Consumer Medicine Information (CMI) summary
The
full CMI on 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 FRUZAQLA?
FRUZAQLA contains the active ingredient fruquintinib. FRUZAQLA is used to treat adult
patients with colorectal cancer (CRC) that has spread to other parts of the body (metastatic).
It is used when other treatments have not worked or when other treatments are not
suitable for you.
2. What should I know before I use FRUZAQLA?
Do not use if you have ever had an allergic reaction to FRUZAQLA 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 FRUZAQLA and affect how it works.
4. How do I use FRUZAQLA?
Recommended dose: 5 mg once daily (approximately same time each day) for 21 days (3
weeks), followed by 7 days (1 week) of no medicine.
FRUZAQLA can be taken with or without food and should be swallowed as a whole capsule.
5. What should I know while using FRUZAQLA?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using FRUZAQLA.
If you are pregnant, intending to get pregnant or to father a child, tell your doctor
immediately
|
|
Things you should not do
|
Do not stop using this medicine without talking to your doctor first.
|
|
Driving or using machines
|
Do not drive or operate machinery if you experience symptoms that affect your ability
to concentrate and react.
|
|
Looking after your medicine
|
Keep the medicine in a cool, dry place where the temperature stays below 30°C.
|
6. Are there any side effects?
Reduced blood platelets, reduced thyroid activity, weight loss and decreased appetite,
high blood pressure, voice change/ hoarseness, diarrhoea, painful dry mouth, mouth
sores/ulcers, redness, pain, blisters and swelling of palms/ soles of feet, pain in
muscles, bones, joints, chest or neck, protein in urine, weakness, tiredness. Upper
respiratory infection, fever, sore throat, cough, pneumonia, low blood cell counts,
nosebleeds, throat pain, pancreatic enzyme elevation, hole in stomach, toothache,
gum or lip pain, mouth sores, rash. Severely elevated blood pressure, digestive system
bleeding (stomach, throat, rectum bowel), severe stomach pain, confusion, seizure,
vision change, abnormal liver function test, yellowing skin/white part of eyes, dark
coloured urine, burning pain when urinating, right upper stomach pain, nausea, vomiting,
bruising, severe cough, trouble breathing, redness/pain in any part body, severe chest
pain/ pressure, pain in arm, leg back, neck or jaw, shortness of breath, numbness/weakness
of face, arm or leg, confusion, trouble talking or walking, severe headache, dizziness/loss
of balance. 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):
fruquintinib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using FRUZAQLA. 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 FRUZAQLA.
Where to find information in this leaflet:
1. Why am I using FRUZAQLA?
FRUZAQLA contains the active ingredient fruquintinib. FRUZAQLA belongs to a group of medicines called antineoplastic (or anti-cancer) agents
which are used to treat cancer.
FRUZAQLA is used to treat adult patients with colorectal cancer (CRC) that has spread
to other parts of the body (metastatic). It is used when other treatments have not
worked or when other treatments are not suitable for you.
FRUZAQLA stops tumours from making new blood vessels and therefore slows down the
growth of cancer. Blood vessels would usually provide the tumour with nutrients and
oxygen.
2. What should I know before I use FRUZAQLA?
Warnings
Do not use FRUZAQLA if:
you are allergic to fruquintinib, 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:
take any medicines for any other conditions
have any other medical conditions including:
high blood pressure
bleeding problems or are taking medicines to thin the blood or prevent blood clots
severe stomach or bowel problems
liver problems
kidney problems or have protein in your urine
skin problems
recently had severe or persistent headache, trouble with your vision, seizures or
fits, or altered mental status such as confusion, memory loss or loss of orientation
have an infection
recently had or going to have a surgical procedure or have an unhealed wound
recently had problems with blood clots in your blood vessels including stroke, heart
attack, embolism or thrombosis
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
Tell your doctor if you are pregnant or intend to become pregnant.
FRUZAQLA has not been studied in pregnant women. FRUZAQLA should not be used during
pregnancy. If you are pregnant, think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this medicine. Your
doctor will discuss with you the potential risks of taking this medicine during pregnancy.
Women who are able to become pregnant and male patients with female partners who are
able to become pregnant should use highly effective contraceptive methods during treatment,
and for at least 2 weeks following the last dose of FRUZAQLA. Talk to your doctor
about the right methods of contraception for you and your partner.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether FRUZAQLA passes into breast milk. You should not breast-feed
during treatment with this medicine and for at least 2 weeks following the last dose
of FRUZAQLA. Talk to your doctor about the best way to feed your baby during this
time.
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 FRUZAQLA and affect how it works. These include:
rifampicin, a medicine used to treat tuberculosis or other infections
efavirenz, a medicines used to treat HIV-1 infection
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FRUZAQLA.
4. How do I use FRUZAQLA?
FRUZAQLA should only be prescribed by a doctor experienced in cancer treatment.
