2.5 mg / ml powder for concentrate for infusion solution
bendamustine hydrochloride
1. What Bendamustine Accord is and what it is used for
Bendamustine Accord is a medicine used to treat certain cancers ( cytostatics ).
Bendamustine Accord is used as a single medicine or in combination with other medicines to treat the following cancers:
- chronic lymphocytic leukemia if combination chemotherapy with fludarabine is not appropriate
- non-Hodgkin’s lymphoma when the results of previous rituximab treatment were short-lived or completely absent
- multiple myeloma when treatment with thalidomide or bortezomib is not appropriate.
Bendamustine hydrochloride contained in Bendamustine Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using the Bendamustine Accord
Do not use Bendamustine Accord
- if you are allergic to bendamustine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you are breast-feeding. If treatment with Bendamustine Accord is necessary while breast-feeding, breast-feeding must be stopped (see “Pregnancy, breast-feeding and fertility”)
- if you have a severe liver failure (liver damage)
- if the skin or whites of the eyes are yellow due to problems with the liver or blood
- if you have severe bone marrow function (bone marrow depression) and the values for your white blood cells ( leukocytes ) or platelets ( platelets ) are very low
- if you have undergone major surgery within 30 days before starting treatment
- if you have an infection, especially if it is associated with low white blood cell count (leukocytopenia)
- in connection with vaccination against yellow fever.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Bendamustine Accord
- if the ability to form blood cells in your bone marrow is impaired. The number of white blood cells and platelets should be checked before starting treatment with Bendamustine Accord, before each new course, and between courses.
- if you have an infection. Contact your doctor if you have signs of infection, e.g. fever or lung problems.
- if you get any skin reaction when you are treated with Bendamustine Accord. These skin reactions can be exacerbated.
- if you get painful red or purple rashes that spread and blisters and/or other injuries begin to appear on the mucous membranes (eg mouth and lips), especially if you have previously had photosensitivity, infection of the respiratory tract (e.g. bronchitis ), and/or fever.
- if you already have any heart disease (eg heart attack, chest pain, severe heart rhythm disturbances).
- if you feel pain in the side, have blood in the urine, or if your urine volume decreases. If your disease is very severe, your body may not be able to get rid of all the slag from the dying cancer cells. This condition is called tumor lysis syndrome and can lead to kidney failure or heart problems within 48 hours of the first dose of a Bendamustine Accord. Your doctor can make sure you get enough fluids (hydrated) and can give you other medicines to prevent the problem from occurring.
- if you have a severe allergic reaction or hypersensitivity reaction. Remember if you experience infusion-related reactions after the first course.
Other medicines and Bendamustine Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If Bendamustine Accord is used together with medicines that inhibit the formation of blood cells in the bone marrow, this can lead to a greater effect on the bone marrow.
About Bendamustine Accord is used with a medicine that affects your immune response can lead to greater impact on the immune response message.
Cytostatics may weaken the effect of vaccination with live viruses. Cytostatics also increases the risk of infection when vaccinated with live viruses (eg vaccines against viral diseases).
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 taking this medicine.
Pregnancy
Bendamustine Accord can damage the hereditary system and has caused malformations in experimental animals. Bendamustine Accord must not be used during pregnancy unless clearly prescribed by your doctor. If you have to take the medicine during pregnancy, discuss the risk of birth defects with your doctor, and genetic counseling is recommended.
Women of childbearing potential must use effective contraception both before and during treatment with Bendamustine Accord. If you become pregnant during treatment with Bendamustine Accord, contact your doctor immediately and ask for genetic counseling.
Breast-feeding
Bendamustine Accord should not be used during breast-feeding. If treatment with Bendamustine Accord is necessary during the breastfeeding period, you must stop breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Fertility
If you are a man, you should avoid having children during the treatment with Bendamustine Accord and 6 months after the end of treatment. There is also a risk that treatment with Bendamustine Accord will lead to infertility. You should therefore investigate the possibilities of sperm storage before starting treatment.
