Dosing & Uses
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
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (29)
- 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.
- ceritinib
ceritinib will increase the level or effect of doxorubicin liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- 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.
- larotrectinib
larotrectinib will increase the level or effect of doxorubicin liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- 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.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, doxorubicin liposomal. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- 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 (123)
- 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.
- atogepant
doxorubicin liposomal will increase the level or effect of atogepant 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.
- fosaprepitant
fosaprepitant 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.
- isavuconazonium sulfate
doxorubicin liposomal will increase the level or effect of isavuconazonium sulfate 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.
- lenacapavir
lenacapavir will increase the level or effect of doxorubicin liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir (a moderate CYP3A4 inhibitor) may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.
- levoketoconazole
levoketoconazole will increase the level or effect of doxorubicin liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
levoketoconazole will increase the level or effect of doxorubicin liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. - 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 (13)
- acetazolamide
acetazolamide will increase the level or effect of doxorubicin liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of doxorubicin liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- 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.
- cyclophosphamide
cyclophosphamide will increase 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.
- hydrocortisone
hydrocortisone 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.
- ruxolitinib topical
doxorubicin liposomal will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
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
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
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.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%)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Doxil 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 |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 (such as 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. Get medical help right away.Family members and caregivers should take precautions (such as 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 last or get worse, tell your doctor or pharmacist promptly.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 (such as hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (such as 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 (such as 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 (such as 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 (such as sore throat that doesn't go away, fever, chills), 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 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. 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 (such as anemia, neutropenia, thrombocytopenia), gout, heart problems, a history of receiving any anthracycline-type drug (such as doxorubicin, idarubicin, daunorubicin, mitoxantrone), infection, liver problems, radiation treatment (especially to the chest area), kidney problems.Liposomal doxorubicin can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using liposomal doxorubicin before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lower the risk of bleeding gums.Children may be more sensitive to the side effects of this drug, especially effects on the heart.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using liposomal doxorubicin. Liposomal doxorubicin may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. 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 (such as 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: Lab and/or medical tests (such as complete blood counts, heart studies, liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: 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 February 2023. Copyright(c) 2023 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.
Formulary
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