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.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What Bendamustine medac is and what it is used for

Bendamustine medac is a medicine that contains an active substance called bendamustine hydrochloride (hereafter referred to as bendamustine).

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

Bendamustine medac is used as the sole 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 have been short-lived or completely absent
  • multiple myeloma when high-dose chemotherapy with autologous stem cell transplantation (transplantation with own stem cells ) or treatment with thalidomide or bortezomib is not appropriate.

Bendamustine hydrochloride contained in Bendamustine medac 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 using Bendamustine medac

Do not use Bendamustine medac

  • 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 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 severely impaired 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 or nurse before using Bendamustine medac:

  • 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 medac, before each new course and between courses.
  • if you have an infection . Contact a doctor if you have signs of infection , e.g. fever or lung problems.
  • if you already have any heart disease (eg heart attack, chest pain, severe heart rhythm disturbances).

Talk to your doctor or nurse while taking Bendamustine medac:

  • if you experience nausea and / or vomiting . Your doctor may give you a medicine that reduces nausea.
  • 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 and / or heart problems within 48 hours of the first dose of a Bendamustine medac. Your doctor can make sure you get enough fluids (hydrated) and give you other medicines to prevent the problem from occurring.
  • if you get any skin reaction when treated with Bendamustine medac. These reactions may 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 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 medac should avoid having children during treatment and for 6 months after stopping treatment. Find out the possibilities of storing sperm before starting treatment – treatment with Bendamustine medac 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 medicines and Bendamustine medac

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

Other drugs can be affected by bendamustine hydrochloride, which in turn can affect the way bendamustine hydrochloride works. Bendamustine hydrochloride can affect and be affected by the following drugs:

If Bendamustine medac is used with other medicines that inhibit the formation of blood cells in the bone marrow , the effect on the bone marrow can be strengthened.

About Bendamustine medac is used with a medicine that affects your immune response , the effect on the immune response et reinforced.

Chemotherapy can reduce the effectiveness of live virus vaccination . Cytostatics also increase the risk of infection after vaccination with live vaccine (eg vaccine 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 medac can damage the hereditary system and has caused malformations in experimental animals. Bendamustine medac should not be used during pregnancy unless clearly indicated by a doctor. If you need to be treated during pregnancy, talk to your doctor about the risk of birth defects and the need for genetic counseling.

Fertility

If you are a woman and could become pregnant, you must use an effective method of contraception both before and during treatment with Bendamustine medac. If you become pregnant while being treated with Bendamustine medac, contact your doctor immediately and ask for genetic counseling.

If you are a man, you should avoid having children when you are treated with Bendamustine medac and for another 6 months after stopping treatment. Bendamustine medac can lead to infertility , so it may be a good idea to find out about the possibility of storing your sperm before starting treatment.

Breast-feeding

Bendamustine medac must not be used during breast-feeding. If treatment with Bendamustine medac is necessary while breast-feeding, breast-feeding must be stopped.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Bendamustine hydrochloride has a significant effect 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 medac

Bendamustine medac 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 white blood cell count and / or platelet counties lower than certain levels.

These values ​​are tested regularly.

Chronic lymphocytic leukemia

  • 100 mg Bendamustine medac per square meter body area (calculated based on your weight and height): days 1 and 2
  • The course is repeated at 4-week intervals up to 6 times

Non-Hodgkin’s lymphoma

  • 120 mg Bendamustine medac per square meter body area (calculated based on your weight and height): days 1 and 2
  • The course is repeated at 3-week intervals at least 6 times

Multiple myeloma

  • 120‑150 mg Bendamustine medac per square meter body area (calculated based on your weight and height): days 1 and 2
  • 60 mg prednisone per square meter body surface area (calculated based on your weight and height) intravenously (injected into a vein) or orally (orally): day 1‑4
  • The course is repeated at 4-week intervals at least 3 times

Treatment must be stopped if the white blood cell count and / or platelet count drops to certain 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). Bendamustine medac must not be used if you have severe hepatic impairment. No dose adjustment is required in patients with renal impairment. The attending physician decides if a dose adjustment is necessary.

How the medicine is given

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

The prescribed infusion solution is given as an intravenous infusion for 30-60 minutes.

Length of treatment

There are no set time limits for how long treatment with Bendamustine medac 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 if you have any further questions on the use of Bendamustine medac, ask your doctor or nurse.

If you forget to use Bendamustine medac

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

If you stop using Bendamustine medac

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.

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).

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 needle is inserted may be a sign that the medicine has ended up outside the blood vessel. This can cause pain and difficult to heal skin lesions.

