Generic drug: bendamustine hydrochloride

Brand name: Treanda

What is Treanda (bendamustine hydrochloride), and how does it work?

Treanda (bendamustine hydrochloride) injection is an antineoplastic (anticancer) medication used to treat chronic lymphocytic leukemia. Treanda is also used to treat indolent B-cell non-Hodgkin lymphoma after other medications have been tried without successful treatment of this condition.

What are the side effects of Treanda?

Common side effects of Treanda include:

What is the dosage for Treanda?

Selection Of Treanda Formulation To Administer

  • Treanda is available in two formulations, a solution (Treanda Injection) and a lyophilized powder (Treanda for Injection).
  • Do not use Treanda Injection if you intend to use closed system transfer devices (CSTDs), adapters and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS) prior to dilution in the infusion bag.
  • If using a syringe to withdraw and transfer Treanda Injection from the vial into the infusion bag, only use a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer Treanda Injection into the infusion bag. Polypropylene syringes are translucent in appearance.
  • Treanda Injection and the reconstituted Treanda for Injection have different concentrations of bendamustine hydrochloride. The concentration of bendamustine hydrochloride in the solution is 90 mg/mL and the concentration of bendamustine hydrochloride in the reconstituted solution of lyophilized powder is 5 mg/mL. Do not mix or combine the two formulations.
  • Treanda Injection must be withdrawn and transferred for dilution in a biosafety cabinet (BSC) or containment isolator using a polypropylene syringe with a metal needle and a polypropylene hub.
  • If a CSTD or adapter that contains polycarbonate or ABS is used as supplemental protection prior to dilution , only use Treanda for Injection, the lyophilized powder formulation.

Dosing Instructions For CLL

Recommended Dosage

The recommended dose is 100 mg/m² administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.

Dose Delays, Dose Modifications And Reinitiation Of Therapy For CLL
  • Delay Treanda administration in the event of Grade 4 hematologic toxicity or clinically significant ≥ Grade 2 nonhematologic toxicity. Once non-hematologic toxicity has recovered to less than or equal to Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) ≥ 1 x 109/L, platelets ≥ 75 x 109/L], reinitiate Treanda at the discretion of the treating physician. In addition, consider dose reduction.
  • Dose modifications for hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 50 mg/m² on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m² on Days 1 and 2 of each cycle.
  • Dose modifications for non-hematologic toxicity: for clinically significant Grade 3 or greater toxicity, reduce the dose to 50 mg/m² on Days 1 and 2 of each cycle.
  • Consider dose re-escalation in subsequent cycles at the discretion of the treating physician.

Dosing Instructions For NHL

Recommended Dosage

The recommended dose is 120 mg/m² administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles.

Dose Delays, Dose Modifications And Reinitiation Of Therapy For NHL
  • Delay Treanda administration in the event of a Grade 4 hematologic toxicity or clinically significant greater than or equal to Grade 2 non-hematologic toxicity. Once non-hematologic toxicity has recovered to ≤ Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) ≥ 1 x 109/L, platelets ≥ 75 x 109/L], reinitiate Treanda at the discretion of the treating physician. In addition, consider dose reduction.
  • Dose modifications for hematologic toxicity: for Grade 4 toxicity, reduce the dose to 90 mg/m² on Days 1 and 2 of each cycle; if Grade 4 toxicity recurs, reduce the dose to 60 mg/m² on Days 1 and 2 of each cycle.
  • Dose modifications for non-hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 90 mg/m² on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 60 mg/m² on Days 1 and 2 of each cycle.

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What drugs interact with Treanda?

Effect Of Other Drugs On Treanda

CYP1A2 Inhibitors
  • The coadministration of Treanda with CYP1A2 inhibitors may increase bendamustine plasma concentrations and may result in increased incidence of adverse reactions with Treanda.
  • Consider alternative therapies that are not CYP1A2 inhibitors during treatment with Treanda.
CYP1A2 Inducers
  • The coadministration of Treanda with CYP1A2 inducers may decrease bendamustine plasma concentrations and may result in decreased efficacy of Treanda.
  • Consider alternative therapies that are not CYP1A2 inducers during treatment with Treanda.

Is Treanda safe to use while pregnant or breastfeeding?

  • Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
  • Advise females to inform their healthcare provider of a known or suspected pregnancy.
  • Advise female patients of reproductive potential to use effective contraception during treatment with Treanda and for at least 6 months after the final dose.
  • Males with female partners of reproductive potential should use effective contraception during treatment with Treanda and for at least 3 months after the final dose.
  • Females should not breastfeed during treatment with Treanda and for at least 1 week after the final dose.

Summary

Treanda (bendamustine hydrochloride) injection is an antineoplastic (anticancer) medication used to treat chronic lymphocytic leukemia. Treanda is also used to treat indolent B-cell non-Hodgkin lymphoma after other medications have been tried without successful treatment of this condition. Common side effects of Treanda include nausea, vomiting, diarrhea, tiredness, weakness, mouth sores, constipation, upset stomach, swelling in your hands or feet, headache, dizziness, drowsiness, loss of appetite, weight loss, and mild skin rash.

Treatment & Diagnosis

Medications & Supplements

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Medically Reviewed on 3/19/2021
References
All sections courtesy of the U.S. Food and Drug Administration