Bendeka

Approved Uses

Bendeka is an intravenous medication prescribed for the treatment of specific types of cancer in adults. Its primary uses include:

• Chronic Lymphocytic Leukemia (CLL): This is a type of cancer that begins in the white blood cells found in the bone marrow. Bendeka is used as a treatment for patients with this condition.
• Indolent B-cell Non-Hodgkin Lymphoma (NHL): This is a slow-growing cancer of the lymphatic system. Bendeka is used for patients whose disease has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Bendeka belongs to a class of medications known as alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. It is administered by a healthcare professional in a medical setting, such as a hospital or clinic.

How Bendeka Works

Bendeka contains the active ingredient bendamustine, which belongs to a class of medications known as alkylating agents. These drugs are designed to target and kill cells that divide rapidly, a primary characteristic of cancer cells.

The medication works through several steps to stop the progression of cancer:

• DNA Targeting: Once Bendeka enters the bloodstream and reaches the cancer cells, it attaches to the cell's DNA.
• Cross-linking: The drug forms chemical bonds between the strands of the DNA. This process, called cross-linking, prevents the DNA strands from separating as they normally would during cell division.
• Stopping Replication: Because the DNA strands cannot separate, the cancer cell is unable to replicate its genetic material or create new cells.
• Cell Death: When the cell's DNA is damaged beyond repair and it can no longer divide, the cell eventually dies.

By interfering with the life cycle of cancer cells, Bendeka helps to reduce the number of abnormal cells in conditions such as chronic lymphocytic leukemia (CLL) and certain types of non-Hodgkin lymphoma (NHL).

Common Side Effects

Many people receiving Bendeka experience side effects during treatment. Common symptoms include:

• Nausea and vomiting
• Diarrhea or constipation
• Fatigue and general weakness
• Fever and headache
• Cough
• Rash
• Mouth sores
• Loss of appetite and weight loss

Serious Side Effects

Bendeka can cause serious complications that require medical monitoring. Contact a healthcare provider immediately if you experience:

• Low blood cell counts: A significant drop in white blood cells, red blood cells, or platelets, which can lead to infections, anemia, or unusual bleeding and bruising.
• Infusion reactions: Symptoms such as chills, fever, itching, or rash that occur during or shortly after the medication is administered.
• Severe skin reactions: Serious rashes that may lead to blistering or peeling skin.
• Liver toxicity: Signs include yellowing of the skin or eyes, dark urine, or stomach pain.
• Tumor lysis syndrome: A condition resulting from the rapid death of cancer cells, which can cause kidney issues.
• Infections: An increased risk of serious infections, such as pneumonia or the reactivation of shingles.
• Heart issues: New or worsening chest pain, shortness of breath, or heart rhythm changes.
• Secondary cancers: There is a risk of developing other types of cancer, such as leukemia, later in life after treatment.

Myelosuppression

Treatment with Bendeka often leads to a decrease in blood cell counts, including white blood cells, platelets, and red blood cells. This can increase the risk of infection, bleeding, and fatigue. Blood counts are typically monitored weekly or as directed by a healthcare provider to manage these risks.

Infections

Serious and sometimes fatal infections can occur during treatment. These include pneumonia, sepsis, and the reactivation of previous infections such as Hepatitis B or shingles. Patients with low white blood cell counts are at a higher risk for these complications.

Infusion and Allergic Reactions

Infusion-related reactions are common and can range from mild to life-threatening. Symptoms may include fever, chills, itching, or rash. Severe anaphylaxis has been reported, particularly in patients who have had previous reactions to bendamustine or its components, such as polyethylene glycol 400.

Skin Reactions

Severe skin reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, have occurred. These conditions require immediate medical attention. If a serious skin reaction is suspected, treatment may be suspended or discontinued permanently.