How much to take
The recommended dose of FRUZAQLA is 5 mg once daily at approximately the same time
each day for 21 days (3 weeks), followed by 7 days (1 week) of no medicine. This three
weeks on, one week off treatment period is 1 cycle of treatment.
FRUZAQLA can be taken with or without food and should be swallowed as a whole capsule.
Your doctor may reduce your dose if necessary.
Follow the instructions provided and use FRUZAQLA until your doctor tells you to stop.
When to take FRUZAQLA
FRUZAQLA should be taken once a day at about the same time each day.
If you forget to take FRUZAQLA
If you miss your dose at the usual time and it is almost time for your next dose (less
than 12 hours), skip the dose you missed and take your next dose when you are meant
to.
If there are more than 12 hours until your next dose, take the dose you missed dose
and then take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed. This may increase the
chance of getting an unwanted side effect.
If you vomit after taking FRUZAQLA, do not take a replacement capsule. Continue to
take your next dose at the usual time.
If you use too much FRUZAQLA
If you think that you have used too much FRUZAQLA, 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 FRUZAQLA?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking FRUZAQLA.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
Use highly effective contraception to prevent pregnancy while you are being treated
with FRUZAQLA.
If you are going to have surgery, tell the surgeon that you are taking this medicine.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will do blood tests and other tests from time to time to monitor your
progress and check for side effects. If necessary, your doctor may decide to reduce
your dose, temporarily interrupt your treatment or stop it altogether.
Call your doctor straight away if you:
experience:
very high blood pressure
severe headache
severe chest pain
passing blood in the stools or passing black stools
passing blood in the urine
severe stomach (abdominal) pain or stomach pain that does not go away
coughing/vomiting up blood.
confusion, seizures (fits)
changes in vision
Remind any doctor, dentist or pharmacist you visit that you are using FRUZAQLA.
Things you should not do
Do not stop taking medicine unless your doctor tells you to.
Do not give this medicine to anyone else, even if they
have the same condition as you.
Do not use this medicine to treat any other complaints unless your doctor tells you
to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how FRUZAQLA
affects you.
FRUZAQLA may cause vision disturbances or tiredness in some people.
Do not drive or use machines during treatment if such signs occur.
Looking after your medicine
Keep in a cool, dry place where the temperature stays below 30°C.
Keep your capsules in the bottle until it is time to take them. If you take the capsules
out of the bottle they may not keep well. Keep the bottle tightly closed. Do not remove
desiccant cartridge from the bottle.
Store away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
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.
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.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
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
|
|
reduced activity of the thyroid gland
weight loss and decreased appetite
high blood pressure
voice changes or hoarseness
diarrhoea
painful or dry mouth, mouth sores or ulcers
abnormal liver function test results
burning or pain when urinating
redness, pain, blisters and swelling of the palms of the hands or soles of the feet
pain in the muscles, bones, joints, chest or neck
protein in your urine
weakness and excessive tiredness
upper respiratory tract infection
fever
sore throat
cough
pneumonia
low blood cell counts
reduced number of blood platelets
low levels of potassium in blood
nosebleed
throat pain
elevations of pancreatic enzymes
toothache, gum pain, lip pain or mouth sores
rash
delayed healing of a wound
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
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 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 FRUZAQLA contains
|
Active ingredient
(main ingredient)
|
1 mg or 5 mg fruquintinib
|
|
Other ingredients
(inactive ingredients)
|
FRUZAQLA 1 mg hard capsules:
Inactive ingredients: maize starch, microcrystalline cellulose and purified talc
capsule shells contain gelatin, titanium dioxide, tartrazine and sunset yellow FCF.
capsules are imprinted with TekPrint SW-9008 Black Ink (ARTG PI No 2328).
FRUZAQLA 5 mg hard capsules:
Inactive ingredients: maize starch, microcrystalline cellulose and purified talc
capsule shells contain gelatin, titanium dioxide, brilliant blue FCF and allura red
AC
capsules are imprinted with TekPrint SW-9008 Black Ink (ARTG PI No 2328)
|
Do not take this medicine if you are allergic to any of these ingredients.
What FRUZAQLA looks like
FRUZAQLA 1 mg capsules are an opaque hard gelatin capsule, size 3 (approximate length
16 mm), with a yellow cap and a white body imprinted with “HM013” over “1mg” in black
ink (AUST R 422039).
FRUZAQLA 5 mg capsules are an opaque hard gelatin capsule, size 1 (approximate length
19 mm), with a red cap and a white body imprinted with “HM013” over “5mg” in black
ink (AUST R 422038).
Who distributes FRUZAQLA
Takeda Pharmaceuticals Australia Pty Ltd
Level 39, 225 George Street
Sydney, NSW 2000
Australia
Telephone: 1800 012 612
This leaflet was prepared in October 2024.
TAKEDA and the TAKEDA Logo are registered trademarks of Takeda Pharmaceutical Company
Limited.
FRUZAQLA and the FRUZAQLA Logo are registered trademarks of HUTCHMED Group Enterprises
Limited, used under license.