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BENDEKA

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Overview

What is BENDEKA?

BENDEKA (bendamustine hydrochloride) injection is an alkylating agent. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-, monohydrochloride. Its empirical molecular formula is CHClNO ∙ HCl, and the molecular weight is 394.7. Bendamustine hydrochloride contains a mechlorethamine group and a benzimidazole heterocyclic ring with a butyric acid substituent, and has the following structural formula:

BENDEKA (bendamustine hydrochloride) injection is supplied as a sterile, clear, and colorless to yellow ready-to-dilute solution in a multiple-dose clear glass vial. Each milliliter contains 25 mg of bendamustine hydrochloride, 0.1 mL of Propylene Glycol, USP, 5 mg of Monothioglycerol, NF, in Polyethylene Glycol 400, NF. Sodium hydroxide may have been used to adjust the acidity of polyethylene glycol 400.



What does BENDEKA look like?



What are the available doses of BENDEKA?

Injection: 100 mg/4 mL (25 mg/mL) in a multiple-dose vial. ()

What should I talk to my health care provider before I take BENDEKA?

How should I use BENDEKA?

BENDEKA (bendamustine hydrochloride) injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

100 mg/m infused intravenously over 10 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles ()

Dose modifications for hematologic toxicity: for Grade 3 or greater toxicity, reduce dose to 50 mg/m on Days 1 and 2; if Grade 3 or greater toxicity recurs, reduce dose to 25 mg/m2 on Days 1 and 2. ()

Dose modifications for non-hematologic toxicity: for clinically significant Grade 3 or greater toxicity, reduce the dose to 50 mg/m on Days 1 and 2 of each cycle. ()

Dose re-escalation may be considered. ()


What interacts with BENDEKA?

Sorry No Records found


What are the warnings of BENDEKA?

Sorry No Records found


What are the precautions of BENDEKA?

Sorry No Records found


What are the side effects of BENDEKA?

Sorry No records found


What should I look out for while using BENDEKA?

BENDEKA (bendamustine hydrochloride) injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol.


What might happen if I take too much BENDEKA?

The intravenous LD of bendamustine hydrochloride is 240 mg/m in the mouse and rat. Toxicities included sedation, tremor, ataxia, convulsions and respiratory distress.

Across all clinical experience, the reported maximum single dose received was 280 mg/m. Three of four patients treated at this dose showed ECG changes considered dose-limiting at 7 and 21 days post-dosing. These changes included QT prolongation (one patient), sinus tachycardia (one patient), ST and T wave deviations (two patients) and left anterior fascicular block (one patient). Cardiac enzymes and ejection fractions remained normal in all patients.

No specific antidote for bendamustine hydrochloride overdose is known. Management of overdosage should include general supportive measures, including monitoring of hematologic parameters and ECGs.


How should I store and handle BENDEKA?

Store BENDEKA (bendamustine hydrochloride) injection in refrigerator, 2°-8°C (36°-46°F). Retain in original carton until time of use to protect from light.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.AloraNDC 0023-5885-12AloraNDC 0023-5886-15AloraNDC 0023-5887-17AloraNDC 0023-5888-11Store at 20-25°C (68-77°F).  [See USP controlled room temperature.]Do not store unpouched. Apply immediately upon removal from the protective pouch.Discard used in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.Keep out of reach of children.For all medical inquiries contact:AllerganMedical Communications 1-800-678-1605Distributed by: Allergan USA, Inc.Irvine, CA 92612Rev. 02/2018© 2018 Allergan. All rights reserved.ALORA® is a registered trademark of Allergan Sales, LLC.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Bendamustine is a bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring. Mechlorethamine and its derivatives form electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways. Bendamustine is active against both quiescent and dividing cells. The exact mechanism of action of bendamustine remains unknown.

Non-Clinical Toxicology
BENDEKA (bendamustine hydrochloride) injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol.

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with any agents known to affect cardiac contractility and/or conduction (see ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem hydrochloride (see ).

As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.

Bendamustine hydrochloride caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies ( ). Three patients (2%) died from myelosuppression-related adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with Grade 3 thrombocytopenia, and pneumonia from an opportunistic infection (CMV).

BENDEKA (bendamustine hydrochloride) injection causes myelosuppression. Monitor complete blood counts, including leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. In the clinical trials, blood counts were monitored every week initially.  Hematologic nadirs occurred predominantly in the third week of therapy. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle.  Prior to the initiation of the next cycle of therapy, the ANC should be ≥ 1 x 10/L and the platelet count should be ≥ 75 x 10/L.

The following serious adverse reactions have been associated with bendamustine hydrochloride in clinical trials and are discussed in greater detail in other sections of the prescribing information.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).