SUMMARY CMI

Funnel Web Spider 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 Funnel Web Spider Antivenom?

Funnel Web Spider Antivenom contains the active ingredient funnel-web spider antivenom (rabbit). Funnel Web Spider Antivenom is given to those people who become ill from venom after being bitten by a funnel web spider.

For more information, see Section 1. Why am I using Funnel Web Spider Antivenom? in the full CMI.

2. What should I know before being given Funnel Web Spider 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 Funnel Web Spider Antivenom? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Funnel Web Spider 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 Funnel Web Spider Antivenom given?

• The dose for both adults and children is the contents of two vials (125 units X 2 vials = 250 units). This dose can be repeated as necessary.

More instructions can be found in Section 4. How is Funnel Web Spider Antivenom given? in the full CMI.

5. What should I know while being given Funnel Web Spider Antivenom?

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

6. Are there any side effects?

Common side effects may include: allergic reactions, rash and hives.

If you experience the following serious side effects, tell your doctor immediately:

• 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

Funnel Web Spider Antivenom

Active ingredient(s): funnel-web spider antivenom (rabbit)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Funnel Web Spider 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 Funnel Web Spider Antivenom.

Where to find information in this leaflet:

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

1. Why am I using Funnel Web Spider Antivenom?

Funnel Web Spider Antivenom contains the active ingredient funnel web spider antivenom (rabbit). Funnel Web Spider Antivenom is a spider antivenom and is an injection designed to help neutralise the effect of the poison (venom) of the funnel web spider.

Funnel Web Spider Antivenom is used to treat people who become ill after being bitten by a funnel web spider.

2. What should I know before being given Funnel Web Spider Antivenom?

Warnings

Funnel Web Spider Antivenom should not be given if:

• You do not have any ill effects from the spider bite. 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
• have allergies to any other medicines
• have allergies to any other substances such as foods, preservatives or dyes
• have ever received an injection containing rabbit serum
• have ever had an injection of Funnel Web Spider 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 Funnel Web Spider Antivenom.

4. How is Funnel Web Spider Antivenom given?

How much is given

The dose for both adults and children is the contents of two vials (125 units X 2 vials = 250 units). This dose can be repeated as necessary.

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

When is Funnel Web Spider Antivenom given

Funnel Web Spider Antivenom should only be given when you become ill after being bitten by a funnel web spider.

How is Funnel Web Spider Antivenom given

This medicine is injected slowly into a vein. As the vials contain a dry powder, it is first necessary to dissolve the powder in sterile water and then inject the solution. The vial can be gently swirled to help the powder dissolve.

Funnel Web Spider Antivenom does not contain any antimicrobial preservative. It should be used once and any residue discarded.

5. What should I know while being given Funnel Web Spider 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 the 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 rabbit serum, side effects occur more commonly in those who have allergies, particularly if they have ever had injections before which were also prepared from rabbits. 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

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 Funnel Web Spider Antivenom contains

What Funnel Web Spider Antivenom looks like

Funnel Web Spider Antivenom is a freeze dried powder contained in a vial. The contents of the vial are dissolved in sterile water before use. After adding water, the solution is colourless. The solution's clarity (clearness) can range from clear to slightly milky.

AUST R 31847.

Who distributes Funnel Web Spider Antivenom

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

This leaflet was prepared in July 2021.

Published by MIMS December 2021

1 Name of Medicine

Funnel web spider antivenom (rabbit) as active ingredient.

2 Qualitative and Quantitative Composition

Funnel Web Spider Antivenom is prepared from the plasma of rabbits immunised with the venom of the male Sydney funnel web spider (Atrax robustus). Each vial of the product contains 125 units of antivenom as approximately 100 mg immunoglobulin which has been standardised to neutralise 1.25 mg of funnel web spider venom. Once reconstituted, the product also contains 81 mg glycine, 69 mg sodium chloride, 9 mg dibasic sodium phosphate and 3 mg monobasic sodium phosphate dihydrate per vial. Each vial contains ≤ 810 mg of plasma protein of rabbit origin.

