2.5 mg / ml powder for concentrate for infusion solution 
Bendamustine hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Bendamustine Fresenius Kabi is and what it is used for 
2. What you need to know before you use Bendamustine Fresenius Kabi 
3. How to use Bendamustine Fresenius Kabi 
4. Possible side effects 
5. How to store Bendamustine Fresenius Kabi 
6. Contents of the pack and other information

1. What Bendamustine Fresenius Kabi is and what it is used for

Bendamustine Fresenius Kabi is a medicine used to treat certain cancers ( cytostatics).

Bendamustine Fresenius Kabi is used as the sole drug or in combination with other drugs 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 Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you use Bendamustine Fresenius Kabi

Do not use Bendamustine Fresenius Kabi

  • if you are allergic to bendamustine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
  • if you are breastfeeding; If treatment with bendamustine hydrochloride is necessary while breast-feeding, breast-feeding must be stopped (see section Pregnancy, breast-feeding and fertility ).
  • if you have severe liver failure (liver damage)
  • if the skin or whites of the eyes are yellow due to liver or blood problems (jaundice)
  • if you have severe bone marrow function (bone marrow depression) and the number of white blood cells and / or platelets is 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 ( leukopenia )
  • in connection with vaccination against yellow fever.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using Bendamustine Fresenius Kabi

  • 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 Fresenius Kabi, 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 treated with Bendamustine Fresenius Kabi. 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 Fresenius Kabi. Your doctor can make sure you get enough fluids (hydrated) and give you other medicines to prevent the problem from occurring.
  • if you have a severe allergic reaction or hypersensitivity reaction. Pay attention to infusion-related reactions (eg fever, chills, itching, or rash) after the first course of treatment.

Men treated with bendamustine should avoid having children during treatment and for a further 6 months after stopping treatment. Find out the possibilities of preserving sperm before starting treatment as treatment can lead to permanent infertility (sterility) (see section Pregnancy, breast-feeding and fertility ).

Children and young people

There is no experience with the use of bendamustine hydrochloride in children and adolescents.

Other drugs and Bendamustine Fresenius Kabi

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If bendamustine hydrochloride is used in combination with other medicines that weaken bone marrow function, the effect on bone marrow function may be enhanced.

If bendamustine hydrochloride is used with a medicine that affects your immune response , the effect on the immune response et reinforced.

Cytostatics may weaken the effect of vaccination with live viruses .

Cytostatics also increase the risk of infection when vaccinated with live vaccines (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 hydrochloride can damage the hereditary system and has caused malformations in experimental animals. Bendamustine Fresenius Kabi must not be used during pregnancy unless clearly prescribed by a doctor. If you need to be treated during pregnancy, discuss the risk of birth defects with a doctor, and genetic counseling is recommended.

If you become pregnant while being treated with Bendamustine Fresenius Kabi, contact your doctor immediately and ask for genetic counseling.

Contraceptives should be used by both men and women

Men

If you are a man, you should avoid having children when you are treated with Bendamustine Fresenius Kabi and for another 6 months after stopping treatment.

Women

If you are a woman of childbearing potential , you should use an effective contraceptive both before and during treatment.

Breast-feeding

Bendamustine Fresenius Kabi must not be used during breast-feeding. If treatment with Bendamustine Fresenius Kabi is necessary during the breast-feeding period, you must stop breast-feeding.

Fertility

Men

Treatment with Bendamustine Fresenius Kabi can lead to infertility (sterility) in men. If you are a man and want to be able to have children after the end of treatment, you should seek advice on sperm preservation before starting treatment.

Women

If you are a woman and want to be able to have children after treatment, you should talk to your doctor for advice.

Driving and using machines

Bendamustine hydrochloride has a major impact on the ability to drive and use machines. Do not drive or use machines if you experience side effects such as dizziness or impaired coordination.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 Fresenius Kabi

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Bendamustine Fresenius Kabi is given as a drip into a vein ( intravenously ) 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 number of white blood cells and / or plateletsis below established levels. These values ​​are regularly tested by your doctor.