Driving and using machines
Bendamustine Accord has a major impact on the ability to drive and use machines. Do not drive or use machines if you experience side effects, e.g. dizziness or impaired coordination. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Bendamustine Accord
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Bendamustine Accord is given as a drip into a vein for 30-60 minutes. Dosage varies and the drug can be given either as a single treatment or in combination with other drugs. Treatment should not be initiated if the value of the white blood cells ( leukocytes ) and/or platelets in the blood is too low. These values are tested regularly.
Chronic lymphocytic leukemia
| 100 mg Bendamustine Accord per square meter of body surface area (calculated by height and weight). | Day 1 and 2 |
| The treatment is repeated every 4 weeks. The treatment can be repeated up to 6 times. |
Non-Hodgkin’s lymphoma
| 120 mg Bendamustine Accord per square meter of body surface area (calculated by height and weight). | Day 1 and 2 |
| The treatment is repeated every 3 weeks. The treatment is repeated at least 6 times. |
Multiple myeloma
| 120–150 mg Bendamustine Accord per square meter of body surface area (calculated by height and weight). | Day 1 and 2 |
| 60 mg prednisone per square meter of body surface area (calculated by height and weight) by injection or orally. | Day 1–4 |
| The treatment is repeated every 4 weeks. The treatment is repeated at least 3 times. |
Treatment must be stopped if the number of white blood cells drops to established levels. Treatment can be continued when the white blood cell count and platelet count have increased.
Liver or kidney failure
Dosage may need to be adjusted according to the degree of liver failure (30% in patients with moderate hepatic impairment). No dose adjustment is required in patients with renal impairment. The attending physician decides on any dose adjustments.
Method of administration
Treatment with Bendamustine Accord must be done under the supervision of a physician experienced in the treatment of cancer. Your doctor will prescribe the dose of Bendamustine Accord that is right for you and will take the necessary precautions.
The attending physician gives the prescribed infusion solution as a rapid intravenous infusion (drip into a vein) for 30-60 minutes.
Length of treatment
There are no set time limits for how long treatment with Bendamustine Accord should be given. The duration of treatment depends on the disease and the effect of the treatment.
If you have any further questions on the use of Bendamustine Accord, ask your doctor, pharmacist, or nurse.
If you forget to use Bendamustine Accord
If a dose of Bendamustine Accord is missed, your doctor will usually continue treatment according to the usual dosing schedule.
If you stop using Bendamustine Accord
The attending physician decides whether to discontinue treatment or to switch to another drug.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of the side effects listed below may be detected by tests performed by your doctor.
In very rare cases, tissue damage ( necrosis ) has occurred, as the drug has inadvertently ended up outside the blood vessel (extravasation). A burning sensation in which the infusion needle is inserted may be a sign that administration is taking place outside the blood vessels. The consequences of such an administration can be painful and difficult to heal
skin damage.
A dose-limiting side effect of Bendamustine Accord is impaired bone marrow function, which usually returns to normal after treatment. Impaired bone marrow function can lead to a decrease in the number of blood cells, which in turn can lead to an increased risk of infection, anemia, or an increased risk of bleeding.
Very common (may affect more than 1 user in 10)
- Low white blood cell count (disease-fighting cells in your blood)
- Reduced hemoglobin (the protein in red blood cells that transport oxygen throughout the body)
- Low platelet count (colorless blood cells that help the blood to coagulate)
- Infection is
- Nausea
- Vomiting
- Mucositis
- Increased creatinine value in the blood (a chemical residue produced by your muscles)
- Increased urea value in the blood (a chemical residue)
- Fever
- Fatigue
- Headache.
