Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 5mg/mL( 2-mL, 5.5-mL single-dose vials)
- Includes diluent for reconstitution
Cutaneous T-Cell Lymphoma
Indicated for CTCL in patients who have received at least 1 prior systemic therapy
14 mg/m2 IV on days 1, 8, and 15 of 28-d cycle
Continue until disease progression or intolerable toxicity
Peripheral T-Cell Lymphoma
Indication was voluntarily withdrawn in the U.S. by manufacturer in August 2021 based on failure to meet the primary efficacy endpoint of progression free survival in a phase 3 trial evaluating romidepsin plus CHOP versus CHOP for first-line peripheral T-cell lymphoma patients
Dosage Modifications
Nonhematologic toxicities (except alopecia)
- Grade 2 or 3 toxicity: Hold dose until toxicity declines to Grade 1 or baseline, then restart at 14 mg/m2
- If Grade 3 toxicity recurs, hold dose until toxicity returns to Grade 1 or baseline and the dose should be permanently reduced to 10 mg/m2
- Grade 4 toxicity: Hold dose until toxicity declines to Grade 1 or baseline, then the dose should be permanently reduced to 10 mg/m2
- Discontinued if Grade 3 or 4 toxicities recur after dose reduction
Hematologic toxicities
- Grade 3 or 4 neutropenia or thrombocytopenia: Hold dose until toxicity improves to ANC >1.5×109/L and/or platelet count >75×109/L or baseline, then restart at 14 mg/m2
- Grade 4 febrile (>38.5°C) neutropenia or thrombocytopenia that requires platelet transfusion: Delay dose until the specific cytopenia returns to Grade 1 or baseline, and then permanently reduce dose to 10 mg/m2
Renal impairment
- No dose adjustment required
- Pharmacokinetics of romidepsin not influenced by renal impairment
Hepatic impairment
- Mild: No dose adjustment required
- Moderate (bilirubin levels >1.5x to ≤3x ULN): Reduce starting dose to 7 mg/m2
- Severe (bilirubin levels >3x ULN): Reduce starting dose to 5 mg/m2
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- lefamulin
lefamulin will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Lefamulin is contraindicated with CYP3A substrates know to prolong the QT interval.
Serious - Use Alternative (86)
- abametapir
abametapir will increase the level or effect of romidepsin 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.
- amiodarone
amiodarone and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- amobarbital
amobarbital will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- apalutamide
apalutamide will decrease the level or effect of romidepsin 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.
- arsenic trioxide
arsenic trioxide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- artemether
artemether and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- artemether/lumefantrine
artemether/lumefantrine and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- atazanavir
atazanavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.
- bosentan
bosentan will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- butabarbital
butabarbital will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- carbamazepine
carbamazepine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- ceritinib
ceritinib and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- cimetidine
cimetidine will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- clarithromycin
clarithromycin will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.
- clozapine
clozapine and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- dabrafenib
dabrafenib will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- darunavir
darunavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.
- dexamethasone
dexamethasone will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- disopyramide
disopyramide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- dofetilide
dofetilide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- dolasetron
dolasetron and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- droperidol
droperidol and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- entrectinib
romidepsin and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.
- enzalutamide
enzalutamide will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erdafitinib
erdafitinib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.
- erythromycin base
erythromycin base will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin lactobionate
erythromycin lactobionate will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin stearate
erythromycin stearate will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- etravirine
etravirine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- fexinidazole
fexinidazole and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.
fexinidazole will increase the level or effect of romidepsin 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. - flecainide
flecainide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- fosamprenavir
fosamprenavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.
- fosphenytoin
fosphenytoin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- glasdegib
romidepsin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.
- haloperidol
haloperidol and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- ibutilide
ibutilide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- idelalisib
idelalisib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- iloperidone
iloperidone and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- indinavir
indinavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.
- inotuzumab
inotuzumab and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.
- ivosidenib
ivosidenib and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.
ivosidenib will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs. - ketoconazole
ketoconazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.
- lonafarnib
lonafarnib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.
- lopinavir
lopinavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lumefantrine
lumefantrine and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- macimorelin
macimorelin and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.
- methadone
methadone and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- mifepristone
mifepristone will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- mobocertinib
mobocertinib and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.
- nafcillin
nafcillin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- nefazodone
nefazodone will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.
- nelfinavir
nelfinavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.
- nevirapine
nevirapine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- ondansetron
ondansetron and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.
- oxcarbazepine
oxcarbazepine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of romidepsin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, 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..
- paliperidone
paliperidone and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- panobinostat
romidepsin and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.
