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bendamustine (Rx)Brand and Other Names:Bendeka

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for injection (Bendeka)

  • 90mg/mL (45mg/0.5mL vial; 180mg/2mL vial) (Treanda)
  • 100mg/4mL (25mg/mL) (Bendeka)

lyophilized powder single vials (Treanda)

  • 25mg
  • 100mg
  • Teva announced that Bendeka (bendamustine HCl) injection solution is now available to replace Treanda (bendamustine HCl) lyophilized powder for reconstitution
  • Teva will continue to process orders for Treanda through March 30, 2016, after which any submitted or open orders will be canceled
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Chronic Lymphocytic Leukemia

100 mg/m² IV infution on days 1 & 2 of 28-day cycle, repeated for up to 6 cycles 

Dosage modifications

  • Hematologic toxicity
    • ≥Grade 3: Reduce dose to 50 mg/m² on Days 1 and 2
    • If ≥grade 3 toxicity reoccurs, reduce dose to 25 mg/m² on Days 1 and 2
  • Nonhematologic toxicity
    • Clinically significant toxicity ≥grade 3: Reduce dose to 50 mg/m² on Days 1 and 2 of each cycle
    • Dose re-escalation may be considered

Orphan designation

  • Oral dosage formulation for CLL
  • Sponsor
    • Exinda Theapeutics LLC; 8430 Rovana Circle, Suite B; Sacramento, California 95828

Non-Hodgkin Lymphoma

Indicated for treatment of indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen

120 mg/m² IV infusion on days 1 and 2 of 21-day cycle repeated for up to 8 cycles 

Dosage modifications

  • Hematologic toxicity
    • Grade 4: Reduce dose to 90 mg/m² on Days 1 and 2 of each cycle
    • If grade 4 toxicity recurs, reduce dose to 60 mg/m² on Days 1 and 2 of each cycle  
  • Non-hematologic toxicity
    • ≥Grade 3: Reduce dose to 90 mg/m² on Days 1 and 2 of each cycle
    • If toxicity ≥grade 3 reoccurs, reduce dose to 60 mg/m² on Days 1 and 2 of each cycle

Renal Impairment

Mild-to-moderate: Use caution

CrCl <40 mL/min: Not recommended

Hepatic Impairment

Mild: Use caution

Moderate (AST or ALT 2.5-10 xULN and bilirubin 1.5-3 xULN): Use not recommended

Severe hepatic impairment (bilirubin >3 times ULN): Use not recommended

Mantle Cell Lymphoma (Off-label)

90 mg/m² IV days 2 and 3 of 28-day cycle in combination with rituximab for up to 4 cycles 

Safety and efficacy not established

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Interactions

Interaction Checker

bendamustine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
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            Adverse Effects

            >10%

            Lymphopenia (68-99%)

            Leukopenia (61-94%; grade 3/4, 28-56%)

            Anemia (88-89%; grades 3/4 11-13%)

            Thrombocytopenia (77-86%; grade 3/4, 11-25%)

            Neutropenia (75-86%; grade 3/4, 43-60%)

            Nausea (20-75%)

            Fatigue (9-57%)

            Vomiting (16-40%)

            Diarrhea (9-37%)

            Bilirubin increased (<34%; grade 3/4, 3%)

            Constipation (<29%)

            Fever (24-34%)

            Pyrexia (24%)

            Anorexia (<23%)

            Cough (4-22%)

            Headache (<21%)

            Weight loss (7-18%)

            Dehydration (<16%)

            Rash (8-16%)

            Stomatitis (<15%)

            Back pain (<14%)

            Dizziness (<14%)

            Chills (6-14%)

            Peripheral edema (13%)

            Abdominal pain (5-13%)

            Insomnia (<13%)

            Dyspepsia (<11%)

            Weakness (8-11%)

            1-10%

            Upper respiratory infection (10%)

            Gastroesophageal reflux disease (<10%)

            Urinary tract infection (<10%)

            Xerostomia (9%)

            Hypokalemia (<9%)

            Anxiety (8%)

            Hyperuricemia (<7%)

            Tachycardia (<7%)

            Taste alteration (<7%)

            Arthralgia (<6%)

            Chest pain (<6%)

            Depression (<6%)

            Hypotension (<6%)

            Injection site pain (<6%)

            Pain (<6%)

            Pruritus (5-6%)

            Febrile neutropenia (3-6%)

            Rash (5%)

            Postmarketing Reports

            Injection or infusion site reactions including phlebitis

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            Warnings

            Contraindications

            Hypersensitivity to bendamustine or mannitol

            Atrial fibrillation, congestive heart failure (some fatal), myocardial infarction (some fatal), palpitation

