SUMMARY CMI

Box Jellyfish Antivenom

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 Box Jellyfish Antivenom?

Box Jellyfish Antivenom contains the active ingredient box jellyfish antivenom (ovine). Box Jellyfish Antivenom is given to patients who become ill or who have extreme pain that does not respond to pain killer medications after being stung by a box jellyfish.

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

2. What should I know before being given Box Jellyfish Antivenom?

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 being given Box Jellyfish Antivenom? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Box Jellyfish Antivenom 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 is Box Jellyfish Antivenom given?

• The dose for both adults and children is one vial (20,000 units). The dose can be repeated as necessary.

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

5. What should I know while being given Box Jellyfish Antivenom?

For more information, see Section 5. What should I know while being given Box Jellyfish Antivenom? in the full CMI.

6. Are there any side effects?

Common side effects include allergic reactions, rash and hives.

Tell your doctor immediately if you notice any of the following:

• sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
• rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting
• pinkish, itchy swellings on the skin, also called hives or nettle rash
• fever, swelling, skin rash, joint pains and swelling of the glands in the neck, armpit or groin, anytime up to two weeks after the injection.

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

Box Jellyfish Antivenom

Active ingredient(s): box jellyfish antivenom (ovine)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Box Jellyfish Antivenom. 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 Box Jellyfish Antivenom.

Where to find information in this leaflet:

1. Why am I using Box Jellyfish Antivenom?
2. What should I know before being given Box Jellyfish Antivenom?
3. What if I am taking other medicines?
4. How is Box Jellyfish Antivenom given?
5. What should I know while being given Box Jellyfish Antivenom?
6. Are there any side effects?
7. Product details

1. Why am I using Box Jellyfish Antivenom?

Box Jellyfish Antivenom contains the active ingredient box jellyfish antivenom (ovine). Box Jellyfish Antivenom is Box Jellyfish Antivenom is an injection designed to help neutralise the effect of the poison (venom) of the box jellyfish.

Box Jellyfish Antivenom is given to people who become ill after being stung by a box jellyfish. It is also used in those people who have severe pain from the stings which cannot be controlled with pain relieving medicines.

2. What should I know before being given Box Jellyfish Antivenom?

Warnings

Do not use Box Jellyfish Antivenom if:

• You do not have any ill effects or have extreme pain that does not respond to pain killer medications after being stung by a box jellyfish.

Always check the ingredients to make sure you can use this medicine although it can be an emergency, life-saving product and should not be withheld from anyone who needs it.

Check with your doctor if you:

• have any other medical conditions especially the following: asthma, hayfever
• take any medicines for any other condition.
• take any medicines for any other condition
• have allergies to any other medicines
• have allergies to any other substances such as foods, preservatives or dyes
• have ever received injection containing sheep serum.
• have ever received injection of Box Jellyfish Antivenom.

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.

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.

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

4. How is Box Jellyfish Antivenom given?

How much is given

The dose for both adults and children is one vial (20,000 units). The dose can be repeated as necessary.

Your doctor will take precautions to counteract any allergic reactions if they should happen.

When is Box Jellyfish Antivenom given

• Box Jellyfish Antivenom should be only given to those people who become ill or have extreme pain that does not respond to pain killer medications after being stung by a box jellyfish.

How is Box Jellyfish Antivenom given

Usually, this medicine is diluted and given slowly as a drip into a vein. In situations where it is not possible to inject the antivenom into a vein, the contents of 3 vials may be injected into 3 different places in muscles on the body.

Box Jellyfish antivenom does not contain any antimicrobial preservative. It should be used once and any residue discarded.

5. What should I know while being given Box Jellyfish Antivenom?

When medicines are produced in animals and injected into you, it is always possible that viruses or other substances could be present in the medicine and cause an illness. These could be viruses or other infectious agents which may not yet have been discovered. In the past, there have been no reports of this ever having happened with this product.

If you have any queries about any aspect of this medicine, or questions regarding information in this leaflet, discuss them with your doctor or pharmacist.

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.

As the antivenom is made from sheep serum, side effects occur more commonly in those who have allergies, particularly if they have ever had injections before which were also prepared from sheep. Allergic reactions can be treated by your doctor.

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

Serious side effects

These may be serious side effects. You may need urgent 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.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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 Box Jellyfish Antivenom contains

What Box Jellyfish Antivenom looks like

Box Jellyfish Antivenom is a clear, straw coloured, viscous solution in a clear glass vial.

AUST R 74891.

Who distributes Box Jellyfish Antivenom

Seqirus Pty Ltd
ABN 26 160 735 035
63 Poplar Road
Parkville 3052
Victoria
Australia

This leaflet was prepared in June 2021.

Published by MIMS December 2021

1 Name of Medicine

Box Jellyfish Antivenom (ovine) as active ingredient.

2 Qualitative and Quantitative Composition

Box Jellyfish Antivenom is prepared from the plasma of sheep immunised with the venom of the box jellyfish (Chironex fleckeri). Each vial contains 20,000 units of antivenom. The product also contains phenol 2.2 mg, sodium chloride 8 mg, water for injections to 1 mL in an aqueous solution. Each vial contains ≤ 100 mg per mL of plasma protein of ovine origin. The product volume is potency dependant thus it varies from batch to batch. Please refer to the product volume printed on the carton.

3 Pharmaceutical Form

Box Jellyfish Antivenom is a solution for injection (20,000 U). It is a clear to opalescent, straw coloured, viscous solution in a clear glass vial.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of patients who exhibit manifestations of systemic envenoming or who have extensive local involvement causing extreme pain which does not respond to routine analgesic therapy.