- pentamidine
pentamidine and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- pentobarbital
pentobarbital will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- phenobarbital
phenobarbital will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- phenytoin
phenytoin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of romidepsin and phenytoin, a potent CYP3A4 inducer, as this may decrease romidepsin concentrations and efficacy.
- pimozide
pimozide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- pitolisant
romidepsin and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.
- primidone
primidone will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- procainamide
procainamide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.
- quinidine
quinidine will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
quinidine and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. - ribociclib
ribociclib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
ribociclib increases toxicity of romidepsin by QTc interval. Avoid or Use Alternate Drug. - rifabutin
rifabutin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- rifampin
rifampin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- rifapentine
rifapentine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- ritonavir
ritonavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.
- saquinavir
saquinavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors shoul d be avoided if possible.
- secobarbital
secobarbital will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- sotorasib
sotorasib will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.
- St John's Wort
St John's Wort will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.
- tucatinib
tucatinib will increase the level or effect of romidepsin 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.
- umeclidinium bromide/vilanterol inhaled
romidepsin increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- vandetanib
romidepsin, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. Avoid coadministration with drugs known to prolong QT interval; if a drug known to prolong QT interval must be used, more frequent ECG monitoring is recommended.
vandetanib and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. - vemurafenib
vemurafenib and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. Concomitant use of vemurafenib with drugs that prolong QT interval is not recommended. Romidepsin may also increase vemurafenib levels.
- vilanterol/fluticasone furoate inhaled
romidepsin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- voriconazole
voriconazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.
romidepsin and voriconazole both increase QTc interval. Avoid or Use Alternate Drug. Concurrent administration of romidepsin with voriconazole may cause an increase in systemic romidepsin concentrations and prolong QTc interval. - voxelotor
voxelotor will increase the level or effect of romidepsin 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 (133)
- albuterol
albuterol and romidepsin both increase QTc interval. Use Caution/Monitor.
- alfuzosin
romidepsin and alfuzosin both increase QTc interval. Use Caution/Monitor.
alfuzosin and romidepsin both increase QTc interval. Use Caution/Monitor. - amiodarone
amiodarone will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- amitriptyline
amitriptyline and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- amoxapine
amoxapine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- apomorphine
apomorphine and romidepsin both increase QTc interval. Use Caution/Monitor.
- aprepitant
aprepitant will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- arformoterol
arformoterol and romidepsin both increase QTc interval. Use Caution/Monitor.
- aripiprazole
aripiprazole and romidepsin both increase QTc interval. Use Caution/Monitor.
- artemether/lumefantrine
artemether/lumefantrine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- atomoxetine
atomoxetine and romidepsin both increase QTc interval. Use Caution/Monitor.
- azithromycin
azithromycin and romidepsin both increase QTc interval. Use Caution/Monitor.
azithromycin will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. - bedaquiline
romidepsin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- berotralstat
berotralstat will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.
- carbamazepine
carbamazepine will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- cenobamate
cenobamate will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
- chloramphenicol
chloramphenicol will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- chloroquine
chloroquine increases toxicity of romidepsin by QTc interval. Use Caution/Monitor.
- chlorpromazine
chlorpromazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- cholera vaccine
romidepsin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- citalopram
romidepsin and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.
- clarithromycin
clarithromycin will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
clarithromycin and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - clomipramine
clomipramine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- cobicistat
cobicistat will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- conivaptan
conivaptan will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- crizotinib
crizotinib increases levels of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.
crizotinib increases levels of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.
crizotinib and romidepsin both increase QTc interval. Use Caution/Monitor. - cyclosporine
cyclosporine will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
cyclosporine will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. - dasatinib
dasatinib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
dasatinib and romidepsin both increase QTc interval. Use Caution/Monitor. - deferasirox
deferasirox will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- degarelix
degarelix and romidepsin both increase QTc interval. Use Caution/Monitor.
- dengue vaccine
romidepsin 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.
- desipramine
desipramine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- dichlorphenamide
dichlorphenamide and romidepsin both decrease serum potassium. Use Caution/Monitor.
- doxepin
doxepin and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- dronedarone
dronedarone will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
dronedarone will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
dronedarone and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - efavirenz
efavirenz will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong 3A4 inducers should be avoided if possible.
- elagolix
elagolix decreases levels of romidepsin 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.
- encorafenib
encorafenib, romidepsin. 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.
