Bendamustine hydrochloride

What is Bendamustine hydrochloride?

• Bendamustine hydrochloride (Treanda; Bendeka; Belrapzo) is an alkylating drug used in the treatment of chronic lymphocytic leukemia (CLL), B-cell non-Hodgkin lymphoma (NHL) that got worse during or within 6 months after treatment with rituximab.

Bendamustine

Bendamustine2DCSD

What are the uses of this medicine?

Bendamustine hydrochloride (Treanda; Bendeka; Belrapzo) is indicated for the treatment of:

• patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.
• patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine.

What drug interactions can this medicine cause?

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

Is this medicine FDA approved?

• Bendamustine was approved for medical use in the United States in 2008.
• It is on the World Health Organization's List of Essential Medicines.

How should this medicine be used?

Recommended dosage and administration:

Bendeka dosage regimen For CLL:

• 100 mg/m2 infused intravenously over 10 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.

For NHL:

• 120 mg/m2 infused intravenously over 10 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles.

Treanda dosage regimen For CLL:

• 100 mg/m2 infused intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.

For NHL:

• 120 mg/m2 infused intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: Treanda

• As Injection: 45 mg/0.5 mL or 180 mg/2 mL (90 mg/mL) in a single-dose vial.
• For Injection: 25 mg or 100 mg lyophilized powder in a single-dose vial for reconstitution.

Bendeka

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

Belrapzo

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

This medicine is available in fallowing brand namesː

• Treanda ; Bendeka; Belrapzo

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea and fatigue

In CLL:

• anemia
• thrombocytopenia
• neutropenia
• lymphopenia
• leukopenia
• hyperbilirubinemia
• pyrexia
• nausea
• vomiting

In NHL:

• lymphopenia
• leukopenia
• anemia
• neutropenia
• thrombocytopenia
• nausea
• fatigue
• vomiting
• diarrhea
• pyrexia
• constipation
• anorexia
• cough
• headache
• weight decreased
• dyspnea
• rash
• stomatitis

What special precautions should I follow?

• Bendamustine hydrochloride caused severe myelosuppression. Delay or reduce dose, and restart treatment based on ANC and platelet count recovery.
• Infection, including pneumonia, sepsis, septic shock, hepatitis and death has occurred in adult and pediatric patients. Monitor for fever and other signs of infection or reactivation of infections and treat promptly.
• Progressive multifocal leukoencephalopathy (PML), including fatal cases, have occurred following treatment with bendamustine, primarily in combination with rituximab or obinutuzumab. Monitor for new or worsening neurological, cognitive or behavioral signs or symptoms suggestive of PML.
• Severe anaphylactic reactions have occurred. Monitor clinically and discontinue drug for severe reactions. Pre-medicate in subsequent cycles for milder reactions.
• Tumor lysis syndrome associated with bendamustine hydrochloride has occurred in patients in clinical trials and in postmarketing reports. May lead to acute renal failure and death; anticipate and use supportive measures in patients at high risk.
• Fatal and serious skin reactions have been reported with bendamustine hydrochloride injection. Discontinue for severe skin reactions. Cases of SJS, DRESS and TEN, some fatal, have been reported.
• Fatal and serious cases of liver injury have been reported with bendamustine hydrochloride injection. Monitor liver chemistry tests prior to and during treatment.
• Pre-malignant and malignant diseases have been reported. Monitor patients for the development of secondary malignancies. Perform dermatologic evaluations during and after treatment with Treanda; Bendeka.
• Bendamustine hydrochloride extravasations have been reported. Take precautions to avoid extravasation, including monitoring intravenous infusion site during and after administration.
• Treanda ; Bendeka Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use an effective method of contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• sedation
• tremor
• ataxia
• convulsions
• respiratory distress
• QT prolongation
• sinus tachycardia
• left anterior fascicular block

Management of overdosage:

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

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Treanda Active ingredient:

• BENDAMUSTINE HYDROCHLORIDE

Inactive ingredients:

• PROPYLENE GLYCOL
• N,N-DIMETHYLACETAMIDE

Bendeka Active ingredient:

• BENDAMUSTINE HYDROCHLORIDE

Inactive ingredients:

• PROPYLENE GLYCOL
• MONOTHIOGLYCEROL
• POLYETHYLENE GLYCOL 400
• SODIUM HYDROXIDE

Belrapzo Active ingredient:

• BENDAMUSTINE HYDROCHLORIDE

Inactive ingredients:

• PROPYLENE GLYCOL
• MONOTHIOGLYCEROL
• POLYETHYLENE GLYCOL 400
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

Treanda Distributed By:

• Teva Pharmaceuticals USA, Inc.
• Parsippany, NJ

Bendeka Distributed By:

• Teva Pharmaceuticals USA, Inc.
• North Wales, PA
• Product of Italy

Belrapzo Marketed by:

• Eagle Pharmaceuticals, Inc.
• 50 Tice Boulevard, Suite 315
• Woodcliff Lake, NJ

What should I know about storage and disposal of this medication?

• Store Bendeka (bendamustine hydrochloride) injection in refrigerator, 2°C to 8°C (36°F to 46°F). Retain in original carton until time of use to protect from light.
• Store Treanda Injection in refrigerator 2°C to 8°C (36°F to 46°F). Retain in original package until time of use to protect from light.
• Treanda for Injection may be stored up to 25°C (77°F) with excursions permitted up to 30°C (86°F). Retain in original package until time of use to protect from light.
• Store BELRAPZO (bendamustine hydrochloride) in refrigerator, 2°C to 8°C (36°C to 46°F). Retain in original carton until time of use to protect from light.

• Dailymed label info on Bendamustine hydrochloride
• FDA Bendamustine hydrochloride

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