4.2 Dose and Method of Administration

Not everyone who is stung by a box jellyfish needs antivenom. In cases of severe systemic envenoming, cardiopulmonary resuscitation and other appropriate first aid measures recommended by local guidelines must be instituted when necessary before giving antivenom. Antivenom should be administered as soon as possible after resuscitation has commenced. Ideally this will be in an intensive care facility.
The contents of one vial (20,000 units) should be administered slowly by intravenous infusion after dilution with an intravenous solution such as Hartmann's solution or 0.9% w/v sodium chloride. The dose is the same for both adults and children.
The antivenom should be diluted 1 in 10, although a dilution of 1 in 5 may be more appropriate for patients at risk of fluid overload. Seek expert advice regarding dilution of antivenom to avoid fluid overload, as required.
In the past, some authorities have advocated premedication with 0.25 mL of 1:1,000 adrenaline subcutaneously and intravenous antihistamine to reduce the chance of anaphylactic shock, particularly in those patients who are known to be at risk, but such use is controversial (see Section 4.4 Special Warnings and Precautions for Use).
If intravenous administration is not practical, 3 vials should be given undiluted by the intramuscular route at 3 separate sites.
The aim of antivenom therapy is to neutralise the venom. Sufficient antivenom must be given to combat the effects of the venom. Lack of response to the antivenom may indicate that treatment is inadequate and more antivenom may be required.
The patient must be monitored for at least 6 hours after conclusion of the antivenom infusion.
Before starting the infusion of antivenom, adrenaline should be prepared ready to use, as anaphylactic reactions can occur rapidly (see Section 4.4 Special Warnings and Precautions for Use).
Should an anaphylactic reaction occur, suspend administration of antivenom and implement treatment measures immediately according to an appropriate protocol or guideline.
As delayed serum sickness is relatively common following the use of large volumes of foreign protein, patients who have received antivenom should be advised of the symptoms of serum sickness and warned to seek urgent medical attention if such symptoms develop. It may occasionally be necessary to treat both envenoming and anaphylaxis simultaneously. Box Jellyfish Antivenom contains no antimicrobial preservative. Use in one patient on one occasion only and discard any residue.

4.3 Contraindications

There are no absolute contraindications, but the product should not be used unless there is clear evidence of systemic envenoming or extensive local involvement with intractable pain.
See Section 4.4 Special Warnings and Precautions for Use for use of Box Jellyfish Antivenom in patients with a known allergy.

4.4 Special Warnings and Precautions for Use

When medicinal products prepared from animal plasma are administered, infectious diseases due to the transmission of infective agents cannot be totally excluded. This applies to pathogens of hitherto unknown origin. This possibility must always be considered and should be conveyed, whenever possible, to patients who may receive the product. Historically there have been no known recorded cases of transmission of viruses by this product.
Most stings from box jellyfish are not life threatening although the initial pain following tentacle contact may be severe. Severe envenoming following extensive tentacle contact over one or more limbs can cause death within 20 minutes.
In serious cases of envenoming, cessation of respiration and cardiac arrest can occur very soon after the sting. In these cases it is essential to immediately initiate cardiopulmonary resuscitation and other appropriate first aid measures recommended by local guidelines, before commencing antivenom therapy.
Severe cases of systemic envenoming should be managed in an intensive care unit.
As this product is prepared from animal plasma, severe allergic reactions may follow, including anaphylactic shock. Adrenaline must be available during antivenom therapy and prepared ready for use prior to antivenom administration. Anaphylactic reactions may be more likely to occur in those who are atopic or have previously received ovine plasma. In the past, some authorities have advocated premedication with subcutaneous adrenaline and intravenous antihistamine, particularly in those patients who are known to be at risk, but such use is controversial.
The results of skin testing to determine patients who may have an allergic reaction are not satisfactory and should not be undertaken.
Antivenoms may bind complement and produce an anaphylactoid reaction in patients who have had no previous contact with ovine protein.
The risk of such a reaction can be reduced by adequate dilution of the antivenom prior to infusion, although care should be taken to avoid fluid overload (see Section 4.2 Dose and Method of Administration).
Should anaphylaxis occur, suspend administration of antivenom, and implement treatment measures immediately, according to an appropriate protocol or guideline. Further administration of antivenom should be considered in the light of the relative problems of envenoming and anaphylaxis.
Delayed serum sickness can occur following the use of animal derived antivenoms. The most common manifestations include fever, cutaneous eruptions, arthralgia, lymphadenopathy and albuminuria. Less commonly, arthritis, nephritis, neuropathy and vasculitis can occur. The condition can appear days or weeks after the use of antivenom but can occur as soon as 12 hours after a second injection of a similar animal protein. Patients should be advised of the symptoms of serum sickness and warned to seek urgent medical attention if such symptoms develop.
The incidence of serum sickness is greater with larger volumes of antivenom.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

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 person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions, presented below according to system organ class and frequency, have been identified during postapproval use of CSL antivenoms. Adverse event frequencies are defined as follows.
Very common: ≥ 1/10; common: ≥ 1/100 and < 1/10; uncommon: ≥ 1/1000 and < 1/100; rare: ≥ 1/10,000 and < 1/1000; and very rare: < 1/10,000.

Immune system disorders.

Skin and subcutaneous tissue disorders.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No specific information is available on absorption, distribution, metabolism or excretion of antivenom.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

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.

6.4 Special Precautions for Storage

Box Jellyfish Antivenom should be protected from light and stored between 2 to 8°C. Refrigerate. Do not freeze.

6.5 Nature and Contents of Container

Box Jellyfish Antivenom is available in clear glass vials.
The vial and all associated components do not contain natural rubber latex.

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

Not applicable.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes