Label Changes for:

Treanda (bendamustine hydrochloride) for Injection, for Intravenous Infusion

October 2008

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Myelosuppression
  • Skin Reactions
  • Other Malignancies (new)

ADVERSE REACTIONS

  • Initial Section
  • Clinical Trials Experience in NHL (new)
  • Table 3
  • Table 4
  • Postmarketing Experience (new)

USE IN SPECIFIC POPULATIONS

  • Geriatric Use
  • In CLL and NHL studies, there were no clinically significant differences in the adverse reaction profile between geriatric (> 65 years of age) and younger patients.
  • Non-Hodgkin’s Lymphoma
  • Efficacy (Overall Response Rate and Duration of Response) was similar in patients < 65 years of age and patients > 65 years. Irrespective of age, all of the 176 patients experienced at least one adverse reaction.
  • Effect of Gender
    • No clinically significant differences between genders were seen in the overall incidences of adverse reactions in either CLL or NHL studies.
    • Non-Hodgkin’s Lymphoma
      • The pharmacokinetics of bendamustine were similar in male and female patients with indolent NHL. No clinically-relevant differences between genders were seen in efficacy (ORR and DR).

WARNINGS AND PRECAUTIONS

Myelosuppression:

...In the two NHL studies, 98% of patients had Grade 3-4 myelosuppression (see Table 4). Three patients (2%) died from myelosuppression-related adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with Grade 3 thrombocytopenia, and pneumonia from an opportunistic infection (CMV).

Skin Reactions:

...In a study of Treanda (90 mg/m2) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for rituximab (see rituximab package insert). The relationship to Treanda cannot be determined. Where skin reactions occur, they may be progressive and increase in severity with further treatment. If skin reactions are severe or progressive, Treanda should be withheld or discontinued.

Other Malignancies:

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. The association with Treanda therapy has not been determined.

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