenance.

Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in increments of 500 mg iron (1 tablet) per day every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards.
In clinical practice, treatment will be based on the need to control serum phosphorus levels, though patients who respond to Velphoro therapy usually achieve optimal serum phosphorus levels at doses of 1500 mg to 2000 mg iron per day (3 to 4 tablets).
If one or more doses are missed, the normal dose of the medication should be resumed with the next meal.

Maximum tolerated daily dose.

The maximum recommended dose is 3000 mg iron (6 tablets) per day.

Paediatric population.

The safety and efficacy of Velphoro in children below the age of 18 years has not yet been established. No data are available.

Elderly.

Velphoro has been administered to over 248 seniors (≥ 65 years of age) according to the approved dosing regimen. Of the total number of subjects in clinical studies of Velphoro, 29.7% were aged 65 and over, while 8.7% were aged 75 and over. No special dosage and administration guidelines were applied to seniors in these studies and the dosing schedules were not associated with any significant concerns.

Renal impairment.

Velphoro is indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. There is no clinical data available with Velphoro in patients with earlier stage of renal impairment.

Hepatic impairment.

Generally, patients with severe hepatic impairment were excluded from participating in clinical studies with Velphoro. However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in the clinical studies with Velphoro.

Method of administration.

Velphoro is for oral administration only. Velphoro chewable tablet must be taken with meals. In order to maximise the adsorption of dietary phosphate, the total daily dose should be divided across the meals of the day. Patients are not required to drink more fluid than they normally would. Tablets must be chewed or crushed; tablets must not be swallowed whole.

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.

See Section 4.2 Dose and Method of Administration, Elderly.

Paediatric use.

The safety and efficacy of Velphoro in children below the age of 18 years has not yet been established. No data are available.

Effects on laboratory tests.

Velphoro can cause discoloured (black) stool. Discoloured (black) stool may visually mask gastrointestinal (GI) bleeding. However, Velphoro does not affect guaiac based (Hemoccult) or immunological based (iColo Rectal and Hexagon Obti) faecal occult blood 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.

There are no data on the effect of Velphoro on fertility in humans. No adverse effects on mating performance, fertility, and litter parameters were noted following treatment of rats with Velphoro at up to 20 times the maximum clinical dose.
(Category B3)
There are no available clinical data from the use of Velphoro on exposed human pregnancies.
Reproductive and developmental toxicity studies in animals revealed no risk with respect to pregnancy, parturition or postnatal development. However, a maternotoxic dose of Velphoro at 5 times the maximum clinical dose was associated with reduced fetal weight and delayed ossification in a rabbit embryofetal development study. A no-effect level was established at 2.5 times the maximum clinical dose.
Velphoro should only be used by pregnant women if clearly needed following careful assessment of benefit/ risk.
 There are no available clinical data from the use of Velphoro in lactating women.
Since absorption of iron from Velphoro is minimal (see Section 5.2 Pharmacokinetic Properties), excretion of iron from Velphoro in breast milk is unlikely. A decision on whether to continue breastfeeding or to continue therapy with Velphoro should be made taking into account the benefit of breastfeeding to the child and the benefit of Velphoro therapy to the mother.

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.

No postmarketing experience to date - until first undesirable effect from post-marketing spontaneous reporting.

Reporting suspected adverse reactions.

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 http://www.tga.gov.au/reporting-problems.

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.

Velphoro contains a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water and the phosphate ions throughout the physiological pH range of the gastrointestinal tract.
Serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption.

Clinical trials.

A randomised, open label, active controlled dose ranging phase 2 study over 6 weeks was performed in 154 patients on haemodialysis. Out of these, 128 patients received fixed dosages of Velphoro, whereas 26 patients were on the comparator drug (sevelamer hydrochloride). Velphoro was shown to be pharmacologically active from 1000 mg iron/day to 2500 mg iron/day with significant dose dependent serum phosphorus lowering effects. The 250 mg iron/day dose was ineffective. Velphoro doses of 1000 or 1500 mg iron/day appeared to be comparable to sevelamer hydrochloride 4800 mg iron/day in lowering serum phosphorus. There were no patient reported dose limiting treatment emergent adverse events (AEs). Mean changes in iron parameters (ferritin, TSAT and transferrin) and vitamins (A, D, E and K) were generally not clinically meaningful and showed no apparent trends across the treatment groups. Velphoro had a similar gastrointestinal AE profile to sevelamer hydrochloride and no dose dependent trend in gastrointestinal events was observed.
One phase 3 clinical study has been performed in patients with chronic kidney disease (CKD) on dialysis to investigate the efficacy and safety of Velphoro in this population. This study was an open label, randomised, active controlled (sevelamer carbonate), parallel group study for up to 55 weeks and included 1055 patients. Adult patients with hyperphosphataemia (serum phosphorus levels ≥ 1.94 mmol/L) were treated with Velphoro at a starting dose of 1000 mg iron/day followed by an 8 week dose titration period. Noninferiority to sevelamer carbonate was determined at week 12. Subjects were continued on their study medication from week 12 to week 55. From week 12 to 24, dose titrations were allowed for both tolerability and efficacy reasons.
In a subpopulation of 93 haemodialysis patients, the Velphoro maintenance dose (1000 to 3000 mg iron/day) was statistically significantly superior in sustaining the phosphorus lowering effect at week 27 (p < 0.001) compared with the noneffective low dose (250 mg iron/day) from week 24 to week 27 (see Table 3).
Mean serum phosphorus levels were 2.5 mmol/L at baseline and 1.8 mmol/L at week 12 for Velphoro (reduction by 0.7 mmol/L). Corresponding levels for sevelamer carbonate at baseline were 2.4 mmol/L and 1.7 mmol/L at week 12 (reduction by 0.7 mmol/L), respectively.
The serum phosphorus reduction was maintained over 52 weeks. Serum phosphorus levels and calcium phosphorus product levels were reduced as a consequence of the reduced dietary phosphate absorption.
The mean daily dose of Velphoro over 52 weeks of treatment was 1650 mg iron (3.3 tablets) and the mean daily dose of sevelamer carbonate was 6960 mg (8.7 tablets). The age, gender, race, or dialysis did not affect the efficacy of Velphoro. See Figure 1.

