Bendamustine hydrochloride powder for injection vial
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about BENDAMUSTINE VIATRIS. 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 being
given BENDAMUSTINE VIATRIS against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet while being treated.
You may need to read it again.
What BENDAMUSTINE VIATRIS is used for
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.
This medicine is available only with a doctor's prescription.
Before you are given BENDAMUSTINE VIATRIS
When you must not use it
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;
Are breastfeeding;
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.
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
Do not use this medicine if you are pregnant.
Like most medicines used to treat cancer, BENDAMUSTINE VIATRIS is not recommended
for use during pregnancy.
Do not breastfeed if you are using this medicine.
Before you start to use it
Tell 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.
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.
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.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start
taking BENDAMUSTINE VIATRIS.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
shop.
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.
How BENDAMUSTINE VIATRIS is 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.
What do I do if I receive too much? (overdose)
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, tell your doctor or nurse immediately or go to Accident
and Emergency at your nearest hospital.
You may need urgent medical attention.
While you are using BENDAMUSTINE VIATRIS
Things you must 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.
If you become pregnant while taking this medicine, tell your doctor immediately.
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.
Things to be careful of
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. If you have any of these symptoms, do not drive, operate machinery or
do anything else that could be dangerous.
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.
Side effects
Like all medicines, BENDAMUSTINE VIATRIS can have side effects. Some of these effects
may be serious. However, there may be ways to reduce the discomfort of these effects.
You may need medical treatment if you get some of the side effects.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well
while you are being treated with BENDAMUSTINE VIATRIS.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
Low counts of white blood cells; decrease in the red pigment of the blood (haemoglobin);
low counts platelets; decreased number of red blood cells (anaemia)
Infections
Feeling sick (nausea); vomiting; fatigue; chills, fever, headache or cough
Mucosal inflammation
Increased blood level of creatinine, glucose or urea
Bleeding
Hypersensitivity reactions such as allergic inflammation of the skin (dermatitis),
nettle rash (urticaria)
A rise in liver enzymes AST/ALT
A rise in bile pigment
A rise in the enzyme alkaline phosphatase
Low potassium, sodium or calcium blood levels
Disturbed function of the heart; disturbed heart rhythms (arrhythmia)
Low or high blood pressure
Diarrhoea; constipation, or stomach pain
Sore mouth
Loss of appetite or weight loss
Hair loss
Missed periods (amenorrhoea)
Insomnia, anxiety, or depression
Dehydration including excessive thirst and urine production
Tell your doctor as soon as possible if you notice any of the following:
Infection of the blood (sepsis)
Severe allergic hypersensitivity reactions (anaphylactic reactions); signs similar
to anaphylactic reactions (anaphylactoid reactions)
Drowsiness
Loss of voice (aphonia)
Acute circulatory collapse
Reddening of the skin (erythema); inflammation of the skin (dermatitis); itching;
skin rash
Excessive sweating
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
Pneumonia (primary atypical inflammation of the lungs)
Break-down of red blood cell
Anaphylactic shock (rapid decrease in blood pressure sometimes with skin reactions
rash)
Disturbed sense of taste; altered sensations
Feeling unwell; pain in the limbs
Anticholinergic syndrome (disease of the nervous system); neurological disorders
Ataxia (lack of coordination)
Inflammation of the brain; inflammation of the veins
Increased heart rate; heart attack; chest pain; heart failure
Formation of tissue in the lungs (fibrosis of the lungs)
Bleeding inflammation of the gullet; bleeding stomach
Infertility
Multiple organ failure.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
After using BENDAMUSTINE VIATRIS
Storage
BENDAMUSTINE VIATRIS should be kept in a cool dry place, protected from light, where
temperature stays below 25°C.
Product description
What it 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.
Ingredients
BENDAMUSTINE VIATRIS contains 25 mg or 100 mg of bendamustine hydrochloride as the
active ingredient.
The vial also contains the following inactive ingredient:
mannitol
Sponsor
BENDAMUSTINE VIATRIS is supplied in Australia by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
This leaflet was prepared in December 2022.
Australian registration numbers:
BENDAMUSTINE VIATRIS 25 mg: AUST R 320951
BENDAMUSTINE VIATRIS 100 mg: AUST R 320950
BENDAMUSTINE VIATRIS_cmi\Dec22/00