doxorubicin (Rx)

Brand and Other Names:Adriamycin, Caelyx, more...Rubex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL

powder for injection

  • 10mg
  • 50mg

Cancers

Cancer of breast, ovary, prostate, stomach, thyroid; small cell cancer of lung, liver; squamous cell cancer of head and neck; multiple myeloma, Hodgkin's disease, lymphomas, ALL, AML

60-75 mg/m² IV q21Days OR  

60 mg/m² IV q14Days OR

40-60 mg/m² IV q21-28Days OR

20 mg/m²/dose qweek

Hepatocellular Carcinoma (Orphan)

Orphan indication sponsor

  • Delcath Systems, Inc; Rockefeller Center, 23rd Floor; New York, NY 10020

Renal Impairment

Dose adjustment not necessary

Hepatic Impairment

Serum bilirubin <1.2 mg/dL: Dose adjustment not necessary

Serum bilirubin 1.2-3 mg/dL [20.5-51.3 micromoles/L]: Give 50% dose

Serum bilirubin: 3.1-5 mg/dL [53-85.5 micromoles/L]: Give 25% dose

Severe hepatic impairment: Contraindicated

Administration

Limit lifetime cumulative dose to <550 mg/m² to reduce risk of cardiotox

Monitor: CBC, cardiac function, LFTs

Dosage Forms & Strengths

injectable solution

  • 2mg/mL

powder for injection

  • 10mg
  • 20mg
  • 50mg

Cancers

Cancer of stomach, neuroblastoma, thyroid; liver; squamous cell cancer of head and neck; multiple myeloma, Hodgkin's disease, lymphomas, ALL, AML

35-75 mg/m² IV q21Days OR  

20-30 mg/m²/dose qweek

60-90 mg/m² IV over 96 hr q3-4weeks OR

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Interactions

Interaction Checker

and doxorubicin

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              Serious - Use Alternative (32)

              • abametapir

                abametapir will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              • adenovirus types 4 and 7 live, oral

                doxorubicin decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • apalutamide

                apalutamide will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • chloramphenicol

                chloramphenicol will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • cobicistat

                cobicistat will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • dacomitinib

                dacomitinib will increase the level or effect of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • darolutamide

                darolutamide will increase the level or effect of doxorubicin by Other (see comment). Avoid or Use Alternate Drug. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions and consider dose reduction of BCRP substrate drug (refer BCRP substrate prescribing information).

              • deferiprone

                deferiprone, doxorubicin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • enzalutamide

                enzalutamide will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • erdafitinib

                erdafitinib will increase the level or effect of doxorubicin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.

              • fexinidazole

                fexinidazole will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • givosiran

                givosiran will increase the level or effect of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP2D6 substrates with givosiran. If unavoidable, decrease the CYP2D6 substrate dosage in accordance with approved product labeling.

              • idelalisib

                idelalisib will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

              • influenza virus vaccine quadrivalent, adjuvanted

                doxorubicin decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                doxorubicin decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • itraconazole

                itraconazole will increase the level or effect of doxorubicin by Other (see comment). Avoid or Use Alternate Drug. Doxorubicin is a CYP3A4 and P-gp substrate. Avoid use in combination with CYP3A4 and P-gp inhibitors due to the potential for increased doxorubicin systemic exposure and effects.

              • lasmiditan

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

                lasmiditan increases levels of doxorubicin by Other (see comment). Avoid or Use Alternate Drug. Comment: Lasmiditan inhibits BCRP in vitro. Avoid coadministration of lasmiditan with BCRP substrates.

              • lonafarnib

                doxorubicin will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

              • lopinavir

                lopinavir will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • lorlatinib

                lorlatinib will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • nefazodone

                nefazodone will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • palifermin

                palifermin increases toxicity of doxorubicin 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.

              • ribociclib

                ribociclib will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • saquinavir

                saquinavir will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • sotorasib

                sotorasib will decrease the level or effect of doxorubicin 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 doxorubicin 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.