Chronic lymphocytic leukemia

100 mg Bendamustine Fresenius Kabi per square meter of body surface area (calculated based on your height and weight) Day 1 and 2
The regimen is repeated every 4 weeks up to 6 times

Non-Hodgkin’s lymphoma

120 mg Bendamustine Fresenius Kabi per square meter of body surface area (calculated based on your height and weight) Day 1 and 2
The regimen is repeated every 3 weeks at least 6 times

Multiple myeloma

120-150 mg Bendamustine Fresenius Kabi per square meter body area (calculated based on your height and weight) Day 1 and 2
60 mg prednisone per square meter of body surface area (calculated based on your height and weight) Day 1-4
The course is repeated every 4 weeks at least 3 times

Treatment should be discontinued if the number of white blood cells and / or platelets drops to established levels.

Treatment can be continued when the number of white blood cells and platelets has increased.

Hepatic or renal impairment

Depending on the degree of hepatic impairment, it may be necessary to adjust someone (30% adjustment in patients with moderate hepatic impairment). No dose adjustment is necessary in patients with renal impairment. The attending physician decides if a dose adjustment is necessary.

How the medicine is given

Treatment with Bendamustine Fresenius Kabi must be performed under the supervision of a physician experienced in the treatment of cancer. Your doctor will prescribe the dose of Bendamustine Fresenius Kabi that is right for you and will take the necessary precautions.

The treating physician gives the prescribed infusion solution as a rapid intravenousinfusion for 30-60 minutes.

Length of treatment

There are no set time limits for how long treatment regimens with Bendamustine Fresenius Kabi should be given. The duration of treatment depends on the disease and on the effect of the treatment.

If you have any further questions, or have any questions about the treatment with Bendamustine Fresenius Kabi, talk to your doctor or nurse.

If you forget to use Bendamustine Fresenius Kabi

If a dose of Bendamustine Fresenius Kabi is missed, the doctor will usually continue treatment according to the usual dosing schedule.

If you stop using Bendamustine Fresenius Kabi

The attending physician decides whether to discontinue treatment or whether to switch to another treatment.

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.

In very rare cases, tissue damage ( necrosis ) has occurred, as Bendamustine Fresenius Kabi has leaked outside the blood vessel (extravasation). A burning sensation at the point where the needle is inserted may be a sign that the drug is leaking outside the blood vessel. This can cause pain and difficult to heal skin lesions.

A side effect that limits the dosage one of Bendamustine Fresenius Kabi is weakened bone marrow function. In general, bone marrow function 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.

Contact a doctor or seek medical attention immediately if you notice any of the following side effects (no known frequency):

Severe rash including Stevens-Johnson syndrome and toxic epidermal necrolysis . These can appear as reddish dot-like 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).

Other side effects:

Very common (may affect more than 1 user in 10)

  • low white blood cell count (disease-fighting cells in your blood)
  • impaired hemoglobin value (a protein in red blood cells that carries 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
  • disturbed metabolism due to dying cancer cells that release their contents into the bloodstream (tumor lysis syndrome)
  • decreased number of red blood cells ( anemia ), which can make the skin pale and cause weakness or shortness of breath
  • low number of neutrophils , (a common type of white blood cell important to fight infection )
  • hypersensitivity reactions , such as allergic inflammation of the skin ( dermatitis ) and hives ( urticaria )
  • elevated levels of the liver enzymes AST / ALT (which may indicate inflammationor damage to cells in the liver)
  • elevated levels of enzyme an alkaline phosphatase (an enzyme formed mainly in the liver and skeleton)
  • elevated levels of bilirubin in the blood (a substance formed during the normal breakdown of red blood cells )
  • low potassium in the blood (a nutrient necessary for the function of nerve and muscle cells, including those in your heart)
  • abnormal heart function, such as palpitations ( palpitation ) or chest pain ( angina pectoris )
  • arrhythmias in the heart ( arrhythmias )
  • low or high blood pressure ( hypotension or hypertension )
  • impaired lung function
  • diarrhea
  • constipation
  • pain in the mouth (inflammation of the mouth)
  • loss of appetite
  • hair loss
  • skin changes
  • missed menstruation
  • pain
  • insomnia
  • overindulge
  • dehydration
  • dizziness
  • itchy rash ( urticaria )

