Administration of BENDEKA®1

Dosage strength 100 mg/4 mL
Formulation Ready-to-dilute solution
Concentration 25 mg/mL
Infusion bag volume 50 mL
Infusion time 'Short-time' infusion of 10 minutes
Diluent options
  • 0.9% Sodium Chloride Injection, USP; or
  • 2.5% Dextrose/0.45% Sodium Chloride Injection, USP; or
  • 5% Dextrose Injection, USP
Admixture stability
  • 6-hour final admixture stability at room temperature (15º to 30ºC or 59º to 86ºF) and room light when diluted with 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP
  • 3-hour final admixture stability at room temperature (15º to 30ºC or 59º to 86ºF) and room light when diluted with 5% Dextrose Injection, USP
  • 24-hour final admixture stability when refrigerated (2º to 8ºC or 36º to 46ºF)
Device compatibility No dimethylacetamide (DMA)-related device compatibility issues
How supplied

Multiple-dose vials
BENDEKA is supplied in individual cartons of 5 mL clear multiple-dose vials containing:

  • 100 mg/4 mL of bendamustine HCl as a clear and colorless to yellow ready-to-dilute solution
Product storage
  • Store BENDEKA at recommended refrigerated storage conditions (2° to 8°C or 36° to 46°F). When refrigerated the contents may partially freeze. Allow the vial to reach room temperature (15° to 30°C or 59° to 89°F) prior to use
  • Retain in original carton until time of use to protect from light
  • After first use, the multiple-dose vial should be stored in original carton in the refrigerator (2º to 8ºC or 36º to 46ºF), and then discarded after 28 days. Not recommended for greater than a total of 6 dose withdrawals

BENDEKA NDC: 63459-348-04
J Code: J9034 Injection, bendamustine hcl (bendeka), 1mg

Effective January 1, 2017, it will be necessary to use the newly assigned J code with your pharmacy and/or patient medication management systems.

100 mg/4 mL
Ready-to-dilute solution
25 mg/mL
50 mL
'Short-time' infusion of 10 minutes
  • 0.9% Sodium Chloride Injection, USP; or
  • 2.5% Dextrose/0.45% Sodium Chloride Injection, USP; or
  • 5% Dextrose Injection, USP
  • 6-hour final admixture stability at room temperature (15º to 30ºC or 59º to 86ºF) and room light when diluted with 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP
  • 3-hour final admixture stability at room temperature (15º to 30ºC or 59º to 86ºF) and room light when diluted with 5% Dextrose Injection, USP
  • 24-hour final admixture stability when refrigerated (2º to 8ºC or 36º to 46ºF)
No dimethylacetamide (DMA)-related device compatibility issues

Multiple-dose vials
BENDEKA is supplied in individual cartons of 5 mL clear multiple-dose vials containing:

  • 100 mg/4 mL of bendamustine HCl as a clear and colorless to yellow ready-to-dilute solution
  • Store BENDEKA at recommended refrigerated storage conditions (2° to 8°C or 36° to 46°F). When refrigerated the contents may partially freeze. Allow the vial to reach room temperature (15° to 30°C or 59° to 89°F) prior to use
  • Retain in original carton until time of use to protect from light
  • After first use, the multiple-dose vial should be stored in original carton in the refrigerator (2º to 8ºC or 36º to 46ºF), and then discarded after 28 days. Not recommended for greater than a total of 6 dose withdrawals
BENDEKA NDC: 63459-348-04
J Code: J9034 Injection, bendamustine hcl (bendeka), 1mg

Effective January 1, 2017, it will be necessary to use the newly assigned J code with your pharmacy and/or patient medication management systems.

BENDEKA is indicated for the treatment of patients with

  • Chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.
  • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Important Safety Information

Contraindication: BENDEKA® (bendamustine HCl) injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine HCl, polyethylene glycol 400, propylene glycol, or monothioglycerol.

Myelosuppression: Bendamustine HCl caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. Monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle.

Infections: Infection, including pneumonia, sepsis, septic shock, hepatitis and death has occurred. Patients with myelosuppression following treatment with BENDEKA are more susceptible to infections. Patients treated with bendamustine HCl are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients should undergo appropriate monitoring, prophylaxis, and treatment measures prior to administration.

Anaphylaxis and Infusion Reactions: Infusion reactions to bendamustine HCl have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe (Grade 3-4) reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.

Tumor Lysis Syndrome: Tumor lysis syndrome associated with bendamustine HCl has occurred. The onset tends to be within the first treatment cycle with bendamustine HCl 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. There may be an increased risk of severe skin toxicity when bendamustine HCl and allopurinol are administered concomitantly.

Skin Reactions: Fatal and serious skin reactions have been reported with bendamustine HCl and include, 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 bendamustine HCl was given as a single agent and in combination with other anticancer agents or allopurinol. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue BENDEKA.

Hepatotoxicity: Fatal and serious cases of liver injury have been reported with bendamustine HCl. Combination therapy, progressive disease or reactivation of hepatitis B were confounding factors in some patients. Most cases were reported within the first three months of starting therapy. Monitor liver chemistry tests prior to and during BENDEKA therapy.

Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with bendamustine HCl, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma. The association with BENDEKA has not been determined.

Extravasation Injury: Bendamustine HCl extravasations have been reported in post-marketing resulting in hospitalizations from erythema, marked swelling, and pain. Assure good venous access prior to starting BENDEKA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of BENDEKA.

Embryo-fetal Toxicity: Bendamustine HCl can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using BENDEKA.

Most Common Adverse Reactions:

  • Adverse reactions (frequency >5%) during infusion and within 24 hours post-infusion are nausea and fatigue.
  • Most common non-hematologic adverse reactions for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting.
  • Most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.
  • Most common hematologic abnormalities (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

TO REPORT ADVERSE REACTIONS: Contact us at 1-800-896-5855 or usmedinfo@tevapharm.com.

Please see Full Prescribing Information for BENDEKA.
Reference: 1. BENDEKA® (bendamustine hydrochloride) injection [Current Prescribing Information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.
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BENDEKA is indicated for the treatment of patients with

  • Chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.
  • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Important Safety Information

Contraindication: BENDEKA® (bendamustine HCl) injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine HCl, polyethylene glycol 400, propylene glycol, or monothioglycerol.

Myelosuppression: Bendamustine HCl caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. Monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle.

Infections: Infection, including pneumonia, sepsis, septic shock, hepatitis and death has occurred. Patients with myelosuppression following treatment with BENDEKA are more susceptible to infections. Patients treated with bendamustine HCl are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients should undergo appropriate monitoring, prophylaxis, and treatment measures prior to administration.

Anaphylaxis and Infusion Reactions: Infusion reactions to bendamustine HCl have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe (Grade 3-4) reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.

Tumor Lysis Syndrome: Tumor lysis syndrome associated with bendamustine HCl has occurred. The onset tends to be within the first treatment cycle with bendamustine HCl 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. There may be an increased risk of severe skin toxicity when bendamustine HCl and allopurinol are administered concomitantly.

Skin Reactions: Fatal and serious skin reactions have been reported with bendamustine HCl and include, 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 bendamustine HCl was given as a single agent and in combination with other anticancer agents or allopurinol. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue BENDEKA.

Hepatotoxicity: Fatal and serious cases of liver injury have been reported with bendamustine HCl. Combination therapy, progressive disease or reactivation of hepatitis B were confounding factors in some patients. Most cases were reported within the first three months of starting therapy. Monitor liver chemistry tests prior to and during BENDEKA therapy.

Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with bendamustine HCl, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma. The association with BENDEKA has not been determined.

Extravasation Injury: Bendamustine HCl extravasations have been reported in post-marketing resulting in hospitalizations from erythema, marked swelling, and pain. Assure good venous access prior to starting BENDEKA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of BENDEKA.

Embryo-fetal Toxicity: Bendamustine HCl can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using BENDEKA.

Most Common Adverse Reactions:

  • Adverse reactions (frequency >5%) during infusion and within 24 hours post-infusion are nausea and fatigue.
  • Most common non-hematologic adverse reactions for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting.
  • Most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.
  • Most common hematologic abnormalities (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

TO REPORT ADVERSE REACTIONS: Contact us at 1-800-896-5855 or usmedinfo@tevapharm.com.

Please see Full Prescribing Information for BENDEKA.