              • tipranavir

                tipranavir will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • tofacitinib

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

              • trastuzumab

                trastuzumab, doxorubicin. Either increases toxicity of the other by unknown mechanism. Avoid or Use Alternate Drug. Trastuzumab may cause cardiomyopathy. Incidence and severity was highest when used with anthracycline-containing chemotherapy regimens. If possible, avoid anthracycline-based therapy for 7 months after last trastuzumab/hyaluronidase dose. If anthracyclines are used, carefully monitor cardiac function.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, doxorubicin. Either increases toxicity of the other by unknown mechanism. Avoid or Use Alternate Drug. Trastuzumab may cause cardiomyopathy. Incidence and severity was highest when used with anthracycline-containing chemotherapy regimens. If possible, avoid anthracycline-based therapy for 7 months after last trastuzumab/hyaluronidase dose. If anthracyclines are used, carefully monitor cardiac function.

              • tucatinib

                tucatinib will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

              • voxelotor

                voxelotor will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

              Monitor Closely (134)

              • abiraterone

                abiraterone increases levels of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Avoid coadministration of abiraterone with substrates of CYP2D6. If alternative therapy cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate.

              • acalabrutinib

                acalabrutinib increases levels of doxorubicin by Other (see comment). Use Caution/Monitor. Comment: Acalabrutinib may increase exposure to coadministered BCRP substrates by inhibition of intestinal BCRP.

                acalabrutinib, doxorubicin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • amiodarone

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

              • apalutamide

                apalutamide will decrease the level or effect of doxorubicin by increasing elimination. Use Caution/Monitor. Apalutamide weakly induces BCRP and may decrease systemic exposure of drugs that are BCRP substrates.

              • aprepitant

                aprepitant will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • atazanavir

                atazanavir will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • atorvastatin

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

              • avapritinib

                doxorubicin will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • axitinib

                doxorubicin increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • belatacept

                belatacept and doxorubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • belzutifan

                belzutifan will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

              • berotralstat

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

              • bevacizumab

                bevacizumab, doxorubicin. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of cardiotoxicity (CHF). Caution is warranted.

              • bosentan

                bosentan will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • bosutinib

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

              • butabarbital

                butabarbital will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • carbamazepine

                carbamazepine will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cenobamate

                cenobamate will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              • cholera vaccine

                doxorubicin, cholera vaccine. 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.

              • cimetidine

                cimetidine will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • clarithromycin

                clarithromycin will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • conivaptan

                conivaptan will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • crizotinib

                crizotinib increases levels of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.

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

              • cyclophosphamide

                doxorubicin increases toxicity of cyclophosphamide by unspecified interaction mechanism. Use Caution/Monitor. Increased risk of hemorrhagic cystitis.

              • cyclosporine

                cyclosporine will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

                cyclosporine increases levels of doxorubicin by decreasing renal clearance. Use Caution/Monitor.

              • dabrafenib

                dabrafenib will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

              • darunavir

                darunavir will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • dasatinib

                dasatinib will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • dengue vaccine

                doxorubicin 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.

              • denosumab

                doxorubicin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • desvenlafaxine

                desvenlafaxine will increase the level or effect of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Desvenlafaxine inhibits CYP2D6; with higher desvenlafaxine doses (ie, 400 mg) decrease the CYP2D6 substrate dose by up to 50%; no dosage adjustment needed with desvenlafaxine doses <100 mg

              • dexamethasone

                dexamethasone will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • dichlorphenamide

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

              • digoxin

                doxorubicin decreases levels of digoxin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              • diltiazem

                diltiazem will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • dronedarone

                dronedarone will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • duvelisib

                duvelisib will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.

              • efavirenz

                efavirenz will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • elagolix

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

                elagolix will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

              • eliglustat

                eliglustat increases levels of doxorubicin 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.

                eliglustat increases levels of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the concomitant drug and titrate to clinical effect.

