SUMMARY CMI

Red Back 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 Red Back Spider Antivenom?

Red Back Spider Antivenom contains the active ingredient red-back spider antivenom (equine). Red Back Spider Antivenom is given to those people who become ill from venom after being bitten by a red back spider.

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

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

3. What if I am taking other medicines?

Some medicines may interfere with Red Back 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 Red Back Spider Antivenom given?

• The dose for both adults and children is one vial (500 units). This dose can be repeated as necessary.

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

5. What should I know while being given Red Back Spider Antivenom?

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

6. Are there any side effects?

Common side effects may include allergic reactions.

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
• Chest pain
• High temperature

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

Red Back Spider Antivenom

Active ingredient(s): red-back spider antivenom (equine)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Red Back 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 Red Back Spider Antivenom.

Where to find information in this leaflet:

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

1. Why am I using Red Back Spider Antivenom?

Red Back Spider Antivenom contains the active ingredient red back spider antivenom (equine). Red Back Spider Antivenom is an injection designed to help neutralise the effect of the poison (venom) of the red back spider.

Red Back Spider Antivenom is used to treat people who become ill after being bitten by a red back spider.

2. What should I know before being given Red Back Spider Antivenom?

Warnings

Red Back Spider Antivenom should not be given if:

• You do not have any ill effects from the red back 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 any allergies to any other medicines
• have allergies to any other substances such as foods, preservatives or dyes
• have ever received injections made from horse serum (such as snake bite antivenoms, and other antivenoms)
• have ever had an anti-tetanus injection before 1974.

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 Red Back Spider Antivenom.

4. How is Red Back Spider Antivenom given?

How much is given

• The dose for both adults and children is one vial (500 units). This dose can be repeated as necessary.
• Your doctor will take precautions to counteract any allergic reactions if they should happen.

When is Red Back Spider Antivenom given

• Red Back Spider Antivenom should only be given when you become ill after being bitten by a red back spider.

How to is Red Back Spider Antivenom given

• This medicine is usually injected into a muscle, or in life-threatening cases may be diluted and given through a vein.
• Red Back 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 Red Back 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.

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 horse serum, side effects occur more commonly in those who have allergies, particularly if they have ever had injections before which were also prepared from horses. 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.

Less serious 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 Red Back Spider Antivenom contains

What Red Back Spider Antivenom looks like

Red Back Spider Antivenom is a colourless to light straw coloured, slightly viscous, transparent solution in a vial.

AUST R 74893.

Who distributes Red Back Spider 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

Red-back spider antivenom (equine) as active ingredient.

2 Qualitative and Quantitative Composition

Red Back Spider Antivenom is prepared from the plasma of horses immunised with the venom of the female red back spider (Latrodectus hasselti).) Each vial contains 500 units of antivenom which has been standardised to neutralise 5 mg of venom. Each 1 mL of product also contains 2.2 mg phenol, 8 mg sodium chloride and water for injections to 1 mL. Each vial contains ≤ 100 mg per mL of plasma protein of equine 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

Red Back Spider Antivenom (500 U) is a solution for injection available as vials containing 500 units of antivenom in aqueous solution. It is a colourless to light straw coloured, slightly viscous, transparent solution in a vial.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a red back spider (Latrodectus hasselti).

4.2 Dose and Method of Administration

A large proportion of people bitten by red back spiders have symptoms that are so mild that antivenom is not necessary. When there is evidence of severe local and/or systemic envenoming by a red back spider, the contents of one vial (500 units) should be given intramuscularly. The dose is the same for both adults and children.
In cases of life threatening envenoming, the intravenous route may be used. The antivenom is first diluted 1:10 in Hartmann's solution or 0.9% w/v sodium chloride. Seek expert advice regarding dilution of antivenom to avoid fluid overload, as required.

Note.

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 Red Back 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.
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 horse serum. This would include patients who received Tetanus Antitoxin prior to 1974. 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 initial skin testing are not satisfactory and should not be undertaken.
Should anaphylaxis occur, suspend administration of antivenom and implement treatment measures 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.
Severe cases of systemic envenoming should be managed in an intensive care unit. Although the local effects of envenoming (severe pain, erythema, swelling and sweating) may occur in the first hour, severe systemic effects may not occur until 12 hours after the bite.
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, but can be expected to occur in at least 5% of patients receiving horse serum for the first time.

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 Seqirus Red Back 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.

Blood and lymphatic system disorders.

Immune system disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

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

Red Back Spider Antivenom should be protected from light and stored at 2-8°C. Do not freeze.

6.5 Nature and Contents of Container

Red Back Spider Antivenom is available 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