bendamustine (Rx)

Brand and Other Names:Bendeka, Belrapzo, more...Treanda
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, ready-to-dilute solution

  • 100mg/4mL (25mg/mL) (Bendeka; Belrapzo; generic)

injection, lyophilized powder for reconstitution

  • 25mg/single-dose vial (Treanda; generic)
  • 100mg/single-dose vial (Treanda; generic)

Chronic Lymphocytic Leukemia

100 mg/m² IV infusion on days 1 and 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

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

Dosage Modifications

Renal impairment

  • Mild-to-moderate: Use caution
  • CrCl <30 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

and bendamustine

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      Serious - Use Alternative

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              Serious - Use Alternative (7)

              • abametapir

                abametapir will increase the level or effect of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP1A2 substrates. If not feasible, avoid use of abametapir.

              • givosiran

                givosiran will increase the level or effect of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP1A2 substrates with givosiran. If unavoidable, decrease the CYP1A2 substrate dosage in accordance with approved product labeling.

              • lasmiditan

                lasmiditan increases levels of bendamustine by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • palifermin

                palifermin increases toxicity of bendamustine by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • sotorasib

                sotorasib will decrease the level or effect of bendamustine by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

              • tepotinib

                tepotinib will increase the level or effect of bendamustine by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

              • tofacitinib

                bendamustine, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (58)

              • berotralstat

                berotralstat will increase the level or effect of bendamustine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

              • busulfan

                bendamustine, busulfan. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • butabarbital

                butabarbital decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.

              • carbamazepine

                carbamazepine decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.

              • carboplatin

                bendamustine, carboplatin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • carmustine

                bendamustine, carmustine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • chlorambucil

                bendamustine, chlorambucil. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • cholera vaccine

                bendamustine decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • cigarette smoking

                cigarette smoking decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.

              • cimetidine

                cimetidine increases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Decreased conversion of bendamustine to active metabolites. Concentration of active metabolites of bendamustine may be decreased.

              • ciprofloxacin

                ciprofloxacin increases levels of bendamustine by decreasing metabolism. Use Caution/Monitor. Decreased conversion of bendamustine to active metabolites. Concurrent administration of a CYP1A2 inhibitor such as ciprofloxacin may increase bendamustine concentrations. .

              • cisplatin

                bendamustine, cisplatin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • cyclophosphamide

                bendamustine, cyclophosphamide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • dacarbazine

                bendamustine, dacarbazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • dengue vaccine

                bendamustine decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • dichlorphenamide

                dichlorphenamide and bendamustine both decrease serum potassium. Use Caution/Monitor.

              • elagolix

                elagolix will increase the level or effect of bendamustine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • eliglustat

                eliglustat increases levels of bendamustine by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.

              • erythromycin base

                erythromycin base decreases effects of bendamustine by decreasing metabolism. Use Caution/Monitor. Decreased conversion of bendamustine to active metabolites.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate decreases effects of bendamustine by decreasing metabolism. Use Caution/Monitor. Decreased conversion of bendamustine to active metabolites.

              • erythromycin lactobionate

                erythromycin lactobionate decreases effects of bendamustine by decreasing metabolism. Use Caution/Monitor. Decreased conversion of bendamustine to active metabolites.

              • erythromycin stearate

                erythromycin stearate decreases effects of bendamustine by decreasing metabolism. Use Caution/Monitor. Decreased conversion of bendamustine to active metabolites.

              • esomeprazole

                esomeprazole decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Consentration of active metabolites may be increased.

              • ethinylestradiol

                ethinylestradiol increases levels of bendamustine by decreasing metabolism. Use Caution/Monitor. Bendamustine is metabolized to minimally active metabolites by CYP1A2. Ethinyl estradiol is a weak CYP1A2 inhibitor and concurrent administration may increase bendamustine concentrations in plasma. .

              • fexinidazole

                fexinidazole will increase the level or effect of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • fingolimod

                bendamustine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • fluvoxamine

                fluvoxamine will increase the level or effect of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Decreased conversion of bendamustine to active metabolite. May decrease concentration of active metabolites

              • fostamatinib

                fostamatinib will increase the level or effect of bendamustine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp substrates. Monitor for toxicities of the P-gp substrate drug that may require dosage reduction when given concurrently with fostamatinib.

              • glecaprevir/pibrentasvir

                glecaprevir/pibrentasvir will increase the level or effect of bendamustine by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely.