              • eluxadoline

                eluxadoline increases levels of doxorubicin by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered BCRP substrates.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP2D6 inhibitor; caution with CYP2D6 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

              • encorafenib

                encorafenib, doxorubicin. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

              • erythromycin base

                erythromycin base will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • erythromycin lactobionate

                erythromycin lactobionate will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • erythromycin stearate

                erythromycin stearate will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • eslicarbazepine acetate

                eslicarbazepine acetate will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ethotoin

                doxorubicin decreases levels of ethotoin by increasing metabolism. Use Caution/Monitor.

              • etravirine

                etravirine will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • fedratinib

                fedratinib will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

                fedratinib will increase the level or effect of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP2D6 substrates as necessary.

              • finerenone

                doxorubicin will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

              • fingolimod

                doxorubicin 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. .

              • flibanserin

                doxorubicin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

              • fluconazole

                fluconazole will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • fosamprenavir

                fosamprenavir will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • fosphenytoin

                fosphenytoin will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                doxorubicin decreases levels of fosphenytoin by increasing metabolism. Use Caution/Monitor.

              • fostamatinib

                fostamatinib will increase the level or effect of doxorubicin 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.

              • fostemsavir

                fostemsavir will increase the level or effect of doxorubicin by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir.

              • ganciclovir

                ganciclovir increases toxicity of doxorubicin by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.

              • glecaprevir/pibrentasvir

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

                glecaprevir/pibrentasvir will increase the level or effect of doxorubicin by decreasing metabolism. Use Caution/Monitor. Glecaprevir/pibrentasvir may increase plasma concentration of BCRP substrates.

              • grapefruit

                grapefruit will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • hydroxyurea

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

              • iloperidone

                iloperidone increases levels of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

              • indinavir

                indinavir will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • isoniazid

                isoniazid will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • istradefylline

                istradefylline will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

                istradefylline will increase the level or effect of doxorubicin 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 doxorubicin 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.

              • ivosidenib

                ivosidenib will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ketoconazole

                ketoconazole will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • lapatinib

                lapatinib will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • lemborexant

                doxorubicin will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

              • letermovir

                letermovir increases levels of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • lomitapide

                doxorubicin increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

                lomitapide increases levels of doxorubicin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.

              • lonafarnib

                lonafarnib will increase the level or effect of doxorubicin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

              • lorcaserin

                lorcaserin will increase the level or effect of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              • meningococcal group B vaccine

                doxorubicin decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • mercaptopurine

                doxorubicin increases toxicity of mercaptopurine by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of hepatotoxicity.

              • midazolam intranasal

                doxorubicin will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

              • mifepristone

                mifepristone will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • mirabegron

                mirabegron will increase the level or effect of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              • mitotane

                mitotane decreases levels of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

              • nafcillin

                nafcillin will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inducers may increase metabolism of CYP3A4 substrates

              • nefazodone

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

              • nelfinavir

                nelfinavir will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • nevirapine

                nevirapine will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • nicardipine

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

              • nifedipine

                nifedipine will decrease the level or effect of doxorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • nilotinib

                nilotinib will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • ofatumumab SC

                ofatumumab SC, doxorubicin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • olaparib

                doxorubicin and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • oxcarbazepine

                oxcarbazepine will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • paclitaxel

                paclitaxel increases levels of doxorubicin by decreasing renal clearance. Modify Therapy/Monitor Closely. Monitor for doxorubicin-induced cardiovascular toxicity.

              • paclitaxel protein bound

                paclitaxel protein bound increases levels of doxorubicin by decreasing renal clearance. Modify Therapy/Monitor Closely. Monitor for doxorubicin-induced cardiovascular toxicity.

              • pentobarbital

                pentobarbital will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • phenobarbital

                phenobarbital will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                phenobarbital decreases levels of doxorubicin by increasing elimination. Use Caution/Monitor.

