2. What should I know before I am given BENDAMUSTINE VIATRIS?
Do not use if you have ever had an allergic reaction to bendamustine hydrochloride
or any of the ingredients listed at the end of the CMI.
3. What if I am taking other medicines?
4. How is BENDAMUSTINE VIATRIS given?
Your treatment with BENDAMUSTINE VIATRIS will take place in a specialised medical
unit, under the supervision of a doctor experienced in the use of cytotoxic medicinal
products.
Your doctor will decide what dose you will receive. The dose will be calculated from
your height and weight. It will also depend on factors such as kidney function, liver
function and other medicines you are being given.
5. What should I know while I am given BENDAMUSTINE VIATRIS?
|
Things you should do
|
Remind any doctor, nurse, dentist or pharmacist you visit that you are using BENDAMUSTINE
VIATRIS.
Keep all of your doctor’s appointments and keep follow-up appointments with your doctor
to check your progress.
Avoid people with infections.
Be careful when using a toothbrush, toothpick or dental floss.
Be careful not to cut yourself when you are using sharp objects such as a razor or
nail cutter
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how BENDAMUSTINE VIATRIS
affects you.
This medicine may cause sleepiness, dizziness, lack of coordination or fatigue in
some people.
|
|
Looking after your medicine
|
Store in a cool dry place, protected from light, where temperature stays below 25°C
|
6. Are there any side effects?
Less serious side effects: infections, feeling sick (nausea), vomiting, fatigue, chills, fever, headache or
cough, bleeding, hypersensitivity reactions such as allergic inflammation of the skin,
diarrhoea, constipation, stomach pain, sore mouth, loss of appetite, hair loss, missed
periods, insomnia, anxiety, or depression, dehydration. Serious side effects: drowsiness, severe allergic hypersensitivity reactions, inflammation or reddening
of the skin, loss of voice, excessive sweating, anaphylactic shock, disturbed sense
of taste, altered sensations, lack of coordination, chest pain. This is not a complete list of side effects.
Active ingredient(s):
bendamustine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BENDAMUSTINE VIATRIS. 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 BENDAMUSTINE VIATRIS.
Where to find information in this leaflet:
1. Why am I being given BENDAMUSTINE VIATRIS?
BENDAMUSTINE VIATRIS contains the active ingredient bendamustine hydrochloride. BENDAMUSTINE VIATRIS belongs to a group of medicines called antineoplastic or cytotoxic
medicines. You may also hear of these being called chemotherapy medicines. These medicines
are used to kill cancer cells.
BENDAMUSTINE VIATRIS is used for the treatment of certain types of cancer.
BENDAMUSTINE VIATRIS is used alone (monotherapy) or in combination with other medicines
for the treatment of the following forms of cancer:
Chronic lymphocytic leukaemia;
Indolent, Stage III-IV Non-Hodgkin's Lymphoma and Stage III-IV Mantle Cell Lymphoma.
It is prescribed for patients who have not been previously treated.
Indolent Non-Hodgkins Lymphoma. It is prescribed for patients who have received one
or more prior treatment and whose cancer is still progressing.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
2. What should I know before I am given BENDAMUSTINE VIATRIS?
Warnings
Do not use BENDAMUSTINE VIATRIS if you:
are hypersensitive (allergic) to the active substance, bendamustine hydrochloride
or any of the other ingredients listed at the end of this leaflet.
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.
Always check the ingredients to make sure you can use this medicine.
have severe liver dysfunction (damage to the functional cells of the liver);
have yellowing of the skin or whites of the eyes caused by liver or blood problems
(jaundice);
have severely disturbed bone marrow function (bone marrow depression) and serious
changes in your number of white blood cells and platelets in the blood;
have had major surgical operations less than 30 days before starting treatment;
have an infection, especially one accompanied by a reduction in white blood cells
(leukocytopaenia);
in combination with yellow fever vaccines.
Check with your doctor if you:
have or have had any of the following medical conditions:
reduced capability of the bone marrow to replace blood cells
infections, including fever or lung symptoms
skin reaction. The reaction may increase in severity
heart disease (e.g. heart attack, chest pain, severely disturbed heart rhythms)
hepatitis B infection
severe allergic or hypersensitivity reactions. You should pay attention to infusion
reactions after your first cycle of BENDAMUSTINE VIATRIS therapy.
take any medicines for any other condition.
Unintentional injection into the tissue outside blood vessels (extravasal injection)
should be stopped immediately. The needle should be removed after a short aspiration.
Thereafter, the affected area of tissue should be cooled. The arm should be elevated.
Additional treatments like the use of corticosteroids are not of clear benefit.
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
Do not use this medicine if you are pregnant or intend to become pregnant.
Like most medicines used to treat cancer, BENDAMUSTINE VIATRIS is not recommended
for use during pregnancy.
Do not use this medicine if you are breastfeeding or intend to breastfeed.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
Fertility
Women of childbearing potential must use effective methods of contraception both before
and during BENDAMUSTINE VIATRIS therapy. Men receiving treatment with BENDAMUSTINE
VIATRIS are advised not to conceive a child during treatment for up to 6 months afterwards.
