TREANDA® (bendamustine HCl) | Use in Special Populations

Use of TREANDA in patients with renal impairment

In a population pharmacokinetic analysis of TREANDA^® in patients receiving 120 mg/m² there was no meaningful effect of renal impairment (CrCL 40-80 mL/min, N=31) on the pharmacokinetics of TREANDA
Bendamustine has not been studied in patients with CrCL <40 mL/min
No formal studies assessing the impact of renal impairment on the pharmacokinetics of TREANDA have been conducted
In preclinical studies, approximately 90% of TREANDA administered was recovered primarily in the feces

Use of TREANDA in patients with hepatic impairment

ULN = upper limit of normal; AST = aspartate aminotransferase; ALP = alkaline phosphatase; ALT = alanine aminotransferase

In a population pharmacokinetic analysis of TREANDA in patients receiving 120 mg/m² there was no meaningful effect of mile (total bilirubin ≤ ULN, AST ≥ ULN to 2.5 x ULN, and/or ALP ≥ ULN to 5.0 x ULN, N=26) hepatic impairment on the pharmacokinetics of TREANDA
Bendamustine has not been studied in patients with moderate or severe hepatic impairment
No formal studies assessing the impact of hepatic impairment on the pharmacokinetics of TREANDA have been conducted

Use in pregnancy

TREANDA can cause fetal harm 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 throughout treatment and for 3 months after TREANDA therapy has stopped
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus
Advise patients to report pregnancy immediately
Advise patients to avoid nursing

Other specific populations

Nursing mothers
Advise patients to avoid nursing while taking TREANDA. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants and tumorigenicity shown for TREANDA in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric use
The safety and effectiveness of TREANDA in pediatric patients have not been established.
Geriatric use
There were no clinically significant differences in adverse reactions between geriatric (≥65 years of age) and younger patients.
Effect of gender
No clinically significant differences between genders were seen in the overall incidences of adverse reactions.

TREANDA for injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. TREANDA is also indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

The following serious adverse reactions have been associated with TREANDA: myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions including SJS/TEN, other malignancies, and extravasation. Some of these reactions have been fatal, including myelosuppression, infections, and SJS/TEN (when TREANDA was administered concomitantly with allopurinol and other medications known to cause SJS/TEN). Patients should be monitored closely for these reactions and treated promptly if any occur. Adverse reactions may require interventions such as decreasing the dose of TREANDA, or withholding or delaying treatment. Myelosuppression is frequently severe and should be expected when treating patients with TREANDA.

TREANDA is contraindicated in patients with a known hypersensitivity to bendamustine or mannitol. Women should be advised to avoid becoming pregnant while using TREANDA.

The most common non-hematologic adverse reactions associated with TREANDA (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.