TREANDA had a manageable side effect profile in the pivotal Phase 3 trial

• 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 alopecia

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TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

Please see full Prescribing Information.

Contraindications

TREANDA is contraindicated in patients with a known hypersensitivity to bendamustine or mannitol.

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Warnings and precautions

• Myelosuppression

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.

• Infections

Monitor for fever and other signs of infection and treat promptly.

• Infusion reactions and anaphylaxis

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.

• Tumor lysis syndrome

May lead to acute renal failure and death. Take precautions in patients at high risk.

• Skin reactions

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.

• Other malignancies

Pre-malignant and malignant diseases have been reported.

• Extravasation

Take precautions to avoid extravasation, including monitoring intravenous infusion site during and after administration.

• Use in pregnancy

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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Post-marketing experience

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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Drug interactions

• Patients receiving concomitant CYP1A2 inhibitors/inducers
  
Inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) have potential to increase plasma concentrations of TREANDA and decrease plasma concentrations of active metabolites. Inducers of CYP1A2 (e.g., 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.

Concomitant CYP1A2 inhibitors or inducers have the potential to affect the exposure of TREANDA

• 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

Click here for additional information on Managing Side Effects.

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