SUMMARY CMI

VENOFER^®

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 VENOFER?

VENOFER provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency. For more information, see Section 1. Why am I using VENOFER? in the full CMI.

2. What should I know before I use VENOFER?

Do not use if you have ever had an allergic reaction to VENOFER 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 VENOFER? in the full CMI.

3. What if I am taking other medicines?

Some medicines, such as iron tablets and VENOFER may interfere with each other. 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 VENOFER?

Your doctor or nurse will prepare this medicine for you. VENOFER is a sterile solution which is diluted immediately before use. It is given by intravenous infusion or by slow injection into the venous limb of the dialysis line for haemodialysis patients. More instructions can be found in Section 4. How do I use VENOFER? in the full CMI.

5. What should I know while using VENOFER?

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

6. Are there any side effects?

The common side effects include dizziness, temporary change in taste, injection site reactions (such as pain, irritation, discolouration, burning, swelling or bruising). Serious side effects include rapid, shallow breathing, cold and clammy skin, chest pain, weakness and fainting, weak rapid pulse, convulsions, facial swelling and difficulty in breathing.

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

VENOFER^®

Active ingredient: iron sucrose

Consumer Medicine Information (CMI)

This leaflet provides important information about using VENOFER. 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 VENOFER.

Where to find information in this leaflet:

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

1. Why am I using VENOFER?

VENOFER contains the active ingredient iron sucrose.

VENOFER provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency. Ask your doctor if you have any questions about why VENOFER has been prescribed for you.

This medicine is only available with a doctor's prescription. There is no evidence that it is addictive.

2. What should I know before I use VENOFER?

Warnings

Do not use VENOFER if:

• you are allergic to iron sucrose or any of the ingredients listed at the end of this leaflet.
• your anaemia is not due to a shortage of iron
• you are in the first trimester of a pregnancy
• you have a condition known as haemo-chromatosis (an excess of iron in the body) or a genetic tendency towards this condition.

Check with your doctor if you:

• or a blood relative have the condition known as haemochromatosis
• have an infection
• have liver disease

You should be aware that:

• a blood test should have been carried out to ensure treatment with this medicine is appropriate
• if you have a history of asthma, eczema or other atopic allergies you are more susceptible to experience allergic reactions
• intravenous iron preparations can cause severe allergic reactions. These allergic reactions may include chest pain. Tell your doctor immediately if you experience it.

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

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.

You should be aware that:

• slow heartbeat may occur in unborn babies whose mothers have been administered intravenous iron due to allergic reactions in the mother.

Use in children

The safety and efficacy of VENOFER in children has not been established.

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, such as iron tablets and VENOFER may interfere with each other.

These medicines may be affected by VENOFER or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines.

Your doctor has more information on medicines to be careful with or avoid while being given this medicine.

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

4. How do I use VENOFER?

How much to take

Your doctor will decide what dose and for how long you will receive VENOFER. This depends on your response to the treatment. Your doctor may change the dose and frequency of your medicine as your condition changes.

How to take

• Your doctor or nurse will prepare this medicine for you.
• VENOFER is a sterile solution which is diluted immediately before use. It is given by intravenous infusion or by slow injection into the venous limb of the dialysis line for haemodialysis patients.
• It must not be given by intramuscular or subcutaneous injection.

If you are given too much VENOFER

As VENOFER is given to you under the supervision of your doctor, it is very unlikely that you will be given an overdose.

If you think that you have been given too much, you may need urgent medical attention.

You should immediately:

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

Things you must do

• Your doctor may order regular blood tests while you are receiving VENOFER in order to monitor your iron levels.

Call your doctor straight away:

• If you experience any side effects after being given VENOFER

Remind any doctor, dentist or pharmacist you visit that you are using VENOFER as it may interact with other medicines or anaesthetics they may use.

