Bendamustine
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment Do not use bendamustine hydrochloride injection in patients with creatinine clearance (CLcr) < 30 mL/min. [see Clinical Pharmacology]
Dosing in liver impairment
Hepatic Impairment Do not use bendamustine hydrochloride injection in patients with AST or ALT 2.5 to 10 × upper limit of normal (ULN) and total bilirubin 1.5 to 3 × ULN, or total bilirubin > 3 × ULN [see Clinical Pharmacology]
Preparation and administration
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Preparation for Intravenous Administration Bendamustine hydrochloride injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Bendamustine hydrochloride injection is in a multiple-dose vial. Bendamustine hydrochloride injection is a clear and colorless to yellow solution. Store bendamustine hydrochloride injection at recommended refrigerated storage conditions (2°C to 8°C or 36°F to 46°F).
When refrigerated the contents may freeze. Allow the vial to reach room temperature (15°C to 30°C or 59°F to 86°F) prior to use. Observe the contents of the vial for any visible solid or particulate matter and discoloration. Do not use the product if solid or particulate matter is observed after reaching room temperature.
Intravenous Infusion Aseptically withdraw the volume needed for the required dose from the 25 mg/mL solution as per Table A below and immediately transfer to a 500 mL infusion bag of one of the following diluents: - 0.9% Sodium Chloride Injection, USP; or - 2.5% Dextrose/0.45% Sodium Chloride Injection, USP. The resulting final concentration of bendamustine hydrochloride injection in the infusion bag should be within 0.05 mg/mL to 0.7 mg/mL.
After transferring, thoroughly mix the contents of the infusion bag. The admixture should be a clear and colorless to slightly yellow solution. Use either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, for dilution, as outlined above. No other diluents have been shown to be compatible.
Table A: Volume (mL) of Bendamustine Hydrochloride Injection required for dilution into 500 mL of 0.9% Sodium Chloride Injection, USP, or 0.45% Sodium Chloride/2.5% Dextrose Injection, USP for a given dose (mg/m 2 ) and [See table below.] 5.4 3.6 1.6 7.7 5.8 3.8 1.7 8.2 6.1 4.1 1.8 8.6 6.5 4.3 1.9 9.1 6.8 4.6 2 9.6 7.2 4.8 2.1 10.1 7.6 5 2.2 10.6 7.9 5.3 2.3 11 8.3 5.5 2.4 11.5 8.6 5.8 2.5 12 9 6 2.6 12.5 9.4 6.2 2.7 13 9.7 6.5 2.8 13.4 10.1 6.7 2.9 13.9 10.4 7 3 14.4 10.8
Admixture Stability Bendamustine hydrochloride injection contains no antimicrobial preservative. The admixture should be prepared as close as possible to the time of patient administration. If diluted with 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, the final admixture is stable for 24 hours when stored refrigerated (2°C to 8°C or 36°F to 46°F) or for 3 hours when stored at room temperature (15°C to 30°C or 59°F to 86°F) and room light.
Administration of diluted bendamustine hydrochloride injection must be completed within this period of time. Bendamustine hydrochloride injection is supplied in a multiple-dose vial. Retain the partially used vial in original package to protect from light and store refrigerated (2°C to 8°C or 36°F to 46°F) if additional dose withdrawal from the same vial is intended.
Stability of Partially Used Vials (Needle Punched Vials) Bendamustine hydrochloride injection is supplied as a multiple-dose vial. Although it does not contain any antimicrobial preservative, bendamustine hydrochloride injection is bacteriostatic. The partially used vials are stable for up to 28 days when stored in its original carton under refrigeration (2°C to 8°C or 36°F to 46°F).