Common (may affect up to 1 in 10 people)
- Bleeding
- Disrupted metabolism due to dying cancer cells that release slag products into the blood
- Decreased number of red blood cells, which can make the skin pale and cause weakness or shortness of breath ( anemia )
- Low neutrophil count (a common type of white blood cell important for fighting infections )
- Hypersensitivity reactions, e.g. allergic dermatitis ( dermatitis ) and hives ( urticaria )
- Elevated liver enzyme levels (AST / ALT) may indicate inflammation or damage to cells in the liver
- Elevated levels of alkaline phosphatase (an enzyme made mainly in the liver and skeleton)
- Elevated levels of bile pigments (a substance formed during the normal breakdown of red blood cells )
- Low potassium levels in the blood (a nutrient necessary for the function of nerve and muscle cells, including those in your heart)
- Disorders of heart function
- Cardiac arrhythmias ( arrhythmia )
- Low or high blood pressure ( hypotension or hypertension )
- Impaired lung function
- Diarrhea
- Constipation
- Soreness in the mouth ( stomatitis )
- Loss of appetite
- Hair loss
- Skin changes
- Absence of menstruation ( amenorrhea )
- Pain
- Insomnia
- Overindulge
- Dehydration
- Dizziness
- Itchy rash ( urticaria ).
Uncommon (may affect up to 1 in 100 people)
- Accumulation of fluid in the pericardium (fluid penetrates between the two layers of the pericardium)
- Impaired formation of all types of blood cells in the bone marrow (the fungus-like material on the inside of your bones where blood cells are formed)
- Acute leukemia
- Heart attack, chest pain
- Heart failure
Rare (may affect up to 1 in 1,000 people)
- Infection in the blood ( sepsis )
- Severe allergic hypersensitivity reactions (anaphylactic reactions)
- Symptoms reminiscent of anaphylactic reactions (anaphylactoid reactions)
- Drowsiness
- Lose voice (aphony)
- Acute circulatory failure (decreased blood pressure and blood flow which leads to a deterioration of the supply of oxygen and other nutrients to the body and removal of toxic substances)
- Redness ( erythema )
- Inflammation of the skin ( dermatitis )
- Itching ( pruritus )
- Spotty rash (macular exanthema)
- Heavy sweating ( hyperhidrosis )
- Impaired bone marrow function, which can make you feel sick or can be seen on blood tests.
Very rare (may affect up to 1 in 10,000 people)
- Primary atypical pneumonia ( pneumonia )
- Degradation of red blood cells
- The rapid drop in blood pressure with skin reactions or rash (anaphylactic shock )
- Changed sense of taste
- Emotional disorders ( paresthesia )
- Discomfort and pain in arms and legs ( peripheral neuropathy )
- Severe conditions that result in blockade of specific receptors in the nervous system
- Disorder of the nervous system
- Coordination difficulties ( ataxia )
- Brain inflammation ( encephalitis )
- Increased heart rate ( tachycardia )
- Inflammation of the veins ( phlebitis )
- Connective tissue formation in the lungs ( pulmonary fibrosis )
- Bleeding and inflammation of the esophagus (hemorrhagic esophagitis )
- Bleeding in the stomach or intestines
- Infertility
- Multiple organ failure
Has been reported (occurs in an unknown number of users)
- Kidney failure
- Liver failure
- Irregular and often fast heart rate ( atrial fibrillation )
- Painful red or purple rash that spreads and blisters and/or other damage that begins to appear on the mucous membranes (eg mouth and lips), especially if you have previously had photosensitivity, infection of the respiratory tract (eg bronchitis ), and/or fever.
- Rash with combination therapy with rituximab
- Pneumonitis ( pneumonia )
- Bleeding from the lungs.
Tumors ( myelodysplastic syndrome, acute myeloid leukemia (AML), bronchial cancer) have been reported following treatment with Bendamustine Accord. No clear association with bendamustine could be established.
Contact a doctor or seek medical attention immediately if you notice any of the following side effects (no known frequency):
- Severe rash, including Steven Johnson’s syndrome and toxic epidermal necrolysis. These can appear as reddish spot-like spots or circular plaques, often with blisters in the middle of the torso, flaky skin, sores in the mouth, nose, eyes, and genitals and can be followed by fever and flu-like symptoms.
