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

Reimbursement services from Teva

product codes

BENDEKA® NDC

63459-348-04

J Code

J9034 Injection, bendamustine hcl (bendeka), 1mg

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

For more information, call 1-888-483-8279.

Reimbursement assistance and support from CORE

CORE hotline reimbursement services offer patients and providers:

  • AssistPoint® —simplify paperwork with this convenient way to submit electronic records and forms

  • Benefit verification and coverage determination

  • Precertification and prior authorization support

  • Coverage guidelines and claim requirements of payers

  • Support through the claims and appeals process

  • Templates for letters of medical necessity

  • Teva Cares Foundation Patient Assistance Program referrals

  • Teva Cares Foundation offers a Patient Assistance Program to provide FDA-approved products free of charge for patients who qualify

  • Teva Oncology also provides support to patient advocacy organizations, such as the Leukemia & Lymphoma Society and others that have programs designed to help patients access the treatment they need

Use of CORE services is not a guarantee of payment. Payments are based on medical necessity at the time a claim is received.

To enroll in CORE:

Phone

1.888.587.3263

image

Fax

1.866.676.4073

image

Reimbursement services from Teva

product codes

BENDEKA® NDC

63459-348-04

J Code

J9034 Injection, bendamustine hcl (bendeka), 1mg

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

For more information, call 1-888-483-8279.

Reimbursement assistance and support from CORE

CORE hotline reimbursement services offer patients and providers:

  • AssistPoint® —simplify paperwork with this convenient way to submit electronic records and forms

  • Benefit verification and coverage determination

  • Precertification and prior authorization support

  • Coverage guidelines and claim requirements of payers

  • Support through the claims and appeals process

  • Templates for letters of medical necessity

  • Teva Cares Foundation Patient Assistance Program referrals

  • Teva Cares Foundation offers a Patient Assistance Program to provide FDA-approved products free of charge for patients who qualify

  • Teva Oncology also provides support to patient advocacy organizations, such as the Leukemia & Lymphoma Society and others that have programs designed to help patients access the treatment they need

Use of CORE services is not a guarantee of payment. Payments are based on medical necessity at the time a claim is received.

To enroll in CORE:

Phone

1.888.587.3263

image

Fax

1.866.676.4073

image

Resources for Patients

image

Steve's Journey with CLL

image

Understanding treatment with BENDEKA

Help your patients understand what they can expect from treatment with BENDEKA

Download now

Resources for healthcare professionals

Reprints

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CLL Case Study brochure

Teva Oncology also provides support to patient advocacy organizations

Download study

Steve's Journey with CLL


Important Safety Information

BENDEKA® (bendamustine HCI) 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.

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.

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.

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 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.

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.

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.

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.

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.

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