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.
 
IDHIFA ®
  • Download PDF Standard Print
  • Download PDF Large Print
(enasidenib)
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 IDHIFA.
 
 

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 of treatment.
If you have not fully understood these instructions, ask your doctor again before taking Idhifa.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
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 this medicine.
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 become pregnant.
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 doctor.
Idhifa can be taken with or without food. The tablets should not be chewed, split or crushed.

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 some hints.

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:

Female patients:
Tell your doctor immediately if you suspect that you may be pregnant.
All patients:
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Idhifa.
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:

Female patients:
Do not become pregnant whilst taking Idhifa.
All patients:
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 you.
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 or machines.

SIDE EFFECTS

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 of them.
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 hospital:
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 or hospitalisation.
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

Storage

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.

Disposal

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.

PRODUCT DESCRIPTION

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

Ingredients

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)

Distributor:

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)

  • Download PDF Standard Print
  • Download PDF Large Print