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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using TALTZ?
TALTZ contains the active ingredient ixekizumab. TALTZ is used to treat plaque psoriasis,
psoriatic arthritis, ankylosing spondylitis (also known as radiographic axial spondyloarthritis)
and non-radiographic axial spondyloarthritis.
2. What should I know before I use TALTZ?
Do not use if you have ever had an allergic reaction to TALTZ or any of the ingredients
listed at the end of the CMI.
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?
Some medicines may interfere with TALTZ and affect how it works.
4. How do I use TALTZ?
TALTZ is given as an injection under your skin, known as a subcutaneous injection.
Your first dose will be given by a doctor, nurse or pharmacist.
Each autoinjector or syringe contains one dose of TALTZ (80mg). The first dose of
TALTZ for plaque psoriasis and psoriatic arthritis is 160 mg (two 80mg injections).
The dose of TALTZ for radiographic and non-radiographic axial spondyloarthritis is
80 mg (one injection).
5. What should I know while using TALTZ?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using TALTZ.
Keep all of your doctor's appointments so that your progress can be checked.
If you need to get vaccinated, tell your doctor you are taking TALTZ before you have
the vaccination.
|
|
Things you should not do
|
Do not stop using TALTZ unless your doctor tells you to.
Do not use TALTZ if you think it has been frozen or exposed to excessive heat.
Do not use TALTZ if you notice that the autoinjector or syringe is damaged, or the
medicine is cloudy, distinctly brown or has particles in it.
|
|
Looking after your medicine
|
TALTZ autoinjector or syringe is single use only.
Keep your unused TALTZ autoinjector or syringe in a fridge between 2°C to 8°C. Do
not freeze or shake.
Keep TALTZ in the original package in order to protect it from light.
|
6. Are there any side effects?
Side effects include injection site reactions (e.g. red skin or pain); stomach pain
or diarrhoea due to inflammatory bowel disease; upper respiratory tract infections
with symptoms such as sore throat and stuffy nose. More serious side effects include
allergic reactions; severe itching of the skin, with red rash or raised bumps.
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:
ixekizumab
(phonetic pronunciation - ixe-kiz-u-mab)
Consumer Medicine Information (CMI)
This leaflet provides important information about using TALTZ. 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 TALTZ.
Where to find information in this leaflet:
1. Why am I using TALTZ?
TALTZ contains the active ingredient ixekizumab. Ixekizumab is a monoclonal antibody. Monoclonal antibodies are proteins that recognise
and bind specifically to certain proteins in the body.
TALTZ belongs to a group of medicines called interleukin (IL) inhibitors. TALTZ works
by neutralising the activity of the protein called IL-17A, which is present in high
levels in psoriasis.
TALTZ is used to treat:
plaque psoriasis
psoriatic arthritis
ankylosing spondylitis (also known as radiographic axial spondyloarthritis)
non-radiographic axial spondyloarthritis.
Plaque psoriasis is a skin condition caused by inflammation affecting the skin. TALTZ reduces inflammation
and other symptoms of the disease, such as scaling, itching and pain. TALTZ is used
in adult patients with moderate-to-severe plaque psoriasis who are candidates for
systemic therapy or phototherapy.
Psoriasis arthritis is an inflammatory disease of the joints, often accompanied by psoriasis. You will
first be given other medicines to treat psoriasis arthritis but may be given TALTZ
if you do not respond well to these medicines. TALTZ can be used alone or with other
medicines, such as methotrexate.
Axial spondyloarthritis
Ankylosing spondyloarthritis
(radiographic axial spondyloarthritis) is an inflammatory disease primarily affecting the spine which causes inflammation
of the sacroiliac and spinal joints. This condition is visible with X-rays.
Non-radiographic axial spondyloarthritis is an inflammatory disease primarily affecting the spine which causes inflammation
of the sacroiliac and spinal joints. This condition is not visible with X-rays.
2. What should I know before I use TALTZ?
Warnings
Do not use TALTZ if:
you are allergic to ixekizumab, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine
if the product appears cloudy, discoloured, or contains particles
if the packaging is torn or shows signs of tampering.
Check with your doctor if you:
currently have an infection or have long-term or repeated infections
have tuberculosis. You may be tested for tuberculosis before you receive treatment
with TALTZ
have ulcerative colitis or Crohn's disease
are receiving any other treatment for psoriasis, such as immunosuppressant or phototherapy
with ultraviolet (UV) light
have recently had a vaccination or if you are due to have a vaccination during treatment
with TALTZ
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?
Vaccination
Tell your doctor about your vaccination history.
Live vaccines cannot be used while you are on TALTZ. You should consider completing
all the immunisation required for your age group before starting on TALTZ.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. The effects
of TALTZ in pregnant women are not known.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
if TALTZ is excreted in breastmilk.
Use in children
TALTZ has not been studied in patients under 18 years of age.
Use in elderly
TALTZ may be used in elderly patients aged 65 years and over.
This medicine is not addictive.
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.
Tell your doctor, nurse or pharmacist if you have recently had or are due to have
a vaccination. You should not be given certain types of vaccines while using TALTZ.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TALTZ.
4. How do I use TALTZ?
TALTZ is given as an injection under your skin, known as subcutaneous injection.
You and your doctor, nurse or pharmacist should decide if you should inject TALTZ
yourself.
Your first dose will be given by a doctor, nurse or pharmacist. It is important not
to try to inject yourself until you have been trained by a doctor, nurse or pharmacist.
A caregiver may also give you your TALTZ injection after proper training.
How much to use
Each autoinjector or syringe contains one dose of TALTZ (80 mg).
