What Bendamustine ACTe is and what it is used for?
Bendamustine ACTe is a medicine which is used for the treatment of certain types of cancer (cytotoxic medicine).
Bendamustine ACTe is used alone (monotherapy) or in combination with other medicines for the treatment of the following forms of cancer:
Before you are given Bendamustine ACTe
You should not be given Bendamustine ACTe:
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before using Bendamustine ACTe in case of:
Other medicines and Bendamustine ACTe
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If Bendamustine ACTe 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 ACTe 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, breast-feeding 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 ACTe can cause genetic damage and has caused malformations in animal studies. You should not use Bendamustine ACTe 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.
If you are a woman of childbearing potential, you must use an effective method of contraception both before and during treatment with Bendamustine ACTe. If pregnancy occurs during your treatment with Bendamustine ACTe you must immediately inform your doctor and should use genetic consultation.
Bendamustine ACTe must not be administered during breast-feeding. If treatment with Bendamustine ACTe is necessary during lactation you must discontinue breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Men receiving treatment with Bendamustine ACTe are advised not to father 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.
If you are a man, you should avoid fathering a child during treatment with Bendamustine ACTe and for up to 6 months after treatment has stopped. There is a risk that treatment with Bendamustine ACTe will lead to infertility and you may wish to seek advice on conservation of sperm before treatment starts.
Driving and using machines
Bendamustine ACTe has major influence on the ability to drive and to use machines. Do not drive or operate machines if you experience side effects, such as dizziness or lack of coordination.
How Bendamustine ACTe is given?
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 ACTe 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) and/or your blood platelets have fallen to counts below determined levels.
Your doctor will determine these values at regular intervals.
Chronic lymphocytic leukaemia
|Bendamustine ACTe 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 ACTe 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 Hydrochloride 120 – 150 mg per square meter of your body surface area (based on your height and weight).
|on Days 1+2
|Prednisone 60 mg per square meter of your body surface area (based on your height and weight) by injection or orally.
|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 have 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 ACTe should be undertaken only by doctors experienced in tumour therapy. Your doctor will give you the exact dose of Bendamustine ACTe 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 ACTe. Duration of treatment depends on disease and response to treatment.
If you are at all worried or have any questions regarding treatment with Bendamustine ACTe, please speak to your doctor or pharmacist.
If you forget to use Bendamustine ACTe
If a dose of Bendamustine ACTe has been forgotten, your doctor will usually retain the normal dosage schedule.
If you stop using Bendamustine ACTe
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.
Possible Side Effects
Like all medicines, Bendamustine ACTe 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 ACTe 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 ACTe is impaired bone-marrow function, which usually returns to normal after treatment. Suppressed bone marrow function may lead to low counts of blood cells, which in turn may lead to an increased risk of infection, anaemia or a heightened risk of bleeding.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
• Bleeding (haemorrhage)
• Disturbed metabolism caused by dying cancer cells releasing their contents into the blood stream
• Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia)
• Low counts of neutrophils (a common type of white blood cell important to fighting off infections)
• Abnormally low concentration of neutrophils (a type of white blood cell) in the blood leading to increased susceptibility to infection (neutropenia)
• Hypersensitivity reactions such as allergic inflammation of the skin (dermatitis), nettle rash (urticarial)
• A rise in liver enzymes AST/ALT (which may indicate inflammation or damage to cells in the liver)
• A rise in the enzyme alkaline phosphatase (an enzyme made mostly in the liver and bones)
• A rise in bile pigment (a substance made during the normal breakdown of red blood cells)
• Low potassium blood levels (a nutrient that is necessary for the function of nerve and muscle cells, including those in your heart)
• Disturbed function (dysfunction) of the heart
• Disturbed heart rhythms (arrhythmia)
• Low or high blood pressure (hypotension or hypertension)
• Disturbed lung function
• Sore mouth (stomatitis)
• Loss of appetite
• Hair loss
• Skin changes
• Missed periods (amenorrhoea)
• Itchy rash (urticarial)
