• Bendeka is a brand (trade) name for bendamustine HCL which may be used to treat chronic lymphocytic leukemia (CLL) and a certain type of non-Hodgkin lymphoma.
• Although the exact way Bendeka works is not known, its structure means that it readily forms bonds with other electron-rich molecules, which result in interstrand DNA crosslinks and very strong (covalent) bonds. 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.
• Bendeka belongs to the class of medicines known as alkylating agents. It may also be called a nitrogen mustard derivative or a cytotoxic 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.

• May be used to treat chronic lymphocytic leukemia (CLL).
• May also be given to people with 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.
• Administered as a 10-minute infusion into a vein usually on days 1 and 2 of a 28- or 21-day cycle.
• 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.
• Lung nodules are not commonly found after Bendeka and Rituxan therapy. Lung nodules are commonly found during routine X-rays, showing up on one in every 500 X-rays. Most are benign (noncancerous). Interstitial lung disease is considered a rare complication of Bendeka plus rituximab therapy but one that doctors should monitor for because it may be potentially fatal.
• Bendeka replaced Treanda in 2016. This was because Bendeka is compatible with polycarbonate or acrylonitrile-butadiene-styrene (ABS)-containing infusion equipment, and Treanda was not. Bendeka also has a shorter infusion time than Treanda. Bendeka has the same indications for use and side effects as Treanda.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience 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, nausea, rash, tiredness, swelling of the eyelids, face, lips, hands, or feet, and weight loss are the most commonly reported side effects.
• Other side effects that may occur include infections or a recurrence of infections, kidney or liver damage, other cancers, and leaking of Bendeka into the surrounding skin causing tissue damage. Infusion reactions, causing symptoms such as fever, chills, pruritus, and a rash, are common. Severe allergic reactions are rare. Consider treatment with antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.
• Severe myelosuppression (Grade 3-4) occurred in 98% of patients in two studies. 2% of patients died as a result. Monitor complete blood counts, including leukocytes, platelets, hemoglobin, and neutrophils frequently.
• People treated with Bendeka are more susceptible to infections, such as pneumonia, sepsis, septic shock, and hepatitis; some may cause death. Advise patients to contact their physician at the first sign of an infection.
• 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.
• Bendeka may need to be temporarily or permanently stopped if Grade 4 hematologic toxicity, or greater than or equal to Grade 2 non-hematologic toxicity occurs. Once blood counts have improved and the toxicity improved to less than or equal to Grade 1 then Bendeka may be reinitiated if desired. Consider a dosage reduction.
• Must be administered by a health professional, either in their offices, the hospital, or at an infusion center. Bendeka is a cytotoxic drug and special handling and disposal procedures must be followed.
• Avoid in people with moderate to severe kidney disease (CL_CR30 mL/min) or with AST or ALT values of 2.5 to 10 times the upper limit of normal or total bilirubin levels of 1.5 to 3 times the upper limit of normal.
• Although Bendeka 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 Bendeka are blood cells, and cells in the mouth, stomach, and bowel.
• Tumor lysis syndrome has been reported with Bendeka, typically within the first cycle of treatment. Consider preventive measures, such as vigorous hydration and close monitoring of laboratory values, particularly potassium and uric acid levels. Allopurinol has also been used at the start of Bendeka treatment (although this may increase the risk of severe skin toxicity).
• Fatal and serious skin reactions have also been reported with Bendeka, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Other serious effects include serious and fatal cases of liver injury (usually within the first 3 months), and malignancies, such as myelodysplastic syndrome, or acute myeloid leukemia.
• A few people are 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.
• Bendeka must be kept in a refrigerator before use (at 2°C to 8°C [36°F-46°F]).
• Bendeka can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment with Bendeka and for at least 6 months after the final dose. Males with female partners of reproductive potential should use effective contraception during treatment and for at least 3 months after the final dose. Breastfeeding is not recommended during Bendeka treatment and for at least one week after the final dose. Bendeka may impair male fertility.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Bendeka is a cytotoxic drug and must be administered by a health professional in a doctor's office with monitoring equipment. Tell your doctor if any adverse events happen during the infusion or soon afterward, such as rash, diarrhea, nausea or vomiting, or tiredness. If you notice any leakage of Bendeka during your infusion, tell the nurse/doctor straight away and wash the skin immediately with soap and water.
• If you experience any allergic-type reactions, such as rash, facial swelling, or difficulty breathing, tell your doctor immediately.
• While you are being administered Bendeka, you will need frequent monitoring of your white blood cells, platelets, and red blood cells. Report any signs of infection to your doctor.
• Bendeka can cause serious side effects, such as liver toxicity. Tell your doctor if you experience any signs of liver failure, such as yellowing of the skin or eyes, anorexia, bleeding, or easy bruising.
• Bendeka may cause tiredness and affect your ability to drive or operate machinery. Do not drive or perform complex tasks if it affects you like this.
• Tell your doctor or other health care provider about all the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements.
• Always tell your doctor about other underlying conditions you may have, such as heart rhythm disturbances.
• Bendeka is harmful to a developing baby and you should not take it if you are pregnant and for 6 months after the final dose. If you inadvertently become pregnant while taking Bendeka, tell your doctor right away. Females should also not breastfeed while being administered Bendeka and for at least 1 week following the final dose. Bendeka may also impair the fertility of males who have been administered it.

• The effectiveness of Bendeka has been investigated in several trials. 59% of patients with Binet Stage B CLL responded to Bendeka compared with 26% of those assigned chlorambucil. A complete response was reported in 8% of people, compared to < 1% with chlorambucil. Progression-free survival was reported as 18 months with Bendeka and 6 months with chlorambucil.
• For non-Hodgkin lymphoma, the overall response rate was 74% with Bendeka, and 13% of patients reported a complete response. The duration of the response was a median of 9.2 months.

Medicines that interact with Bendeka may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Bendeka. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Bendeka include:

• allopurinol
• anticonvulsants such as carbamazepine or phenobarbital
• antipsychotics, such as clozapine
• azathioprine
• biologics, such as adalimumab
• brewer's yeast or probiotics, such as Bifidobacterium infantis or Lactobacillus sp.
• caffeine
• chloramphenicol
• ciprofloxacin or norfloxacin
• daunorubicin or doxorubicin
• deferiprone
• echinacea
• esomeprazole
• etanercept
• fingolimod
• ganciclovir
• heart medications such as amiodarone
• hydroxyurea
• isoniazid
• live vaccines, such as the BCG vaccine, hepatitis vaccine, live influenza vaccine, mumps, or the measles vaccine
• mercaptopurine
• methotrexate
• ozanimod
• pegfilgrastim
• rifampin
• vitamin e
• zidovudine.

Coadministration with CYP1A2 inhibitors, such as ciprofloxacin, enoxacin, or fluvoxamine may increase the risk of side effects of Bendeka. Coadministration with CYP1A2 inducers, such as phenytoin, rifampin, ritonavir, or smoking may decrease the effectiveness of Bendeka.

Note that this list is not all-inclusive and includes only common medications that may interact with Bendeka. You should refer to the prescribing information for Bendeka for a complete list of interactions.