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.
1. Why am I given ISTODAX?
ISTODAX contains the active ingredient romidepsin. ISTODAX is used to treat a type
of cancer called peripheral T-cell lymphoma, or PTCL, in patients who have received
at least one previous treatment for this condition.
2. What should I know before I am given ISTODAX?
Do not use if you have ever had an allergic reaction to romidepsin 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 ISTODAX and affect how it works.
4. How am I given ISTODAX?
ISTODAX will be given to you as an intravenous (IV) infusion into your vein by your
doctor or nurse.
Your doctor will choose the correct dose of ISTODAX for you.
5. What should I know while using ISTODAX?
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Things you should do
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Remind any doctor, dentist, pharmacist, nurses or healthcare professionals you visit
that you are using ISTODAX.
Tell all doctors, dentists, and pharmacists who are treating you that you are being
given ISTODAX.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being
given ISTODAX.
Drink plenty of fluid while taking ISTODAX.
Keep all of your doctor's appointments so that your progress can be checked.
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Driving or using machines
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ISTODAX may cause tiredness or the feeling of weakness in some people. If you have
any of these symptoms, do not drive, operate machinery or do anything else that could
be dangerous.
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6. Are there any side effects?
Like all medicines, ISTODAX can cause side effects. Your doctor will discuss potential
side effects with you and will explain the risks and benefits of your treatment. Some
side effects can be serious and you may require medical attention. Contact your doctor
immediately or go to the Emergency Department at your nearest hospital if you have
any signs or symptoms (changes to your normal self), particularly if they are getting
worse or do not go away.
(ISS toe dax)
Active ingredient(s):
romidepsin (roe" mi dep' sin)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ISTODAX. 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 ISTODAX.
Where to find information in this leaflet:
1. Why am I given ISTODAX?
ISTODAX contains the active ingredient romidepsin. ISTODAX is a type of anti-cancer medicine that belongs to a group of medicines known
as histone deacetylase or HDAC inhibitors.
ISTODAX is used to treat a type of cancer called peripheral T-cell lymphoma, or PTCL,
in patients who have received at least one previous treatment for this condition.
PTCL is a disease in which a type of white blood cell from your immune system, called
T-cells, grows abnormally. ISTODAX works by slowing or stopping the growth of these
cancer cells. This medicine has also been shown to kill cancer cells.
2. What should I know before I am given ISTODAX?
Warnings
Do not use ISTODAX if:
you are allergic to romidepsin, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the 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
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes.
have a history of heart problems or are taking medicines used to help treat abnormal
rhythms of the heart (anti-arrhythmics).
ISTODAX treatment has been associated with the occurrence of abnormal heart rhythms.
Your doctor may conduct a heart function (electrocardiograph [ECG]) test before and
during treatment to monitor the activity of your heart.
have a history of blood conditions which affect the number of blood cells in your
body.
This medicine can cause a reduction in the numbers of blood cells. Your doctor will
ask you to take regular blood tests to monitor the levels of your blood cells.
have a history of frequent infections, or a history of hepatitis B or Epstein Barr
virus infection.
This medicine can cause a reduction in the numbers of blood cells used by the body
to fight infection. Your doctor will ask you to take regular blood tests to monitor
the levels of your blood cells.
are pregnant or plan to become pregnant.
ISTODAX can harm your unborn baby. Your doctor will ask you to have a pregnancy test
prior to starting treatment with ISTODAX. Your doctor can discuss with you the risks
and benefits of using this medicine during pregnancy.
use reliable means of contraception during treatment and treatment interruptions,
and for at least 4 weeks after ISTODAX treatment has stopped.
Your doctor will tell you what method of contraception to use.
are breast-feeding or plan to breast-feed.
It is not known if ISTODAX passes into breast milk. Your doctor will help to decide
if you should stop breast-feeding when you start treatment with this medicine.
have a history of kidney problems.
have problems with the amount of potassium or magnesium in your blood.
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
Check with your doctor if you are pregnant or intend to become pregnant.
ISTODAX is not recommended for use in pregnant women. ISTODAX can harm your unborn
baby. Your doctor will ask you to have a pregnancy test prior to starting treatment
with ISTODAX. Your doctor can discuss with you the risks and benefits of using this
medicine during pregnancy.
Use reliable means of contraception during treatment and treatment interruptions,
and for at least 4 weeks after ISTODAX treatment has stopped. Your doctor will tell
you what method of contraception to use.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known if ISTODAX passes into breast milk. Your doctor will help to decide
if you should stop breast-feeding when you start treatment with this medicine.
