doxorubicin liposomal (Rx)

Brand and Other Names:Doxil, Lipodox, more...Myocet
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL

Kaposi Sarcoma

Indicated for AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy

20 mg/m² IV q3Weeks  

Ovarian Cancer

Indicated for ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy

50 mg/m² IV q4Weeks x 4 courses minimum  

Multiple Myeloma

Indicated in combination with bortezomib for multiple myeloma in patients who have not previously received bortezomib and have received at least 1 prior therapy

30 mg/m² IV on day 4 following bortezomib 1.3 mg/m² on days 1, 4, 8 & 11 q3Weeks  

Dosage Modifications

Hepatic impairment: Reduce dose if serum bilirubin ≥1.2 mg/dL

Hand-foot syndrome or stomatitis

  • Grade 1: If no previous grade 3 or 4 toxicity, no dose adjustment required; if previous grade 3 or 4 toxicity, delay up to 2 wk then decrease dose by 25%
  • Grade 2: Delay dose up to 2 wk or until resolved to grade 0-1; discontinue if not resolved after 2 wk; if resolve (no previous grades 3-4 toxicity), continue at previous dose; if resolve (hx of previous grades 3-4 toxicity), decrease dose by 25%
  • Grade 3: Delay dose up to 2 wk or until resolved to grade 0-1, then decrease dose by 25%; discontinue if no resolution after 2 wk
  • Grade 4: Delay dose up to 2 wk or until resolved to grade 0-1, then decrease dose by 25% and return to original dose interval; discontinue if no resolution after 2 wk

Neutropenia or thrombocytopenia

  • Grade 1: No dose reduction
  • Grade 2 or 3: Delay until ANC ≥1,500 and platelets ≥75,000; resume treatment at previous dose
  • Grade 4: Delay until ANC ≥1,500 and platelets ≥75,000; resume at 25% dose reduction or continue previous dose with prophylactic granulocyte growth factor

Other toxicities

  • Fever ≥38°C and ANC <1,000/mm³: Withhold dose for this cycle if before Day 4; decrease dose by 25%, if after Day 4 of previous cycle
  • On any day of drug administration after Day 1 of each cycle (platelet count <25,000/mm³, Hgb <8 g/dL, ANC <500/mm³): Withhold dose for this cycle if before Day 4; decrease dose by 25%, if after Day 4 of previous cycle AND if bortezomib is reduced for hematologic toxicity
  • Grade 3 or 4 nonhematologic toxicity: Hold dose until recovered to

Sarcomas (Orphan)

Treatment of soft tissue sarcomas

Orphan indication sponsor

  • GP-Pharm SA; Pol. Ind. Els Vinyets els Fogars n 2, Quinti de Mediona; Barcelona, Spain

Hepatocellular Carcinoma (Orphan)

Lyso-thermosensitive liposomal doxorubicin

Orphan indication sponsor

  • Celsion Corporation; 10220-L Old Columbia Road; Columbia, MD 21046

Safety and efficacy not established

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              Serious - Use Alternative (26)

              • abametapir

                abametapir will increase the level or effect of doxorubicin liposomal 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.

              • apalutamide

                apalutamide will decrease the level or effect of doxorubicin liposomal 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.

              • cobicistat

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

              • dabigatran

                doxorubicin liposomal will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

              • dacomitinib

                dacomitinib will increase the level or effect of doxorubicin liposomal 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.

              • edoxaban

                doxorubicin liposomal will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

              • enzalutamide

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

              • fexinidazole

                fexinidazole will increase the level or effect of doxorubicin liposomal 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 liposomal 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 liposomal 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 liposomal 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 liposomal 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.

              • lonafarnib

                doxorubicin liposomal 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • lorlatinib

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

              • nefazodone

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

              • palifermin

                palifermin increases toxicity of doxorubicin liposomal 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.

              • pomalidomide

                doxorubicin liposomal decreases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • ribociclib

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

              • saquinavir

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

              • tipranavir

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

              • tofacitinib

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

              • trastuzumab

                trastuzumab, doxorubicin liposomal. 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 liposomal. 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 liposomal 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 liposomal 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 (118)

              • abiraterone

                abiraterone increases levels of doxorubicin liposomal 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.

              • amiodarone

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

              • apalutamide

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

              • atazanavir

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

              • atorvastatin

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

              • avapritinib

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

              • axitinib

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

              • belatacept

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

              • belzutifan

                belzutifan will decrease the level or effect of doxorubicin liposomal 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.

              • bevacizumab

                bevacizumab, doxorubicin liposomal. 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • butabarbital

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

              • carbamazepine

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

              • cenobamate

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

              • clarithromycin

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

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

              • conivaptan

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

              • crizotinib

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

              • cyclophosphamide

                doxorubicin liposomal 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

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

              • dabrafenib

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

              • darunavir

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

              • dasatinib

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

              • dengue vaccine

                doxorubicin liposomal 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 liposomal, 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 liposomal 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • dichlorphenamide

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

              • digoxin

                doxorubicin liposomal 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • dronedarone

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

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

              • duvelisib

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

              • elagolix

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

                elagolix will decrease the level or effect of doxorubicin liposomal 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 liposomal 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 liposomal 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.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of doxorubicin liposomal 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 liposomal 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 liposomal. 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • erythromycin ethylsuccinate

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

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

              • erythromycin lactobionate

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

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

              • erythromycin stearate

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

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

              • eslicarbazepine acetate

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

              • ethotoin

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

              • etravirine

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

              • fedratinib

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

              • finerenone

                doxorubicin liposomal 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 liposomal 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 liposomal 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • fosamprenavir

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

              • fosphenytoin

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

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

              • fostemsavir

                fostemsavir will increase the level or effect of doxorubicin liposomal 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 liposomal by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.

              • grapefruit

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

              • hydroxyurea

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

              • iloperidone

                iloperidone increases levels of doxorubicin liposomal by aldehyde dehydrogenase inhibition. 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • isoniazid

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

              • istradefylline

                istradefylline will increase the level or effect of doxorubicin liposomal 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 liposomal 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.

              • itraconazole

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

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

              • ivosidenib

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

              • ketoconazole

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

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

              • lapatinib

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

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

              • lemborexant

                doxorubicin liposomal 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.

              • lomitapide

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

              • lorcaserin

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

              • mercaptopurine

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

              • midazolam intranasal

                doxorubicin liposomal 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • mirabegron

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

              • mitotane

                mitotane decreases levels of doxorubicin liposomal 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 liposomal 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 liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • nelfinavir

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

              • nevirapine

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

              • nicardipine

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

              • nifedipine

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

              • nilotinib

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

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

              • ofatumumab SC

                ofatumumab SC, doxorubicin liposomal. 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 liposomal 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • paclitaxel

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

              • paclitaxel protein bound

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

              • pentobarbital

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

              • phenobarbital

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

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

              • phenytoin

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

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

              • ponatinib

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

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

              • primidone

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

              • quinidine

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

              • ranolazine

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

              • regorafenib

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

              • rifampin

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

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

              • ritonavir

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

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

              • rolapitant

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

              • secobarbital

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

              • siponimod

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

              • sorafenib

                sorafenib, doxorubicin liposomal. 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

              • stavudine

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

              • stiripentol

                stiripentol, doxorubicin liposomal. 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.

              • streptozocin

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

              • tacrolimus

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

              • tazemetostat

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

                doxorubicin liposomal 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 liposomal 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 liposomal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Assess need to reduce dose of CYP2D6-metabolized drug.

              • tinidazole

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

              • trastuzumab

                trastuzumab, doxorubicin liposomal. 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 liposomal. 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 liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • valganciclovir

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

              • verapamil

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

                verapamil increases toxicity of doxorubicin liposomal 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 liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • zidovudine

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

                doxorubicin liposomal decreases effects of zidovudine by Other (see comment). Use Caution/Monitor. Comment: Concomitant administration of zidovudine and doxorubicin should be avoided since an antagonistic relationship has been demonstrated in vitro.

              Minor (8)

              • armodafinil

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

              • artemether/lumefantrine

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

              • dactinomycin

                doxorubicin liposomal, 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.