              • hydroxyurea

                bendamustine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • ifosfamide

                bendamustine, ifosfamide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • influenza A (H5N1) vaccine

                bendamustine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • influenza virus vaccine (H5N1), adjuvanted

                bendamustine decreases effects of influenza virus vaccine (H5N1), adjuvanted by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • istradefylline

                istradefylline will increase the level or effect of bendamustine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

              • ivacaftor

                ivacaftor increases levels of bendamustine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Ivacaftor and its M1 metabolite has the potential to inhibit P-gp; may significantly increase systemic exposure to sensitive P-gp substrates with a narrow therapeutic index.

              • lomustine

                bendamustine, lomustine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • mechlorethamine

                bendamustine, mechlorethamine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • melphalan

                bendamustine, melphalan. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • mexiletine

                mexiletine increases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Decreased conversion of bendamustine to active metabolites. Concentration of active metabolites of bendamustine may be decreased.

              • omeprazole

                omeprazole decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.

              • pentobarbital

                pentobarbital decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.

              • phenobarbital

                phenobarbital decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.

              • ponatinib

                ponatinib increases levels of bendamustine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • ponesimod

                ponesimod and bendamustine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • primidone

                primidone decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.

              • rifampin

                rifampin decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.

              • rucaparib

                rucaparib will increase the level or effect of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP1A2 substrates, if clinically indicated.

              • sarecycline

                sarecycline will increase the level or effect of bendamustine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

              • secobarbital

                secobarbital increases effects of bendamustine by increasing metabolism. Use Caution/Monitor. Increased conversion of bendamustine to active metabolites.

                secobarbital decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.

              • siponimod

                siponimod and bendamustine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                bendamustine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • smoking

                smoking increases effects of bendamustine by increasing metabolism. Use Caution/Monitor. Increased conversion of bendamustine to active metabolites.

              • stiripentol

                stiripentol, bendamustine. affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP1A2 inhibitor and inducer. Monitor CYP1A2 substrates coadministered with stiripentol for increased or decreased effects. CYP1A2 substrates may require dosage adjustment.

              • streptozocin

                bendamustine, streptozocin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • thiotepa

                bendamustine, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

              • tobacco use

                tobacco use increases effects of bendamustine by increasing metabolism. Use Caution/Monitor. Increased conversion of bendamustine to active metabolites.

              • tucatinib

                tucatinib will increase the level or effect of bendamustine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

              • zileuton

                zileuton increases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Decreased conversion of bendamustine to active metabolites. Concentration of active metabolites of bendamustine may be decreased.

              Minor (0)

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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

                Blood and lymphatic systems disorders: Pancytopenia, myelosuppression

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

                General disorders and administration site conditions: Injection site reactions (including irritation, swelling), infusion site reactions (including pruritus, irritation, swelling)

                Immune system disorders: Anaphylaxis Infections and infestations: Pneumocystis jiroveci pneumonia

                Respiratory, thoracic and mediastinal disorders: Pneumonitis

                Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (with concomitant allopurinol and other medications known to cause the syndrome), toxic epidermal necrolysis (with concomitant allopurinol and other medications known to cause the condition), drug reaction with eosinophilia and systemic symptoms (DRESS)

                Tumor lysis syndrome

                Skin reactions

                Hepatotoxicity

                Other malignancies

                Extravasation Injury

                Non-melanoma skin cancer

                Progressive multifocal leukoencephalopathy (PML)

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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

                Fatal and serious skin reactions have been reported with bendamustine treatment in clinical trials and postmarketing safety reports, including toxic skin reactions [Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)], bullous exanthema, and rash; events occurred when given as a single agent and in combination with other anticancer agents or allopurinol; monitor patients with skin reactions closely; if skin reactions are severe or progressive, withhold or discontinue bendamustine hydrochloride injection

                Tumor lysis syndrome reported with use; onset tends to be within first treatment cycle of bendamustine hydrochloride and, without intervention, may lead to acute renal failure and death; preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels

                Fatal and serious cases of liver injury reported with bendamustine hydrochloride injection

                Monitor liver chemistry tests prior to and during treatment

                Erythema and marked 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

                Malignancies

                • Pre-malignant and malignant diseases reported in patients receiving therapy, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, bronchial carcinoma, and non-melanoma skin cancer, including basal cell carcinoma and squamous cell carcinoma
                • Monitor patients for development of secondary malignancies; perform dermatologic evaluations during and after treatment

                Progressive multifocal leukoencephalopathy (PML)

                • PML including fatal cases, reported following treatment with bendamustine, primarily in combination with rituximab or obinutuzumab
                • Consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive, or behavioral signs or symptoms
                • If PML is suspected, withhold treatment and perform appropriate diagnostic evaluations
                • Consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML
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                Pregnancy & Lactation

