Treanda

Approved Uses

Treanda is primarily used to treat two specific types of cancer:

• Chronic Lymphocytic Leukemia (CLL): This is a slow-growing cancer that affects the white blood cells (lymphocytes) in the bone marrow and blood.
• Indolent B-cell Non-Hodgkin Lymphoma (NHL): This is a slow-growing type of lymphoma. Treanda is specifically indicated for patients whose NHL has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

How It Is Administered

Treanda is given as an injection into a vein (intravenous infusion) by a healthcare provider in a hospital or clinic setting. It belongs to a class of medications known as alkylating agents, which work by slowing or stopping the growth of cancer cells in the body.

Mechanism of Action

Treanda belongs to a group of drugs called alkylating agents. It is designed to target and destroy cancer cells by interfering with their genetic material.

The medication works through the following process:

• DNA Damage: Once inside the body, the drug attaches to the DNA strands within cancer cells.
• Cross-linking: It creates chemical bonds, or cross-links, between these DNA strands. This prevents the strands from separating, which is a necessary step for the cell to copy its DNA.
• Cell Death: Because the cancer cell cannot replicate its DNA, it is unable to divide and grow. This damage eventually triggers the cell to die.

While Treanda affects both healthy and cancerous cells, it is particularly effective against cancer cells because they usually divide more rapidly and are less able to repair the damage caused by the medication.

Common Side Effects

Many people receiving Treanda experience mild to moderate side effects. These may include:

• Nausea and vomiting
• Diarrhea or constipation
• Loss of appetite and weight loss
• Headache
• Feeling very tired or weak
• Dizziness
• Cough
• Mouth sores
• Mild skin rash

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following serious symptoms:

• Signs of infection, such as fever, chills, or persistent sore throat
• Unusual bruising or bleeding
• Shortness of breath or chest pain
• Severe skin reactions, including blistering, peeling, or painful rashes
• Pain, swelling, or redness at the injection site
• Signs of liver problems, such as yellowing of the skin or eyes and dark urine
• Signs of kidney issues, such as swelling in the legs or feet and changes in urination

Blood Cell Counts

Treanda can significantly lower the number of blood cells in your body. This includes white blood cells, which help fight infection; red blood cells, which carry oxygen; and platelets, which help the blood clot. Your doctor will monitor your blood counts regularly during treatment to check for anemia, increased infection risk, or bleeding risks.

Bone Marrow Suppression

Treanda often causes a significant drop in white blood cells, red blood cells, and platelets. This condition, known as myelosuppression, can increase the risk of serious infections, anemia, and easy bruising or bleeding. Healthcare providers perform regular blood tests to monitor these levels and may delay treatment if counts are too low.

Infections

Treatment with Treanda increases the risk of serious and sometimes fatal infections, such as pneumonia or sepsis. There is also a risk of viral reactivation, including hepatitis B or herpes zoster (shingles). Patients may be prescribed preventive medications to reduce these risks.

Infusion and Skin Reactions

Infusion reactions are common and can be severe, including anaphylaxis. Additionally, serious skin reactions like Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) have been reported. These reactions can be fatal and require immediate medical attention if a rash, blisters, or peeling skin develops.

Tumor Lysis Syndrome

The rapid breakdown of cancer cells during treatment can lead to tumor lysis syndrome (TLS), which may cause kidney failure or heart rhythm problems. This risk is highest during the first treatment cycle, and healthcare providers may use specific medications or hydration to help prevent it.

Liver Toxicity

Treanda may cause liver injury or inflammation. Monitoring liver function through blood tests is necessary before and during treatment, especially for patients with pre-existing liver conditions.

Device Compatibility Warning

The FDA has warned that certain formulations of Treanda injection solution should not be used with closed system transfer devices (CSTDs), adapters, or syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). The drug can cause these specific plastics to dissolve or crack, which may lead to device failure, contamination, or leakage.

Other Risks

• Secondary Cancers: There is a risk of developing other types of cancer, such as myelodysplastic syndrome or acute myeloid leukemia, following treatment.
• Pregnancy and Fertility: Treanda can cause fetal harm. Effective contraception is recommended for both men and women during treatment and for a period after the final dose. The drug may also impair male fertility.
• Extravasation: If the drug leaks out of the vein into the surrounding tissue during injection, it can cause severe tissue damage, swelling, or redness.

Pregnancy

Treanda may cause fetal harm when administered to a pregnant woman. Animal studies have shown that the medication can cause birth defects or pregnancy loss. It is important to discuss the potential risks with a healthcare provider before starting treatment.

Patients of reproductive potential should follow these contraception guidelines:

• Females: Use effective birth control during treatment and for at least 6 months after the final dose.
• Males: Use effective birth control during treatment and for at least 3 months after the final dose if your partner can become pregnant.

If pregnancy occurs during treatment, contact a healthcare provider immediately.

Breastfeeding

There is no information on whether Treanda is present in human breast milk or how it might affect a nursing infant. Because of the potential for serious adverse reactions, breastfeeding is not recommended during treatment and for at least 1 week after the last dose.

Available Forms

Treanda is supplied in two formats for intravenous administration:

• Lyophilized Powder: This form comes in a vial and must be reconstituted and diluted before use.
• Injection Solution: This form is a concentrated liquid in a vial that must be diluted before administration.

Both forms are intended for use by a healthcare provider and are given as an infusion into a vein.

FDA Approved Indications

Treanda (bendamustine hydrochloride) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of the following conditions:

• Chronic lymphocytic leukemia (CLL): It is indicated for the treatment of patients with CLL, though its comparative efficacy to first-line therapies other than chlorambucil has not been fully established.
• Indolent B-cell non-Hodgkin lymphoma (NHL): It is indicated for patients whose disease has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

FDA Safety Communications

The FDA has issued a specific safety warning regarding the liquid formulation of Treanda (injection solution). This formulation contains N,N-dimethylacetamide (DMA), a solvent that can interact negatively with certain plastics.

The FDA warns against using the Treanda injection solution with closed system transfer devices (CSTDs), adapters, or syringes that contain polycarbonate or acrylonitrile-butadiene-styrene (ABS). The interaction between the drug and these materials can cause:

• Device failure, including leaking, breaking, or cracking.
• Contamination of the drug product with plastic components.
• Potential skin or respiratory exposure risks for healthcare professionals.

Healthcare providers are instructed to verify the compatibility of all administration equipment before use or to use the lyophilized powder formulation of Treanda, which does not contain DMA and is not subject to this specific device warning.

Factors Influencing Cost

The total cost of treatment with Treanda is determined by several factors:

• Dosage and Frequency: The amount of medication needed is based on the patient's body size and the condition being treated.
• Administration Fees: Treanda is given as an intravenous infusion by a healthcare professional. Costs typically include fees for the medical facility and the professional services required for administration.
• Generic Availability: Bendamustine, the active ingredient in Treanda, is available as a generic medication, which may be less expensive than the brand-name version.

Insurance and Assistance

Most insurance plans cover Treanda, but out-of-pocket expenses like copays and deductibles vary. Some patients may qualify for financial assistance programs or co-pay cards provided by the manufacturer to help manage costs.