What is Treanda used for and how does it work?

• Treanda may be used to treat chronic lymphocytic leukemia (CLL) or indolent (slow-growing) B-cell non-Hodgkin lymphoma that has progressed despite treatment.
• Treanda is an alkylating agent that works against resting and dividing cells.
• Treanda is available in two formulations, a solution and a lyophilized powder that needs to be reconstituted.
• It is administered as a 30-minute infusion into your vein usually on days 1 and 2 of a 28-day cycle, up to 6 cycles.

Treanda (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 Treanda work?

Treanda 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. Treanda is active against both resting and dividing cells.

Although the exact way Treanda 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 Treanda given?

Treanda 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 30 minutes.

Treanda is available in two formulations, a solution (Treanda injection) and a lyophilized powder (Treanda for injection) that needs to be reconstituted. Treanda Injection and the reconstituted Treanda for Injection have different concentrations of bendamustine hydrochloride which are as follows:

• Treanda injection contains bendamustine at a concentration of 90 mg/mL
• Treanda for injection contains bendamustine at a concentration of 5mg/mL in the reconstituted solution.

Do not mix or combine the two formulations.

The recommended dose of Treanda is 100 mg/m² administered intravenously over 30-minutes on days 1 and 2 of a 28-day cycle, up to 6 cycles.

Only polypropylene syringes with a metal needle should be used to withdraw and transfer Treanda injection into the infusion bag. Treanda injection should not be used with closed system transfer devices, adapters, or syringes containing polycarbonate or acrylonitrile-butadiene-styrene before dilution in the infusion bag.

What are the side effects of Treanda?

Although Treanda is more effective at killing cancerous cells compared to normal cells, normal cells are still affected, which results in side effects. Normal cells most affected by chemotherapy with Treanda are blood cells, and cells in the mouth, stomach, and bowel.

The most common side effects of Treanda include:

• Black tarry stools
• Bleeding gums
• Blood in the urine or stools
• Diarrhea
• Constipation
• Cough
• Difficulty breathing
• Headache
• Loss of appetite
• Low red and white blood cells, low platelets
• Mouth ulcers and irritation
• Nausea
• Rash
• Stuffy or runny nose
• Tiredness
• Weight loss.

Other side effects that may occur include:

• Infections or a recurrence of infections
• Kidney or liver damage
• Other cancers
• Leaking of Treanda into the surrounding skin causing burning or stinging
• Swelling of the eyelids, face, lips, hands, or feet.