Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Box Jellyfish Antivenom.

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 having Box Jellyfish Antivenom against the benefits they expect it will have.

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

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

What Box Jellyfish Antivenom is used for

What it is used for

Box Jellyfish Antivenom is given to those 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.

Before antivenom is given, first aid measures must be used.

Not everyone who is stung needs the antivenom, as small areas of stinging are not usually dangerous even though they are very painful. However, people who have large areas of stinging can become dangerously ill very quickly. In these people CPR (cardiopulmonary resuscitation) and other first aid measures must be given before starting antivenom therapy. In these people it is also essential to use an appropriate amount of antivenom to counteract the effects of the poison.

As Box Jellyfish Antivenom sometimes needs to be given quickly before arrival at hospital, the injection may be given by paramedical personnel such as ambulance officers.

How it works

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

It is made by immunising sheep against the venom of the box jellyfish and then collecting that part of the sheep’s blood which neutralises this poison.

The antivenom is purified and made into an injection for people who may need it after being stung by a box jellyfish.

Ask your doctor if you have any questions about why this medicine has been given to you

Before you are given Box Jellyfish Antivenom

When you must not be given it

As there are sometimes unpleasant and dangerous reactions to the antivenom (see Side Effects), it should not be given to people who have no effects from the sting.

However as Box Jellyfish Antivenom can be an emergency life-saving product, it should not be withheld from anyone who needs it.

Before you are given it

Tell your doctor if:

1. you have allergies to:

• any other medicines
• any other substances such as foods, preservatives or dyes.

2. you have, or have had any medical conditions, especially the following:

• asthma
• hayfever.

3. you have ever received an injection containing sheep serum.
4. you have ever had an injection of Box Jellyfish Antivenom.
5. you are pregnant or you are breast feeding.
   Your doctor can 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 are given Box Jellyfish Antivenom.

How Box Jellyfish Antivenom is 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.

How it is given

Usually, this medicine is diluted and given slowly as a drip into a vein. In situations where it is impossible to inject the fluid into a vein, or when the injection is given by paramedical personnel away from medical help, the contents of 3 vials should be injected into 3 different places in muscles on the outside of the thigh.

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

After having 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after having Box Jellyfish Antivenom. It may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

As the injection 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 in sheep. Allergic reactions can be treated by your doctor.

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

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.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

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

Storing Box Jellyfish Antivenom

Box Jellyfish Antivenom is usually stored in a doctor’s surgery, hospital or ambulance. However, if you need to store it:

• Keep it where children cannot reach it.
• Keep it in the original pack until it is needed.
• Keep it in the refrigerator, between 2°C and 8°C and protect it from light. Do not freeze Box Jellyfish Antivenom.

Do not use Box Jellyfish Antivenom after the expiry date printed on the pack.

Do not use Box Jellyfish Antivenom if the packaging is torn or shows signs of tampering.

Product description

What it looks like

Box Jellyfish Antivenom is supplied in a vial.

Ingredients

Active ingredient:

• 20,000 units of Box Jellyfish Antivenom.

Other ingredients:

• phenol
• sodium chloride
• water for injections

This product also contains substances from sheep blood.

Box Jellyfish Antivenom does not contain latex.

Name and Address of Sponsor

Box Jellyfish Antivenom is sponsored by:

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

The Australian Registration Number is AUST R 74891.

This leaflet was prepared in June 2019.

Published by MIMS October 2019

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