- epinephrine racemic
epinephrine racemic and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- erythromycin base
erythromycin base will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
erythromycin base and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - erythromycin ethylsuccinate
erythromycin ethylsuccinate will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
erythromycin ethylsuccinate and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - erythromycin lactobionate
erythromycin lactobionate will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
erythromycin lactobionate and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - erythromycin stearate
erythromycin stearate will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
erythromycin stearate and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - escitalopram
escitalopram increases toxicity of romidepsin by QTc interval. Use Caution/Monitor.
- ethinylestradiol
romidepsin decreases effects of ethinylestradiol by receptor binding competition. Use Caution/Monitor.
- ezogabine
ezogabine, romidepsin. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed with ezogabine, particularly when dose titrated to 1200 mg/day. QT interval should be monitored when ezogabine is prescribed with agents known to increase QT interval.
- fedratinib
fedratinib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- fluconazole
fluconazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
fluconazole and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - fluoxetine
fluoxetine and romidepsin both increase QTc interval. Use Caution/Monitor.
- fluphenazine
fluphenazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- fluvoxamine
fluvoxamine and romidepsin both increase QTc interval. Use Caution/Monitor.
- foscarnet
foscarnet and romidepsin both increase QTc interval. Use Caution/Monitor.
- fostemsavir
romidepsin and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.
- gemtuzumab
romidepsin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- goserelin
goserelin increases toxicity of romidepsin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- grapefruit
grapefruit will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- griseofulvin
griseofulvin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- histrelin
histrelin increases toxicity of romidepsin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- imipramine
imipramine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- indacaterol, inhaled
indacaterol, inhaled, romidepsin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- indapamide
indapamide and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- isoniazid
isoniazid will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- istradefylline
istradefylline will increase the level or effect of romidepsin 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.
- itraconazole
itraconazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor for toxicity related to increased romidepsin exposure and follow the dose modifications for toxicity when romidepsin is initially coadministered with strong CYP3A4 inhibitor.
itraconazole and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - ketoconazole
ketoconazole will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
ketoconazole and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - lapatinib
lapatinib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
lapatinib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
lapatinib and romidepsin both increase QTc interval. Use Caution/Monitor. - lenvatinib
romidepsin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- leuprolide
leuprolide increases toxicity of romidepsin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- levofloxacin
levofloxacin and romidepsin both increase QTc interval. Use Caution/Monitor.
- lomitapide
lomitapide increases levels of romidepsin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.
- lonafarnib
lonafarnib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.
- lorlatinib
lorlatinib will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- maprotiline
maprotiline and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- mestranol
romidepsin decreases effects of mestranol by receptor binding competition. Use Caution/Monitor.
- miconazole vaginal
miconazole vaginal will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- mifepristone
mifepristone, romidepsin. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.
- mitotane
mitotane decreases levels of romidepsin 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.
- modafinil
modafinil will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- moxifloxacin
moxifloxacin and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- nefazodone
nefazodone will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- nicardipine
nicardipine will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- nilotinib
nilotinib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
nilotinib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
nilotinib and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - nortriptyline
nortriptyline and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- octreotide
octreotide and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- octreotide (Antidote)
octreotide (Antidote) and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- ofatumumab SC
ofatumumab SC, romidepsin. 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.
- ofloxacin
ofloxacin and romidepsin both increase QTc interval. Use Caution/Monitor.
- olodaterol inhaled
romidepsin and olodaterol inhaled both increase QTc interval. Use Caution/Monitor. Drugs that prolong the QTc interval and may potentiate the effects of beta2 agonists on the cardiovascular system; increased risk of ventricular arrhythmias
- osilodrostat
osilodrostat and romidepsin both increase QTc interval. Use Caution/Monitor.
- oxaliplatin
oxaliplatin will increase the level or effect of romidepsin by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.
- ozanimod
ozanimod and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.
- pasireotide
romidepsin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.
- pazopanib
pazopanib and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- perphenazine
perphenazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- posaconazole
posaconazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
posaconazole and romidepsin both increase QTc interval. Use Caution/Monitor. - protriptyline
protriptyline and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- quetiapine
quetiapine, romidepsin. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Avoid use with drugs that prolong QT and in patients with risk factors for prolonged QT interval. Postmarketing cases show QT prolongation with overdose in patients with concomitant illness or with drugs known to cause electrolyte imbalance or prolong QT.
- quinine
romidepsin and quinine both increase QTc interval. Use Caution/Monitor.
- ranolazine
ranolazine will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
ranolazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. - rifampin
rifampin will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- rilpivirine
rilpivirine increases toxicity of romidepsin by QTc interval. Use Caution/Monitor. Rilpivirine should be used with caution when co-administered with a drug with a known risk of Torsade de Pointes.
