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 VORANIGO?
VORANIGO contains the active ingredient vorasidenib. VORANIGO is used to treat, following
surgery, specific brain cancers (astrocytoma or oligodendroglioma) that contain a
particular mutated (abnormal) form of the isocitrate dehydrogenase-1 (IDH1) or isocitrate
dehydrogenase-2 (IDH2) enzyme. VORANIGO is used in adults and adolescents aged 12
and over. For more information, see Section
1. Why am I using VORANIGO? in the full CMI.
2. What should I know before I use VORANIGO?
Do not use if you have ever had an allergic reaction to vorasidenib, the active ingredient
in VORANIGO, 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. For more information, see
Section 2 in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with VORANIGO and affect how it works. A list of these
medicines is in
Section 3 in the full CMI.
4. How do I use VORANIGO?
The usual dose of VORANIGO in adults and adolescents 12 years of age and older is:
40 mg taken orally once daily for patients weighing at least 40 kg
20 mg taken orally once daily for patients weighing less than 40 kg
The tablets should be taken once daily at about the same time each day. You should
not eat food at least 2 hours before and 1 hour after taking VORANIGO. More instructions
can be found in Section
4. How do I use VORANIGO? in the full CMI.
5. What should I know while using VORANIGO?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using VORANIGO.
Take all blood tests including liver function tests as directed by your doctor (prior
to starting treatment, every 2 weeks during the first 2 months of the treatment and
then once monthly throughout the duration of the treatment or as directed by your
doctor).
If you or your partner use a hormonal contraceptive, you must also use effective barrier
method contraception (e.g. condoms or a diaphragm) during treatment with VORANIGO
and for at least 3 months after the last dose.
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Things you should not do
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Do not stop using VORANIGO suddenly without consulting your doctor.
You should not take VORANIGO together with certain medicines. Some medicines may affect
how VORANIGO works for you and VORANIGO may affect how other medicines you take work
for you. See further information in Section 3. What if I am taking other medicines?
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Driving or using machines
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VORANIGO is not likely to affect your ability to drive or use any tools or machines.
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Looking after your medicine
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Store in a cool dry place below 30°C. Keep Out of Reach of Children.
Once opened, VORANIGO should be used within 60 days. Close the bottle tightly.
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6. Are there any side effects?
VORANIGO is usually well tolerated, however all medications may have unwanted effects
in some people. The most common serious side effect is increased liver enzymes in
the blood. Symptoms may include yellowing of your skin or the white part of your eyes
(jaundice), dark ’tea-coloured’ urine, loss of appetite, pain on the upper right side
of your stomach area, feeling very tired or weak. 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:
Vorasidenib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using VORANIGO. 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 VORANIGO.
Where to find information in this leaflet:
1. Why am I using VORANIGO?
VORANIGO is a cancer medicine that contains the active substance vorasidenib. It is
used to treat specific cancers of the brain with changed (mutated) genes that make
proteins known as IDH1 or IDH2, which play an important role in making energy for
cells. When the IDH1 gene or IDH2 gene is mutated, the IDH1 or IDH2 protein is changed
and does not function properly. This results in changes in the cell that can lead
to the development of cancer. VORANIGO blocks the mutated form of the IDH1 or IDH2
protein and helps to slow or stop the cancer from growing.
VORANIGO is used to treat adults and adolescents from 12 years of age and older with
cancers of the brain called astrocytoma or oligodendroglioma following surgery.
This medicine is only used in patients whose brain cancer is related to a change (mutation)
in the IDH1 or IDH2 protein.
Your doctor will perform a test to check if your cancer has an IDH1 or IDH2 mutation
to make sure that VORANIGO is the right treatment for you.
Speak to your doctor if you have any questions about this test and the results.
2. What should I know before I use VORANIGO?
There are some people who should not take VORANIGO. Please read the list below. If
you think any of these situations apply to you or you have any questions, please see
your doctor.