              • phenytoin

                phenytoin will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                doxorubicin decreases levels of phenytoin by increasing metabolism. Use Caution/Monitor.

              • ponatinib

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

                ponatinib increases levels of doxorubicin by Other (see comment). Use Caution/Monitor.

              • primidone

                primidone will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • quinidine

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

              • ranolazine

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

              • regorafenib

                regorafenib will increase the level or effect of doxorubicin by Other (see comment). Modify Therapy/Monitor Closely. Regorafenib likely inhibits BCRP (ABCG2) transport. Coadministration with a BCRP substrate may increase systemic exposure to the substrate and related toxicity.

              • rifabutin

                rifabutin will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifampin

                rifampin will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                rifampin will decrease the level or effect of doxorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • ritonavir

                ritonavir will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • rolapitant

                rolapitant will increase the level or effect of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Rolapitant may increase plasma concentrations of CYP2D6 substrates for at least 28 days following rolapitant administration.

              • rucaparib

                rucaparib will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

              • safinamide

                safinamide will increase the level or effect of doxorubicin by Other (see comment). Use Caution/Monitor. Safinamide and its major metabolite may inhibit intestinal BCRP. Monitor BCRP substrates for increased pharmacologic or adverse effects.

              • sarecycline

                sarecycline will increase the level or effect of doxorubicin 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 will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • siponimod

                siponimod and doxorubicin 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

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

              • sofosbuvir/velpatasvir

                sofosbuvir/velpatasvir will increase the level or effect of doxorubicin by Other (see comment). Use Caution/Monitor. Velpatasvir is an inhibitor of the drug transporter BCRP. Coadministration may increase systemic exposure of drugs that are BCRP substrates.

              • sorafenib

                sorafenib, doxorubicin. unknown mechanism. Use Caution/Monitor. In clinical studies, an increase of 21% and 47% and no changes in the AUC of doxorubicin were observed with coadministration of sorafenib 400 mg twice daily. The clinical importance of these findings is unknown.

              • St John's Wort

                St John's Wort will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                St John's Wort will decrease the level or effect of doxorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • stavudine

                doxorubicin decreases effects of stavudine by Other (see comment). Use Caution/Monitor. Comment: Mechanism: inhibition of phosphorylation process.

              • stiripentol

                stiripentol, doxorubicin. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

                stiripentol will increase the level or effect of doxorubicin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

                stiripentol will increase the level or effect of doxorubicin by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a BCRP transport inhibitor. Consider dosage reduction for BCRP substrates if adverse effects are experienced when coadministered.

              • streptozocin

                streptozocin increases levels of doxorubicin by decreasing metabolism. Use Caution/Monitor.

              • tacrolimus

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

              • tafamidis

                tafamidis will increase the level or effect of doxorubicin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

              • tafamidis meglumine

                tafamidis meglumine will increase the level or effect of doxorubicin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

              • tazemetostat

                tazemetostat will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                doxorubicin will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tecovirimat

                tecovirimat will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

              • terbinafine

                terbinafine will increase the level or effect of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Assess need to reduce dose of CYP2D6-metabolized drug.

              • tinidazole

                doxorubicin will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • trastuzumab

                trastuzumab, doxorubicin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, doxorubicin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trazodone

                trazodone will decrease the level or effect of doxorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • tucatinib

                tucatinib will increase the level or effect of doxorubicin 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.

              • valganciclovir

                valganciclovir increases toxicity of doxorubicin by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.

              • vemurafenib

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

              • verapamil

                verapamil will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                verapamil increases levels of doxorubicin by decreasing metabolism. Use Caution/Monitor. Coadministration of doxorubicin and calcium channel blockers may increase the risk of doxorubicin cardiotoxicity. .

              • voriconazole

                voriconazole will increase the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • zidovudine

                zidovudine increases toxicity of doxorubicin by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.

                doxorubicin decreases effects of zidovudine by Other (see comment). Use Caution/Monitor.