- Widespread rash, high body temperature, enlarged lymph nodes, and involvement of other body organs (drug side effect with eosinophilia and systemic symptoms also known as DRESS or drug hypersensitivity syndrome).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Bendamustine Accord
Keep this medicine out of sight – and the sight of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
No special temperature instructions. Keep the vial in the outer carton. Sensitive to light.
Shelf life after opening the medicine pack or preparing the infusion solution
Infusion solutions prepared according to the instructions given at the end of this leaflet are stable in polyethylene bags at 25 ° C for 3.5 hours and at 2-8 ° C for two days. Bendamustine Accord contains no preservatives. From a microbiological point of view, the solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
The user is responsible for the aseptic handling of the product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is bendamustine hydrochloride.
1 vial contains 25 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).
1 vial contains 100 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).
After reconstitution, 1 ml of concentrate contains 2.5 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).
The other ingredient is mannitol.
What the medicine looks like and the contents of the pack
Vial of amber glass with bromobutyl rubber stopper and tear-off aluminum cap.
Bendamustine Accord is available in packs of 5, 10, or 20 vials of 25 mg bendamustine hydrochloride and 1 or 5 vials of 100 mg bendamustine hydrochloride.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex HA1 4HF
UK
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
This medicinal product is authorized under the European Economic Area under the names:
| Name of Member State | Name of the medicine |
|---|---|
| Austria | Bendamustine Accord 2.5 mg / ml powder for concentrate for infusion solution |
| Denmark | Bendamustine Hydrochloride Accord |
| Finland | Bendamustine Accord 2.5 mg / ml kuiva-aine Välikonsentraatiksi infusion infettät varten |
| Ireland | Bendamustine 25 mg / 100mg Powder for concentrate for Solution for Infusion |
| Iceland | Bendamustine Accord 2.5 mg / ml powder for concentrate for solution for infusion |
| Norway | Bendamustine Accord |
| Poland | Bendamustine Accord |
| Spain | Bendamustine Accord 2.5 mg/ml powder for concentrate for solution for perfusion |
| Slovakia | Bendamustine Accord 2.5 mg / ml dose of infusion concentrate |
| Belgium | Bendamustine Accord 2.5 mg/ml powder for concentrate for infusion solution |
| Bulgaria | Bendamustine Accord 2.5 mg / ml Concentrate for concentrate infusion |
| Cyprus | Bendamustine Accord 2.5 mg / ml |
| Czech Republic | Bendamustine Accord 2.5 mg / ml concentrate for concentrate for infusion |
| Germany | Bendamustine Accord 2.5 mg/ml powder for the preparation of an infusion solution concentrate |
| Estonia | Bendamustine Accord |
| Greece | Bendamustine Accord 2.5 mg / ml powder for concentrated solution for infusion |
| Hungary | Bendamustine Accord 2.5mg / ml for infusion infusion or concentrates |
| Italy | Bendamustine Accord |
| Latvia | Bendamustine Accord 2.5 mg / ml powder for the infusion of concentrated concentrate |
| Lithuania | Bendamustine Accord 2.5 mg/ml milteliai concentrate infuziniam tirpalui |
| Malta | Bendamustine hydrochloride Accord 2.5 mg / ml powder for concentrate for solution for infusion |
| Netherlands | Bendamustine Accord 2.5 mg / ml powder for concentrate for solution for infusion |
| Portugal | Bendamustine Accord 2.5 mg / ml concentrated for perfusion solution |
| Romania | Bendamustine Accord 2.5 mg / ml powder for concentrate for perfused solution |
| Slovenia | Bendamustine Accord 2.5 mg / ml prescription concentrate for infusion |
| UK | Bendamustine hydrochloride Accord 2.5 mg / ml Powder for concentrate for solution for infusion |
| France | BENDAMUSTINE ACCORD 2.5 mg / ml, powder for dilution solution for perfusion |