Tumor Lysis Syndrome

This condition occurs when cancer cells break down rapidly, releasing their contents into the bloodstream. This can lead to kidney failure and heart rhythm problems. Preventive measures, such as increased hydration and specific medications, are often used for those at high risk.

Liver Toxicity

Bendeka may cause liver injury or inflammation. Healthcare providers monitor liver function tests regularly, especially in patients with a history of liver disease or those taking other medications that may affect the liver.

Other Risks

• Secondary Cancers: There is a risk of developing other types of cancer, such as myelodysplastic syndrome or acute myeloid leukemia, following treatment.
• Extravasation: If the medication leaks out of the vein during infusion, it can cause severe tissue damage, redness, and swelling at the injection site.
• Pregnancy and Fertility: Bendeka can cause harm to a developing fetus. Effective contraception is recommended for both men and women during treatment and for a specific period afterward.

Pregnancy Risks

Bendeka can cause fetal harm when administered to a pregnant woman. Research indicates that the medication may lead to birth defects or the death of a fetus. Patients should inform their healthcare provider immediately if they become pregnant or suspect they are pregnant during treatment.

Contraception and Testing

Healthcare providers typically perform a pregnancy test before starting Bendeka in individuals who can become pregnant. To prevent pregnancy during and after treatment, the following guidelines are generally recommended:

• Females: Use effective contraception during treatment and for at least 6 months after the final dose.
• Males: Use effective contraception (such as condoms) during treatment and for at least 3 months after the final dose if the partner is of reproductive potential.

Breastfeeding

It is not known whether bendamustine passes into human milk or how it affects milk production. However, because of the risk of serious side effects in a nursing child, breastfeeding is not recommended during treatment and for at least 1 week after the last dose of Bendeka.

Fertility

Bendeka may impair male fertility, which could affect the ability to father a child. Individuals concerned about future fertility should discuss options for fertility preservation with their medical team before beginning therapy.

Available Forms

Bendeka is supplied in the following form:

• Intravenous Injection: A ready-to-use, clear, colorless to yellow solution provided in multi-dose vials.

This medication is intended for administration into a vein by a healthcare provider in a clinical setting. Unlike some other formulations of the same active ingredient, this version does not require reconstitution before use.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Bendeka (bendamustine hydrochloride) in December 2015. It is a rapid-infusion, low-volume formulation of bendamustine. The medication is approved for the following uses:

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

Safety Communications and Monitoring

The FDA monitors the safety of Bendeka through the FDA Adverse Event Reporting System (FAERS). In 2016, the FDA identified a potential signal of serious risk regarding severe skin reactions associated with bendamustine products. These reactions include Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Following this identification, the FDA required updates to the drug labeling to include warnings about these serious skin conditions. There is currently no Risk Evaluation and Mitigation Strategy (REMS) program required for this medication.

Administration and Facility Fees

Bendeka is administered as an intravenous infusion by healthcare professionals in a clinical setting, such as a hospital or infusion center. Because it is not a medication you pick up at a retail pharmacy, the total cost often includes the price of the drug itself along with fees for the medical staff, equipment, and the facility where the treatment is provided.

Insurance and Medicare Coverage

Most private insurance plans and Medicare Part B typically cover Bendeka when it is used for FDA-approved indications. Your specific out-of-pocket expenses, such as deductibles, copayments, or coinsurance, will vary based on your individual health plan's benefits and whether the treatment facility is in-network.

Financial Assistance Programs

The manufacturer of Bendeka may offer financial assistance programs, such as co-pay savings cards for eligible patients with commercial insurance. For those who are uninsured or underinsured, patient assistance programs may be available to help cover the cost of the medication. Some independent charitable foundations also provide grants to assist with treatment costs for specific types of cancer.

Generic Alternatives

Generic versions of bendamustine (the active ingredient in Bendeka) are available. Generic medications are generally less expensive than brand-name drugs. You should consult with your healthcare provider or insurance company to determine if a generic version is an appropriate and covered option for your treatment plan.