3 Pharmaceutical Form

Funnel Web Spider Antivenom is a freeze dried powder for reconstitution for intravenous injection (125 U). Pre-reconstitution it is a white, freeze dried powder in a glass vial. Post-reconstitution it is a clear to slightly opalescent, colourless solution.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a funnel web spider.

4.2 Dose and Method of Administration

The dose of Funnel Web Spider Antivenom is dependent on the extent of envenoming. The recommended initial dose is 2 vials of Funnel Web Spider Antivenom. Each vial is reconstituted with 10 mL of Water for Injections BP. Gently swirl to ensure the product is fully dissolved; the vial may be inverted to assist dissolution. A clear to slightly opalescent colourless solution is typically obtained within 10 minutes. After complete dissolution the product must be used immediately. Funnel Web Spider Antivenom should be administered by slow intravenous injection.
The dose is the same for both adults and children.
Before giving the injection 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).
The patient should receive the antivenom in an intensive care unit if possible and always in a setting where resuscitation facilities are immediately available.
Should an anaphylactic reaction occur, cease administration of antivenom and implement treatment measures immediately according to an appropriate protocol or guideline.
It may occasionally be necessary to treat both envenoming and anaphylaxis simultaneously.
If the effects of the venom have not been completely reversed, the dose of antivenom may be repeated in 15 minutes, providing it is safe to do so. In a few cases, further doses may be needed.
A proportion of people bitten by funnel web spiders have symptoms that are so mild that antivenom is not necessary. It is estimated that the proportion of those bitten by funnel web spiders who become seriously ill is between 1 in 5 and 1 in 10. First aid with pressure bandaging and immobilisation tends to delay the onset of the illness and may allow local detoxification. Removal of the bandage may precipitate the onset of symptoms and signs of envenoming.
The patient should be observed for signs of envenoming for at least four hours after being bitten or after removing the pressure bandage before a decision is made not to administer the antivenom.
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.
Funnel Web Spider 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 with the potential for serious toxic effects. (See Section 4.4 Special Warnings and Precautions for Use for use of Funnel Web Spider 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.
If the patient has received effective first aid (firm bandaging and a splint), symptoms and signs of envenoming may not become apparent until removal of the bandage but may then develop rapidly.
Removal of the bandage and splint may precipitate the systemic effects of the venom in patients who have been bitten.
These typically consist of severe local pain, nausea, vomiting, abdominal pain, profuse sweating, salivation, lachrymation and severe dyspnoea. Mental confusion leading to coma may occur as well as hypertension and pulmonary oedema. Local and general fasciculation of muscles is usually present.
A proportion of people bitten by funnel web spiders have symptoms that are so mild that antivenom is not necessary.
The patient should be observed for signs of envenoming for at least four hours after being bitten or after removing the pressure bandage before a decision is made not to administer the antivenom.
As systemic effects of the venom can occur rapidly it may be necessary to urgently commence appropriate treatment including antivenom administration.
As this product is prepared from animal serum, severe allergic reactions may follow, including anaphylactic shock, though this is uncommon. Adrenaline must be available during antivenom therapy and prepared ready for use prior to antivenom administration. Anaphylactoid reactions are more likely to occur in those who are atopic or who have previously received rabbit serum.
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.
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 envenomation and anaphylaxis.
Severe cases of systemic envenoming should be managed in an intensive care unit.
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.

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 a 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 post approval use of Funnel Web Spider Antivenom. 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 Poisons Information Centre on 131 126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

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

Funnel Web Spider Antivenom should be protected from light and stored below 8°C (Refrigerate). The reconstituted product must be used immediately.

6.5 Nature and Contents of Container

Funnel Web Spider Antivenom is supplied in a single clear glass vial.
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