Label Changes for:
Bendeka (bendamustine hydrochloride)
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)
WARNINGS AND PRECAUTIONS
- Addition of paragraph...Patients treated with bendamustine hydrochloride are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients should undergo appropriate measures (including clinical and laboratory monitoring, prophylaxis, and treatment) for infection and infection reactivation prior to administration.
Post-Marketing Experience (addition of the following sub-sections):
- Blood and lymphatic systems disorders: Pancytopenia.
- Cardiovascular disorders: Atrial fibrillation, congestive heart failure (some fatal), myocardial infarction (some fatal), palpitation.
- General disorders and administration site conditions: Injection site reactions (including phlebitis, pruritus, irritation, pain, swelling), infusion site reactions (including phlebitis, pruritus, irritation, pain, swelling).
- Immune system disorders: Anaphylaxis.
- Infections and infestations: Pneumocystis jiroveci pneumonia.
- Respiratory, thoracic and mediastinal disorders: Pneumonitis.
- Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (with concomitant allopurinol and other medications known to cause the syndrome), Toxic epidermal necrolysis (with concomitant allopurinol and other medications known to cause the condition).