2. What should I know before I use KAVIGALE?
Do not use if you have ever had an allergic reaction to sipavibart or any of the ingredients
listed at the end of the CMI.
Check with your doctor if you have low numbers of blood platelets (which help blood
clotting), any blood clotting problems or are taking a medicine to prevent blood clots
(an anticoagulant).
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.
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.
4. How is KAVIGALE given?
The recommended dose is 300 milligrams (mg).
KAVIGALE is given by your doctor or nurse as an injection into your muscle (usually
the muscle of your thigh) or as an infusion into your vein. The infusion lasts about
6-20 minutes.
5. What should I know while using KAVIGALE?
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Things you should do
|
Remind any healthcare provider that you visit that you are using KAVIGALE.
Contact your doctor right away if you get symptoms of COVID-19.
|
|
Things you should not do
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Do not stop being given KAVIGALE unless you have discussed it with your doctor first.
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|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how KAVIGALE
affects you. It is unlikely that KAVIGALE will affect your ability to drive or use
machines.
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Looking after your medicine
|
Your healthcare provider is responsible for storing this medicine and disposing of
any unused product correctly.
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6. Are there any side effects?
All medicines can have side effects. If you do experience side effects, most of them
are minor and temporary. However, some side effects may be serious and could require
urgent medical attention or hospitalisation.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
Active ingredient(s):
sipavibart
Consumer Medicine Information (CMI)
This leaflet provides important information about using KAVIGALE. 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 KAVIGALE.
Where to find information in this leaflet:
1. Why am I using KAVIGALE?
KAVIGALE contains the active ingredient sipavibart. Sipavibart is a type of protein called a monoclonal antibody. KAVIGALE is a passive
immunisation that works specifically against the SARS-CoV-2 virus by preventing it
from entering human cells. This can help prevent you from getting COVID-19 illness.
KAVIGALE is used for the pre-exposure prophylaxis (prevention) of COVID 19 infection.
It can be given to adults and adolescents aged 12 years and older weighing at least
40 kg who have a weakened immune system caused by a medical condition, or by medicines
or treatments.
KAVIGALE is not recommended as a substitute for vaccination in individuals for whom
COVID-19 vaccination is recommended.
2. What should I know before I use KAVIGALE?
Warnings
Do not use KAVIGALE if:
You are allergic to sipavibart, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any allergies
have low numbers of blood platelets (which help blood clotting)
any blood clotting problems or are taking a medicine to prevent blood clots (an anticoagulant)
have any other medical conditions
are taking, have recently taken or might take any medicines for any other condition.
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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your healthcare provider for advice before receiving this medicine.
Tell your doctor if you are pregnant, or if you might be pregnant. There is not enough
information to be sure that KAVIGALE is safe for use in pregnancy. KAVIGALE will only
be given if the potential benefits of treatment outweigh the potential risks to the
mother and the unborn child.
Talk to your doctor if you are breastfeeding or intend to breastfeed. This is because
it is not yet known whether KAVIGALE passes into human breast milk, or what the effects
might be on the baby or milk production. Your doctor will help you decide whether
to keep breast feeding or to start treatment with this medicine.
Children and adolescents
KAVIGALE should not be given to children under 12 years of age or weighing less than
40 kg.
3. What if I am taking other medicines?
If you are getting a COVID-19 vaccine, tell your doctor, nurse or pharmacist that
you have used or are using KAVIGALE.
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. This is because it is not yet known if this medicine
affects other medicines, or if it is affected by them.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect KAVIGALE.
4. How is KAVIGALE given?
How much KAVIGALE is given
The recommended dose for the prevention of COVID-19 is 300 milligrams (mg).
For continuous prevention of COVID-19 you may need to receive repeat doses of 300
mg KAVIGALE every 3 months.
How will you be given KAVIGALE
KAVIGALE is given by your healthcare provider as an injection into your muscle (usually
the muscle of your thigh) or as an infusion into your vein. The infusion lasts about
6-20 minutes.
Your doctor or nurse will decide how long you will be monitored after you are given
the medicine. This is in case you have side effects.
If you use too much KAVIGALE
As KAVIGALE is given under the close supervision of a healthcare provider it is unlikely
that you will be given too much. If you are concerned that you have been given too
much KAVIGALE, tell your healthcare provider immediately, phone the Poisons Information
Centre (by calling 13 11 26) or go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using KAVIGALE?