Uncommon (may affect up to 1 in 100 people)

  • accumulation of fluid in the pericardium (fluid enters the pericardium surrounding the heart)
  • impaired formation of all types of blood cells (in the soft material inside your bones where the blood cells are formed)
  • acute leukemia
  • heart attack, chest pain
  • heart failure

Rare (may affect up to 1 in 1,000 people)

  • blood poisoning ( sepsis )
  • severe allergic hypersensitivity reactions (anaphylactic reactions)
  • impaired bone marrow function, which may make you feel sick or may be seen on blood tests
  • symptoms reminiscent of anaphylactic reactions (anaphylactoid reactions)
  • drowsiness
  • lose your voice
  • acute circulatory failure (decreased blood pressure and blood flow leading to a deterioration in the supply of oxygen and other nutrients to the body)
  • reddening of the skin
  • dermatitis ( dermatitis )
  • itching
  • skin rash (maculopapular rash)
  • heavy sweating

Very rare (may affect up to 1 in 10,000 people)

  • primary atypical pneumonia ( pneumonia )
  • degradation of red blood cells
  • rapid drop in blood pressure, sometimes with skin reactions or rash (anaphylactic shock )
  • disturbed sense of taste
  • changes in the sense of touch ( paresthesia )
  • discomfort and pain in arms and legs ( peripheral neuropathy )
  • severe condition that results in blockade of specific receptors in the nervous system
  • nervous system disorder (anticholinergic syndrome)
  • impaired coordination
  • brain inflammation ( encephalitis )
  • increased heart rate ( tachycardia )
  • inflammation in a friend ( phlebitis )
  • formation of connective tissue in the lungs ( pulmonary fibrosis )
  • inflammation of the esophagus with bleeding ( hemorrhagic esophagitis )
  • bleeding in the stomach or intestines
  • infertility (inability to have children)
  • multi-organ damage

Has been reported (occurs in an unknown number of users)

  • liver failure
  • kidney 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], tracheal carcinoma) have been reported following treatment with bendamustine hydrochloride. No obvious association with bendamustine hydrochloride could be established.

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 Fresenius Kabi

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 expiration date is the last day of the specified month.

No special storage instructions.

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 durable in polyethylene bags at room temperature and 60% relative humidity for 3.5 hours and in refrigerator temperature for 2 days. Bendamustine Fresenius Kabi contains no preservatives. Therefore, solutions stored longer than the stated shelf life must not be used.

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 and would normally not be longer than 24 hours at 2 ° C to 8 ° C, unless reconstitution / dilution has taken place under controlled and validated aseptic conditions.

Do not use this medicine if you notice visible changes in the solution.

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.

One vial contains 25 mg bendamustine hydrochloride.

One vial contains 100 mg bendamustine hydrochloride.

After reconstitution , 1 milliliter of concentrate contains 2.5 mg of bendamustine hydrochloride.

  • The other ingredient is mannitol.

What the medicine looks like and the contents of the pack

Amber-colored glass vials with chlorobutyl rubber stoppers sealed with a green or blue aluminum snap cap.

White to off-white freeze-dried powder or powder cake.

Bendamustine Fresenius Kabi is available in packs of 1, 5, 10 or 20 vials each containing 25 mg bendamustine hydrochloride and 1 or 5 vials each containing 100 mg bendamustine hydrochloride.

Marketing Authorisation Holder

Fresenius Kabi AB

751 74 Uppsala

Manufacturer

Fresenius Kabi Deutschland GmbH

Pfingstweide 53

61169 Friedberg

Germany

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road

Bordon, Hampshire, GU35 0NF

UK

Muhammad Nadeem

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