The side effect of Bendamustine medac that is dose-limiting is weakened bone marrow function.

In general, bone marrow function returns to normal after treatment. Bone marrow failure may lead to reduced blood cell s, which in turn can lead to increased risk of infection you, anemia ( anemia ) or increased risk of bleeding.

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

  • low white blood cell count ( leukopenia )
  • decreased hemoglobin value ( hemoglobin is the red dye in the blood)
  • low platelet count ( thrombocytopenia )
  • infection is
  • nausea
  • vomiting
  • mucositis
  • increased creatinine levels in the blood
  • increased urea value in the blood
  • fever
  • fatigue
  • headache

Common side effects (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 may cause paleness, weakness or shortness of breath
  • low number of neutrophils ( neutropenia )
  • hypersensitivity reactions , e.g. allergic dermatitis ( dermatitis ), hives ( urticaria )
  • elevated levels of the liver enzymes AST / ALT
  • elevated value of enzyme an alkaline phosphatase (AFOS)
  • increased value of bilirubin (bile dye)
  • low potassium levels in the blood
  • disturbed cardiac function (palpitations, angina)
  • arrhythmias in the heart ( arrhythmia )
  • low or high blood pressure ( hypotension or hypertension )
  • disturbed lung function
  • diarrhea
  • constipation
  • pain in the mouth (inflammation of the mouth)
  • loss of appetite
  • hair loss
  • skin changes
  • absent menstruation ( amenorrhea )
  • pain
  • insomnia
  • overindulge
  • dehydration
  • dizziness
  • itchy rash ( urticaria )

Uncommon side effects (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 ( myelodysplastic syndrome )
  • acute leukemia
  • heart attack, chest pain
  • heart failure

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

  • blood poisoning ( sepsis )
  • severe allergic hypersensitivity reactions (anaphylactic reactions)
  • symptoms reminiscent of anaphylactic reactions (anaphylactoid reactions)
  • drowsiness
  • lose your voice
  • sudden circulatory failure
  • redness ( erythema )
  • dermatitis ( dermatitis )
  • itching
  • skin rash (macular exanthema)
  • heavy sweating
  • impaired bone marrow function, which may make you feel sick or may be seen on blood tests

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

  • pneumonia
  • degradation of red blood cells
  • rapid fall in blood pressure, sometimes with skin reactions or rash (anaphylactic shock )
  • disturbed sense of taste
  • disturbed sensation ( paresthesia )
  • discomfort and pain in arms and legs ( peripheral neuropathy )
  • nervous system disorder, so-called anticholinergic syndrome
  • neurological disorders
  • disturbed coordination
  • brain inflammation ( encephalitis )
  • increased heart rate ( tachycardia )
  • inflammation of veins ( phlebitis )
  • formation of connective tissue in the lungs ( pulmonary fibrosis )
  • esophagitis with bleeding (bleeding esophagitis )
  • bleeding in the stomach or intestines
  • infertility (inability to conceive and have children)
  • impaired function in several organs (multiple organ failure)

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
  • bleeding from the lungs

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 medac

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 first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the specified month.

Keep the vial in the outer carton. Sensitive to light.

Shelf life after opening the medicine pack or preparing the infusion solution

After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 3.5 hours at 25 ° C / 60% RH and for 2 days at 2 ° C to 8 ° C in polyethylene bags.

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 ° C to 8 ° C, unless reconstitution / dilution (etc.) has taken place under controlled and validated aseptic conditions. .

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.

1 vial contains 100 mg bendamustine hydrochloride.

After reconstitution , 1 ml 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

White to off-white lyophilised powder in an amber glass vial with a stopper and an aluminum snap cap.

Type I glass vials of 25 ml.

Type I glass vials of 50 ml.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

medac society for clinical specialties mbH

Theaterstr. 6

22880 Wedel

Germany

This medicinal product is authorized under the European Economic Area under the names:

Denmark Bendamedac 2.5 mg / ml
France Bendamustine medac 2.5 mg/ml powder for dilution solution for perfusion
Iceland Bendamustine medac 2.5 mg / ml
Italy Bendamustine medac
Lithuania Bendamustine medac 2.5 mg / ml milteliai infuzinio tirpalo concentratui
Netherlands Bendamustine HCl medac 2.5 mg / ml, powder for concentrate for solution for infusion
UK Bendamustine hydrochloride 2.5 mg / ml Powder for concentrate for solution for infusion
Germany Bendamustin medac 2.5 mg / ml powder for concentrate for infusion

Muhammad Nadeem

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