Treanda

The recommended dose of Treanda (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 Treanda (Bendamustine), depending on how well you tolerate the medication and how severe side effects are.

As well as interfering with cancer cells, Treanda (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 Treanda (Bendamustine)?"

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 Treanda (Bendamustine) 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 Treanda (Bendamustine) be given exactly as recommended by your doctor. If you miss an appointment to receive Treanda (Bendamustine), contact your doctor as soon as possible to reschedule your appointment.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

25 mg
Each vial of sterile freeze-dried powder contains 25 mg of Treanda (Bendamustine) hydrochloride. Nonmedicinal ingredients: mannitol.

100mg
Each vial of sterile freeze-dried powder contains 100 mg of Treanda (Bendamustine) hydrochloride. Nonmedicinal ingredients: mannitol.

Do not take Treanda (Bendamustine) if you:

• are allergic to Treanda (Bendamustine) hydrochloride or any ingredients of Treanda (Bendamustine), including mannitol
• have a serious infection, including pneumonia, or HIV

There may be an interaction between Treanda (Bendamustine) and any of the following:

• Abiraterone acetate
• Allopurinol
• bacillus Calmette-Guérin (BCG)
• Carbamazepine
• Clozapine
• Deferiprone
• Fluvoxamine
• ketoconazole
• methoxsalen
• Mexiletine
• Phenobarbital
• Primaquine
• primidone
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifampin
• Stiripentol

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 Treanda (Bendamustine). 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.

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 Treanda (Bendamustine).

Low red blood cell count: Treanda (Bendamustine) 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: Treanda (Bendamustine) 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: Treanda (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 Treanda (Bendamustine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Treanda (Bendamustine), and whether any special monitoring is needed.

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

Infection: As well as killing cancer cells, Treanda (Bendamustine) 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 Treanda (Bendamustine) may develop infertility that may last for several years after stopping treatment. Talk to your doctor about infertility management options.

Infusion reaction: When Treanda (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 Treanda (Bendamustine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Treanda (Bendamustine), and whether any special monitoring is needed.

Liver problems: Treanda (Bendamustine) can affect your liver function. If you have severe liver problems, discuss with your doctor how Treanda (Bendamustine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Treanda (Bendamustine), 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.

Secondary cancer: Treanda (Bendamustine) can increase the risk of developing leukemia or Lung Cancer. If you are concerned about this, talk to your doctor about the risks and benefits of using Treanda (Bendamustine).

Surgery: If you need surgery, tell your doctor or anesthetist that you are taking Treanda (Bendamustine).

Tumour lysis syndrome: Treanda (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 Treanda (Bendamustine) at the time of conception, or if it is taken during pregnancy. Use effective birth control starting 2 weeks before receiving Treanda (Bendamustine) and for at least 4 weeks after receiving your last dose. If you become pregnant while taking Treanda (Bendamustine), contact your doctor immediately.

Breast-feeding: It is not known if Treanda (Bendamustine) passes into breast milk. If you are a breast-feeding mother and are taking Treanda (Bendamustine), it may affect your baby. Women who are using Treanda (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 Treanda (Bendamustine) have not been established for children.