This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side affects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
Consumer Medicine Information
This medicine has Provisional Approval in Australia for the treatment of adult patients
with relapsed or refractory acute myeloid leukaemia who are ineligible for haematopoietic
stem cell transplant, and who have an isocitrate dehydrogenase-2 (IDH2) mutation confirmed
by a validated diagnostic test.
The decision to approve this indication has been made on the basis of preliminary
clinical data from a Phase 1/2 clinical trial with a primary endpoint of overall response
rate. An improvement in OS or PFS has not been established. The sponsor is required
to submit further clinical data to confirm the efficacy and safety of the medicine.
WARNING: DIFFERENTIATION SYNDROME
Patients treated with IDHIFA have experienced symptoms of differentiation syndrome,
which can be fatal if not treated. Symptoms may include shortness of breath or trouble
breathing, chest pain, bone pain, cough, fever, or chills, swelling of legs and arms,
swelling around the neck, groin or underarm area and fast weight increase. Speak to
your doctor immediately or go to the nearest hospital emergency room right away, if
you experience any of the above symptoms of differentiation syndrome while taking
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Idhifa.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Idhifa against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT IDHIFA IS USED FOR
Idhifa contains an active substance called enasidenib, which is a medicine that blocks
the action of an abnormal enzyme in our blood cells.
Idhifa has provisional approval in Australia to treat patients diagnosed with acute
myeloid leukaemia (AML) caused by a mutation (change) of the enzyme isocitrate dehydrogenase-2
(IDH2). It is prescribed for patients whose disease has come back after another treatment
or has not improved with another treatment and who are not eligible for a stem cell
transplant. The decision to approve this medicine has been made on the basis of promising
results from preliminary studies. More evidence is required to be submitted when available
to fully confirm the benefit and safety of Idhifa for this use.
AML is a form of cancer which affects our bone marrow and can cause problems with
producing normal blood cells.
Normal IDH2 enzyme plays an important role in making energy for cells. Mutations in
the IDH2 enzyme cause the bone marrow to stop producing normal blood cells that transport
oxygen, fight infection or stop bleeding.
Idhifa blocks the activity of mutated IDH2 enzyme resulting in an increase in the
number of functional blood cells.
This medicine should only be used to treat AML with the IDH2 mutation. Therefore,
before starting treatment your doctor will test for this mutation.
Ask your doctor if you have any questions about how Idhifa works, or why this medicine
has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
Idhifa will only be prescribed to you by a doctor who has experience in medicines
to treat cancers.
BEFORE YOU TAKE IDHIFA
When you must not take it:
Do not take Idhifa if you have an allergy to enasidenib or any of the other ingredients
listed at the end of this leaflet.
Some of the general symptoms of an allergic reaction may include:
shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue or other parts of the body,
rash, itching or hives on the skin.
If you think you may be allergic to Idhifa, ask your doctor for advice.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it:
Follow your doctor’s instructions carefully.
You will have been given specific instructions by your doctor particularly on the
potential effects of enasidenib within 10 days and up to 5 months after initiation
If you have not fully understood these instructions, ask your doctor again before
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Your doctor will ask you to have regular blood tests during treatment with Idhifa.
Your doctor may adjust your dose of Idhifa or stop your treatment based on the results
of your blood tests and on your general condition.
Do not give this medicine to a child or adolescent under the age of 18 years.
Safety and effectiveness in children younger than 18 years have not been established.
For women taking Idhifa
Before starting this treatment, your doctor will discuss your potential to become
pregnant, even if you think this is unlikely. If you are pregnant, think you may be
pregnant or are planning to have a baby, ask your doctor for advice before taking
Your doctor will arrange a pregnancy test before you start your treatment.
Do not use this medicine during pregnancy.
This is because it is not known how it may affect the baby.
Use reliable means of contraception during treatment and treatment interruption, and
for at least 2 monthly cycles after the last dose of Idhifa.
Your doctor will tell you what method of contraception to use.
Do not breastfeed during treatment with Idifa and for at least 2 monthly cycles after
the last dose.
For men taking Idhifa
Before starting this treatment, discuss with your doctor if your partner is able to
If your partner is able to become pregnant, use reliable means of contraception during
Idhifa treatment, during treatment interruption, and for at least 2 months after the
last dose of the medicine.
Your doctor will tell you what method of contraception to use.
Taking other medicines:
Tell your doctor or pharmacist if you are taking any other medicines or have recently
taken any other medicines, including any medicines that you buy without a prescription
from a pharmacy, supermarket or health food shop.
HOW TO TAKE IDHIFA
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
How much to take
The usual starting does of Idhifa is one 100 mg tablet taken orally once each day.
Your doctor will check your progress and may decrease your dose if needed.
How to take it:
Swallow the tablets whole with a full glass of water, once a day as directed by your
Idhifa can be taken with or without food. The tablets should not be chewed, split
When to take it:
Take your medicine at about the same time each day.
How long to take it:
Continue taking Idhifa until your doctor asks you to stop.