              Minor (6)

              • amobarbital

                amobarbital will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • artemether/lumefantrine

                artemether/lumefantrine will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • dactinomycin

                doxorubicin, dactinomycin. unspecified interaction mechanism. Minor/Significance Unknown. Pediatric patients receiving concomitant doxorubicin and dactinomycin have manifested acute "recall" pneumonitis at variable times after local radiation therapy.

              • progesterone, natural

                progesterone, natural increases toxicity of doxorubicin by unspecified interaction mechanism. Minor/Significance Unknown. Enhanced neutropenia.

              • rifapentine

                rifapentine will decrease the level or effect of doxorubicin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ruxolitinib

                doxorubicin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Neutropenia (52%)

              Anemia (52%)

              Leukopenia (42%)

              Pruritus (37%)

              Nausea (37%)

              Stomatitis (37%)

              Fatigue (33%)

              CHF (30%)

              Thrombocytopenia (24%)

              Vomiting (22%)

              Rash (21%)

              Alopecia (15%)

              Anorexia (12%)

              Constipation (12%)

              Diarrhea (10%)

              1-10%

              Cardiomyopathy (0.5-9%)

              Frequency Not Defined

              Photosensitivity

              Cardiac dysrhythmia

              Necrotizing colitis

              Myelosuppression

              Hyperuricemia

              Red urine

              Hyperpigmentation of previously radiated areas

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              Warnings

              Black Box Warnings

              The drug should be administered under the supervision of an experienced cancer chemotherapy physician

              Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride; the risk of cardiomyopathy is proportional to cumulative exposure with incidence rates from 1- 20% for cumulative doses ranging from 300 mg/m2 to 500 mg/m2 when doxorubicin hydrochloride is administered every 3 weeks; the risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy; assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride

              Delayed cardiotoxicity may occur in patients with prior mediastinal irradiation, in those on concurrent cyclophosphamide therapy, or in those with preexisting heart disease. Toxicity may also occur at a lower cumulative dose in patients

              Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision of affected area and skin grafting; immediately terminate drug and apply ice to affected area; do not administer IM or SC

              Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride

              Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur

              Contraindications

              Hypersensitivity

              Active infection

              Severe hepatic impairment

              Baseline neutrophil count <1500/mm³

              Recent MI or severe myocardial insufficiency

              Prior treatment max dose of doxorubicin, daunorubicin, idarubicin, or other anthracyclines

              Cardiomyopathy, CHF, impaired cardiac function

              IM/SC administration

              Cautions

              Vesicant

              Pericarditis and myocarditis reported during or following treatment; assess left ventricular cardiac function (eg, MUGA or echocardiogram) prior to initiation of doxorubicin; discontinue in patients who develop signs or symptoms of cardiomyopathy; consider use of dexrazoxane to reduce incidence and severity of cardiomyopathy due to administration in patients who have received a cumulative doxorubicin hydrochloride dose of 300 mg/m2 and who will continue to receive doxorubicin hydrochloride

              The risk of developing secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) is increased following treatment with doxorubicin hydrochloride. Cumulative incidences ranged from 0.2% at five years to 1.5% at 10 years in two separate trials involving the adjuvant treatment of women with breast cancer. These leukemias generally occur within 1 to 3 years of treatment

              Drug clearance of doxorubicin is decreased in patients with elevated serum bilirubin with increased risk of toxicity; reduce dose in patients with serum bilirubin levels of 1.2 to 5 mg/dL; obtain liver tests including ALT, AST, alkaline phosphatase, and bilirubin prior to and during therapy

              Doxorubicin hydrochloride can induce tumor lysis syndrome in patients with rapidly growing tumors; evaluate blood uric acid levels, potassium, calcium, phosphate, and creatinine after initial treatment; hydration, urine alkalinization, and prophylaxis with allopurinol to prevent hyperuricemia may minimize potential complications of tumor lysis syndrome

