Treanda (bendamustine hydrochloride) Injection

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
• mild skin rash

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• Treanda Injection must be withdrawn and transferred for dilution in a biosafety cabinet (BSC) or containment isolator using a polypropylene syringe with a metal needle and a polypropylene hub.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.

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.

• 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.