Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about being given this medicine,
speak to your doctor or pharmacist.
This medicine is new. Please report side effects. See the full CMI for further details.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I being given PADCEV?
PADCEV contains the active ingredient enfortumab vedotin. PADCEV is used in adults
to treat a kind of cancer called urothelial cancer (urothelial carcinoma). People
get PADCEV when their cancer has spread or cannot be taken out by surgery.
2. What should I know before I am given PADCEV?
PADCEV should not be given if you have ever had an allergic reaction to enfortumab
vedotin 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. PADCEV should not be given to children and adolescents below 18 years of age.
3. What if I am taking other medicines?
Some medicines may interfere with PADCEV and affect how it works.
4. How am I given PADCEV?
Your doctor will give you PADCEV through an infusion (a drip) into a vein (intravenously)
over 30 minutes.
You will get PADCEV once a week for 3 weeks in each 28 day period of treatment. Your
doctor will decide how many treatments you need.
5. What should I know while being given PADCEV?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are being given PADCEV.
Tell your doctor if you have any symptoms of skin reactions, high blood sugar or diabetes,
lung problems, nerve damage, or eye problems.
Tell your doctor if you are taking any other medicines including but not limited to
treatment for fungal infections (e.g., Ketoconazole). Additional medicines are listed
in Section 3. What if I am taking other medicines? in the full CMI. |
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Things you should not do
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It is very important that you do not miss a dose of this medicine (call your doctor
if you cannot make it to your appointment to receive your next dose).
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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 PADCEV
affects you.
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Looking after your medicine
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You will not be asked to store PADCEV. It will usually be stored in the pharmacy or
on the ward. Any unused portion of the solution will be disposed of by your doctor.
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6. Are there any side effects?
Some possible side effects may be serious, and can include skin reactions, high blood
sugar levels, lung problems, nerve damage, and eye problems.
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 .
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WARNING:
SERIOUS SKIN REACTIONS
Tell your doctor right away if you have signs of a severe skin reaction: rash or itching
that continues to get worse or comes back after treatment, skin blistering or peeling,
painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like
symptoms or swollen lymph nodes.
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Active ingredient(s):
enfortumab vedotin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PADCEV. 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 PADCEV.
Where to find information in this leaflet:
1. Why am I being given PADCEV?
PADCEV contains the active ingredient enfortumab vedotin.
PADCEV is used in adults to treat urothelial carcinoma. PADCEV is given to people that have received an immunotherapy medicine and also received
a platinum-containing chemotherapy medicine. People get PADCEV when their cancer has
spread or cannot be taken out by surgery.
2. What should I know before I am given PADCEV?
Warnings
Do not use PADCEV if:
you are allergic to enfortumab vedotin, or any of the ingredients listed at the end
of this leaflet.
always check the ingredients to make sure you can be given this medicine.
Check with your doctor if you:
have high blood sugar or diabetes
are currently experiencing numbness or tingling in your hands or feet
take any other medicines including but not limited to treatment for fungal infections
(e.g., ketoconazole) as they can increase the amount of PADCEV in your blood. If you
normally take these medicines, your doctor might change it and prescribe a different
medicine for you during your treatment with PADCEV.
During treatment, you may be at risk of developing certain side effects. These side
effects can sometimes become life-threatening and can lead to death. These side effects
may happen anytime during treatment or even after your treatment has ended. You may
experience more than one side effect at the same time.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
PADCEV may harm your unborn baby and should not be used during pregnancy.
If you are a woman starting PADCEV who is able to become pregnant, you should use
effective contraception during treatment with PADCEV and for at least 7 months after
stopping PADCEV.
If you are a man taking PADCEV whose partner is able to become pregnant, you should
use effective contraception during treatment with PADCEV and for at least 6 months
after stopping PADCEV.
It is not known if PADCEV passes into your breast milk and could harm your baby. You
should not breastfeed during treatment with PADCEV and for at least 6 months after
stopping PADCEV.
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.
Medicines that may
interfere with
the effect of PADCEV include but are not limited to medicines for treating:
bacterial infections (e.g., clarithromycin)
depression (e.g., nefazodone)
fungal infections (e.g., ketoconazole, voriconazole, posaconazole, itraconazole)
hepatitis C (e.g., boceprevir, telaprevir)
infections with the human immunodeficiency virus (HIV) (e.g., cobicistat, indinavir,
nelfinavir, ritonavir, saquinavir).
epilepsy (e.g., carbamazepine, phenobarbital, phenytoin)
depression (e.g., escitalopram, fluoxetine, sertraline or the herbal medicine St.
John’s Wort (also known as Hypericum perforatum))
tuberculosis (e.g., rifampicin).
Do not take PADCEV with:
the supplement goldenseal (Hydrastis Canadensis).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PADCEV.
4. How am I given PADCEV?
How much to take
PADCEV will be given to you by intravenous (IV) infusion into your vein over 30 minutes.
Your doctor will decide how much to use.
