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 TREMFYA?
TREMFYA contains the active ingredient guselkumab. TREMFYA is used to treat adults
with moderate to severe plaque psoriasis or adults with active psoriatic arthritis.
2. What should I know before I use TREMFYA?
Do not use if you have ever had an allergic reaction to guselkumab 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 TREMFYA and affect how it works.
4. How do I use TREMFYA?
TREMFYA is given by injection under your skin (subcutaneous injection)
5. What should I know while using TREMFYA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TREMFYA.
Tell your doctor, nurse or pharmacist if the medicine starts to upset you or your
symptoms become worse.
Tell your doctor straight away if you develop any symptoms of an infection or allergic
reactions.
Keep all your appointments for doctors.
Use appropriate contraception. Tell your doctor if you become pregnant while using
TREMFYA.
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Things you should not do
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Do not stop using this medicine or change the dose unless your doctor tells you to.
Do not receive a live vaccine while taking TREMFYA.
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Driving or using machines
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Be careful before you drive or use any machines until you know how TREMFYA affects
you. TREMFYA does not usually affect your ability to drive or use machines
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Looking after your medicine
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Store TREMFYA in the refrigerator (between 2°C and 8°C). Do not freeze.
Keep the product in the original carton to protect from light until the time of use.
Do not shake TREMFYA.
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6. Are there any side effects?
Side effects that require urgent medical attention include: Signs of an allergic reaction,
such as rash, itching or hives on the skin, shortness of breath, wheezing or difficulty
breathing, a tight feeling in your chest, swelling of the face, lips, tongue or other
parts of the body; signs of infection such as fever or flu-like symptoms, blood in
your phlegm (mucus), muscle aches, cough, shortness of breath, weight loss, stomach
flu (gastroenteritis), burning when you urinate or urinating more often than normal,
warm, red, or painful skin or sores on your body different from your psoriasis.
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):
guselkumab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using TREMFYA. 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 TREMFYA.
Where to find information in this leaflet:
1. Why am I using TREMFYA?
TREMFYA contains the active ingredient guselkumab. TREMFYA is a type of protein called a monoclonal antibody and works by neutralising
the activity of a protein called IL-23, which is present in increased levels in people
with psoriasis and psoriatic arthritis.
TREMFYA is used to treat:
adults with moderate to severe plaque psoriasis, an inflammatory condition affecting
the skin and nails. TREMFYA can improve skin clearance and nail appearance and reduce
symptoms of psoriasis, such as scaling, shedding, flaking, itching, pain, and burning.
adults with active psoriatic arthritis, an inflammatory disease of the joints in which
psoriasis usually occurs in association with arthritis. If you have active psoriatic
arthritis, you will be given TREMFYA alone or in combination with a conventional Disease
Modifying Anti-Rheumatic Drug (DMARD) such as methotrexate.
2. What should I know before I use TREMFYA?
Warnings
Do not use TREMFYA if:
you are allergic to guselkumab (the active ingredient in the medicine), 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:
are being treated for an infection
have an infection that does not go away or keeps coming back
have tuberculosis (TB) or have been in close contact with someone with TB
think you have an infection or have symptoms of an infection such as:
fever or flu-like symptoms
blood in your phlegm (mucus)
muscle aches
cough
shortness of breath
weight loss
stomach flu (gastroenteritis)
burning when you urinate or urinating more often than normal
warm, red, or painful skin or sores on your body different from your psoriasis
TREMFYA may lower your ability to fight infections and may increase your risk of infections.
Do not use TREMFYA if you have any symptoms of infection unless you are instructed
to by your doctor.
have recently had a vaccination or if you are due to have a vaccination during treatment
with TREMFYA. You should not be given certain types of vaccines (live vaccines) while
using TREMFYA.
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
Check with your doctor if you are pregnant or intend to become pregnant. The effects of this medicine in pregnant women are not known.
If you are a woman of childbearing potential, use adequate contraception while using
TREMFYA and for at least 12 weeks after the last TREMFYA dose. Talk to your doctor
about your contraception options.
Talk to your doctor if you are breastfeeding or intend to breastfeed. You and your doctor should decide if you will breastfeed while using TREMFYA.
Children and adolescents
TREMFYA is not recommended for use in children under the age of 18 years. The safety
of TREMFYA and how effective it is have not been studied in this age group.
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 TREMFYA.
4. How do I use TREMFYA?
How much / When to use TREMFYA
Your doctor will decide how much TREMFYA you need and for how long.
For plaque psoriasis
The first dose is 100 mg (the content of 1 pre-filled syringe or 1 pre-filled pen)
by subcutaneous injection. This may be given by your doctor or nurse.
After the first dose, you will have the next dose 4 weeks later, and then every 8
weeks. Subsequent doses are the same as the first dose (the content of 1 pre-filled
syringe or 1 pre-filled pen).
For psoriatic arthritis
The first dose is 100 mg (the content of 1 pre-filled syringe or 1 pre-filled pen)
by subcutaneous injection. This may be given by your doctor or nurse.