Driving or using machines

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

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Normally, your doctor will get VENOFER from the hospital pharmacy or their consulting rooms. However, if for any reason you take this medicine from the pharmacy to your doctor, it is important to store it in a safe place, away from heat and light, where the temperature stays below 25°C.
• The product should not be frozen.
• Once the ampoules have been opened, they should be used immediately.

Keep it where young children cannot reach it.

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.

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

Serious side effects

Tell your doctor, nurse, or pharmacist if you notice anything else that may be making you feel unwell while you are being given VENOFER, even if you think the problems are not connected with this medicine and are not referred to in this leaflet.

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 VENOFER contains

Venofer does not contain lactose, sucrose, gluten, tartrazine or any azo dyes.

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

What VENOFER looks like

VENOFER is a sterile dark brown, non-transparent aqueous solution contained in a 5 mL glass ampoule. Available in packs of 5 ampoules.

Australian registration number: AUST R 98236

Who distributes VENOFER

VENOFER is supplied in Australia by:
Vifor Pharma Pty Ltd
655 Elizabeth Street
Melbourne VIC 3000
Australia
Ph: 1800 202 674

New Zealand distributor:
Pharmacy Retailing (NZ) Limited
trading as Healthcare Logistics
Auckland, New Zealand

This leaflet was prepared in September 2023.

Published by MIMS November 2023

1 Name of Medicine

Iron sucrose.

2 Qualitative and Quantitative Composition

Each Venofer 5 mL ampoule contains 20 mg/mL iron as iron sucrose (iron (III) hydroxide sucrose complex) as the active ingredient corresponding to 100 mg iron per 5 mL ampoule.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concentrated injection for intravenous use.
Venofer is a dark brown, non-transparent, aqueous solution with a pH of 10.5-11.0 and an osmolarity of 1250 mOsmol/L.

4 Clinical Particulars

4.1 Therapeutic Indications

Venofer is indicated for the treatment of iron deficiency anaemia in patients undergoing chronic haemodialysis and who are receiving supplemental erythropoietin therapy.
The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. serum ferritin, serum iron, transferrin saturation and hypochromic red cells).

4.2 Dose and Method of Administration

The dosage of Venofer is expressed in terms of mg of iron. Each mL contains 20 mg of iron.
Since a test dose without incident does not indicate that subsequent doses will also be reaction free, test doses may still be carried out but are not required.

Treatment of iron deficiency in haemodialysis patients receiving erythropoietin.

Method of administration.

Intravenous drip infusion.

Injection into venous line of dialysis machine.

4.3 Contraindications

The use of Venofer is contraindicated in the following conditions:
hypersensitivity to iron sucrose, Venofer or to any of its excipients listed in Section 6.1 List of Excipients;
anaemia not caused by iron deficiency;
iron overload or disturbances in utilisation of iron;
known haemochromatosis or genetic tendency to haemochromatosis;
pregnancy first trimester.

4.4 Special Warnings and Precautions for Use

Because body iron excretion is limited and excess tissue iron can be hazardous, caution should be exercised to withhold iron administration in the presence of evidence of tissue iron overload. Patients receiving Venofer require periodic monitoring of hematologic and hematinic parameters (haemoglobin, haematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of iron overload. Transferrin saturation values increase rapidly after IV administration of iron sucrose; thus, serum iron values may be reliably obtained 48 hours after IV dosing.
Parenterally administered iron preparations can cause allergic or anaphylactoid reactions, which can be potentially fatal. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction). Therefore, antiallergic treatment should be available along with cardiopulmonary resuscitation facilities and procedures. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes including iron sucrose. Each patient should be observed for adverse effects for at least 30 minutes following each Venofer injection.
There are no data on the safety of Venofer when used in patients who are allergic to iron polymaltose.
In patients with a history of asthma, eczema, other atopic allergies or allergic reactions to other parenteral iron preparations, Venofer should be administered with caution as these patients may be particularly at risk of an allergic reaction.
In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor. Careful monitoring of iron status is recommended to avoid iron overload.
Parenteral iron should be used with caution in the case of acute or chronic infection. It is recommended that the administration of Venofer is stopped in patients with bacteraemia. In patients with chronic infection, a risk/benefit evaluation should be performed.
Hypotension has been reported frequently in hemodialysis patients receiving intravenous iron. Hypotension following administration of Venofer may be related to rate of administration and total dose administered.
Caution should be taken to administer Venofer according to recommended guidelines (see Section 4.2 Dose and Method of Administration).
Care must be taken to avoid paravenous infiltration. If this occurs, the infusion of Venofer should be discontinued immediately. Ice may be applied to cause local vasoconstriction and decrease fluid absorption; massage of the area should be avoided.
Paravenous leakage must be avoided because leakage of Venofer at the injection site may lead to pain, inflammation, sterile abscess and brown discolouration of the skin.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

