2. What should I know before I am given QDENGA?
You should not be given QDENGA if you have ever had a sudden or severe allergic reaction
to the active ingredients of QDENGA or to any of the ingredients in the vaccine (listed
at the end of the CMI). Do not use if you have a very weak or poorly functioning immune
system due to other medical condition or genetic defect, or are on any medicines or
treatments that impact your immune system. Check with your doctor if you have an infection
with fever, have other medical conditions, take any other medicines, recently received
any other vaccines, are pregnant or plan to become pregnant or are breast-feeding
or plan to breastfeed. Talk to your doctor if you have ever fainted from any needle
injection. For more information, see Section
2. What should I know before I am given QDENGA? in the full CMI.
3. What if I am taking other medicines or receiving other vaccines?
Some medicines may interfere with QDENGA and affect how it works. Tell your doctor
if you are taking any medicines that affect your body’s natural defenses (such as
high-dose corticosteroids, chemotherapies or any medicines called “immunoglobulins”).
Tell your doctor or pharmacist if you have recently received any other vaccine. For
more information, see Section
3. What if I am taking other medicines or receiving other vaccines? in the full CMI.
4. How will I be given QDENGA?
Your doctor or healthcare professional will inject the vaccine under the skin (subcutaneous
injection) of your upper arm. You will receive the first dose, followed by a second
dose 3 months after the first injection to complete the vaccination schedule.
5. What should I know after receiving QDENGA?
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Things you should do
|
Keep to your follow up visit for the second QDENGA injection to complete the vaccination
schedule.
Continue to protect yourself against mosquito bites even after vaccination with QDENGA.
Tell your doctor straight away if you:
- do not feel well during or after having received the QDENGA injection.
- believe you might have a dengue infection or develop any signs or symptoms of dengue
infection.
If you are a woman of child-bearing age, take necessary precautions to avoid falling
pregnant for one month after QDENGA vaccination.
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|
Driving or using machines
|
Be careful before you drive or use any machines until you know how QDENGA affects
you. QDENGA has a minor influence on the ability to drive and use machines in the
first days following vaccination.
|
|
Looking after your medicine
|
QDENGA is normally stored in the doctor’s clinic or in the pharmacy. If you need to
store QDENGA, keep QDENGA in the refrigerator between 2°C to 8°C in the original package.
Do not freeze.
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6. Are there any side effects?
Very common side effects: redness or pain at the injection site, headache, muscle
pain, generally feeling unwell, weakness, infections of the nose or throat, fever
and additionally reported in children < 6 years of age: reduced appetite, feeling
sleepy, irritability. Common side effects: swelling, bruising or itching at the injection
site, pain or inflammation of the nose or throat, inflammation of the tonsils, joint
pain, flu-like symptoms. Unknown side effects: reduced number of blood platelets.
Serious side effects: sudden signs and symptoms of a severe allergic reaction. 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.
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): Dengue tetravalent vaccine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using QDENGA.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about QDENGA.
The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available. You should ensure that you
speak to your pharmacist or doctor to obtain the most up to date information on this
medicine. You can also download the most up to date leaflet from www.takeda.com/en-au.
Those updates may contain important information about the medicine and its use of
which you should be aware.
Where to find information in this leaflet:
1. Why am I being given QDENGA?
QDENGA is a vaccine that helps protect against dengue disease. The vaccine can be
given to adults, adolescents and children from 4 years of age. QDENGA contains live
attenuated (weakened) versions of dengue virus serotypes 1, 2, 3 and 4.
Dengue is a disease caused by dengue virus serotypes 1, 2, 3 and 4. The virus is spread
by mosquitos (the Aedes mosquito). If a mosquito bites someone with dengue, it can
pass the virus onto the next person it bites. Dengue is not passed directly from person-to-person.
QDENGA works by stimulating the body’s natural defenses (immune system) to produce
protection against dengue virus if the body is exposed to dengue virus in the future.
Although QDENGA contains live attenuated (weakened) versions of the Dengue viruses,
they are too weak to cause dengue disease in healthy people.
Signs of dengue include fever, headache, pain behind the eyes, muscle and joint pain,
feeling or being sick (nausea and vomiting), swollen glands or skin rash. Signs of
dengue usually last for 2 to 7 days. You can also be infected with dengue virus but
show no signs of illness.
Occasionally, dengue can be severe enough to result in the need to go to hospital
and in rare cases it can cause death.
Severe dengue can give you a high fever and any of the following: severe abdominal
pain, persistent sickness (vomiting), rapid breathing, severe bleeding, bleeding in
the stomach, bleeding gums, feeling tired, feeling restless, coma, having fits (seizures)
and organ failure.
2. What should I know before I am given QDENGA?
Warnings
Do not use QDENGA if:
you are allergic to QDENGA or the active ingredients of QDENGA or to any of the ingredients
listed at the end of this leaflet.