Warnings
Do not use VORANIGO if:
you are allergic to vorasidenib, the active ingredient in VORANIGO, or any of the
other ingredients listed in section 7. Product details
you are pregnant or plan to become pregnant
you have a rare hereditary problems of galactose intolerance, total lactase deficiency
or glucose-galactose malabsorption, as VORANIGO contains lactose
you are under 12 years of age.
Precautions when taking VORANIGO
Blood tests including liver function tests (ALT, AST and total bilirubin) must be
monitored before starting VORANIGO, every two weeks for the first 2 months of treatment
and then monthly throughout the duration of the treatment or as clinically indicated.
The dose of VORANIGO may be reduced, stopped temporarily or permanently according
to your liver function test results.
Check with your doctor if:
you have severe liver problems as you may be treated with VORANIGO only after careful
risk/benefit assessment and will be closely monitored
you have kidney problems
you 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
It is important to tell your doctor if you are pregnant or intend to become pregnant,
or if you are breastfeeding or intend to breastfeed.
Pregnancy
VORANIGO is not recommended for use during pregnancy as it may harm the unborn baby.
People of child-bearing age should have a pregnancy test prior to starting treatment
with VORANIGO and should avoid becoming pregnant during therapy.
If you are pregnant, think you might be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine. Contact your doctor immediately
if you become pregnant whilst taking VORANIGO.
As VORANIGO may affect an unborn developing baby, it is important for women not to
become pregnant for at least 3 months after treatment discontinuation.
Contraception in women and men
People who might become pregnant, and people who have partners who might become pregnant,
should use effective contraception during treatment with VORANIGO and for at least
3 months after the last dose.
VORANIGO may stop hormonal contraceptives from working properly. If you or your partner
use a hormonal contraceptive (e.g. birth control pills, or contraceptive patches or
implants), you should also use a barrier method (e.g. condoms or a diaphragm) to avoid
pregnancy. Talk to your doctor about the right contraceptive method for you and your
partner.
Breastfeeding
It is not known if VORANIGO passes into breast milk. Do not breastfeed your baby during
treatment with VORANIGO and for at least 2 months after the last dose.
Fertility
It is not known if VORANIGO affects fertility. If you are concerned about your fertility
whilst taking VORANIGO talk to your doctor.
Elderly
No dose adjustment for patients 65 years and above.
Children
Do not give this medicine to children under 12 years old because there is no information
about its use 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.
This is because they may reduce how well VORANIGO works or increase the risk of side
effects, or VORANIGO may affect the way these other medicines work.
In particular, tell your doctor if you are taking any of the following medications:
Medicines that may increase the effect of VORANIGO include:
fluvoxamine (medicine used for depression)
ciprofloxacin (antibiotics used for bacterial infections)
Medicines that may reduce the effect of VORANIGO include:
phenytoin (medicine used for epilepsy)
rifampicin (antibiotics used for bacterial infections)
VORANIGO may decrease the effect of these medications:
alfentanil, midazolam (medicine used for anaesthesia in surgery)
carbamazepine (medicine used for epilepsy)
ciclosporin, everolimus, sirolimus, tacrolimus (medicines used after organ transplants
known as immunosuppressants)
fentanyl (medicine used for severe pain)
ifosfamide, ibrutinib (medicines used for cancer)
tamoxifen (medicine used to prevent breast cancer)
darunavir (medicine used for HIV)
hormonal contraceptives.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VORANIGO.
4. How do I use VORANIGO?
How much to take / use
Always take this medicine exactly as your doctor has instructed. Check with your doctor
if you are unsure.
The recommended dose is:
40 mg orally once daily if you weigh at least 40 kg
20 mg orally once daily if you weigh less than 40 kg
You should not eat food at least 2 hours before and 1 hour after taking VORANIGO,
as it can affect how this medicine works. Swallow the tablets whole with water. Do
not split, crush or chew the tablets.
Do not swallow the silica gel desiccant found in the bottle. The silica gel desiccant
helps protect the tablets from moisture. (See Section 5. What should I know while
using VORANIGO?)