              Therapy can increase radiation-induced toxicity to myocardium, mucosa, skin, and liver; radiation recall, including but not limited to cutaneous and pulmonary toxicity, can occur in patients who receive drug after prior radiation therapy

              Secondary oral cancers, primarily squamous cell carcinoma, reported with long-term (ie, >1 yr)

              Use caution in the elderly, liver impairment, and concomitant radiotherapy

              Not effective in malignant melanoma, kidney CA, bowel CA, brain tumors, CNS metastasis

              Therapy can cause myelosuppression; a dose-dependent, reversible neutropenia is predominant manifestation of myelosuppression from therapy; obtain complete blood counts prior to each treatment and carefully monitor patients during treatment for possible clinical complications due to myelosuppression; delay next dose if severe myelosuppression has not improved; consider dose reduction for patients with prolonged myelosuppression based on severity of reaction

              Extravasation

              • Extravasation of doxorubicin hydrochloride can cause severe local tissue injury manifesting as blistering, ulceration, and necrosis requiring wide excision of the affected area and skin grafting
              • Extravasation should be considered if a patient experiences a burning or stinging sensation or shows other evidence indicating peri-venous infiltration or extravasation; however, extravasation may be present in patients who do not experience a stinging or burning sensation or when blood return is present on aspiration of the infusion needle
              • When given via a peripheral venous line, infuse over 10 minutes or less to minimize risk of thrombosis or perivenous extravasation
              • If extravasation is suspected, immediately discontinue intravenous injection or continuous intravenous infusion; apply ice to site intermittently for 15 minutes, 4 times a day for 3 days; in adults, if appropriate, administer dexrazoxane at site of extravasation as soon as possible and within the first 6 hours after extravasation

              Arrhythmias

              • Therapy can result in arrhythmias, including life-threatening arrhythmias, during or within a few hours after treatment and at any time point during treatment; tachyarrhythmias, including sinus tachycardia, premature ventricular contractions, and ventricular tachycardia, as well as bradycardia, can occur
              • Electrocardiographic changes, including non-specific ST-T wave changes, atrioventricular and bundle-branch block can also occur; these electrocardiographic changes may be transient and self-limited and may not require a dosage modification of doxorubicin hydrochloride

              Pediatric patients

              • Based on postmarketing reports, pediatric patients are at risk for developing late cardiovascular dysfunction
              • Risk factors include young age at treatment (especially < 5 years), high cumulative doses and receipt of combined modality therapy; long-term periodic cardiovascular monitoring recommended for all pediatric patients
              • Drug, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure and may also contribute to gonadal impairment, which is usually temporary

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              Pregnancy & Lactation

              Pregnancy

              Based on findings in animals and its mechanism of action, drug can cause fetal harm when administered to a pregnant woman; avoid use during 1st trimester; available human data do not establish presence or absence of major birth defects and miscarriage related to use during 2nd and 3rd trimesters; drug was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) recommended human dose of 60 mg/m2; advise pregnant women of potential risk to a fetus

              Verify pregnancy status of females of reproductive potential prior to initiating therapy

              In females of reproductive potential, drug may cause infertility and result in amenorrhea; premature menopause can occur; recovery of menses and ovulation is related to age at treatment

              Contraception

              • Females: Treatment can cause fetal harm when administered to pregnant women; advise female patients of reproductive potential to use highly effective contraception during treatment and for 6 months after treatment
              • Males: Treatment may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities; due to potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after treatment; males with pregnant partners should use condoms during treatment and for at least 10 days after final dose

              Lactation

              Data are not available regarding effects on breastfed children or milk production

              Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 10 days after the final 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

              Anthracycline; intercalates between DNA base pairs, impairs topoisomerase II function and inhibits replication & transcription

              Distribution

              Protein Bound: 75%

              Vd: 20-30 L/kg (700-1214 L/m²)

              Metabolism

              Predominantly liver

              Metabolites: Doxorubicinol

              Elimination

              Half-Life: 1-3 hr

              Clearance: 8-20 mL/min/kg

              Excretion: Feces (40-50%); urine (5-12%)