              • deferasirox

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

              • progesterone, natural

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

              • quinupristin/dalfopristin

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

              • rifapentine

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

              • ruxolitinib

                doxorubicin liposomal 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%

              Kaposi's Sarcoma

              • Anemia (>50%)
              • Thrombocytopenia (>50%)
              • Neutropenia (10-50%)
              • Anemia (18.2%)
              • Nausea (17%)

              Ovarian cancer >25%

              • Hand-foot syndrome (50%)
              • Nausea (46%)
              • Stomatitis (41%)
              • Asthenia (40.2%)
              • Vomiting (32.6%)
              • Rash (28%)
              • Constipation (>25%)
              • Abdominal pain (>25%)

              Ovarian cancer 10-25%

              • Fever (21.3%)
              • Anorexia (20%)
              • Diarrhea (20%)
              • Peripheral edema
              • Dyspepsia
              • Pharyngitis
              • Dyspnea
              • Alopecia

              1-10%

              Kaposi's Sarcoma 5-10%

              • Asthenia (9.9%)
              • Fever (9.1%)
              • Diarrhea (7.8%)
              • Vomiting (7.8%)
              • Stomatitis (6.8%)
              • Rash (1-5%)
              • Alopecia (1-5%)
              • Increased alkaline phosphatase

              Kaposi's Sarcoma 1-5%

              • Hand-foot syndrome (3.4%)
              • Hypotension
              • Tachycardia
              • Dyspnea
              • Hemolysis
              • Rash

              Ovarian cancer (selected)

              • Neutropenia (13.3%)
              • Anemia (0.4-5.4%)
              • Thrombocytopenia (1.3%)

              <1%

              Abscess

              Acute myeloid leukemia

              Cardiomegaly

              Cardiomyopathy

              Erythema nodosum

              Hyperkalemia

              Hyperuricemia

              Ketosis

              Postmarketing Reports

              Musculoskeletal and connective tissue disorders: Muscle spasms

              Respiratory, thoracic and mediastinal disorders: Pulmonary embolism (in some cases fatal)

              Hematologic disorders: Secondary acute myelogenous leukemia

              Skin and subcutaneous tissue disorders: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, lichenoid keratosis

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              Warnings

              Black Box Warnings

              Myocardial toxicity

              • Can cause myocardial damage, including congestive heart failure, as the total cumulative dose of doxorubicin HCl approaches 550 mg/m²
              • In a clinical study of 250 patients with advanced cancer who were treated with liposomal doxorubicin, the risk of cardiotoxicity was 11% when the cumulative anthracycline dose was between 450-550 mg/m²
              • Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage
              • The risk of cardiomyopathy may be increased at lower cumulative doses in patients with prior mediastinal irradiation

              Infusion-related reactions

              • May include flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat
              • Hypotension occurred in 11% of patients with solid tumors treated with liposomal doxorubicin
              • Serious, life-threatening and fatal infusion reactions have been reported

              Contraindications

              History of severe hypersensitivity to doxorubicin, including anaphylaxis

              Cautions

              Serious and sometimes life-threatening infusion-related reactions reported; ensure that medications to treat infusion-related reactions and cardiopulmonary resuscitative equipment are available for immediate use prior to initiation (see Black Box Warnings)

              Incidence of hand-foot syndrome in 1 trial was 51%, including 24% grade 3 or 4 toxicity (see Dosage Modifications)

              Secondary oral cancers, primarily squamous cell carcinoma, have been reported

              Based on animal data, can cause fetal harm when administered to pregnant women

              Cardiomyopathy

              • Can result in myocardial damage, including acute left ventricular failure; risk of cardiomyopathy is generally proportional to the cumulative exposure (see Black Box Warnings)
              • Include prior use of other anthracyclines or anthracenediones in calculations of cumulative dose; risk of cardiomyopathy may be increased at lower cumulative doses in patients with prior mediastinal irradiation
              • Assess left ventricular cardiac function (e.g. MUGA or echocardiogram) prior to initiation of therapy, during treatment to detect acute changes, and after treatment to detect delayed cardiomyopathy
              • Administer therapy to patients with a history of cardiovascular disease only when the potential benefit of treatment outweighs the risk