If you vomit after taking your usual dose, do not take additional tablets. Take your
next dose as usual on the following day.
When to take VORANIGO
VORANIGO should be taken once daily orally at about the same time each day.
If you forget to take VORANIGO
If a dose is missed or not taken at the usual time (within 6 hours), take the tablets
as soon as possible.
If you missed by more than 6 hours, you should skip the tablets and take the next
dose as usual on the following day.
If you take too much VORANIGO
If you think that you have taken too much VORANIGO, you may need urgent medical attention.
You should immediately do one of the following:
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 one of the above even if there are no signs of discomfort or poisoning.
5. What should I know while using VORANIGO?
Things you should do
Regular Tests
You will be monitored closely by your doctor before and during treatment with VORANIGO.
You will need to have regular blood tests of your liver function, including ALT, AST
and total bilirubin before starting VORANIGO, every 2 weeks during the first 2 months
of treatment and then monthly throughout the duration of the treatment or as clinically
indicated.
The dose of VORANIGO may be reduced, VORANIGO may be stopped temporarily or permanently
according to your liver function test results.
Call your doctor straight away or go straight to the Emergency Department if you experience
any serious side effects:
Remind any doctor, dentist or pharmacist you visit that you are using VORANIGO.
Things you should not do
Do not stop using VORANIGO suddenly without consulting your doctor.
Driving or using machines
This medicine is not likely to affect your ability to drive or use any tools or machines,
but if you feel unwell after taking VORANIGO, do not drive or use any tools or machines
until you feel well again.
Drinking alcohol
Tell your doctor if you drink alcohol.
Drinking alcohol could worsen certain side effects that you may have with VORANIGO.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place below 30°C. Do not store it in the refrigerator, bathroom,
near a sink, in the car, or on windowsills.
Keep the bottle tightly closed.
Keep Out of Reach of Children.
When to discard your medicine
Once opened, VORANIGO should be used within 60 days.
Do not use this medicine after the expiry date which is printed on the bottle label
and box after the expiry date.
The expiry date is the last day of the printed month.
Getting rid of any unwanted medicine
If you no longer need to use VORANIGO or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects. Some side effects may need medical attention.
Ask your doctor or pharmacist if you have any further questions about side effects
after reading the below information.
Less 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
VORANIGO is only available with a doctor's prescription.
What VORANIGO contains
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Active ingredient
(main ingredient)
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Vorasidenib
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Other ingredients
(inactive ingredients)
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Microcrystalline cellulose
Croscarmellose sodium
Silicified microcrystalline cellulose
Magnesium stearate
Sodium lauryl sulfate
Hypromellose
Titanium dioxide
Macrogol 400
Lactose monohydrate
OPACODE WB monogramming ink NS-78-17821 BLACK
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Do not take this medicine if you are allergic to any of these ingredients.
What VORANIGO looks like
10 mg film-coated tablets
White to off-white, round, film-coated tablets, imprinted with ‘10’ in black ink on
one side and plain on the other side.
40 mg film-coated tablets
White to off-white, oblong, film-coated tablets, imprinted with ‘40’ in black ink
on one side and plain on the other side.
VORANIGO is available in a white, high-density polyethylene (HDPE) bottle with polypropylene
(PP) child resistant closure and polyethylene (PE) faced induction heat seal liner.
Each bottle contains 30 film-coated tablets and a silica gel desiccant in a HDPE canister.
The bottles are packaged in a cardboard box; each box contains 1 bottle.
VORANIGO is registered on the Australian Register of Therapeutic Goods. Australian
Register Numbers:
VORANIGO 10mg: AUST R 435450
VORANIGO 40mg: AUST R 438499
Who distributes VORANIGO
Servier Laboratories (Aust.) Pty. Ltd.
Level 4, Building 9
588A Swan Street,
Burnley, 3121, Victoria
This leaflet was prepared in September 2024.