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              Administration

              IV Incompatibilities

              Additive: aminophylline, dacarbazine/ondansetron(?), diazepam, fluorouracil

              Syringe: cisplatin/mitomycin(?), fluorouracil (at high concs of both), furosemide, heparin

              Y-site: allopurinol, amphotericin B cholesteryl sulfate, cefepime, furosemide(?), ganciclovir, heparin(?), piperacillin/tazobactam, propofol

              IV Preparation

              Reconstitute with NS to a final concentration of 2 mg/mL

              Protect from light

              Reconstituted soln stable for 7 d at room temp if protected from light & 15 d at 2-8°C

              IV Administration

              Administered into the tubing of a freely running intravenous infusion of NS or D5W

              Administer over 3-5 min with frequent checks of IV patency via visible blood return

              Monitor for local erythematous streaking (flare rxn) along vein &/or facial flushing (may indicate too rapid administration)

              Extravasation Management

              Terminate injection or infusion immediately & aspirate back as much as possible

              Apply cold pack w/ circulating ice water, ice pack or cryogel pack to extravasation site for 15-20 min QID x 24-48 hr

              Elevate site for 48 hr, then resume normal activity

              Extravasation of <1-2 mL often heal spontaneously. If >3 mL, ulceration may occur.

              Protect site from heat & sunlight

              Varied results in studies using 99% DMSO to treat extravasation, follow institutional policy

              If pain, erythema, &/or swelling persist beyond 48 hr, refer pt immediately to plastic surgeon for consultation & possible debridement

              See also Totect

              Storage

              Store intact vials of solution under refrigeration at 2-8°C

              Protect from light

              Store intact vials of lyophilized powder at room temp(15-30°C)

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              Images

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              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              doxorubicin intravenous

              DOXORUBICIN - INJECTION

              (dox-oh-REW-beh-sin)

              COMMON BRAND NAME(S): Adriamycin, Rubex

              WARNING: This medication must be given slowly into a vein only. It is very important not to inject this medication into a muscle or beneath the skin. If this medication accidentally leaks into surrounding tissue, the skin/muscle may be severely damaged. Notify your doctor right away if redness, blistering, sores, pain, or swelling occur at or near the injection site.Doxorubicin may cause heart problems, including possibly fatal heart failure. Heart problems may occur during doxorubicin therapy or months to years after receiving this medication. Your risk of developing heart problems depends on your dose, medical history (including previous heart disease, radiation therapy in the chest area), and previous use of this and other drugs (including daunorubicin and cyclophosphamide). Children are at higher risk and should be monitored later in life for delayed heart problems. See also Side Effects section.Very rarely, people with cancer who are treated with this type of medication have developed other cancers (e.g., secondary leukemia). The risk is greater if you are over age 50 or have received certain types of chemotherapy or radiation therapy. Consult your doctor for more details.This medication may cause certain severe (rarely fatal) blood disorders (bone marrow suppression leading to low red blood cells/white blood cells /platelets). This can lower your body's ability to fight infection and stop bleeding. Tell your doctor right away if you develop any signs of infection (e.g., fever, chills, persistent sore throat), unusual tiredness, or easy bleeding/bruising.Your doctor will closely monitor you while you are being treated with this medication.Different types of this medication work in different ways. Do not switch types of this medication without your doctor's permission.

              USES: Doxorubicin is an anthracycline type of chemotherapy that is used to treat several different types of cancer. Doxorubicin works by slowing or stopping the growth of cancer cells.

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start receiving doxorubicin and each time you get an infusion. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein by a health care professional. The dosage is based on your medical condition, body size, and response to therapy.If this medication touches your skin, immediately and completely wash the skin with soap and water. If this medication gets in your eye, open the eyelids and flush with plenty of water for 15 minutes. Seek immediate medical attention.Caregivers should take precautions (e.g., wear gloves) to prevent contact with the patient's urine or other body fluid for at least 5 days after treatment. Consult your pharmacist.Unless your doctor instructs you otherwise, drink plenty of cool fluids during treatment with this medication. This helps move the drug quickly through your body and helps reduce some of the side effects.