              Infusion reactions

              • Ensure that medications to treat infusion-related reactions and cardiopulmonary resuscitative equipment are available for immediate use prior to initiation of treatment
              • Initiate infusions at a rate of 1 mg/min and increase rate as tolerated
              • Withhold therapy for Grade 1, 2, or 3 infusion-related reactions and resume at a reduced infusion rate
              • Discontinue therapy for serious or life-threatening infusion-related reactions
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              Pregnancy & Lactation

              Pregnancy

              Based on findings in animals and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; avoid use during the 1st trimester

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

              Contraception

              • Females
              • Advise females of reproductive potential to use effective contraception during and for 6 months after treatment
              • Males
              • Therapy may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities; males with female sexual partners of reproductive potential should use effective contraception during and for 6 months after treatment

              Infertility

              • In females of reproductive potential, therapy may cause infertility and result in amenorrhea; premature menopause can occur; recovery of menses and ovulation is related to age at treatment
              • In males drug may result in oligospermia, azoospermia, and permanent loss of fertility; sperm counts have been reported to return to normal levels in some men; this may occur several years after end of therapy

              Animal data

              • In animal reproduction studies, therapy was embryotoxic in rats and abortifacient in rabbits following intravenous administration during organogenesis at doses approximately 0.12 times the recommended clinical dose
              • Available human data do not establish presence or absence of major birth defects and miscarriage related to use of doxorubicin hydrochloride during 2nd and 3rd trimesters; advise pregnant women of potential risk to a fetus

              Lactation

              Not known whether drug is present in human milk; because many drugs, including anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from therapy, discontinue breastfeeding during treatment

              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 subsequently inhibits DNA and RNA replication

              Doxorubicin is a strong chelator; doxorubicin-iron complex binds to cell membranes and DNA and produces free hydroxyl radicals that cleaves them

              Pharmacokinetics

              Peak Plasma: (20 mg/m²): 8.34±0.49 mcg/mL

              Half-life: 44-55 hr

              AUC (20 mg/m²): 590±59 mcg.hr/mL

              Protein binding: 70%

              Vd: 2.8 L/m²

              Metabolism: Low

              Clearance (20 mg/m²): 41 mL/hr/m²

              Excretion: Urine (5%)

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              Administration

              IV Incompatibilities

              Y-site: ampho B, amphotericin B cholesteryl sulfate, buprenorphine, ceftazidime, cefoperazone, docetaxel, hydroxyzine, mannitol, meperidine, metoclopramide, mitoxantrone, morphine sulfate, ofloxacin, paclitaxel, piperacillin/tazobactam, promethazine, Na-bicarb

              IV Compatibilities

              Y-site: acyclovir, allopurinol, ampicillin, carboplatin, cimetidine, ciprofloxacin, cisplatin, clindamycin, cyclophosphamide, dexamethasone, diphenhydramine, dobutamine, dopamine, fluconazole, fluorouracil, furosemide, granisetron, heparin, lorazepam, MgSO4, KCl, prochlorperazine, TMP/SMX, vancomycin, zidovudine

              IV Preparation

              Dilute aseptically <90 mg doses in 250 mL & >90 mg doses in 500 mL D5W (do NOT use other IV fluids)

              Refrigerate at 2-8°C & administer within 24 hr

              Red translucent dispersion (will not be a clear solution)

              IV Administration

              Initial infusion at 1 mg/min, if no infusion reaction may increase rate to complete infusion in 1 hr

              Do not administer as bolus injection or undiluted suspension

              Do not use in-line filter

              Use cytotoxic precautions for handling, administration, and disposal

              Extravasation Management

              Stop infusion immediately

              Do not remove the needle until attempts are made to aspirate extravasated fluid

              Do not flush the line

              Avoid applying pressure to the site

              Apply ice to the site intermittently for 15 minutes 4 x/day for 3 days

              If the extravasation is in an extremity, elevate the extremity

              Storage

              Store vials refrigerated at 2-8°C

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              doxorubicin, pegylated liposomal intravenous
              -
              2 mg/mL vial
              doxorubicin, pegylated liposomal intravenous
              -
              2 mg/mL vial
              doxorubicin, pegylated liposomal intravenous
              -
              2 mg/mL vial
              doxorubicin, pegylated liposomal intravenous
              -
              2 mg/mL vial
              doxorubicin, pegylated liposomal intravenous
              -
              2 mg/mL vial
              doxorubicin, pegylated liposomal intravenous
              -
              2 mg/mL vial
              Doxil intravenous
              -
              2 mg/mL vial
              Doxil intravenous
              -
              2 mg/mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              doxorubicin, pegylated liposomal intravenous