When to take PADCEV
You will receive your PADCEV over periods of time called cycles. Each PADCEV cycle
is 28 days and you will receive PADCEV on days 1, 8 and 15 of every cycle.
Your doctor will decide how many treatment cycles you need.
If you forget to receive PADCEV
If you miss a dose, call your doctor right away to reschedule your appointment. It
is very important that you do not miss a dose of this medicine.
If you are given too much PADCEV
As PADCEV is given to you under the supervision of your doctor, it is unlikely that
you will be given too much. However, if you experience any side effects after being
given PADCEV, tell your doctor immediately.
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 being given PADCEV?
Things you should do
Call your doctor straight away if you:
have any of the following skin reaction symptoms: rash or itching that continues to
get worse or comes back after treatment, skin blistering or peeling, painful sores
or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms or
swollen lymph nodes. These may be signs of a severe skin reaction that can happen
while receiving PADCEV, particularly during the first few weeks of your treatment.
If it occurs, your doctor will monitor you and may give you a medicine to treat your
condition. She or he may pause PADCEV treatment until symptoms are reduced. If your
skin reaction worsens, your doctor may stop your PADCEV treatment.
have any symptoms of high blood sugar, including: frequent urination, increased thirst,
blurred vision, confusion, drowsiness, loss of appetite, fruity smell on your breath,
nausea, vomiting or stomach pain. You can develop high blood sugar during treatment
with PADCEV.
have any symptoms of lung problems, including cough, shortness of breath or chest
pain. If it occurs, your doctor may pause treatment until symptoms are improved or
reduce your dose. If your symptoms worsen, your doctor may stop your treatment.
have any symptoms of nerve damage (neuropathy) such as numbness, tingling or a tingling
sensation in your hands or feet or muscle weakness, burning, stabbing or shooting
pain. If it occurs, your doctor may pause treatment until symptoms are improved or
reduce your dose. If your symptoms worsen, your doctor may stop your PADCEV treatment.
have eye problems such as dry eyes during your treatment. You can develop certain
eye problems while receiving PADCEV.
Remind any doctor, dentist or pharmacist you visit that you are being given PADCEV.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PADCEV
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
You will not be asked to store PADCEV. It will usually be stored in the fridge (at
2ºC to 8ºC) at the pharmacy or on the ward. Unused portion of the infusion solution
will not be stored for reuse.
Getting rid of any unwanted medicine
Any unused medicine or waste material will be disposed of by your doctor in accordance
with local requirements.
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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Bleeding related:
low red blood cells (anaemia)
decreased white blood cell count
Stomach related:
nausea, diarrhoea and vomiting
General:
tiredness
abnormal walking (gait disturbance)
weight loss
Eating related:
decreased appetite
change in sense of taste
Eye related:
dry eye
Skin related:
hair loss
Liver related:
increased liver enzymes (aspartate aminotransferase [AST] or alanine aminotransferase
[ALT]) (these are blood tests)
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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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Skin reactions:
Stevens-Johnson syndrome
toxic epidermal necrolysis
other severe rashes
Tell your doctor right away if you have any of these signs of a severe skin reaction:
rash or itching that continues to get worse or comes back after treatment
skin blistering or peeling
painful sores or ulcers in mouth or nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes
(frequency not known).
High blood sugar (hyperglycaemia):
Tell your doctor right away if you have any symptoms of high blood sugar, including:
frequent urination
increased thirst
blurred vision
confusion
drowsiness
loss of appetite
fruity smell on your breath
nausea
vomiting
stomach pain
(may affect up to 1 in 10 people).
Respiratory symptoms and lung
problems (lung inflammation):
cough
shortness of breath
chest pain
(frequency not known)
Nerve damage (peripheral neuropathy):
Tell your doctor right away if you get:
numbness
tingling or a tingling sensation in your hands or feet
muscle weakness,
burning, stabbing or shooting pain
(may affect up to 1 in 100 people).
Leakage of PADCEV out of your vein into the tissues around your infusion site (extravasation):
Tell your doctor or get medical help right away if you notice:
any redness, swelling, itching, or discomfort at the infusion site.
If PADCEV leaks from the injection site or the vein into the nearby skin and tissues,
it could cause an infusion site reaction. These reactions can happen right after you
receive an infusion, but sometimes may happen days after your infusion (may affect
up to 1 in 100 people).
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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 PADCEV contains
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Active ingredient
(main ingredient)
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enfortumab vedotin
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Other ingredients
(inactive ingredients)
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histidine,
histidine hydrochloride monohydrate,
trehalose dihydrate, and polysorbate 20
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Do not take this medicine if you are allergic to any of these ingredients.
What PADCEV looks like
PADCEV 20 mg is a white to off-white powder for injection in a vial. (Aust R 355870).
PADCEV 30 mg is a white to off-white powder for injection in a vial. (Aust R 367410).
Who distributes PADCEV
Astellas Pharma Australia Pty Ltd
Suite 2.01, 2 Banfield Road
Macquarie Park NSW 2113
Tel: 1800 751 755 (Medical Information)
This leaflet was prepared in May 2023.