After the first dose, you will have the next dose 4 weeks later, and then every 8
weeks. Subsequent doses are the same as the first dose (the content of 1 pre-filled
syringe or 1 pre-filled pen).
TREMFYA can be used with or without a type of medicine called a conventional Disease-Modifying
Anti-Rheumatic Drug (DMARD), such as methotrexate.
How to use TREMFYA
For treatment of plaque psoriasis or psoriatic arthritis, TREMFYA is given by injection
under your skin (subcutaneous injection) using a pre-filled syringe or a pre-filled
pen (One-Press® patient controlled injector).
At the start of your therapy, TREMFYA may be injected by your healthcare provider.
Your doctor or nurse may decide that it is right for you to learn how to inject TREMFYA
yourself.
It is important not to try to inject yourself until you have been trained by a healthcare
professional. If you have not been trained, please contact your healthcare provider
to schedule a training session.
A caregiver may also give you your TREMFYA injection after proper training.
Before use, remove the carton from the refrigerator and keep the pre-filled syringe
or pre-filled pen inside the carton and allow to reach room temperature by waiting
for 30 minutes.
Read the “Instructions for Use” leaflet for the pre-filled syringe or pre-filled pen
included in the pack carefully before using TREMFYA.
Educational support
The Janssen Immunology Patient Support Program is available to patients prescribed
TREMFYA. It offers:
Injection education
Ongoing medical supplies
Starter kit
Reminder service
Ongoing education
Call 1800 666 845
If you forget to use TREMFYA
If you miss your TREMFYA dose at the usual time, inject a dose as soon as you remember.
Inject your next dose at your next regularly scheduled date. This will put you back
on schedule.
Do not take a double dose to make up for the dose you missed.
If you use too much TREMFYA
If you think that you have used too much TREMFYA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre (in Australia telephone 13 11 26. In New Zealand telephone 0800 POISON or 0800 764 766), 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 TREMFYA?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using TREMFYA.
If you are about to start taking a new medicine, tell your doctor and pharmacist that
you are taking TREMFYA.
Tell your doctor, nurse or pharmacist if the medicine starts to upset you or your
symptoms become worse.
Keep all your appointments for doctors.
Call your doctor straight away if you:
Become pregnant while using TREMFYA
Things you should not do
You should not receive a live vaccine while taking TREMFYA. Talk to your doctor, pharmacist
or nurse before receiving any vaccination while taking TREMFYA.
Do not stop using this medicine or change the dose, unless your doctor tells you to.
Do not give TREMFYA to anyone else even if they have the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TREMFYA
affects you.
TREMFYA should not affect your ability to drive or use machines. However, make sure
you know how you react to it before you do anything that could be dangerous if you
feel dizzy.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store TREMFYA in a refrigerator between 2°C and 8°C.
TREMFYA should not be frozen.
Keep the product in the original carton to protect from light until the time of use.
Do not shake TREMFYA.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
After injecting TREMFYA, place the used syringe or pen immediately into a sharps container.
Do not put the used syringe or pen into your normal household or recycling waste.
The syringe or pen should never be re-used. Discard any unused portions of TREMFYA.
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.
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
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Less serious side effects
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What to do
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Injection site:
redness
pain
Skin:
fungal infection of the skin, for example between the toes (athlete’s foot)
Nervous System:
headache
Joints/Musculoskeletal:
joint pain (arthralgia)
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Signs of an infection:
cold and/or flu symptoms, chest infection (upper respiratory infection)
stomach flu (gastroenteritis)
herpes simplex infections, for example of the lips (cold sores) or genitals (genital
herpes)
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Tell your doctor immediately if you experience any of these side effects
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Signs of an allergic reaction:
rash, itching or hives on the skin
shortness of breath, wheezing or difficulty breathing
a tight feeling in your chest
swelling of the face, lips, tongue or other parts of the body
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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.
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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 TREMFYA contains
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Active ingredient
(main ingredient)
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guselkumab
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Other ingredients
(inactive ingredients)
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histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose, and water
for injection
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No preservatives are present.
Do not take this medicine if you are allergic to any of these ingredients.
What TREMFYA looks like
TREMFYA is a clear, colourless to light yellow solution and may contain clear or white
particles of protein. This appearance is not unusual for solutions containing proteins.
Do not use TREMFYA if the solution is discoloured, cloudy, or you can see other particulate
matter floating in it.
TREMFYA is available as a single use pre-filled syringe or pre-filled pen (One-Press® patient-controlled injector) in a carton. Each carton contains 1 pre-filled syringe
or 1 pre-filled pen.
100 mg pre-filled syringe: AUST R 286020
100 mg pre-filled pen: AUST R 321410
An instruction for use leaflet explaining how to self-administer the product is included
in the pack.
Do not use TREMFYA if the packaging is torn or shows signs of tampering.
Who distributes TREMFYA
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Road
Macquarie Park NSW 2113 Australia
Telephone: 1800 226 334
This leaflet was prepared in November 2024.