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 specialist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I being given PLUVICTO?
PLUVICTO contains the active ingredient lutetium (177Lu) vipivotide tetraxetan. PLUVICTO
is used to treat prostate cancer in adults. For more information, see Section
1. Why am I being given PLUVICTO? in the full CMI.
2. What should I know before being given PLUVICTO?
Do not use if you have ever had an allergic reaction to lutetium (177Lu) vipivotide
tetraxetan or any of the ingredients listed at the end of the CMI.
Talk to your specialist if you have any other medical conditions, take any other medicines,
have household contacts, or you are planning to try for a baby or have an expecting
partner.
3. What if I am taking other medicines?
Some medicines may interfere with PLUVICTO and affect how it works.
4. How do I receive PLUVICTO?
PLUVICTO is given in a hospital or other licensed facility by specially trained staff.
PLUVICTO is given once every 6 weeks into your vein for up to a total of six doses.
5. What should I know while being given PLUVICTO?
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Things you should do
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Attend your appointments every 6 weeks.
Follow advice from your specialist around decreasing radiation exposure to other persons
during travel, hospital visits or at home.
Stay well hydrated and urinate frequently before and after you are given PLUVICTO.
Use a condom for sexual activity during treatment with PLUVICTO and for 14 weeks after
your last dose.
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Things you should not do
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Do not father a child while taking PLUVICTO.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how PLUVICTO
affects you. PLUVICTO may make you feel tired.
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Drinking alcohol
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Tell your specialist if you drink alcohol.
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Looking after your medicine
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You will not need to store, handle, or dispose of this medicine.
The specialist needs to store PLUVICTO below 30°C (do not freeze) and to store in
the original package to protect from ionising radiation (lead shielding).
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6. Are there any side effects?
Common side effects include: tummy pain, constipation, diarrhoea, headache, feeling
sick, dizziness, dry mouth, decreased appetite, dry eye, vomiting. More serious side
effects include: bruising more than normal, tiredness, weakness, pale skin, shortness
of breath, passing less urine than normal, fever, chills, sore throat, or mouth ulcers.
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 ingredients: lutetium (177Lu) vipivotide tetraxetan
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PLUVICTO. You should also speak to your specialist or pharmacist if you would like further information
or if you have any concerns or questions about using PLUVICTO.
Where to find information in this leaflet:
1. Why am I being given PLUVICTO?
PLUVICTO contains the active ingredient lutetium (177Lu) vipivotide tetraxetan. PLUVICTO contains a radioactive material that
binds to a protein found in your prostate called prostate specific membrane antigen
(PSMA). This will destroy cancer cells by delivering a controlled dose of radiation.
PLUVICTO is used to treat adults with a certain type of advanced prostate cancer (called
metastatic castration-resistant prostate cancer) that has spread to other parts of
the body (metastatic) and has already been treated with other cancer treatments. This
type of cancer is a cancer of the prostate (a gland of the male reproductive system)
that does not respond to treatment that decreases male hormones.
2. What should I know before being given PLUVICTO?
Warnings
Do not use PLUVICTO if:
you are allergic to lutetium (177Lu) vipivotide tetraxetan, or any of the ingredients
listed at the end of this leaflet.
Check with your specialist if you:
are frequently sick with fever or chills.
have or have had kidney problems.
are pale, short of breath or bleeding/bruising more than normal.
have or have had any other type of cancer or treatment for cancer, as PLUVICTO adds
to your overall lifetime radiation exposure.
have low levels of certain types of cells in the blood (red blood cells, white blood
cells, neutrophils, and platelets).
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
The safety and efficacy of this medicine have not been established in females.
PLUVICTO can cause harm to an unborn baby. You must limit extended close contact (less
than one metre) with pregnant women for 7 days from receiving each dose of PLUVICTO
to minimise radiation risk.
You must sleep in a separate bedroom from pregnant women for up to 15 days (see section:
things you should do).
Contraception in males
You should avoid sexual activity for 7 days after administration of PLUVICTO.
You should not father a child and should use a condom for sexual activity during treatment
with PLUVICTO and for 14 weeks after your last dose.
Ask your doctor or pharmacist for options of effective birth control.
Fertility
PLUVICTO may cause infertility. Please ask your nuclear medicine doctor how this may
affect you, especially if you are planning to have children in the future. You may
wish to seek advice on collecting and storing of sperm before treatment starts.
Children and adolescents
PLUVICTO has not been studied in children and adolescents under 18 years of age.
You must limit extended close contact (less than one metre) with children for 7 days
from receiving each dose of PLUVICTO to minimise radiation risk.
PSMA test
Tests will be performed to see if PSMA is present on the surface of the cancer cells.
Your cancer is more likely to respond to treatment with PLUVICTO if the test result
is positive.
Treatment monitoring
Your specialist will do blood tests before and during treatment to check your condition
and to notice any side effects as early as possible. Based on the results, your specialist
may decide to delay, modify, or stop your treatment with PLUVICTO if necessary.
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.
Some medicines may interfere with PLUVICTO and affect how it works.
Check with your specialist, GP, or pharmacist if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect PLUVICTO.
4. How do I receive PLUVICTO?
PLUVICTO is given once every 6 weeks into your vein for up to a total of six doses.
PLUVICTO is only given in a hospital or other licensed facility by specially trained
staff.
