Bendamustine belongs to the group of cancer-fighting medications known as antineoplastics, and specifically to the group of antineoplastics called alkylating agents. It prevents the growth of cancer cells by interfering with the genetic material DNA, which is necessary for reproduction of cells.

Bendamustine is used to treat chronic lymphocytic leukemia (CLL) that has not yet been treated, and to treat relapsed non-Hodgkin's lymphoma (NHL) that has been unsuccessfully treated with rituximab or has returned shortly after rituximab treatment has been stopped.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor.

The recommended dose of bendamustine hydrochloride depends on the condition being treated and body size.

For chronic lymphocytic leukemia, the usual adult dose is 100 mg per square metre of body surface area. It is given intravenously (directly into a vein) over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.

For non-Hodgkin's lymphoma, the usual dose is 120 mg per square metre of body surface area. It is given intravenously (directly into a vein) over 60 minutes of Days 1 and 2 of a 21-day cycle, up to 8 cycles.

Your doctor may decrease your dose of bendamustine, depending on how well you tolerate the medication and how severe side effects are.

As well as interfering with cancer cells, bendamustine can interfere with some of your normal cells. This can cause a number of side effects. Keep track of any side effects and report them to your doctor as suggested in the section "What side effects are possible with this medication?"

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. Very careful handling of this medication is required. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive bendamustine, contact your doctor as soon as possible to reschedule your appointment.

25 mg
Each vial of sterile lyophilized powder for injection contains 25 mg of bendamustine hydrochloride. Nonmedicinal ingredients: mannitol.

100 mg
Each vial of sterile lyophilized powder for injection contains 100 mg of bendamustine hydrochloride. Nonmedicinal ingredients: mannitol.

Do not take this medication if you:

• are allergic to bendamustine hydrochloride or any ingredients of this medication, including mannitol

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• tiredness
• constipation
• nausea and vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• dehydration (thirst, dizziness, dry mouth, less urine output)
• difficulty breathing
• fever (over 38°C, or as instructed by your physician or clinic)
• lumps or discoloured patches on the skin
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of increased uric acid in the body (gout; e.g., joint pain, swelling and warmth of joints)
• signs of heart problems (e.g., fast, irregular heartbeat or pulse, chest pain, sudden weight gain, difficulty breathing, leg swelling)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• skin growths or changes to existing skin growths or sores
• skin rash
• symptoms of extravasation (leakage of drug from the veins; redness, pain, swelling or infection at the site of infusion)
• symptoms of an infection such as fever, chills, or painful and difficult urination
• symptoms of a new cancer (e.g., weight loss, fatigue, night sweats, loss of appetite, coughing up blood, persistent cough, fever, frequent infections, bone pain)
• symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
• symptoms of low potassium levels in the blood (e.g., weakness, fatigue, muscle cramps, irregular heartbeat)
• symptoms of a lung infection (e.g., shortness of breath, cough, chest pain)
• symptoms of scarring of the lung (e.g., shortness of breath, fatigue, fever, infection)
• symptoms of severely increased blood pressure (e.g., chest pain, blurred vision, dizziness, excessive tiredness, headache, stronger or faster heart beat)

Seek immediate medical attention if any of the following occur:

• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• symptoms of a serious allergic reaction, such as hives, difficulty breathing, or swelling of the eyelids, throat, and mouth
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• symptoms of progressive multifocal leukoencephalopathy (PML) (e.g., memory loss, trouble thinking, difficulty walking, loss of sight)
• symptoms of tumour lysis syndrome (e.g., producing less urine, cloudy urine, kidney problems, muscle spasms, nausea, shortness of breath)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Low red blood cell count: This medication can reduce the number of red blood cells in the blood. Red blood cells help provide oxygen to different tissues in the body. Tell your doctor of any signs that your red blood cell count is low. Such symptoms may include feeling unusually tired, decreased levels of alertness, loss of appetite, paler-than-normal skin, trouble breathing, or rapid heartbeat.

Blood clotting: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Blood pressure: Bendamustine can cause increased blood pressure. If you have high blood pressure or are taking medications to control blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Extravasation: When bendamustine leaks into tissue surrounding a vein, symptoms such as redness, swelling, and pain can occur around the place of injection. This is called extravasation. If you develop symptoms of extravasation, tell your doctor or nurse immediately.

Heart problems: Bendamustine can cause heart problems such as heart failure, chest pain, heart attack, and abnormal heart rhythms. If you have heart problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: As well as killing cancer cells, this medication can reduce the number of cells that fight infection in the body (white blood cells). Avoid contact with people who have contagious infections and tell your doctor if you begin to notice signs of an infection such as fever or chills.

Infertility: Men treated with bendamustine may develop infertility that may last for several years after stopping treatment. Talk to your doctor about infertility management options.

Infusion reaction: When bendamustine is given, you may experience an infusion reaction (fever, chills, skin rash or itchiness). If you experience an infusion reaction, your doctor may prescribe medications (e.g., antihistamines, acetaminophen, corticosteroids) to be given before future infusions to prevent another reaction.

Kidney problems: If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver problems: Bendamustine can affect your liver function. If you have severe liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using bendamustine. PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision changes, trouble thinking, personality changes or difficulty walking, contact your doctor immediately.

Secondary cancer: This medication can increase the risk of developing leukemia, lung cancer, or certain types of skin cancer. If you are concerned about this, talk to your doctor about the risks and benefits of using this medication.

Surgery: If you need surgery, tell your doctor or anesthetist that you are taking this medication.

Tumour lysis syndrome: Bendamustine, like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may have nausea, shortness of breath, cloudy urine, or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Pregnancy: There is a possibility of birth defects if either the man or woman is taking bendamustine at the time of conception, or if it is taken during pregnancy. Use effective birth control starting 2 weeks before receiving this medication and for at least 4 weeks after receiving your last dose. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if bendamustine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Women who are using bendamustine are advised to not breast-feed. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between bendamustine and any of the following:

• allopurinol
• bacillus Calmette-Guérin (BCG)
• cladribine
• clozapine
• deferasirox
• deferiprone
• fluvoxamine
• leflunomide
• mesalamine
• methoxsalen
• mexiletine
• olsalazine
• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
• stiripentol
• sulfasalazine
• teriflunomide
• vemurafenib

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.