- risperidone
risperidone and romidepsin both increase QTc interval. Use Caution/Monitor.
- ritonavir
ritonavir will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- rucaparib
rucaparib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- selpercatinib
selpercatinib increases toxicity of romidepsin by QTc interval. Use Caution/Monitor.
- siponimod
siponimod and romidepsin 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.
- sorafenib
sorafenib and romidepsin both increase QTc interval. Use Caution/Monitor.
- sotalol
romidepsin and sotalol both increase QTc interval. Modify Therapy/Monitor Closely.
- St John's Wort
St John's Wort will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- stiripentol
stiripentol, romidepsin. 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.
- tacrolimus
tacrolimus will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- tazemetostat
tazemetostat will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- telavancin
romidepsin and telavancin both increase QTc interval. Modify Therapy/Monitor Closely.
- thioridazine
thioridazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- tipranavir
tipranavir will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
tipranavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - topiramate
topiramate will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- trastuzumab
trastuzumab, romidepsin. 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, romidepsin. 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 romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- triclabendazole
triclabendazole and romidepsin both increase QTc interval. Use Caution/Monitor.
- trifluoperazine
trifluoperazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- trimipramine
trimipramine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.
- triptorelin
triptorelin increases toxicity of romidepsin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- tucatinib
tucatinib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.
- vandetanib
vandetanib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- venlafaxine
romidepsin and venlafaxine both increase QTc interval. Use Caution/Monitor.
- verapamil
verapamil will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
verapamil will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. - vinblastine
vinblastine will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- voclosporin
voclosporin, romidepsin. Either increases effects of the other by QTc interval. Use Caution/Monitor.
- warfarin
romidepsin increases effects of warfarin by unknown mechanism. Use Caution/Monitor. Possible elevation of INR.
- zafirlukast
zafirlukast will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ziprasidone
romidepsin and ziprasidone both increase QTc interval. Modify Therapy/Monitor Closely. Avoid using ziprasidone with other QTc prolonging agents.
Minor (0)
Adverse Effects
>10%
Asthenia/fatigue (53-77%)
Anorexia (23-54%)
Constipation (12-40%)
Diarrhea (20-36%)
Nausea (56-86%)
Vomiting (34-52%)
Anemia (19-72%)
Hypomagnesemia (22-28%)
Neutropenia (11-66%)
Thrombocytopenia (17-72%)
Infections (46-54%)
<10%
Hypotension
EKG changes
Exfoliative dermatitis
Pruritus
Hypocalcemia
Hypokalemia
Leukopenia
Lymphopenia
Hypoalbuminemia
Hyperglycemia
Hyponatremia
Increased LFTs
Postmarketing Reports
Pyrexia, dysgeusia, headache cough, dyspnea, abdominal pain stomatitis
Warnings
Contraindications
Hypersensitivity
Cautions
QT prolongation; potassium and magnesium should be within normal limits before administration
Tumor lysis syndrome has been reported; patients with advanced stage disease and/or high tumor burden should be closely monitored and appropriate precautions taken
Monitor hematologic parameters; interrupt/discontinue treatment if thrombocytopenia, leukopenia, or anemia becomes severe
Serious and sometimes fatal infections reported with 30 days after treatment including pneumonia, sepsis, and viral reactivation (eg, Epstein Barr, hepatitis B viruses); risk may be greater in patients with a history of monoclonal antibodies treatment directed against lymphocyte antigens and in patients with disease involvement of the bone marrow
Avoid during pregnancy, no adequate trials exist; based on MOA, likely to cause fetal harm
Drug interaction overview
- Coadministration with other drugs that prolong QT interval (eg, sotalol, dofetilide, erythromycin) may increase risk for serious arrhythmias
- Binds to estrogen and may reduce effectiveness of oral contraceptives
- May increase effect of warfarin (prolonged PT, increased INR)
- Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase romidepsin serum levels
- Potent CYP3A4 inducers (eg, dexamethasone, carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital, St. John’s Wort) may decrease romidepsin serum levels
Pregnancy & Lactation
Pregnancy
Based on its mechanism of action and findings from animal studies, may cause embryo-fetal harm when administered to a pregnant woman
There are no available data on use in pregnant women to inform a drug associated risk of major birth defects and miscarriage
Advise women of the potential risk to fetus and to avoid becoming pregnant during treatment and for at least 1 month after last dose
Animal data
- In an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryofetal toxicity and malformations at exposures below those in patients at the recommended dose
Pregnancy testing
- Perform pregnancy testing in females of reproductive potential within 7 days before initiating
Contraception
- Females of reproductive potential: Use effective contraception during treatment and for at least 1 month after last dose
- May reduce the effectiveness of estrogen-containing contraceptives; use alternative methods of non-estrogen containing contraception (eg, condoms, intrauterine devices)