Post-authorisation data.

A prospective, non-interventional, post-authorisation safety study (VERIFIE) has been conducted, evaluating the short- and long-term (up to 36 months) safety and effectiveness of Velphoro in adult patients on haemodialysis (N=1,198) or peritoneal dialysis (N=160), who were followed in routine clinical practice for 12 to 36 months (safety analysis set, N=1,365). During the study, 45% (N=618) of these patients were concomitantly treated with phosphate binder(s) other than Velphoro. The mean duration of the observation period was 60 weeks and the mean duration of Velphoro therapy was 59.3 weeks.
In the safety analysis set, the most common ADRs were diarrhoea and discoloured faeces, reported by 14% (N=194) and 9% (N=128) of patients, respectively. The incidence of diarrhoea was highest in the first week and decreased with duration of use. Diarrhoea was of mild to moderate intensity in most patients and resolved in the majority of patients within 2 weeks. Discoloured (black) faeces is expected for an oral iron-based compound, and may visually mask gastrointestinal bleeding. For 4 of the 40 documented concomitant gastrointestinal bleeding events, Velphoro-related stool discolouration was reported as causing an insignificant delay in diagnosis of gastrointestinal bleeding, without affecting patient health. In the remaining cases, no delay in diagnosis of gastrointestinal bleeding has been reported.
The results from this study showed that the effectiveness of Velphoro in a real-life setting (including concomitant use of other phosphate binders in 45% of patients), was in line with that observed in the phase 3 clinical study.

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.

The active moiety of Velphoro, pn-FeOOH, is practically insoluble and therefore not absorbed. Its degradation product, mononuclear iron species, can however be released from the surface of pn-FeOOH and be absorbed.
The iron uptake from radiolabelled Velphoro drug substance, 2000 mg iron in 1 day was investigated in 16 CKD patients (8 predialysis and 8 haemodialysis patients) and 8 healthy volunteers with low iron stores (serum ferritin < 100 microgram/L). In healthy subjects, the median uptake of radiolabelled iron in the blood was 0.43% on day 21. In chronic kidney disease patients, the median uptake was minimal, 0.04% on day 21. Blood levels of radiolabelled iron were very low and confined to the erythrocytes.

Distribution.

Due to the insolubility and degradation characteristics of Velphoro, no classical pharmacokinetic studies can be carried out. Therefore, there is no data to determine the distribution of the drug.

Metabolism.

The active moiety of Velphoro, pn-FeOOH, is not metabolised. However, the degradation product of Velphoro, mononuclear iron species, can be released from the surface of polynuclear iron(III)-oxyhydroxide and be absorbed. Clinical studies have demonstrated that the systemic absorption of iron from Velphoro is low.
In vitro data suggest that the sucrose and starch components of the drug substance can be digested to glucose and fructose, and maltose and glucose, respectively. These compounds can be absorbed in the blood.

Excretion.

In animal studies with rats and dogs administered 59Fe-Velphoro drug substance orally, radiolabelled iron was recovered in the faeces but not the urine.

5.3 Preclinical Safety Data

Genotoxicity.

Nonclinical data reveal no special hazard for humans based on conventional studies of genotoxicity.

Carcinogenicity.

Carcinogenicity studies were performed in mice and rats. There was no clear evidence of a carcinogenic effect in mice. Mucosal hyperplasia, with diverticulum/ cyst formation was observed in the colon and caecum of mice after 2 years treatment, but no diverticula/ cysts were seen in long-term studies in rats or dogs.
In rats only mucosal hyperplasia in the large intestine was seen. There was a slightly increased incidence of benign C-cell adenoma in the thyroid of male rats at 12 times the maximum clinical dose that is most likely an adaptive response to the pharmacological effect of Velphoro.

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.

Mixture of polynuclear iron(III)-oxyhydroxide, sucrose, pregelatinised maize starch and potato starch.
Molecular formula: pn-FeOOH + x C12H22O11 + y (C6H10O5)n.

CAS number.

12134-57-5.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes