.

BENDEKA allows patients time off active treatment

 

The only bendamustine infused over 10 MINUTES1

FOR CLL1

 

28-DAY cycle red_arrow.png up to 6 cycles

Recommended BENDEKA dosage is 100 mg/m2 administered intravenously on Day 1 and Day 2

Fixed course of therapy1

Once treatment cycles are completed, patients are taken off active treatment with BENDEKA

BENDEKA can be dose adjusted to help address toxicity1

Dose modifications for CLL*

Toxicity grade On Days 1 and 2, reduce dose to
Hematologic toxicity Initial ≥3 50 mg/m²
Recurrence ≥3 25 mg/m²
Non-hematologic toxicity Initial ≥3 50 mg/m²
Recurrence N/A N/A

*Dose re-escalation may be considered.

  • Dose adjustment1

    BENDEKA can be dose adjusted if toxicity occurs, which may help patients remain on therapy

  • Treatment monitoring1

    On-site infusion with BENDEKA allows healthcare professionals to confirm their patients are receiving treatment

Additional dosing considerations1

  • Delay treatment for Grade 4 hematologic toxicity or clinically
    significant Grade 2 ≥non-hematologic toxicity
  • Concomitant CYP1A2: Consider alternative therapies that are not
    CYP1A2 inducers or inhibitors during treatment with BENDEKA
  • Renal impairment: Do not use in patients with creatinine clearance <30 mL/min
  • Hepatic impairment: Do not use in patients with total bilirubin
    1.5-3 × ULN and AST or ALT 2.5-10 × ULN, or total bilirubin >3 × ULN

BENDEKA offers multiple administration efficiencies

    Multiple administration efficiencies

    Ready-to-dilute solution1

    Multiple-dose vial1

    3 diluent options1

    Admixture stability1

    Ready-to-dilute solution1

    25 mg/mL concentration administered as a 50 mL admixture
    Infused over 10 minutes

    Multiple-dose vial1

    Allow vial to reach room temperature (15oC to 30oC or 59oF to 86oF)

    Six dose withdrawals per vial for up to 28 days from first use when stored in the original carton under refrigeration1

    3 diluent options1

    0.9% Sodium Chloride Injection, USP; 2.5% Dextrose/0.45% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP

    Admixture stability1

    The final admixture is stable up to 6 hours when stored at room temperature*

    *Up to 3 hours when 5% Dextrose Injection, USP, is utilized.

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Important Safety Information

Contraindication: BENDEKA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, 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. BENDEKA causes myelosuppression. 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 BENDEKA 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 bendamustine hydrochloride 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: BENDEKA can cause fetal harm when administered to a pregnant woman. Conduct pregnancy testing prior to initiating treatment and advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with BENDEKA and for at least 6 months after the final dose and males with female partners of reproductive potential to use effective contraception for at least 3 months after the final dose. BENDEKA may also impair fertility in males.

Lactation: Advise patients that breastfeeding is not recommended during treatment with BENDEKA, and for at least 1 week after the last dose.

Most Common Adverse Reactions:

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

Indication

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 — or patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Please see Full Prescribing Information for BENDEKA.

Important Safety Information

Contraindication: BENDEKA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, 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. BENDEKA causes myelosuppression. 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 BENDEKA 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 bendamustine hydrochloride 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: BENDEKA can cause fetal harm when administered to a pregnant woman. Conduct pregnancy testing prior to initiating treatment and advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with BENDEKA and for at least 6 months after the final dose and males with female partners of reproductive potential to use effective contraception for at least 3 months after the final dose. BENDEKA may also impair fertility in males.

Lactation: Advise patients that breastfeeding is not recommended during treatment with BENDEKA, and for at least 1 week after the last dose.

Most Common Adverse Reactions:

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

Indication

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 — or patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

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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Medical Information

For healthcare professionals or patients with specific medical questions about BENDEKA®, please contact Teva Medical Information at:

1-888-4-TEVARX (1-888-483-8279)

To request more information about BENDEKA, click here.