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 each other. These include:
warfarin or any other blood thinner used to prevent blood clots
medicines used to treat heart problems such as arrhythmia (irregular beating of the
heart)
medicines used to treat fungal infections (such as ketoconazole)
medicines used to treat tuberculosis (such as rifampin)
oestrogen-containing oral contraceptive pills for women
St John's Wort.
These medicines may be affected by ISTODAX or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking ISTODAX.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ISTODAX.
4. How am I given ISTODAX?
How is ISTODAX given
ISTODAX will be given to you as an intravenous (IV) infusion into your vein by your
doctor or nurse.
Your doctor will choose the correct dose of ISTODAX for you.
Your dose will depend on your general condition and your height and weight.
Your dose will be calculated based on your body surface area, with the usual dose
of 14 mg ISTODAX per metre squared of body surface area.
ISTODAX will be given to you over a 4-hour period on Days 1, 8 and 15 of a 28-day
cycle. These cycles may be repeated for as long as you continue to receive benefit
from ISTODAX.
Your doctor will check your progress and may change your dose if necessary.
Your doctor may also give you another medicine to help stop you feeling sick (nausea)
and vomiting.
If you have any questions on the use of ISTODAX, ask your doctor.
If you miss a dose of ISTODAX
It is very important for you to keep all appointments to receive ISTODAX. If you miss
an appointment, ask your doctor when to schedule your next dose.
If you are given too much ISTODAX
As ISTODAX 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 ISTODAX, tell your doctor
immediately.
5. What should I know while receiving ISTODAX?
Things you should do
Tell all doctors, dentists, pharmacists, nurses or healthcare professionals who are treating you that you are being given ISTODAX.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being
given ISTODAX.
It may affect other medicines used during or after the surgery.
Drink plenty of fluid while taking ISTODAX. Discuss with your doctor how much water
you should drink.
Having enough fluids may help to reduce the chances of dehydration.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will need to perform regular ECG (heart function) tests and blood tests.
Call your doctor straight away if you:
become pregnant while being given ISTODAX.
Remind any doctor, dentist, pharmacist, nurses or healthcare professionals you visit
that you are using ISTODAX.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ISTODAX
affects you.
ISTODAX may cause tiredness or the feeling of weakness in some people. If you have
any of these symptoms, do not drive, operate machinery or do anything else that could
be dangerous.
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.
Serious side effects
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Serious side effects
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What to do
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Sudden signs of allergy such as rash, itching or hives on the skin; swelling of the
face, lips or tongue or other parts of the body; and/or shortness of breath, wheezing
or trouble breathing.
Symptoms of infection such as fever, chills, sore throat, cough, shortness of breath
with or without chest pain, mouth ulcers, burning with urination, flu-like symptoms
or any other sign of infection.
You may have a low number of white blood cells that fight infection. Patients receiving
ISTODAX can develop serious infections that sometimes lead to death.
Abnormal heart-beat, or feeling dizzy or faint.
This could be due to a change in your heart-rate and/or low levels of potassium or
magnesium in your blood.
Sudden pain in your chest or difficulty in breathing.
This may be due to blood clots in the artery leading to your lungs.
Pain or swelling in your legs, especially in your lower leg or calves.
This may be due to blood clots in the veins of your leg.
Heavy bleeding in the absence of injury.
You may have a very low number of platelets, which are the blood cells that help to
clot your blood.
Racing heart, extreme fatigue, headaches.
You may have a very low number of red blood cells that carry oxygen.
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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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Other 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 ISTODAX contains
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Active ingredient
(main ingredient)
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romidepsin
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Other ingredients
(inactive ingredients)
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Povidone
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Solvent
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Propylene glycol
Anhydrous ethanol
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Potential allergens
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Does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What ISTODAX looks like
ISTODAX is supplied as a dual pack with one vial containing the white to off-white
Istodax powder and the other vial containing a clear solvent.
Registration Numbers
ISTODAX (romidepsin) 10mg powder for injection vial and solvent for reconstitution
vial (AUST R 198854)
Who distributes ISTODAX
Celgene Pty Limited
Level 2, 4 Nexus Court
Mulgrave VIC 3170
Telephone: 1800 CELGENE (1800 235 4363)
ISTODAX® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb
Company
This leaflet was prepared in June 2023.