Bendamustine

Bendamustine is a prescription medication used for the treatment of chronic lymphocytic leukemia or Nonhodgkin lymphoma.

• Bendamustine is available under the following different brand names: Bendeka, Belrapzo, Treanda

Common side effects of Bendamustine include:

• nausea
• vomiting
• diarrhea
• tiredness
• weakness
• mouth sores
• constipation
• upset stomach
• swelling in the hands or feet
• headache
• dizziness
• drowsiness
• loss of appetite
• weight loss
• mild skin rash

Serious side effects of Bendamustine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• sore throat,
• burning in the eyes,
• skin pain,
• red or purple skin rash that spreads and causes blistering and peeling,
• skin rash,
• swollen glands, 
• muscle aches,
• severe weakness,
• yellowing of your skin or eyes (jaundice),
• chills,
• itching during or shortly after the injection,
• pain, swelling, redness, skin changes, or signs of infection at the injection site,
• severe ongoing nausea,
• vomiting,
• diarrhea,
• right-sided upper stomach pain,
• loss of appetite,
• feeling unwell,
• tiredness,
• mouth sores,
• skin sores,
• easy bruising,
• unusual bleeding,
• pale skin,
• cold hands and feet,
• lightheadedness,
• shortness of breath,
• confusion,
• weakness,
• muscle cramps,
• nausea,
• fast or slow heart rate,
• decreased urination, and
• tinging in the hands and feet or around the mouth

Rare side effects of Bendamustine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

 Adult dosage

Injection, ready-to-dilute solution

• 100 mg/4mL (25mg/mL) (Bendeka; Belrapzo; generic)
• Injection, lyophilized powder for reconstitution
• 25 mg/single-dose vial (Treanda; generic)
• 100 mg/single-dose vial (Treanda; generic)
• Chronic Lymphocytic Leukemia
• Adult dosage
• 100 mg/m² IV infusion on days 1 and 2 of a 28-day cycle, repeated for up to 6 cycles
• Non-Hodgkin Lymphoma
• Adult dosage
• 120 mg/m² IV infusion on days 1 and 2 of a 21-day cycle repeated for up to 8 cycles

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Bendamustine has severe interactions with no other drugs.
• Bendamustine has serious interactions with the following drugs:
  • abametapir
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • givosiran
  • idecabtagene vicleucel
  • lasmiditan
  • lisocabtagene maraleucel
  • palifermin
  • ropeginterferon alfa 2b
  • sotorasib
  • tepotinib
  • tisagenlecleucel
  • tofacitinib
• Bendamustine has moderate interactions with at least 59 other drugs.
• Bendamustine has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to bendamustine or mannitol
• Atrial fibrillation, congestive heart failure (some fatal), myocardial infarction (some fatal), palpitation

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bendamustine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bendamustine?”

Cautions

• Interrupt if severe infusion reactions
• Mild-mod renal impairment, mild hepatic impairment
• Possibility of anaphylactic/infusion reactions: severe in rare cases
• Myelosuppression may occur; delay or reduce dose; restart treatment based on ANC and platelet count recovery; complications of myelosuppression may lead to death
• Monitor for fever and other signs of infection and treat promptly
• Severe infusion and anaphylactic reactions reported; monitor clinically and discontinue therapy; premedicate in subsequent cycles for milder reactions
• Tumor lysis syndrome was reported; acute renal failure and death may occur; anticipate and use supportive measures
• Fatal and serious skin reactions have been reported with bendamustine treatment in clinical trials and postmarketing safety reports, including toxic skin reactions [Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)], bullous exanthema, and rash; events occurred when given as a single agent and in combination with other anticancer agents or allopurinol; monitor patients with skin reactions closely; if skin reactions are severe or progressive, withhold or discontinue bendamustine hydrochloride injection
• Tumor lysis syndrome is reported with use; onset tends to be within the first treatment cycle of bendamustine hydrochloride and, without intervention, may lead to acute renal failure and death; preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels
• Fatal and serious cases of liver injury reported with bendamustine hydrochloride injection
• Monitor liver chemistry tests before and during treatment
• Erythema and marked swelling can occur with extravasation; assure good venous access and monitor infusion site during and after administration
• Fetal harm can occur when administered to a pregnant woman; women should be advised to avoid becoming pregnant when receiving bendamustine
• Increased risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster; patients should undergo appropriate measures (including clinical and laboratory monitoring, prophylaxis, and treatment) for infection and infection reactivation before administration

Malignancies

• Pre-malignant and malignant diseases reported in patients receiving therapy, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, bronchial carcinoma, and non-melanoma skin cancer, including basal cell carcinoma and squamous cell carcinoma
• Monitor patients for the development of secondary malignancies; perform dermatologic evaluations during and after treatment

Progressive multifocal leukoencephalopathy (PML)

• PML includes fatal cases reported following treatment with bendamustine, primarily in combination with rituximab or obinutuzumab
• Consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive, or behavioral signs or symptoms
• If PML is suspected, withhold treatment and perform appropriate diagnostic evaluations
• Consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML

Pregnancy and Lactation

• There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; advise pregnant women of the potential risk to the fetus
• Pregnancy testing is recommended for females of reproductive potential before initiation of therapy

Contraception

• Therapy can cause embryo-fetal harm when administered to pregnant women;
• advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after the final dose
• Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with the drug and for at least 3 months after the final dose

Infertility

• Based on findings from clinical studies, therapy may impair male fertility; impaired spermatogenesis, azoospermia, and total germinal aplasia have been reported in male patients treated with alkylating agents, especially in combination with other drugs; in some instances, spermatogenesis may return in patients in remission, but this may occur only several years after intensive chemotherapy has been discontinued; advise patients of the potential risk to their reproductive capacities
• Based on findings from animal studies, the drug may impair male fertility due to an increase in morphologically abnormal
• Spermatozoa; the long-term effects of therapy on male fertility, including the reversibility of adverse effects, have not been studied

Lactation

• There are no data on the presence of drugs or metabolites in either human or animal milk, effects on the breastfed child, or milk production; because of the potential for serious adverse reactions in a breastfed child, advise patients that breastfeeding is not recommended during treatment and for at least 1 week after the last dose