• Bendeka may be used to treat chronic lymphocytic leukemia (CLL) or indolent (slow growing) B-cell non-Hodgkin lymphoma that has progressed despite treatment.
• Bendeka is an alkylating agent that works against resting and dividing cells.
• It is administered as a 10-minute infusion into your vein usually on days 1 and 2 of a 28- or 21-day cycle.

Bendeka (bendamustine HCl) may be used to treat two types of cancer:

• Chronic lymphocytic leukemia (CLL)
• Slow-growing (indolent) B-cell non-Hodgkin lymphoma (NHL) that has progressed despite treatment with rituximab or a rituximab-containing regimen within the past 6 months.

What is chronic lymphocytic leukemia (CLL)?

Chronic lymphocytic leukemia (CLL) is a cancer of the lymphocytes, and it is the most common type of leukemia. It is caused by a genetic mutation in the DNA of blood-producing cells.

For CLL, the most common change is a deletion, or loss, of part of a chromosome. In most patients with CLL, the deletion is found on chromosome 13, but other chromosomes such as 11 and 17 can also be affected. In some patients with CLL, there is an extra chromosome 12.

This mutation causes the blood cells to produce abnormal, ineffective lymphocytes that continue to live and multiply when normal lymphocytes would die. These abnormal lymphocytes accumulate in the blood and certain organs, where they cause complications and crowd healthy cells out of the bone marrow and interfere with normal blood cell production.

What is non-Hodgkin lymphoma (NHL)?

Non-Hodgkin's lymphoma is cancer that originates in the lymph system, with tumors developing from lymphocytes. Diffuse large B-cell lymphoma is one of the more common subtypes of non-Hodgkin's lymphoma. NHL is often slow-growing and may not require treatment initially.

How does Bendeka work?

Bendeka is a nitrogen mustard derivative and is classified as an alkylating agent. A cell cycle goes through three phases: resting, active growing, and mitosis (division). Alkylating agents work best in the resting phase of the cell cycle, although they may also work in the active phase.

Bendeka is active against both resting and dividing cells. Although the exact way Bendeka works is not known, the structure of it means that it readily forms bonds with other electron-rich structures, which result in interstrand DNA crosslinks and very strong (covalent) bonds. This bonding can lead to cell death in several different ways.

Because cancer cells divide more rapidly than normal cells, they are more affected by this bonding and the death rate of cancerous cells is greater than the death rate of normal cells. This slows the growth of cancer cells in the body.

How is Bendeka given?

Bendeka is administered by a health professional, either in their offices, the hospital or at an infusion center. It is given as an intravenous infusion directly into a vein in your arm over 10 minutes.

• For CLL, Bendeka is usually given on days 1 and 2 of a 28-day treatment cycle. The treatment cycle may be repeated up to six times.
• For NHL, Bendeka is usually given on days 1 and 2 of a 21-day treatment cycle. The treatment cycle may be repeated up to eight times.

What are the side effects of Bendeka?

Although Bendeka is more effective at killing cancerous cells compared to normal cells, normal cells are still affected, which results in side effects.

A few people are also allergic to Bendeka or polyethylene glycol 400, propylene glycol, or monothioglycerol, which are also contained in the infusion. These people should not be given Bendeka.

Normal cells most affected by chemotherapy with Bendeka are blood cells, and cells in the mouth, stomach, and bowel. The most common side effects of Bendeka include:

• Diarrhea
• Constipation
• Cough
• Difficulty breathing
• Headache
• Loss of appetite
• Low red and white blood cells, low platelets
• Mouth ulcers and irritation
• Rash
• Tiredness
• Weight loss.

Hair loss is typically not a common side effect of Bendeka. Reports from the manufacturer indicate hair loss occurred in 1 out of 153 people treated with Bendeka for CLL, and 3 out of 100 people treated with Bendeka for NHL.

Other side effects that may occur include:

• Infections or a recurrence of infections
• Kidney or liver damage
• Other cancers
• Leaking of Bendeka into the surrounding skin causing tissue damage.