Signs and symptoms of an allergic reaction may include rash, hives, itching on skin,
swelling of the face, tongue or other parts of the body, shortness of breath, wheezing
or difficulty breathing. Always check the ingredients to make sure you can use this
vaccine.
you have a very weak or poorly functioning immune system (the body’s natural defenses).
This may be due to other medical conditions (for example, HIV infection) or genetic
defects.
you are taking any medicine or receiving any treatment that affect the immune system
(for example, high-dose corticosteroids or chemotherapies or immunoglobulin blood
products).
you are pregnant or breast-feeding.
If you are not sure whether you should be given QDENGA, talk to your doctor.
Check with your doctor if you:
have any allergies to any other vaccines or medicines or any other substances.
have a severe infection with a high fever. It might be necessary to postpone the vaccination
until recovery. A minor infection such as a cold should not be a problem, but talk
to your doctor about this before being vaccinated.
have ever had any health problems when given a vaccine.
have ever fainted following or even before any needle injection.
Your doctor will carefully consider the risks and benefits of vaccination.
As with any vaccine, QDENGA may not protect all people who receive the vaccine, and
protection might decrease over time.
Temporary, stress-related responses associated with the process of receiving your
injection may occur. This may include dizziness, fainting, sweating, increased heart
rate and/or anxiety. If you start to feel dizzy or faint at any time during the process
of receiving your injection, let your doctor or healthcare professional know. Take
actions to avoid falling and injuring yourself, such as sitting or lying down.
After receiving QDENGA, 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 planning to become pregnant.
Talk to your doctor if you are breastfeeding or planning to breastfeed.
QDENGA is not recommended to be given to pregnant women or during breastfeeding.
Take necessary precautions to avoid falling pregnant for one month after QDENGA vaccination.
Use in elderly
Ask your doctor for advice whether it is beneficial for you to receive QDENGA.
There are no data for adults above 60 years of age.
Use in young children
Children less than 4 years of age must not receive QDENGA.
3. What if I am using other medicines or receiving other vaccines?
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.
Some medicines may interfere with QDENGA and affect how it works.
Tell your doctor or pharmacist if you are taking or have recently taken any of the
following:
medicines that affect your body’s natural defenses (“immunosuppressants”), such as
high-dose corticosteroids or chemotherapies.
treatment with “immunoglobulins” or blood products containing immunoglobulins, such
as blood or plasma.
If you are taking or have recently taken any of these medicines, your doctor will
wait for at least 4 weeks after the immunosuppressive medicines are stopped or at
least 6 weeks (preferably 3 months) after the immunoglobulins are stopped before giving
you QDENGA.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect QDENGA.
Getting QDENGA with other vaccines
QDENGA can be given at the same time as hepatitis A vaccine, yellow fever vaccine
or human papillomavirus vaccine using a separate syringe and at a separate injection
site (another part of your body, usually the other arm).
Tell your doctor or pharmacist if you are being given or have recently received any
other vaccines.
Your doctor, nurse or pharmacist will be able to tell you what to do if QDENGA is
to be given with another medicine or vaccine.
4. How will I be given QDENGA?
QDENGA is given as an injection just under the skin (subcutaneous injection) by your
doctor or trained healthcare professional.
The doctor or healthcare professional will prepare the injection for you before you
are given it.
If you have any concerns about this, talk to your doctor, nurse or pharmacist.
How much you will receive
You will receive two injections of QDENGA (0.5 mL each dose). You will be given the
first dose, followed by a second dose 3 months after the first injection to complete
the vaccination schedule.
Your doctor or healthcare professional will schedule a follow-up visit for your second
injection. It is important that you return at the scheduled time for your follow-up
injection.
How QDENGA is given
Your doctor or trained healthcare professional will inject the vaccine just under
the skin in the upper arm.
The vaccine must not be given directly into the veins (intravascularly).
If you miss an appointment to receive QDENGA
If you miss your scheduled QDENGA injection, or if you are unable to go back at the
scheduled time for your second injection, tell your doctor and arrange another visit
as soon as possible.
If you have any further questions on the use of the vaccine, ask your doctor, pharmacist
or nurse.
If you are given too much QDENGA
If you think that you have used too much QDENGA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, 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 after receiving QDENGA?
Things you should do
Make sure you attend your follow-up visit with the doctor or clinic for the second
QDENGA injection.
It is important the second injection is given 3 months after the first injection.
This will ensure the best effect of the vaccine in protecting you against Dengue.
As with all vaccines given by injection, there is a very small risk of a sudden or
severe allergic reaction. See additional information under Section
6. Are there any side effects?
Remind any doctor, nurse or pharmacist you visit that you have been given QDENGA.
Continue to protect yourself against mosquito bites even after vaccination with QDENGA.
This includes using insect repellents, wearing protective clothing, and using mosquito
nets.
As with any vaccine, QDENGA may not protect everybody who receives it and protection
may decrease over time. You may still get dengue fever from mosquito bites.