Uncommon (may affect up to 1 in 100 people):
• Accumulation of fluid in the heart sac (escape of fluid into the pericardial space)
• Ineffective production of all blood cells in the bone marrow (the spongy material inside your bones where blood cells are made)
• Acute leukaemia
• Heart attack, chest pain (myocardial infarct)
• Heart failure
Rare (may affect up to 1 in 1,000 people):
• Infection of the blood (sepsis)
• Severe allergic hypersensitivity reactions (anaphylactic reactions)
• Signs similar to anaphylactic reactions (anaphylactic reactions)
• Loss of voice (aphonic)
• Acute circulatory collapse (failure of blood circulation mainly from a cardiac origin with failure to maintain the supply of oxygen and other nutrients to the tissues and removing toxins)
• Reddening of the skin (erythema)
• Inflammation of the skin (dermatitis)
• Itching (pruritus)
• Skin rash (macular exanthema)
• Excessive sweating (hyperhidrosis)
• Reduction in your bone marrow function, which may make you feel unwell or show up in your blood tests
Very rare (may affect up to 1 in 10,000 people):
• Primary atypical inflammation of the lungs (pneumonia)
• Breakdown of red blood cells
• Rapid decrease in blood pressure sometimes with skin reactions or rash (anaphylactic shock)
• Disturbed sense of taste
• Altered sensations (paraesthesia)
• Malaise and pain in the limbs (peripheral neuropathy)
• Serious conditions resulting in the blockade of specific receptors in the nervous system
• Disorders of the nervous system
• Lack of coordination (ataxia)
• Inflammation of the brain (encephalitis)
• Increased heart rate (tachycardia)
Not known (frequency cannot be estimated from the available data):
• Renal failure
• Liver failure
• Irregular and often rapid heart rate (atrial fibrillation)
• Painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membranes (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
• Bleeding from the lungs
There have been reports of tumours (myelodysplastic syndrome, AML, bronchial carcinoma) following treatment with Bendamustine ACTe. No clear relationship with Bendamustine ACTe 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).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
The following information is intended for healthcare professionals only:
As with all similar cytotoxic substances, stricter safety precautions apply as far as nursing staff and doctors are concerned, due to the potentially genome-damaging and cancer-causing effect of the preparation. Avoid inhalation (breathing in) and contact with the skin and mucous membranes when handling Bendamustine ACTe (wear gloves, protective clothing, and possibly a face mask!). If any parts of the body become contaminated, clean them carefully with soap and water, and flush the eyes with 0.9% (isotonic) saline solution. If possible, it is advisable to work on a special safety work bench (laminar flow) with a disposable absorbing sheet that is impermeable to liquids. Contaminated articles are cytotoxic waste. Please comply with national guidelines on the disposal of cytotoxic material. Pregnant staff must be excluded from working with cytostatics.
The concentrate for solution for infusion has to be diluted with sodium chloride 9mg/ml (0.9%) solution for injection and then administered by intravenous infusion. Aseptic technique is to be used.
10 ml by shaking
in 40 ml by shaking
As soon as a clear solution is obtained (generally after 5 – 10 minutes), the total recommended dose of Bendamustine ACTe is immediately diluted with 0.9% (isotonic) saline solution to obtain a final volume of approximately 500 ml. Bendamustine ACTe must not be diluted with other solutions for infusion or injection. Bendamustine ACTe must not be mixed in an infusion with other substances.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this
How to store Bendamustine ACTe?
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 and carton after ‘EXP’. The expiry date refers to the last day of that month.
Store below 30°C. Keep vial in outer carton in order to protect from light.
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 for 3.5 hours, and in a refrigerator they are stable for 2 days. Bendamustine ACTe contains no preservatives. The solutions should not therefore be used after these lengths of time.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ° to 8 °C, unless reconstitution/dilution (etc.) has taken place in controlled and validated 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.
What Bendamustine ACTe contains?
The active substance is bendamustine hydrochloride.
One vial contains 25 mg of bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).
One vial contains 100 mg of bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).
After reconstitution 1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).
The other ingredients are Mannitol and Tertiary butyl alcohol.
What Bendamustine ACTe looks like and contents of the pack?
Bendamustine ACTe is a White to off White lyophilized powder contained in an amber glass vial.
It is supplied in packs containing:
Bendamustine ACTe is available in packs containing 1 x 25 mg vial along with information booklet.
Bendamustine ACTe is available in packs containing 1 x 100 mg vial along with information booklet.