Consumer medicine information

Funnel Web Spider Antivenom

Funnel web spider antivenom

BRAND INFORMATION

Brand name

Funnel Web Spider Antivenom

Active ingredient

Funnel web spider antivenom

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Funnel Web Spider Antivenom.

What is in this leaflet

This leaflet answers some common questions about Funnel Web Spider 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 Funnel Web Spider 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 Funnel Web Spider Antivenom is used for

What it is used for

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

Not everyone who is bitten needs the antivenom as some people have only very mild effects from the bite or none at all. However some people can become very ill after being bitten and in these people it is essential to use an appropriate amount of antivenom to counteract the effects of the poison.

How it works

Funnel Web Spider Antivenom is an injection designed to help neutralise the effect of the poison (venom) of the funnel web spider.

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

The antivenom is then purified and made into an injection for people who may need it after being bitten by a funnel web spider.

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

Before you are given Funnel Web Spider 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 bite.

However as Funnel Web Spider 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.
  1. you have, or have had any medical conditions, especially the following:
  • asthma
  • hayfever.
  1. you have ever received an injection containing rabbit serum.
  2. you have ever had an injection of Funnel Web Spider Antivenom.
  3. 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 Funnel Web Spider Antivenom.

How Funnel Web Spider Antivenom is 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.

How it is 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.

After having 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 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 Funnel Web Spider 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 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.

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 Funnel Web Spider Antivenom

Funnel Web Spider 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. After it has been mixed with water it must be used straight away.
  • Keep it in the refrigerator, below 8°C and protect it from light.

Do not use Funnel Web Spider Antivenom after the expiry date printed on the pack.

Do not use Funnel Web Spider Antivenom if the packaging is torn or shows signs of tampering.

Product description

What it looks like

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

Ingredients

Active ingredient:

  • 125 units of Funnel Web Spider Antivenom.

Other ingredients:

  • glycine
  • sodium chloride
  • dibasic sodium phosphate
  • monobasic sodium phosphate dihydrate.

This product also contains substances from rabbit blood.

Funnel Web Spider Antivenom does not contain latex.

Name and Address of Sponsor

Funnel Web Spider 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 31847.

This leaflet was prepared in June 2019.

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Funnel Web Spider Antivenom

Active ingredient

Funnel web spider antivenom

Schedule

S4

 

1 Name of Medicine

Funnel web spider antivenom (rabbit) as active ingredient.

6.7 Physicochemical Properties

Not applicable.

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.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Funnel Web Spider Antivenom is a purified immunoglobulin (mainly immunoglobulin G), derived from rabbit plasma, which contains specific antibodies against the toxic substances in the venom of the Sydney funnel web spider, Atrax robustus.
There is evidence to show that the antivenom is effective in the treatment of patients bitten by some other funnel web spiders of the Hadronyche genus.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties


5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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.

4.3 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.

No data available.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
There is no information on the use of this product in pregnant women. It is advisable to carefully weigh the risks of untreated envenoming against the expected benefits and potential risks of antivenom administration.
No information is available on the use of the product during lactation. It is advisable to carefully weigh the risks of untreated envenoming against the expected benefits and potential risks of antivenom administration.

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.

Common: allergic reactions including anaphylactic shock and delayed serum sickness.

Skin and subcutaneous tissue disorders.

Common: urticaria, rash.

Reporting suspected adverse effects.

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.

4.2 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.

4.7 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.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

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.

Summary Table of Changes