            Cautions

            Interrupt if severe infusion reactions

            Mild-mod renal impairment, mild hepatic impairment

            Possibility of anaphylactic/infusion reactions: severe in rare cases

            Myelosuppression may occur; delay or reduce dose; restart treatment based on ANC and platelet count recovery; complications of myelosuppression may lead to death

            Monitor for fever and other signs of infection and treat promptly

            Severe infusion and anaphylactic reactions reported; monitor clinically and discontinue therapy; premedicate in subsequent cycles for milder reactions

            Tumor lysis syndrome reported; acute renal failure and death may occur; anticipate and use supportive measures

            Discontinue for severe skin reactions; cases of SJS and TEN, some fatal, reported when bendamustine was administered concomitantly with allopurinol and other medications known to cause these syndromes

            Premalignant and malignant diseases reported

            Erythema and maked swelling can occur with extravasation; assure good venous access and monitor infusion site during and after administration

            Fetal harm can occur when administered to a pregnant woman; women should be advised to avoid becoming pregnant when receiving bendamustine

            Increased risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster; patients should undergo appropriate measures (including clinical and laboratory monitoring, prophylaxis, and treatment) for infection and infection reactivation prior to administration

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: It is not known whether this drug is excreted in milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Alkylating agent that cross-links single or double DNA strands resulting in DNA breakdown; cell cycle-nonspecific

            Pharmacokinetics

            Protein Bound: 94-96%

            Vd: 25 L

            Half-Life: 40 min

            Metabolism: CYP1A2 (low amount)

            Time to peak (serum): At end of infusion

            Excretion: Feces (90%); urine (1-10%)

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            Administration

            IV Preparation

            Available in 2 formulations, a solution and a lyophilized powder

            Do not mix or combine the 2 formulations

            Each formulation vial is intended for single dose only

            Solution for injection (45 mg/0.5 mL or 180 mg/2 mL solution)

            • Do NOT use the solution with devices containing polycarbonate or acrylonitrile-butadiene-styrene (ABS) including closed system transfer devices (CSTDs), adapters, and syringes
            • Contains N,N-dimethylacetamide (DMA), which is incompatible with devices that contain polycarbonate or ABS
            • Only use a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer solution for injection
            • Polypropylene syringes are translucent in appearance
            • Solution for 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
            • Aseptically transfer calculated dose amount to 500 mL 0.9% NaCl or 2.5% dextrose/0.45% NaCl infusion bag
            • The resulting final concentration of bendamustine HCl in the infusion bag should be within 0.2-0.7 mg/mL
            • Visually inspect the filled syringe and the prepared infusion bag to ensure the lack of visible particulate matter prior to administration; the admixture should be a clear colorless to yellow solution

            Lyophilized powder vials (25 mg/vial or 100 mg/vial)

            • Aseptically reconstitute each lyophilized powder vial as follows:
              • 25 mg vial: Add 5 mL of only sterile water for injection
              • 100 mg vial: Add 20 mL of only sterile water for injection
              • Shake well to yield a clear, colorless to a pale yellow solution with a bendamustine HCl concentration of 5 mg/mL
              • The lyophilized powder should completely dissolve in 5 minutes
              • The reconstituted solution must be transferred to the infusion bag within 30 minutes of reconstitution
              • If particulate matter is observed, the reconstituted product should not be used
            • Futher dilution
              • Aseptically withdraw the volume needed for the required dose (based on 5 mg/mL concentration) and immediately transfer to 500 mL 0.9% NaCl or 2.5% dextrose/0.45% NaCl infusion bag
              • The resulting final concentration of bendamustine HCl in the infusion bag should be within 0.2-0.6 mg/mL
              • After transferring, thoroughly mix the contents of the infusion bag
              • Visually inspect the filled syringe and the prepared infusion bag to ensure the lack of visible particulate matter prior to administration
              • The admixture should be a clear and colorless to slightly yellow solution

            IV Administration

            CLL: Infuse over 30 min

            NHL: Infuse over 60 min

            Storage

            Does not contain preservatives

            Unopened vials

            • Refrigerate between 2-8°C (36-46°F)
            • Retain in original package until time of use to protect from light

            Final admixture

            • Refrigerated: Stable for 24 hr when stored under refrigerated conditions at 2-8°C (36-46°F)
            • Room temperature: Stable at room temperature (15-30°C or 59-86°F) and room light for 2 hr (diluted solution for injection) or 3 hr (reconstituted and diluted lyophilized powder)
            • Administration must be completed within this period
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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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