- bendamustine hydrochloride monohydrate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0765 .
Bendamustine hydrochloride 2.5mg/ml Powder
PACKAGE LEAFLET: INFORMATION FOR THE USER
Bendamustine hydrochloride 2.5 mg/ml Powder for concentrate for solution for infusion
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What bendamustine is and what it is used for
2. What you need to know before you use bendamustine
3. How to use bendamustine
4. Possible side effects
5. How to store bendamustine
6. Contents of the pack and other information
1. WHAT BENDAMUSTINE IS AND WHAT IT IS USED FOR
Bendamustine hydrochloride 2.5mg/ml Powder for concentrate for solution for infusion is a medicine containing an active substance called bendamustine hydrochloride (hereafter called bendamustine).
Bendamustine is a medicine which is used for the treatment of certain types of cancer (cytotoxic medicine).
Bendamustine is used alone (monotherapy) or in combination with other medicines for the treatment of the following forms of cancer:
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BENDAMUSTINE
Do not use bendamustine
Do not use bendamustine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before using bendamustine.
Warnings and precautions
Talk to your doctor or pharmacist before using bendamustine
Other medicines and bendamustine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If bendamustine is used in combination with medicines which inhibit the formation of blood in the bone marrow, the effect on the bone marrow may be intensified.
If bendamustine is used in combination with medicines which alter your immune response, this effect may be intensified.
Cytostatic medicines may diminish the effectiveness of live-virus vaccination. Additionally cytostatic medicines increase the risk of an infection after vaccination with live vaccines (e.g. viral vaccination).
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Bendamustine can cause genetic damage and has caused malformations in animal studies. You should not use bendamustine during pregnancy unless certainly indicated by your doctor. In case of treatment you should use medical consultation about the risk of potential adverse effects of your therapy for the unborn child and genetic consultation is recommended.
Bendamustine must not be administered during breastfeeding. If treatment with bendamustine is necessary during lactation you must discontinue breastfeeding.
If you are a woman of childbearing potential you must use an effective method of contraception both before and during treatment with bendamustine. If pregnancy occurs during your treatment with bendamustine you must immediately inform your doctor and should use genetic consultation.
If you are a man, you should avoid fathering a child during treatment with bendamustine and for up to 6 months after treatment has stopped. There is a risk that treatment with bendamustine will lead to infertility and you may wish to seek advice on conservation of sperm before treatment starts.
Men receiving treatment with bendamustine are advised not to conceive a child during treatment and for up to 6 months afterwards. Before starting treatment, you should seek advice on storing sperm because of the possibility of permanent infertility.
Driving and using machines
No studies on the effects on the ability to drive and to use machines have been performed. Do not drive or operate machines if you experience side effects, such as dizziness or lack of coordination.
3. HOW TO USE BENDAMUSTINE
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Bendamustine is administered into a vein over 30-60 minutes in various dosages, either alone (monotherapy) or in combination with other medicines.
Treatment should not be started if your white blood cells (leukocytes) have fallen to counts below determined levels. Your doctor will determine these values at regular intervals.
Chronic lymphocytic leukaemia
Bendamustine 100 mg per square metre of your body surface area (based on your height and weight) on Days 1+2
Repeat the cycle after 4 weeks up to 6 times
Bendamustine 120 mg per square metre of your body surface area (based on your height and weight) on Days 1+2
Repeat the cycle after 3 weeks at least 6 times
Bendamustine 120 – 150 mg per square metre of your body surface area (based on your height and weight) on Days 1+2
Prednisone 60 mg per square metre of your body surface area (based on your height and weight) i.v. or per os on Days 1 – 4
Repeat the cycle after 4 weeks at least 3 times
Treatment should be terminated if white blood cell (leukocyte) and/or platelet values dropped to determined levels. Treatment can be continued after white blood cell and platelet values have increased.
Impaired liver or kidney function
Dependent on the degree of impairment of your liver function it may be necessary to adjust your dose (by 30% in case of moderate liver dysfunction). No dose adjustment is necessary in case of impairment of kidney function. Your attending doctor will decide whether a dosage adjustment is necessary.
How it is administered
Treatment with bendamustine should be undertaken only by doctors experienced in tumour therapy. Your doctor will give you the exact dose of bendamustine and use the necessary precautions.
Your attending doctor will administer the solution for infusion after preparation as prescribed. The solution is administered into a vein as a short-term infusion over 30 – 60 minutes.
Duration of use
There is no time limit laid down as a general rule for treatment with bendamustine. Duration of treatment depends on disease and response to treatment.
If you are at all worried or have any questions regarding treatment with bendamustine, please speak to your doctor or nurse.
If you forget to use bendamustine
If a dose of bendamustine has been forgotten, your doctor will usually retain the normal dosage schedule.
If you stop using bendamustine
The doctor treating you will decide whether to interrupt the treatment or to change over to a different preparation.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the findings listed below may be found after tests are performed by your doctor.
Tissue decay (necrosis) has been observed very rarely following leakage of bendamustine into the tissue outside the blood vessels (extravascular). A burning sensation where the infusion needle is inserted may be a sign of leakage outside the blood vessels. The consequence can be pain and poorly healing skin defects.
The dose-limiting side-effect of bendamustine is impaired bone-marrow function, which usually returns to normal after treatment. Suppressed bone marrow function may lead to low blood cells, which in turn may lead to an increased risk of infection, anaemia or a heightened risk of bleeding.
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Not known side effects (cannot be estimated from the available data)
There have been reports of tumours (myelodysplastic syndrome, AML, bronchial carcinoma) following treatment with bendamustine. No clear relationship with bendamustine could be determined.
Contact your doctor or seek medical attention immediately if you notice any of the following side effects (frequency not known):
Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Widespread rash, high body temperature, enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE BENDAMUSTINE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label carton after ‘EXP’. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.
Keep the container in the outer carton to protect the content from light.
Note on shelf-life after opening or preparing the solution
Solutions for infusions prepared according to the directions listed at the end of this leaflet are stable in polyethylene bags at room temperature / 60% relative humidity for 3.5 hours, and in a refrigerator they are stable for 2 days. Bendamustine contains no preservatives. The solutions should not therefore be used after these lengths of time. It is the responsibility of the user to maintain aseptic conditions
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What bendamustine contains
After reconstitution 1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride.
What Bendamustine looks like and contents of the pack
White to off-white freeze-dried powder in an amber glass vial with a stopper and alu-cap with flip-top
Type I glass vials of 25 ml or 50 ml.
Packs containing: 25 mg: 1, 5, 10, 20 vials. 100 mg: 1, 5 vials. Not all pack sizes may be marketed.
The Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
This leaflet was last revised in April 2019
‘Zentiva’ is a registered trademark. © 2019 Zentiva