              DOXORUBICIN LIPOSOMAL - INJECTION

              (DOX-oh-ROO-bi-sin LYE-poe-SOE-mal)

              COMMON BRAND NAME(S): Doxil

              WARNING: Liposomal doxorubicin may cause heart problems, including possibly fatal heart failure. Heart problems may occur during liposomal 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.While this drug is first being given into your vein, this medication may cause severe (rarely fatal) reactions, including allergic reactions. Tell your doctor right away if you experience flushing, trouble breathing, swelling of the face, tightness in the chest/throat, chills, back pain, severe dizziness, or fast heartbeat. See also Side Effects section.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: Liposomal doxorubicin is an anthracycline-type chemotherapy drug that is used to treat certain types of cancer (e.g., ovarian cancer, AIDS-related Kaposi's sarcoma, multiple myeloma). It works by slowing or stopping cancer cell growth.

              HOW TO USE: This medication is given by injection into a vein over 30-60 minutes or longer by a health care professional. The dosage is based on your medical condition, body size, and response to therapy. Notify your doctor right away if redness, pain, or swelling occur at or near the injection site.If this medication touches your skin, immediately and completely wash 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.Family members and 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.

              SIDE EFFECTS: See also Warning section.Body aches/pains, headache, nausea, vomiting, constipation, diarrhea, stomach upset, 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.This medication may give a reddish-orange color to your urine, tears, and sweat. 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 several months after treatment has ended.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.Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). Notify your doctor promptly if you experience swelling, pain, redness, dryness, peeling, blisters, or tingling/burning of the hands/feet. The symptoms can be made worse by heat/pressure on your hands/feet. Avoid prolonged sun exposure, tanning booths, and sunlamps, as well as unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may give you something to reduce the symptoms, or decrease or delay your next dose of liposomal doxorubicin.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), drowsiness, trouble sleeping, mental/mood changes (e.g., anxiety, confusion, depression), cough/hoarseness, redness/pain/swelling of arms/legs, eye redness/itching, painful/difficult urination, stomach/abdominal pain, yellowing of the skin/eyes, dark urine, black/tarry stools, bloody mucus or discharge in stools, vision changes (e.g., blindness), fast/irregular heartbeat.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.)Painful swelling or 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 this rare but very serious side effect occurs: 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. Tell your doctor right away if you develop skin redness, pain, tenderness, swelling, peeling, or blisters. Your doctor may prescribe medication to help your skin heal faster and reduce the swelling. Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.In children, radiation recall may occur in the lungs. Tell the doctor right away if you notice wheezing or trouble breathing in the child.Very rarely, people with cancer who are treated with this type of medication have developed other cancers (such as secondary leukemia, oral cancer). Your risk is greater if you have received this medication long-term (more than 1 year), or with certain types of chemotherapy or radiation treatment. Consult your doctor for more details.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: Before using liposomal doxorubicin, tell your doctor or pharmacist if you are allergic to it; or to doxorubicin; or to other drugs containing polyethylene glycol; 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: low blood cell counts (e.g., anemia, neutropenia, thrombocytopenia), gout, heart problems, a history of receiving any anthracycline-type drug (e.g., doxorubicin, idarubicin, daunorubicin, mitoxantrone), infection, liver problems, radiation treatment (especially to the chest area), kidney problems.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 if using liposomal doxorubicin in children because they may be more sensitive to its effects, especially on the heart.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 liposomal doxorubicin. Liposomal 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 liposomal 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 being treated with liposomal doxorubicin. It may decrease this medication'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: unexplained bleeding.

              NOTES: Laboratory and/or medical tests (e.g., 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.

              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.
              Additional Offers
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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.