bendamustine hydrochloride

bendamustine hydrochloride


Pharmacologic class: Alkylating agent

Therapeutic class: Antineoplastic

Pregnancy risk category D


Unclear. Dissociates into electrophilic alkyl groups, which form covalent bonds with electron-rich nucleophilic moieties; bifunctional covalent linkage may cause cell death via several pathways. Acts against both quiescent and dividing cells.


Lyophilized powder for injection: 100 mg in 20-ml single-use vials (with mannitol)

Indications and dosages

Chronic lymphocytic leukemia

Adults: 100 mg/m2 by I.V. infusion over 30 minutes on days 1 and 2 of 28-day cycle for up to six cycles

Dosage adjustment

• Grade 4 hematologic toxicity or clinically significant nonhemologic toxicity at above grade 2

Off-label uses

• Non-Hodgkin's lymphoma


• Hypersensitivity to drug or mannitol


Use cautiously in:

• mild or moderate renal impairment (not recommended in creatinine clearance less than 40 ml/minute)

• mild hepatic impairment (not recommended in moderate or severe hepatic impairment)

• myelosuppression

• concurrent use of CYP1A2 inhibitors or inducers

• pregnant or breastfeeding patients

• children (safety and efficacy not established).


• Give drug by I.V. infusion only.

• Reconstitute with 20 ml sterile water for injection. Wait until powder dissolves completely (approximately 5 minutes).

• Immediately transfer (within 30 minutes of reconstitution) to 500-ml infusion bag of normal saline injection. After transferring, thoroughly mix infusion bag contents. Admixture should be clear and colorless to slightly yellow.

Stay alert for infusion reactions. Signs and symptoms include fever, chills, pruritus, and rash. Rarely, severe anaphylactic and anaphylactoid reactions have occurred. Monitor patient and discontinue drug if severe reaction arises. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles if patient had previous infusion reaction.

• Check I.V. site frequently to avoid extravasation.

Adverse reactions

CNS: asthenia, fatigue, malaise, weakness, somnolence, headache

CV: worsening hypertension

EENT: nasopharyngitis

GI: nausea, vomiting, diarrhea, constipation, dry mouth, mucosal inflammation, stomatitis

Hematologic: myelosuppression (anemia, leukopenia, lymphopenia, neutropenia, thrombocytopenia)

Metabolic: hyperuricemia

Respiratory: cough, pneumonia

Skin: rash, pruritus, toxic skin reactions, bullous exanthema, Stevens-Johnson syndrome, toxic epidermal necrolysis

Other: fever, chills, infection, herpes simplex, weight loss, other malignancies, tumor lysis syndrome, sepsis, infusion reactions and anaphylaxis, hypersensitivity reaction


Drug-drug. Allopurinol: possible increased risk of skin reactions

CYP1A2 inducers (such as omeprazole): potentially decreased bendamustine blood level and increased active metabolite levels

CYP1A2 inhibitors (such as ciprofloxacin, fluvoxamine): potentially increased bendamustine blood level and decreased active metabolite levels

Drug-diagnostic tests. ALT, AST, bilirubin, uric acid: increased levels Creatinine: altered level

Hemoglobin, lymphocytes, neutrophils, platelets, white blood cells: decreased levels

Potassium, uric acid: increased levels

Drug-behaviors. Smoking: potentially decreased bendamustine blood level and increased active metabolite levels

Patient monitoring

• Closely monitor complete blood count with differential and renal and hepatic function test results.

Monitor for skin reactions, including rash, toxic reactions, and bullous exanthema. Such reactions may be progressive and worsen with further treatment. In severe or progressive skin reaction, withhold or discontinue drug.

Watch for tumor lysis syndrome, especially during first treatment cycle. Signs and symptoms include irregular heartbeat, shortness of breath, high potassium level, high uric acid level, and impaired mental ability. Without intervention, acute renal failure and death may occur. Take preventive measures, as ordered, including maintaining adequate volume status, close monitoring of blood chemistry, and allopurinol administration during first 2 weeks of therapy in high-risk patients. However, be aware that concomitant use of allopurinol may increase risk of severe skin toxicity.

Patient teaching

• Instruct patient to report unusual bleeding or bruising, fever, chills, and lip or mouth sores.

• Inform patient that drug may increase risk of infection. Advise patient to wash hands frequently, wear mask in public places, and avoid people with infections.

• Advise female that drug may harm fetus; caution her to avoid becoming pregnant. If patient is pregnant during therapy or becomes pregnant, inform her of risk to fetus.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

References in periodicals archive ?
The companies stated that BENDEKA, a liquid, low-volume (50 mL) and short-time (10-minute) infusion formulation of bendamustine hydrochloride, was approved by the US Food and Drug Administration (FDA) for the treatment of patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
announced today that the anticancer agent TREAKISYM for Injection 100 mg (generic name: bendamustine hydrochloride, "TREAKISYM") has been approved in Japan for an additional indication of chronic lymphocytic leukemia.
Bendamustine hydrochloride is an alkylating agent that has a unique, multifaceted mechanism of action.
Titled "Bendamustine: A Novel Cytotoxic Agent for Hematologic Malignancies," it notes that bendamustine hydrochloride has a chemical structure containing alkylating nitrogen mustard, contributing to its cytotoxic properties.
Pharmaceutical company Eagle Pharmaceuticals (NasdaqGM:EGRX) reported on Tuesday the receipt of the sixth patent from the US Patent and Trademark Office (USPTO) for its liquid bendamustine hydrochloride (HCl) formulations.
Bendamustine hydrochloride is an anticancer agent originally synthesized by German (formerly 'East German') pharmaceutical company Jenapharm and is marketed in Europe under the brand names Ribomustin(R) and Levact(R) as a treatment for non-Hodgkin's lymphoma, multiple myeloma and chronic lymphocytic leukemia.
launched bendamustine hydrochloride ("bendamustine") in Singapore under the brand name Symbenda(R) as a treatment for low-grade non-Hodgkin's lymphoma and chronic lymphatic leukemia.
SymBio Pharmaceuticals Limited has acquired exclusive rights for the development and commercialization of bendamustine hydrochloride in Japan, China, Korea, Taiwan and Singapore from Astellas Pharma GmbH (currently Astellas Deutschland GmbH, Munich, Germany).
Pharmaceutical company Teva Pharmaceutical Industries (NYSE:TEVA)(TASE:TEVA Eagle Pharmaceuticals (NasdaqGM:EGRX) on Tuesday jointly revealed that the New Drug Application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid infusion product has been accepted for filing by the US Food and Drug Administration (FDA).
Supply 2014-1-028 597 vials of Bendamustine Hydrochloride for Clinical Pharmacy Service San Carlos Hospital in Madrid.
M2 PHARMA-July 10, 2014-Eagle Pharmaceuticals receives orphan drug designation for bendamustine hydrochloride from United States Food and Drug Administration