Before starting treatment, you should seek advice on storing sperm because of the
possibility of permanent infertility.
If you have not told your doctor about any of the above, tell them before you start
taking BENDAMUSTINE VIATRIS.
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 BENDAMUSTINE VIATRIS and affect how it works.
In particular, tell your doctor if you are taking any of the following:
medicines that may result in excessive immunosuppression, such as cyclosporine or
tacrolimus.
fluvoxamine, medicines used to treat depression.
ciprofloxacin and aciclovir, medicines use to treat infections.
cimetidine, a medicine used to treat duodenal, gastric ulcers.
viral vaccination.
medicines that inhibit the formation of blood in the bone marrow.
These medicines may be affected by BENDAMUSTINE VIATRIS 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 this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BENDAMUSTINE VIATRIS.
4. How is BENDAMUSTINE VIATRIS given?
Your treatment with BENDAMUSTINE VIATRIS will take place in a specialised medical
unit, under the supervision of a doctor experienced in the use of cytotoxic medicinal
products.
Treatment should not be started if your white blood cells (leukocytes) have fallen
to counts below 3,000 cells/μL and/or your blood platelets have fallen to counts below
75,000 cells/μL. Your doctor will determine these values at regular intervals.
How much is given
Your doctor will decide what dose you will receive. The dose will be calculated from
your height and weight. It will also depend on factors such as kidney function, liver
function and other medicines you are being given.
Dose for Chronic Lymphocytic Leukaemia:
100 mg per square metre of your body surface area
Cycle should be repeated after 4 weeks up to 6 times.
Dose for progressing Non-Hodgkin's Lymphoma:
120 mg per square metre of your body surface area on days 1 and 2
Cycle should be repeated after 3 weeks up to 6 times
Dose for previously not treated indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma:
90 mg per square metre on days 1 and 2
Cycle should be repeated after 4 weeks up to 6 cycles.
Your doctor may change the dose during treatment depending on your response.
Ask your doctor if you want to know more about the dose of BENDAMUSTINE VIATRIS you
receive.
How is it given
BENDAMUSTINE VIATRIS will be dissolved in sterile normal sodium chloride (salt) solution
for injection.
BENDAMUSTINE VIATRIS is administered into a vein over 30-60 minutes in various dosages,
either alone (monotherapy) or in combination with other medicines.
How long is it given
There is no time limit laid down as a general rule for treatment with BENDAMUSTINE
VIATRIS. Duration of treatment depends on disease and response to treatment.
If I receive too much BENDAMUSTINE VIATRIS
As BENDAMUSTINE VIATRIS is given to you under supervision of your doctor, it is very
unlikely that you will receive too much. However, if you experience side effects after
being given BENDAMUSTINE VIATRIS, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, nurse, 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 I am being given BENDAMUSTINE VIATRIS?
Things you should do
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some blood, urine or other tests from time to time to make sure
the medicine is working and to prevent unwanted side effects.
Keep follow-up appointments with your doctor. It is important to have your follow-up
doses of BENDAMUSTINE VIATRIS at the appropriate times to get the best effects from
your treatment.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking BENDAMUSTINE VIATRIS.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine. It may affect other medicines used during surgery.
BENDAMUSTINE VIATRIS can lower the number of white blood cells and platelets in your
blood. This means that you have an increased chance of getting an infection or bleeding.
The following precautions should be taken to reduce your risk of infection or bleeding:
Avoid people who have infections. Check with your doctor immediately if you think
you may be getting an infection, or if you get a fever, chills, cough, hoarse throat,
lower back or side pain.
Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist,
nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with
your doctor before having any dental work.
Be careful not to cut yourself when you are using sharp objects such as a razor or
nail cutter.
Call your doctor straight away if you:
become pregnant while taking this medicine.
Things to be careful of
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BENDAMUSTINE
VIATRIS affects you.
BENDAMUSTINE VIATRIS may cause sleepiness, dizziness, lack of coordination or fatigue
in some people. If you have any of these symptoms, do not drive, operate machinery
or do anything else that could be dangerous.
Looking after your medicine
Store below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place 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.
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
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 BENDAMUSTINE VIATRIS contains
|
Active ingredient
(main ingredient)
|
bendamustine hydrochloride
|
|
Other ingredients
(inactive ingredients)
|
mannitol
|
Do not take this medicine if you are allergic to any of these ingredients.
What BENDAMUSTINE VIATRIS looks like
BENDAMUSTINE VIATRIS is a white to off-white lyophilised powder in a glass vial with
rubber stopper and an aluminium flip-off cap.
Each pack contains one single-use vial.
BENDAMUSTINE VIATRIS 25 mg: AUST R 320951
BENDAMUSTINE VIATRIS 100 mg: AUST R 320950
Who distributes BENDAMUSTINE VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in November 2025.
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