TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia
(CLL). Efficacy relative to first-line therapies other than chlorambucil has not
Important Safety Information
Contraindication: TREANDA is contraindicated in patients with a known hypersensitivity
(e.g., anaphylactic and anaphylactoid reactions) to bendamustine.
Myelosuppression: TREANDA caused severe myelosuppression (Grade 3-4) in 98%
of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related
adverse reactions. If myelosuppression occurs, 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, and death
have occurred. Patients with myelosuppression following treatment with TREANDA are
more susceptible to infections.
Anaphylaxis and Infusion Reactions: Infusion reactions to TREANDA 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 TREANDA treatment
has occurred. The onset tends to be within the first treatment cycle of TREANDA
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 TREANDA and allopurinol are administered concomitantly.
Skin Reactions: Skin reactions have been reported with TREANDA treatment
and include rash, toxic skin reactions, and bullous exanthema. 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. Cases of Stevens-Johnson
syndrome (SJS) and TEN, some fatal, have been reported when TREANDA was administered
concomitantly with allopurinol and other medications known to cause these syndromes.
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 TREANDA.
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.
Extravasation Injury: TREANDA extravasations have been reported in postmarketing
resulting in hospitalizations from erythema, marked swelling, and pain. Ensure good
venous access prior to starting TREANDA infusion and monitor the intravenous infusion
site for redness, swelling, pain, infection, and necrosis during and after administration
Embryo-fetal Toxicity: TREANDA can cause fetal harm when administered to
a pregnant woman. Women should be advised to avoid becoming pregnant while using
Most Common Adverse Reactions: The most common non-hematologic adverse reactions
for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting. The most common hematologic
abnormalities (frequency ≥15%) are anemia, thrombocytopenia, neutropenia, lymphopenia,
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