Indicated for:

Chronic Lymphocytic Leukemia (CLL):

• The treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

Non-Hodgkin Lymphoma (NHL):

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

TREANDA is available in two formulations, a solution (TREANDA Injection) and a lyophilized powder (TREANDA for Injection).

Do not use TREANDA Injection if you intend to use closed system transfer devices (CSTDs), adapters and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS) prior to dilution in the infusion bag.

If using a syringe to withdraw and transfer TREANDA Injection from the vial into the infusion bag, only use a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer TREANDA Injection into the infusion bag.

TREANDA Injection contains N,N-dimethylacetamide (DMA), which is incompatible with devices that contain polycarbonate or ABS. Devices, including CSTDs, adapters, and syringes that contain polycarbonate or ABS have been shown to dissolve when they come in contact with DMA which is present in the product.

TREANDA Injection and the reconstituted TREANDA for Injection have different concentrations of bendamustine hydrochloride. The concentration of bendamustine hydrochloride in the solution is 90 mg/mL and the concentration of bendamustine hydrochloride in the reconstituted solution of lyophilized powder is 5 mg/mL. Do not mix or combine the two formulations.

The effectiveness of TREANDA in pediatric patients has not been established. 

Reports of TREANDA causing severe myelosuppression.

Fatal and serious cases of liver injury have been reported with TREANDA. Most cases were reported within the first three months of starting therapy.

Progressive multifocal leukoencephalopathy (PML), including fatal cases, have occurred following treatment with bendamustine, primarily in combination with rituximab or obinutuzumab.

There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with TREANDA, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia and bronchial carcinoma.

Reports of TREANDA causing tumor lysis syndrome. The onset tends to be within the first treatment cycle of TREANDA and, without intervention, may lead to acute renal failure and death.

Fatal and serious skin reactions have been reported with TREANDA treatment in clinical trials and postmarketing safety reports, including toxic skin reactions (Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), bullous exanthema, and rash.

Infection, including pneumonia, sepsis, septic shock, hepatitis and death has occurred in adult and pediatric patients in clinical trials and in postmarketing reports. Patients treated with TREANDA are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster.

Infusion reactions to TREANDA have occurred commonly in clinical trials.

TREANDA extravasations have been reported in postmarketing resulting in hospitalizations from erythema, marked swelling, and pain.

Inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) have potential to increase plasma concentrations of bendamustine and decrease plasma concentrations of active metabolites. Inducers of CYP1A2 (e.g., omeprazole, smoking) have potential to decrease plasma concentrations of bendamustine and increase plasma concentrations of its active metabolites. Caution should be used, or alternative treatments considered if concomitant treatment with CYP1A2 inhibitors or inducers is needed.

Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant throughout treatment and for 3 months after TREANDA therapy has stopped. Men receiving TREANDA should use reliable contraception for the same time period. Advise patients to report pregnancy immediately.

Advise patients to avoid nursing while receiving TREANDA.

GoToSource

• Use in patients under the age of 18. GoToSource

• First-line in indolent and mantle cell NHL, T-cell NHL, salvage therapy in aggressive B-cell NHL, primary therapy in aggressive B-cell NHL for those unable to tolerate anthracycline-based therapy. GoToSource

• Waldenstrom’s macroglobulinemia. GoToSource

• Multiple myeloma and other solid tumors. GoToSource

• Soft tissue sarcoma. GoToSource

• Breast cancer, small-cell lung cancer and leiomyosarcomas. GoToSource

Hypertension (high blood pressure), pneumonia, hypokalemia (low potassium level), dehydration, asthenia (lack of energy and strength), thrombocytopenia (low platelet count), herpes zoster reactivation, toxic epidermal necrolysis and stevens-johnson syndrome (life-threatening drug reaction). GoToSource

Lymphocytopenia (low lymphocyte count a type of white blood cell) and anemia (decreased red blood cells). GoToSource 

Diffuse alveolar hemorrhage (bleeding into alveoli of lungs). GoToSource

Myelodysplastic syndrome (bone marrow disorder) and myelomonocytic leukemia. GoToSource

Atrial fibrillation (irregular rapid heart rate). GoToSource

Bronchial carcinoma (lung cancer). GoToSource

Reactivation of infections including hepatitis B, cytomegalovirus, varicella zoster virus. GoToSource

Venous thromboembolism (blood clot that starts in a vein). GoToSource

Neutropenia (low level of neutrophils, a type of white blood cell). GoToSource

Infusion reactions. GoToSource

Liver injury, anaphylaxis, tumor lysis syndrome (metabolic disorder) and myelosuppression (bone marrow suppression). GoToSource

Cardiac toxicity. GoToSource

Lawsuits filed for stevens-johnson syndrome and toxic epidermal necrolysis.