- TREANDA® is associated with serious risks, including myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions, other malignancies, and a warning against use in pregnancy
- Some of these adverse reactions required dose modifications, interruptions, or discontinuation
- Patients receiving TREANDA experienced low incidence of alopecia1
HEMATOLOGIC ABNORMALITIES IN PATIENTS WITH INDOLENT B-CELL NHL THAT HAS PROGRESSED
- Prophylactic use of growth factors was allowed in conjunction with the study drug; use was discouraged during the first treatment cycle. Investigators were advised to follow the American Society of Clinical Oncology (ASCO) guidelines1
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NON-HEMATOLOGIC ADVERSE REACTIONS OCCURING IN ≥5% OF PATIENTS
*Patients may have reported more than 1 adverse reaction.
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TREANDA is contraindicated in patients with a known hypersensitivity to bendamustine or mannitol. Women should be advised to avoid becoming pregnant while using TREANDA.
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May warrant treatment delay or dose reduction. Monitor closely and restart treatment based on ANC and platelet count recovery. Complications of myelosuppression may lead to death.
Monitor for fever and other signs of infection and treat promptly.
Severe anaphylactic reactions have occurred. Monitor clinically and discontinue drug for severe reactions. Ask patients about reactions after the first cycle. Consider pre-treatment for cycles subsequent to milder reactions.
May lead to acute renal failure and death. Take precautions in patients at high risk.
Discontinue for severe skin reactions. Cases of Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), some fatal, have been reported when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes.
Pre-malignant and malignant diseases have been reported.
Take precautions to avoid extravasation, including monitoring intravenous infusion site during and after administration.
Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving TREANDA.
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The following adverse reactions have been identified during post-approval use of TREANDA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: anaphylaxis and injection or infusion site reactions, including pruritus, irritation, pain, and swelling.
Skin reactions including SJS and TEN have occurred when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes.
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- Patients receiving concomitant CYP1A2 inhibitors/inducers
Inhibitors of CYP1A2 (eg, fluvoxamine, ciprofloxacin) have potential to increase plasma concentrations of TREANDA and decrease plasma concentrations of active metabolites. Inducers of CYP1A2 (eg, omeprazole, smoking) have potential to decrease plasma concentrations of TREANDA 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.
- TREANDA is primarily metabolized via hydrolysis
TREANDA's active metabolites, gamma-hydroxy bendamustine (M3) and N-desmethyl-bendamustine (M4), are formed via cytochrome P450 CYP1A2.
- Use caution or consider alternative treatments when used with concomitant CYP1A2 inhibitors/inducers
- Inhibitors of CYP1A2 include fluvoxamine and ciprofloxacin
- Inducers of CYP1A2 include omeprazole and smoking
- No formal clinical assessments of pharmacokinetic drug-drug interactions between TREANDA and other drugs have been conducted
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TREANDA is indicated for the treatment of patients with indolent B-cell NHL that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.
The most common non-hematologic adverse reactions (frequency ≥30%) were nausea (75%), fatigue (57%), vomiting (40%), diarrhea (37%), and pyrexia (34%). The most common hematologic abnormalities (frequency ≥15%) were lymphopenia (99%), leukopenia (94%), anemia (88%), neutropenia (86%), and thrombocytopenia (86%).
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.
Please see full Prescribing Information.
References
- Data on file. Cephalon, Inc.