Tell your doctor if you believe you might have a dengue infection, and develop any
of the following symptoms:
high fever
severe abdominal pain
persistent vomiting
rapid breathing
bleeding gums
tiredness
restlessness
blood in vomit
Driving or using machines
Be careful before you drive or use any machines or tools until you know how QDENGA
affects you.
QDENGA has a minor influence on the ability to drive and use machines in the first
days following vaccination.
Make sure you know how you react to QDENGA before you drive a car, operate machinery,
or do anything that could be dangerous if you are unwell.
Looking after your medicine
QDENGA will normally be stored at the doctor’s clinic or in the pharmacy.
If you need to store QDENGA, follow the instructions on the carton to take care of
your vaccine properly.
Keep QDENGA in the refrigerator between 2°C to 8°C.
Do not freeze QDENGA. Freezing destroys the vaccine.
Keep it where children cannot reach it.
Keep QDENGA in the original package.
Do not use QDENGA after the expiry date. If the vaccine is given after the expiry
date, it may not work.
Do not use QDENGA if the packaging is torn or shows signs of tampering.
Getting rid of any unwanted vaccine
It is unlikely that you will be asked to dispose of QDENGA. However, if you no longer
need to be given this vaccine or it is out of date, take it to any pharmacy for safe
disposal.
6. Are there any side effects?
All medicine, including vaccines, 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.
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
|
|
General disorders and administration site conditions:
pain, swelling, bruising, redness or itching around where the injection is given
headache
feeling generally unwell
fever
feeling weak
flu-like symptoms
Musculoskeletal disorders
muscle pain
joint pain
Respiratory and mouth disorders
pain or inflammation of the nose or throat
inflammation of the tonsils
infections of the nose or throat
Blood disorders
reduced number of blood platelets
Metabolic disorders
reduced appetite (children < 6 years of age)
Psychiatric disorders
feeling sleepy (children < 6 years of age)
irritability (children < 6 years of age)
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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
|
Serious side effects
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What to do
|
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Severe allergic (anaphylactic) reactions
If any of these symptoms occur after leaving the place where you or your child received
an injection, contact a doctor immediately:
difficulty breathing
blueness of the tongue or lips
a rash
swelling of the face or throat
low blood pressure causing dizziness or fainting
sudden and serious feeling of illness or unease with drop in blood pressure causing
dizziness and loss of consciousness, rapid heartbeat linked with breathing difficulty.
These signs or symptoms (anaphylactic reactions) usually develop soon after the injection
is given and while you or your child are still in the clinic or doctor’s surgery.
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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 experienced, 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.
7. Product details
QDENGA is only available with a doctor's prescription.
What QDENGA contains
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Active ingredients (main ingredients)
|
Live attenuated (weakened) versions of
dengue virus serotype 1,
dengue virus serotype 2,
dengue virus serotype 3,
dengue virus serotype 4
|
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Other ingredients (inactive ingredients)
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trehalose dihydrate
poloxamer
albumin
monobasic potassium phosphate
dibasic sodium phosphate dihydrate
potassium chloride
sodium chloride
water for injections
|
Each dose of QDENGA (0.5 mL) contains:
not less than 3.3 log10 plaque-forming units (PFU) of dengue virus serotype 1
not less than 2.7 log10 PFU of dengue virus serotype 2
not less than 4.0 log10 PFU of dengue virus serotype 3
not less than 4.5 log10 PFU of dengue virus serotype 4
Do not receive this vaccine if you are allergic to any of these ingredients.
The vaccine was produced in Vero cells by recombinant DNA technology.
What QDENGA looks like
QDENGA is a powder and solvent for injection, which must be mixed by your doctor or
healthcare professional together before use.
The vaccine powder is a white to off-white coloured compact cake, provided in single-dose
glass vials with green flip-off caps.
The solvent (0.22% sodium chloride solution) is a clear and colourless liquid, provided
in either pre-filled syringes or glass vials with purple flip-off caps.
After the vaccine powder is mixed with the solvent to make a solution suitable for
injection, QDENGA is a clear, colourless to pale yellow solution, essentially free
of foreign particulates.
Australian Registration Numbers:
AUST R 506646: vaccine powder vial + solvent pre-filled syringe (with needles)
pack of 1: containing 1 vial of vaccine powder and 1 pre-filled syringe of solvent,
with 2 separate needles
AUST R 484846: vaccine powder vial + solvent vial (without needles)
pack of 1: containing 1 vial of vaccine powder and 1 vial of solvent
pack of 10: containing 10 vials of vaccine powder and 10 vials of solvent
Not all presentations may be available.
Who distributes QDENGA
QDENGA is supplied in Australia by:
Takeda Pharmaceuticals Australia Pty Ltd
Level 39 225 George Street
Sydney, NSW 2000
Australia
Telephone: 1800 012 612
This leaflet was prepared in April 2026.
QDENGA® is a registered trademark of Takeda Vaccines, Inc.
TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company
Limited.