Each vial is not recommended for more than a total of six dose withdrawals. After first use, store the partially used vial in original carton at 2°C to 8°C (36°F to 46°F), and then discard after 28 days.
| Body Surface Area (m2) | Volume of Bendamustine Hydrochloride Injection to withdraw (mL) | ||
|---|---|---|---|
| 120 mg/m2 | 90 mg/m2 | 60 mg/m2 | |
| 1 | 4.8 | 3.6 | 2.4 |
| 1.1 | 5.3 | 4 | 2.6 |
| 1.2 | 5.8 | 4.3 | 2.9 |
| 1.3 | 6.2 | 4.7 | 3.1 |
| 1.4 | 6.7 | 5 | 3.4 |
| 1.5 | 7.2 | 5.4 | 3.6 |
| 1.6 | 7.7 | 5.8 | 3.8 |
| 1.7 | 8.2 | 6.1 | 4.1 |
| 1.8 | 8.6 | 6.5 | 4.3 |
| 1.9 | 9.1 | 6.8 | 4.6 |
| 2 | 9.6 | 7.2 | 4.8 |
| 2.1 | 10.1 | 7.6 | 5 |
| 2.2 | 10.6 | 7.9 | 5.3 |
| 2.3 | 11 | 8.3 | 5.5 |
| 2.4 | 11.5 | 8.6 | 5.8 |
| 2.5 | 12 | 9 | 6 |
| 2.6 | 12.5 | 9.4 | 6.2 |
| 2.7 | 13 | 9.7 | 6.5 |
| 2.8 | 13.4 | 10.1 | 6.7 |
| 2.9 | 13.9 | 10.4 | 7 |
| 3 | 14.4 | 10.8 | 7.2 |
Drug interactions
Check bendamustine against a medication listLabel text (3 paragraphs)
Consider alternative therapies that are not CYP1A2 inducers or inhibitors during treatment with bendamustine hydrochloride injection. ( 7.1 )
7.1 Effect of Other Drugs on Bendamustine Hydrochloride Injection CYP1A2 Inhibitors The coadministration of bendamustine hydrochloride injection with CYP1A2 inhibitors may increase bendamustine plasma concentrations and may result in increased incidence of adverse reactions with bendamustine hydrochloride injection [see Clinical Pharmacology ( 12.3 )]. Consider alternative therapies that are not CYP1A2 inhibitors during treatment with bendamustine hydrochloride injection.
CYP1A2 Inducers The coadministration of bendamustine hydrochloride injection with CYP1A2 inducers may decrease bendamustine plasma concentrations and may result in decreased efficacy of bendamustine hydrochloride injection [see Clinical Pharmacology ( 12.3 )]. Consider alternative therapies that are not CYP1A2 inducers during treatment with bendamustine hydrochloride injection.
Contraindications
Bendamustine hydrochloride injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, absolute ethanol, sodium hydroxide and monothioglycerol. [see Warnings and Precautions ( 5.4 )] Bendamustine hydrochloride injection is contraindicated in patients with a history of a hypersensitivity reaction to bendamustine, polyethylene glycol 400, absolute ethanol, sodium hydroxide and monothioglycerol. Reactions to bendamustine hydrochloride have included anaphylaxis and anaphylactoid reactions. ( 4 , 5.4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary In animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (MRHD) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see Data). There are no available data on bendamustine hydrochloride use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Bendamustine hydrochloride was intraperitoneally administered once to mice from 210 mg/m 2 (approximately 1.8 times the MRHD) during organogenesis and caused an increase in resorptions, skeletal and visceral malformations (exencephaly, cleft palates, accessory rib, and spinal deformities) and decreased fetal body weights. This dose did not appear to be maternally toxic and lower doses were not evaluated.
Repeat intraperitoneal administration of bendamustine hydrochloride in mice on gestation days 7 to 11 resulted in an increase in resorptions from 75 mg/m 2 (approximately 0.6 times the MRHD) and an increase in abnormalities from 112.5 mg/m 2 (approximately 0.9 times the MRHD), similar to those seen after a single intraperitoneal administration. Bendamustine hydrochloride was intraperitoneally administered once to rats from 120 mg/m 2 (approximately the MRHD) on gestation days 4, 7, 9, 11, or 13 and caused embryo and fetal lethality as indicated by increased resorptions and a decrease in live fetuses.
A significant increase in external (effect on tail, head, and herniation of external organs [exomphalos]) and internal (hydronephrosis and hydrocephalus) malformations were seen in dosed rats.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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