.

Bendamustine HCl has an established safety profile in CLL

Hematologic laboratory abnormalities1

  Bendamustine HCI (N=150) Chlorambucil (N=141)
Laboratory abnormality All grades n (%) Grades 3/4 n (%) All grades n (%) Grades 3/4 n (%)
Hemoglobin decreased 134 (89) 20 (13) 155 (82) 12 (9)
Platelets decreased 116 (77) 16 (11) 110 (78) 14 (10)
Leukocytes decreased 92 (61) 42 (28) 26 (18) 4 (3)
Lymphocytes decreased 102 (68) 70 (47) 27 (19) 6 (4)
Neutrophils decreased 113 (75) 65 (43) 85 (61) 30 (21)

Non-hematologic adverse reactions occurring in ≥5% (all grades)1

Bendamustine HCI (N=153) Chlorambucil (N=143)
Body system/adverse reaction All Grades (%) Grades 3/4 (%) All Grades (%) Grades 3/4 (%)
Total % of patients with ≥1 adverse reaction 79 34 67 17
Gastrointestinal disorders Nausea 20 <1 15 <1
Vomiting 16 <1 6 0
Diarrhea 9 1 3 0
General disorders and administration site conditions Pyrexia 24 4 6 1
Fatigue 9 1 6 0
Asthenia 8 0 4 0
Chills 6 0 <1 0
Immune system disorders Hypersensitivity 5 1 2 0
Infections and infestations Nasopharyngitis 7 0 8 0
Infection 6 2 <1 <1
Herpes simplex 3 0 5 0
Investigations Weight decreased 7 0 3 0
Metabolism and nutrition disorders Hyperuricemia 7 2 1 0
Respiratory, thoracic, and mediastinal disorders Cough 4 <1 5 <1
Skin and subcutaneous tissue disorders Rash 8 3 5 2
Pruritus 5 0 1 0

.

  • Adverse reactions in patients ≥651

    No significant differences were found in the adverse reaction profile between patients ≥65 years of age and younger patients

  • Rate of alopecia2

    Less than 1% of patients (1/153) experienced alopecia while being treated with bendamustine compared with no patients (0/143) in the chlorambucil group

Scroll down
Scroll up

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.

References: 1. BENDEKA® (bendamustine hydrochloride) injection [Current Prescribing Information]. North Wales, PA: Teva Pharmaceuticals USA, Inc. 2. Data on file. Parsippany, NJ: Teva Pharmaceuticals.

 

You are about to leave this site

You are about to leave BENDEKAHCP.com and enter a website operated by a third party.

Would you like to continue?

 

Are you a healthcare professional?

The information on this site is intended
for healthcare professsionals

in the United States. Are you a healthcare
professional in the United States?

 

Contact us

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.