How much will I receive
The recommended dose is 7,400 MBq (megabecquerel, the unit used to measure radioactivity)
given into your vein.
When to receive PLUVICTO
You should receive a single dose of PLUVICTO once every 6 weeks, into your vein, for
up to a total of 6 doses (that is for up to 6 separate treatment visits).
Duration of treatment
Your specialist will inform you about the usual length of the procedure.
If you miss an appointment to receive PLUVICTO
Contact your specialist as soon as possible to reschedule. You should receive PLUVICTO
once every 6 weeks.
If you use too much PLUVICTO
PLUVICTO is given in a hospital or other licensed facility. It is unlikely that you
will receive too much. Your specialist will check and treat you if you receive too
much.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your specialist, 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 being given PLUVICTO?
Things you should do
drink plenty of water for 2 days so that you remain hydrated and urinate as often
as possible during the first hours after you are given PLUVICTO.
do not father a child and do use a condom during intercourse throughout treatment
with PLUVICTO and for 14 weeks after your last dose.
limit close contact (less than 1 meter) with others in your household for 2 days or
with children and pregnant women for 7 days from receiving each dose of PLUVICTO.
avoid sexual activity for 7 days from receiving each dose of PLUVICTO.
sleep in a separate bedroom from others in your household for 3 days, from children
for 7 days, or from pregnant women for 15 days from receiving each dose of PLUVICTO.
Use of toilets
Take special precautions to avoid contamination for 2 days
after administration:
You must always sit when using the toilet.
It is essential that you use toilet paper every time you use the toilet.
Always wash your hands well after using the toilet.
Flush all wipes and/or toilet paper down the toilet immediately after use.
Flush any tissues or any other items that contain bodily waste, such as blood, urine,
and faeces down the toilet. Items that cannot be flushed down the toilet, such as
bandages, must be placed in separate plastic waste disposal bags.
Any special medical equipment that could be contaminated by your bodily fluids (e.g.,
catheter bags, colostomy bags, bedpans, water nozzles) must be emptied immediately
into the toilet and then cleaned.
Showering and laundry
Take a shower every day for at least 7 days after administration.
Wash your underwear, pyjamas, sheets, and any clothes that contain sweat, blood, or
urine separately from the laundry of others in your household, using a standard washing
cycle. You do not need to use bleach and you do not need extra rinses.
For care givers
For 2-3 days after administration:
People who are confined to bed or have reduced mobility will preferably receive assistance
from a care giver. It is recommended that when providing assistance in the bathroom,
the care giver wears disposable gloves.
Caregivers who clean up vomit, blood, urine, or faeces should wear plastic gloves,
which should be disposed of in a separate plastic waste disposal bag.
Household waste disposal
All items to be thrown away should be discarded in a separate plastic waste disposal
bag to be used only for this purpose.
Keep the plastic waste disposal bags separate from the other household waste and away
from children and animals.
A member of the hospital staff will tell you how and when to get rid of these waste
disposal bags.
Hospitalisation and emergency care
If for any reason you require emergency medical assistance or are unexpectedly admitted
to the hospital during the first 7 days after administration, you should inform the
healthcare professionals about the name, date, and dose of your radioactive treatment.
Your specialist will inform you if you need to take any other special precautions
after receiving this medicine. Contact your nuclear medicine doctor (your specialist)
if you have any questions or are planning any travel.
Call your specialist straight away if you:
are unable to pass urine when going to the toilet.
Remind any doctor, dentist, or pharmacist you visit that you are using PLUVICTO.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PLUVICTO
affects you. PLUVICTO may make you feel tired.
Drinking alcohol
Tell your specialist if you drink alcohol.
Looking after your medicine
You will not have to store or handle this medicine. This medicine will remain at the
facility where your specialist treated you.
Getting rid of any unwanted medicine
PLUVICTO is only given in special facilities by appropriately qualified staff. They
will be required to dispose of the medicine following treatment in accordance with
special laws.
6. Are there any side effects?
All medicines can have side effects. Some side effects could be serious and may need
medical attention.
See the information below and, if you need to, ask your specialist, GP, or pharmacist
if you have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your specialist 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.
7. Product details
What PLUVICTO contains
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Active ingredient
(main ingredient)
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lutetium (177Lu) vipivotide tetraxetan
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Other ingredients
(inactive ingredients)
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Acetic acid
Sodium acetate
Gentisic acid
Sodium ascorbate
Pentetic acid
Water for injections
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PLUVICTO contains up to 88.75 mg sodium (main component of cooking/table salt) in
each vial. This is equivalent to 4.4% of the recommended maximum daily dietary intake
of sodium for an adult.
PLUVICTO is given to you in your vein ('intravenously') at a hospital or other facility
by appropriately trained staff. Do not receive PLUVICTO if you are allergic to any
of these ingredients.
What PLUVICTO looks like
PLUVICTO is supplied in a glass vial, closed with a stopper and a seal. The vial is
enclosed within a lead container for protective shielding. The amount in the vial
can range from 7.5 mL to 12.5 mL to provide the required amount for your treatment.
Your specialist will determine this.
1000 MBq/mL, vial with lead shield: Aust R 410282.
Who distributes PLUVICTO
PLUVICTO is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1 800 671 203
This leaflet was prepared in July 2024.
Registered trademark of Novartis.
© Copyright Novartis 2024
Internal document code: (plu160724c) based on PI (plu160724i)