- Males with female partners of reproductive potential: Use effective contraception to avoid fathering a child during treatment and for at least 1 month after last dose
Infertility
- Based on findings in animals, romidepsin has the potential to affect male and female fertility
Lactation
- There are no data on presence of drug or its metabolites in human milk, effects on breastfed children, or effects on milk production
- Advise lactating women not to breastfeed during treatment and for at least 1 week after last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Histone deacetylase (HDAC) inhibitor; induces arrest in the cell cycle at G1 and G2/M phases, which in turn causes cell death
Absorption
Peak plasma concentration: 377 ng/mL
AUC: 1549 ng⋅hr/mL
Distribution
Protein bound: 92-94%
Found to be a BSEP and OATP1 inhibitor
Metabolism
Extensive metabolism by CYP3A4 with minor contribution from CYP3A5, CYP1A1, CYP2B6, and CYP2C19
Elimination
Half-life: ~3 hr
No accumulation of plasma concentration of romidepsin was observed after repeated dosing
Administration
IV Compatibility
0.9% NaCl
IV Preparation
Handle according to recommended safe handling procedures for cytotoxic drugs
Reconstitute single-dose vials with supplied diluent (10-mg vial with 2.2 mL ; 27.5-mg vial with 5.5 mL)
Swirl vial contents until there are no visible particles in the resulting solution; reconstituted solution will contain 5 mg/mL
Withdraw and inject desired amount from vials into 500 mL 0.9% NaCl
IV Administration
Administer & dispose according to recommended safe handling procedures for cytotoxic drugs
Infuse IV over 4 hr
Administer IV infusion via volumetric infusion pump
Diluted solution compatible w/ PVC, EVA, PE infusion bags, or glass bottles
Storage
Store according to recommended safe handling procedures for cytotoxic drugs
Unopened vials: Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF) in the carton; protect from light
Reconstituted vials: Stable for at least 8 hr at room temperature
Diluted solutions: Store at room temperature for up to 24 hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| romidepsin intravenous - | 10 mg/2 mL vial |  | |
| romidepsin intravenous - | 10 mg/2 mL vial |  | |
| romidepsin intravenous - | 5 mg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
romidepsin intravenous
ROMIDEPSIN - INJECTION
(ROE-mi-DEP-sin)
COMMON BRAND NAME(S): Istodax
USES: Romidepsin is used to treat certain types of cancer (cutaneous T-cell lymphoma). Romidepsin works by stopping the growth of cancer cells.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before your first romidepsin treatment and each time you get another dose. If you have any questions regarding the information, ask your doctor or pharmacist.This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually over 4 hours on days 1, 8, and 15 of a 28-day treatment cycle. This cycle is then repeated as directed by your doctor.The dosage is based on your medical condition, body size, and response to treatment.You should receive this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.
SIDE EFFECTS: Nausea, vomiting, tiredness, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. It may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills, cough), easy bruising/bleeding.Get medical help right away if you have any very serious side effects, including: chest pain, fast/irregular heartbeat, severe dizziness, fainting.Romidepsin sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.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 receiving this medication, tell your doctor or pharmacist if you are allergic to it; 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: liver disease (such as hepatitis B), heart disease (such as chest pain, heart attack), current/recent infection.Romidepsin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using romidepsin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using romidepsin safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Romidepsin can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using romidepsin. Romidepsin may harm an unborn baby. Your doctor may order a pregnancy test before starting treatment with this medication. Women and men using this medication should ask about reliable forms of birth control during treatment and for 1 month after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication. See also Drug Interactions section.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this medication and for 1 week after stopping this medication. 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: disulfiram, "blood thinners" (such as warfarin).Other medications can affect the removal of romidepsin from your body, thereby affecting how romidepsin works. These drugs include azole antifungals (such as itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (such as clarithromycin), HIV drugs (such as ritonavir), nefazodone, rifamycins (such as rifabutin, rifampin), St. John's wort, and some drugs used to treat seizures (such as carbamazepine), among others.This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication and for 1 month after stopping treatment. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
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.
NOTES: Lab and/or medical tests (such as complete blood count, potassium/magnesium blood levels, EKG, liver function) should be done while you are using this medication. Keep all medical and lab 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: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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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.
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