Things you should do
Tell any other doctors you see that you have had this medicine to prevent COVID-19.
If you are getting a COVID-19 vaccine, tell the doctor, nurse or pharmacist you have
had this medicine.
COVID-19 is caused by different strains (variants) of the SARS-CoV-2 virus that change
over time. KAVIGALE may be less effective at preventing COVID-19 caused by some strains
than others.
Contact your doctor right away if you get symptoms of COVID-19. COVID-19 affects different
people in different ways:
the most common symptoms include fever, chills, sore throat, cough, tiredness and
loss of taste or smell;
the most serious symptoms include difficulty breathing or shortness of breath, loss
of speech or mobility, or confusion and chest pain.
Call your doctor straight away if you:
notice any signs of a cardiac event, such as:
chest pain
shortness of breath
a general feeling of discomfort, illness, or lack of well-being
feeling lightheaded or faint
notice any signs of an allergic reaction, such as:
difficulty breathing or swallowing
swelling of the face, lips, tongue or throat
severe itching of the skin, with a red rash or raised bumps.
notice any signs of a reaction to the infusion. This could happen immediately or within
a few hours of the infusion. Symptoms may include:
fever and chills
feeling tired or weak
feeling sick (nausea) or vomiting
fast heart rate
chest pain or discomfort
muscle aches
feeling lightheaded or faint.
Driving or using machines
It is unlikely that KAVIGALE will affect your ability to drive or use machines.
Looking after your medicine
Your healthcare provider is responsible for storing this medicine and disposing of
any unused product correctly. The following information is intended for healthcare
professionals.
Do not use this medicine after the expiry date which is stated on the carton and vial
label after EXP. The expiry date refers to the last day of that month.
Unopened vials:
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Do not shake.
Store in the original package in order to protect from light.
Prepared syringes or prepared infusion bags should be used immediately. If necessary,
store the prepared syringes or prepared infusion bags for no more than either:
24 hours at 2°C to 8°C, or
4 hours at room temperature up to 25°C.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
Unused medicine or waste material will be discarded by your healthcare professional.
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.
Patients receiving medicines similar to KAVIGALE have experienced some serious allergic
reactions. See Section
5. What should I know while using KAVIGALE? and the serious side effects table below for the signs of an allergic reaction.
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
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Less serious side effects
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What to do
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Injection site related reactions (near where the injection in the muscle was given).
These can happen within 7 days of the injection and resolve within a few days. Symptoms
may include:
bruising
pain
itching
redness
swelling
blood under the skin
numbness and tingling
rash
discolouration
warm feeling on the skin
discomfort
inflammation
Infusion site related reactions (near where the infusion in the vein was given).
These can happen within 7 days of the infusion and resolve within a few days. Symptoms
may include:
bruising
pain
itching
redness
swelling.
Reactions to the infusion.
These can happen at the time of infusion or within a few hours, and usually on the
same day. Symptoms usually resolve within a few days and signs of a reaction to the
infusion may include:
fever and chills
tiredness or weakness
nausea or vomiting
fast heart rate
chest pain or discomfort
muscle aches
joint pain
feeling light headed or faint.
headache
upset stomach
pain
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
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Serious side effects
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What to do
|
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Serious allergic reactions
These can happen within 14 days of the injection and resolve within a few days. Symptoms
may include:
difficulty breathing or swallowing
swelling of the face, lips, tongue or throat
severe itching of the skin, with a red rash, raised bumps or hives, feeling lightheaded
or faint
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these 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.
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 KAVIGALE contains
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Active ingredient
(main ingredient)
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sipavibart
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Other ingredients
(inactive ingredients)
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histidine, histidine hydrochloride monohydrate, arginine hydrochloride, polysorbate 80
and water for injections
|
Do not use this medicine if you are allergic to any of these ingredients.
What KAVIGALE looks like
KAVIGALE is a clear to opalescent, colourless to slightly yellow solution provided
in a clear glass vial with a light green cap.
The vial contains 300 mg of sipavibart in 2 mL.
Each pack contains 1 vial.
(AUST R 459773).
Who distributes KAVIGALE
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in November 2025.
KAVIGALE is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca, 2026
VV-RIM-09206923 v2.0