Plaque psoriasis:
the first dose of TALTZ for plaque psoriasis is 160 mg (two 80 mg injections), followed
by 80 mg (one injection) at weeks 2, 4, 6, 8, 10 and 12
after 12 weeks, your treatment will continue at 80 mg (one injection) every 4 weeks.
Psoriatic arthritis:
the first dose of TALTZ for psoriatic arthritis is 160 mg (two 80 mg injections),
followed by 80 mg (one injection) every 4 weeks
if you have psoriatic arthritis with moderate to severe psoriasis, your first dose
of TALTZ is 160 mg (two 80 mg injections), followed by 80 mg (one injection) at weeks
2, 4, 6, 8, 10 and 12
after 12 weeks, your treatment will continue as 80 mg (one injection) every 4 weeks.
Axial spondyloarthritis (radiographic and non-radiographic):
the dose of TALTZ for axial spondyloarthritis is 80 mg (one injection) every 4 weeks.
You should inject the whole contents of the single use autoinjector or syringe.
When to use TALTZ
TALTZ is for long-term treatment. Your doctor, nurse or pharmacist will regularly
monitor your condition to check that the treatment is having the desired effect.
Do not stop TALTZ just because you feel better. It is important that you do not stop
using TALTZ unless your doctor tells you.
It is not dangerous to stop using TALTZ. However, if you stop, your psoriasis symptoms
may come back.
How to use TALTZ
Read the instructions for use for the autoinjector or syringe carefully before using
TALTZ.
If you forget to use TALTZ
If you have forgotten to inject a dose of TALTZ, inject the dose as soon as you remember,
then talk to your doctor to discuss when you should inject the next dose.
If you use too much TALTZ
If you think that you have accidentally injected more TALTZ than you should, or sooner
than according to your doctor prescription, 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 while using TALTZ?
Things you should do
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will do tests from time to time to make sure TALTZ is working and to prevent
unwanted side effects.
If you need to get vaccinated, tell your doctor you are taking TALTZ before you have
the vaccination. You should not be given a live vaccination while being treated with
TALTZ.
Remind any doctor, dentist or pharmacist you visit that you are using TALTZ.
While you are using TALTZ, tell your doctor or pharmacist before you start any new
medicine.
Tell your doctor if you become pregnant or plan to breastfeed while using TALTZ.
Things you should not do
Do not use the medicine if you think it has been frozen or exposed to excessive heat.
It may not work as well.
Do not use the medicine if you notice that the autoinjector or syringe is damaged,
or the medicine is cloudy, distinctly brown or has particles in it.
Do not give your TALTZ to anyone else, even if they have the same condition as you.
You doctor has prescribed TALTZ specifically for you.
Looking after your medicine
A TALTZ autoinjector or syringe is for single use only.
Keep your unused TALTZ autoinjector or syringe in a fridge between 2°C to 8°C. Do
not freeze or shake.
Do not use if it has been frozen.
Keep TALTZ in the original package in order to protect it from light.
If needed, the TALTZ autoinjector or syringe can be left out of the refrigerator for
up to 5 days at a temperature not above 30°C, for example while travelling or transporting
it from the pharmacy.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep TALTZ where young children cannot reach it.
When to discard your medicine
After 5 days out of the refrigerator, the TALTZ autoinjector or syringe must be discarded.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
Empty autoinjectors and syringes should be disposed of in a sharps container or similar
puncture proof container composed pf hard plastic or glass.
Ask your doctor, nurse or pharmacist where you can dispose of the container once it
is full.
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.
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
|
Less serious side effects
|
What to do
|
|
Injection site reactions:
red skin or pain
Infection:
upper respiratory tract infections with symptoms such as sore throat and stuffy nose
fever, sore throat or mouth ulcers
running nose
influenza
Fungal infection:
athlete's foot
oral thrush
Oropharyngeal related:
pain in the back of the throat
Eye related:
discharge from the eye with itching, redness and swelling
Gastrointestinal:
nausea (feeling sick)
stomach pain or diarrhoea due to inflammatory bowel disease (including ulcerative
colitis or Crohn's disease)*
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
*New cases of inflammatory bowel disease or "flare-ups" can happen with TALTZ and
can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis
or Crohn's disease), tell your doctor if you have worsening symptoms during treatment,
or develop new symptoms such as stomach pain or diarrhoea.
Serious side effects
|
Serious side effects
|
What to do
|
|
Signs of serious allergic reaction - signs may include:
difficulty in breathing or swallowing
swelling of the face, lips, tongue or throat
severe itching of the skin, with red rash or raised bumps, hives
|
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.
|
|
Possible serious infections - signs may include:
fever, flu-like symptoms, night sweats
feeling tired or short of breath, cough which will not go away
warm, red and painful skin or painful skin rash with blisters
|
Stop using TALTZ and call your doctor immediately. You doctor will decide if and when
you may restart treatment
|
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 TALTZ contains
|
Active ingredient
(main ingredient)
|
Ixekizumab (rch)
|
|
Other ingredients
(inactive ingredients)
|
Sodium citrate dihydrate
Citric acid
Sodium chloride
Polysorbate 80
Water for injections
|
Do not take this medicine if you are allergic to any of these ingredients.
What TALTZ looks like
TALTZ is a clear solution for injection. Its colour may vary from colourless to slightly
yellow.
TALTZ is available as a prefilled autoinjector (also known as a pen) (Aust R 253893)
and a prefilled syringe (Aust R 253892), in pack sizes of 1 and 2.
Not all pack sizes may be available.
Who distributes TALTZ
Eli Lilly Australia Pty Ltd
Level 9, 60 Margaret Street
Sydney NSW 2000
Phone: 1800 454 559
This leaflet was prepared in March 2023
vA11.0