As with all parenteral iron preparations, Venofer should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced. Therefore, oral iron therapy should be discontinued 24 hours prior to the first injection of iron sucrose and should not be started within 5 days after the last injection of iron sucrose.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Venofer is unlikely to influence the ability to drive or use machines.
However, if symptoms such as dizziness, confusion or lightheadedness occur following the administration of Venofer, affected patients should not drive a car or use machines until the symptoms have abated.

4.8 Adverse Effects (Undesirable Effects)

The most frequently reported adverse drug reactions (ADRs) of Venofer in clinical trials were transient taste perversion, hypotension, fever and shivering, injection site reactions and nausea, occurring 0.5 to 1.5% of the patients. Non-serious hypersensitivity reactions occurred rarely.
In general, hypersensitivity reactions are potentially the most serious adverse reactions (see Section 4.4 Special Warnings and Precautions for Use). In pregnancy, foetal bradycardia associated to hypersensitivity in the mother may occur with parenteral iron preparations (see Section 4.6 Fertility, Pregnancy and Lactation).
Table 1 summarises the adverse drug reactions that have been reported in temporal relationship with the administration of Venofer, with at least a possible causal relationship.

Reporting suspected adverse reactions.

4.9 Overdose

Overdose can cause iron overload which may manifest itself as haemosiderosis.
Overdosage should be treated with supportive measures and, if required, an iron chelating agent.
For the information of the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

In healthy adults treated with intravenous doses of Venofer, its iron component exhibits first order kinetics with an elimination half-life of 6 h, total clearance of 1.2 L/h, nonsteady-state apparent volume of distribution of 10.0 L and steady-state apparent volume of distribution of 7.9 L. Since iron disappearance from serum depends on the need for iron in the iron stores and iron utilising tissues of the body, serum clearance of iron is expected to be more rapid in iron deficient patients treated with Venofer as compared to healthy individuals. The effects of age and gender on the pharmacokinetics of Venofer have not been studied.
The iron sucrose complex is not dialyzable through CA 210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. In in vitro studies, the amount of iron sucrose in the dialysate fluid was below the level of detection of the assay (less than 2 parts per million).

Distribution.

Metabolism and excretion.

5.3 Preclinical Safety Data

Carcinogenicity.

Genotoxicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The excipients are water for injections and sodium hydroxide for pH adjustment.

6.2 Incompatibilities

Venofer must not be mixed with other medicinal products except sterile 0.9% m/V sodium chloride (NaCl) solution. There is the potential for precipitation and/or interaction if mixed with other solutions or medicinal products. The compatibility with containers other than glass, polyethylene and PVC is not known.

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 container and after dilution with sterile 0.9% m/V sodium chloride (NaCl) solution: from a microbiological point of view, the product should be used immediately.
Contains no antimicrobial agent. Product is for single use in one patient only. Discard any residue.

6.4 Special Precautions for Storage

Store below 25°C. Do not freeze. Store in the original package.

6.5 Nature and Contents of Container

5 mL solution in one ampoule (Type I glass) in pack sizes of 5.

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

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription only medicine).

Summary Table of Changes