If you forget to take it:
If you have missed a dose of Idhifa, take a tablet as soon as possible on the same
day, and return to the normal schedule the following day.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
If you take too much Idhifa (overdose):
In Australia, immediately telephone your doctor or Poisons Information Centre (telephone
13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if
you think that you or anyone else may have taken too much Idhifa.
Do this even if there are no signs of discomfort or poisoning. Keep the telephone
numbers for these places handy.
WHILE YOU ARE TAKING IDHIFA
Things you must do:
Tell your doctor immediately if you suspect that you may be pregnant.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
If you are about to be started on any new medicine, remind your doctor, dentist or
pharmacist that you are taking Idhifa
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor will do some blood tests regularly to make sure the medicine is working
and to prevent unwanted side effects.
Things you must not do:
Do not become pregnant whilst taking Idhifa.
Do not have sexual intercourse without using effective means of contraception described
to you by your doctor.
Do not stop taking Idhifa (unless you suspect that you are pregnant) or change the
dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give this medicine to anyone else, even if they have the same condition as
Do not take this medicine to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Things to be careful of:
Be careful driving or operating machinery until you know how Idhifa affects you.
This medicine is not likely to affect you being able to drive, cycle or use any tools
Tell your doctor or pharmacist as soon as possible if your symptoms worsen while you
are taking Idhifa.
Like all medicines, Idhifa can have side effects, although not everybody gets them
and some are uncommon. Sometimes they are serious, most of the time they are not.
You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list of side effects. You may not experience any
Tell your doctor if you notice any of the following and they worry you:
Diarrhoea, feeling sick (nausea), vomiting, decrease in appetite.
The above list mainly includes the more common side effects of your medicine.
Tell your doctor immediately if you notice the following:
shortness of breath or trouble breathing, chest pain, bone pain, cough, fever, or
chills, swelling of legs and arms, swelling around the neck, groin or underarm area
and fast weight increase.
These may be signs of a condition called the differentiation syndrome that can occur
within 10 days to five months after starting the medicine.
high temperature, feeling tired, sick (nausea), or weak, tingling or pain in your
legs, stomach, or arms, trouble breathing.
diarrhoea, feeling sick (nausea), being sick (vomiting), decreased appetite.
These symptoms may get better after the first month of treatment.
muscle cramps or twitches, weakness, confusion, producing less urine.
These may be signs of a condition called tumour lysis syndrome and can occur within
the first three months of treatment.
your skin appears yellowish.
This may be caused by an increased amount of a substance called bilirubin in your
blood and can occur during the first month of treatment.
The above list includes serious side effects that may require medical attention.
If any of the following happens (symptoms of general allergic reactions), stop taking
Idhifa and see a doctor immediately or go to Accident and Emergency at your nearest
Shortness of breath, wheezing or difficulty breathing; swelling of the face, lips,
mouth tongue or throat which may cause difficulty in swallowing or breathing; swelling
of other parts of the body; rash, itching or hives on the skin; flaking or peeling
of the skin.
These could be symptoms of an allergic reaction.
The above list includes very serious side effects. You may need urgent medical attention
Tell your doctor or pharmacist immediately if any of the side effects gets worse,
or if you notice any other side effects not listed in this leaflet.
AFTER TAKING IDHIFA
Keep the bottle of tablets tightly closed to protect from moisture.
Store in a cool dry place where the temperature stays below 25°C.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed,
take any unused Idhifa tablets to your pharmacist.
Medicines should not be disposed of via wastewater or household waste. These measures
will help to protect the environment.
What Idhifa looks like
The film-coated tablets are packaged in high density polyethylene (HDPE) bottles with
a desiccant, induction seal and liner (tamper evident), and child resistant cap. Each
bottle contains 30 tablets.
Idhifa 50 mg tablets are pale yellow to yellow oval-shaped film-coated tablets, engraved
with "ENA" on one side and "50" on the other side.
Idhifa 100 mg tablets are pale yellow to yellow capsule-shaped film-coated tablets,
engraved with "ENA" on one side and "100" on the other side
Idhifa tablets contain an active ingredient called enasidenib.
The other ingredients in the tablets are:
Microcrystalline cellulose, sodium starch glycollate, hydroxypropyl cellulose, colloidal
silicon dioxide, magnesium stearate, hypromellose acetate succinate, sodium lauryl
sulfate (E 487).
The capsule shells contain:
Opadry II Yellow Film Coating: polyvinyl alcohol, titanium dioxide (E171), polyethylene
glycol 3350 (Macrogol 3350 / PEG 3350), purified talc, iron oxide yellow (E172)
Idhifa is supplied in Australia by:
Celgene Pty Limited
Level 15, 60 City Road
Southbank VIC 3006.
Telephone: 1800 CELGENE (1800 235 4363).
This leaflet was updated in January 2020.
Australian Registration Numbers:
Idhifa (enasidenib) 50 mg film-coated tablets - AUST R 311541
Idhifa (enasidenib) 100 mg film-coated tablets - AUST R 311542
® = Registered Trademark
(Celgene Version 1.0.0)