              SIDE EFFECTS: See also Warning section.Nausea, vomiting, diarrhea, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be needed to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet and lifestyle, such as eating several small meals and limiting activity, may help lessen some of these effects. If any of these effects continue or worsen, notify your doctor or pharmacist.Doxorubicin may give a reddish color to your urine, tears, and sweat. This effect may start in the first hours after treatment and may last up to several days. This is a normal effect of the drug and should not be mistaken for blood in your urine.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.Nail changes (including fungal infections in the nail beds) may rarely occur.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), redness/flushing of face, eye redness/itching, cough/hoarseness, persistent diarrhea, joint pain, pain in the lower back/side/stomach/abdomen, painful/difficult urination, stopped/missed menstrual periods, black/tarry stools, bloody mucus or discharge in stools, fast/irregular heartbeat, dizziness, decreased urination.Painful sores on the lips, mouth and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water.Get medical help right away if you have any very serious side effects, including: chest pain.Within days to weeks after doxorubicin treatment, a serious skin reaction that looks likes a severe sunburn (radiation recall) may develop on any area of skin that has been previously treated with radiation. Also, doxorubicin may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you have skin redness, pain, tenderness, swelling, peeling, blisters, or if you get sunburned. Your doctor may prescribe medication to help your skin heal faster and reduce the swelling.In children, radiation recall may occur in the lungs. Tell the doctor right away if you notice wheezing or trouble breathing in the child.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.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: See also Side Effects section.Before using doxorubicin, tell your doctor or pharmacist if you are allergic to it; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, 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: a current infection, low blood cell counts (e.g., anemia, neutropenia, thrombocytopenia), gout, heart problems (e.g., recent heart attack, heart failure, irregular heartbeat), a history of receiving any anthracycline-type drug (e.g., doxorubicin, idarubicin, daunorubicin, mitoxantrone), kidney problems, liver disease, severe mouth sores (stomatitis), radiation treatment (especially to the chest area).Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lower the risk of bleeding gums.Wash your hands well to prevent the spread of infections.Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially to radiation recall in the lungs, heart problems, or another cancer later on in life. Doxorubicin, in combination with other chemotherapies, may also slow the growth of children before puberty.This medication can affect fertility in males. It can also affect menstruation in females and cause premature menopause. Ask your doctor for more details.Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will give you a pregnancy test before starting treatment. You should not become pregnant while using doxorubicin. Doxorubicin may harm an unborn baby. Ask about reliable forms of birth control to use during treatment with this medication and for 6 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.Men who have a pregnant partner must use a condom during sexual activity during doxorubicin treatment and for 10 days after treatment has stopped. Men with a female partner of childbearing age who is not pregnant should ask about reliable forms of birth control to use during treatment with this medication and for 3 months after stopping treatment. If your partner becomes pregnant or thinks she may be pregnant, tell the doctor right away.This medication passes into breast milk. Because of the potential risk to the infant, breast-feeding is not recommended while using this drug and for 10 days 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: digoxin, progesterone, streptozocin, stavudine, trastuzumab, zidovudine.Other medications can affect the removal of doxorubicin from your body, which may affect how doxorubicin works. Examples include azole antifungals (such as ketoconazole), calcium channel blockers (e.g., verapamil, nifedipine), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital, primidone), among others.Avoid eating foods or products containing turmeric (curcumin) while taking doxorubicin. It may decrease doxorubicin's effects. Consult your doctor or pharmacist for more details.

              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: seizures, unexplained bleeding.

              NOTES: Laboratory and/or medical tests (e.g., blood mineral levels, complete blood counts, heart studies, liver function tests) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details. Keep all your medical and laboratory appointments.

              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: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              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.

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              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.
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              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.