                Pregnancy

                There are no available data on 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 potential risk to fetus

                Pregnancy testing recommended for females of reproductive potential prior to initiation of therapy

                Contraception

                • Therapy can cause embryo-fetal harm when administered to pregnant women;
                • advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after final dose
                • Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with drug and for at least 3 months after final dose

                Infertility

                • Based on findings from clinical studies, therapy may impair male fertility; impaired spermatogenesis, azoospermia, and total germinal aplasia have been reported in male patients treated with alkylating agents, especially in combination with other drugs; in some instances spermatogenesis may return in patients in remission, but this may occur only several years after intensive chemotherapy has been discontinued; advise patients of potential risk to their reproductive capacities
                • Based on findings from animal studies, drug may impair male fertility due to an increase in morphologically abnormal
                • Spermatozoa; the long-term effects of therapy on male fertility, including the reversibility of adverse effects, have not been studied

                Animal data

                • In animal reproduction studies, intraperitoneal administration to pregnant mice and rats during organogenesis at doses 0.6-1.8 times the maximum recommended human dose (MRHD) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth

                Lactation

                There are no data on presence of drug or metabolites in either human or animal milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions in breastfed child, advise patients that breastfeeding is not recommended during treatment and for at least 1 week after the last dose

                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 ready-to-dilute solution that requires further dilution, and a lyophilized powder that requires reconstitution and then further dilution

                Do not mix or combine the 2 formulations

                Each formulation vial is intended for single dose only

                Ready-to-dilute solution for injection

                • Aseptically withdraw the volume needed for the required dose from the 25 mg/mL solution and immediately transfer the solution to a 50 mL infusion bag of 0.9% NaCl, 2.5% dextrose/0.45% NaCl, or 5% dextrose
                • Final concentration following dilution should be within 1.85-5.6 mg/mL
                • After transferring, thoroughly mix the contents of the infusion bag
                • The admixture should be a clear, and 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
                • Further 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

                BRAND FORM. UNIT PRICE PILL IMAGE
                Treanda intravenous
                -
                100 mg vial
                Treanda intravenous
                -
                25 mg vial
                Bendeka intravenous
                -
                25 mg/mL vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                bendamustine intravenous

                BENDAMUSTINE - INJECTION

                (BEN-da-MUS-teen)

                COMMON BRAND NAME(S): Bendeka, Treanda

                USES: This medication is used to treat certain types of cancer (such as lymphoma, chronic lymphocytic leukemia - CLL). Bendamustine belongs to a class of cancer chemotherapy drugs known as alkylating agents. It works by killing cancer cells or slowing their growth.

                HOW TO USE: This medication is injected slowly into a vein by a health care professional as directed by your doctor.The dosage is based on your medical condition, body size, and response to treatment. Before each cycle, you should have blood tests to find the best dose for you and to see whether you need to wait before receiving this drug again.Before you receive this medication, your doctor may direct you to take a fever reducer, an antihistamine, and a corticosteroid such as dexamethasone to help prevent side effects. Use these additional medications exactly as directed by your doctor. (See also Side Effects section.)If bendamustine leaks out of the vein into the surrounding area, it may cause serious skin and tissue damage. Tell your health care professional right away if you experience pain, irritation, redness, or swelling at the injection site. Prompt treatment of the leakage will help reduce discomfort and possible skin damage.

                SIDE EFFECTS: See also How to Use section.Nausea, vomiting, diarrhea, tiredness, headache, dizziness, weakness, or mouth sores may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: unusual tiredness, pale skin, easy bruising/bleeding, swelling ankles/feet/hands, unusual skin changes, signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Get medical help right away if you have any signs of infections (such as a sore throat or cough that doesn't go away, fever, chills, swollen lymph nodes).Bendamustine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.Some people treated with this medication may rarely get other cancers (such as skin cancer). Consult your doctor for more details.Bendamustine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist promptly.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using bendamustine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders, kidney problems, liver problems, recent/current infection.Bendamustine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy or tired. Alcohol or marijuana (cannabis) can make you more dizzy or tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication can affect fertility in males. Ask your doctor for more details.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using bendamustine. Bendamustine may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women should ask about reliable forms of birth control while using this medication and for 6 months after stopping treatment. Men with female partners of childbearing age should ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. However, breast-feeding is not recommended while using this drug and for 1 week after stopping treatment. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: idelalisib, nalidixic acid, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include fast/irregular heartbeat and fainting.

                NOTES: Lab and/or medical tests (such as complete blood count, liver/kidney function, skin exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

                MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                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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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.