Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 4mg/single-dose vial
Small Cell Lung Cancer
Indicated for metastatic small cell lung cancer (SCLC) in patients with disease progression on or after platinum-based chemotherapy
3.2 mg/m2 IV q21Days
Initiate treatment only if absolute neutrophil count (ANC) ≥1,500 cells/mm3 and platelet count ≥100,000/mm3
Continue until disease progression or unacceptable toxicity
Dosage Modifications
Dose reduction
- First dose reduction: 2.6 mg/m2 IV q21Days
- Second dose reduction: 2 mg/m2 IV q21Days
- Unable to tolerate 2 mg/m2 or dose delay >2 weeks: Permanently discontinue
Neutropenia
- Grade 4 or any grade febrile neutropenia: Withhold until Grade ≤1, resume at reduced dose
- Patients with isolated Grade 4 neutropenia (neutrophil count <500 cells/mm3) may receive granulocyte colony-stimulating factor prophylaxis rather than undergo lurbinectedin dose reduction
Thrombocytopenia
- Grade 3 with bleeding or Grade 4: Withhold until platelets ≥100,000/mm3; resume at reduced dose
Hepatotoxicity
- Grade 2: Withhold until Grade ≤1, resume at same dose
- Grade ≥3: Withhold until Grade ≤1, resume at reduced dose
Rhabdomyolysis
- Grade 2: Withhold until Grade ≤1, resume at same dose
- Grade ≥3: Permanently discontinue
Other adverse reactions
- Grade 2: Withhold until Grade ≤1, resume at same dose
- Grade ≥3: Withhold until Grade ≤1, resume at reduced dose OR permanently discontinue
Strong CYP3A4 inhibitors
- Avoid coadministration
- If coadministration unavoidable, reduce lurbinectedin dose by 50%
- After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration
Renal impairment
- Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
- Severe (CrCl <30 mL/min): Not studied
Hepatic impairment
- Mild (total bilirubin ≤ULN and AST >ULN, or total bilirubin 1-1.5x ULN and any AST): No dosage adjustment necessary
- Moderate or severe (total bilirubin >1.5x ULN and any AST): Not studied
Dosing Considerations
Verify pregnancy status for females of reproductive potential before initiating
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (108)
- amiodarone
amiodarone will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- amobarbital
amobarbital will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- apalutamide
apalutamide will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- aprepitant
aprepitant will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- armodafinil
armodafinil will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- atazanavir
atazanavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- axicabtagene ciloleucel
lurbinectedin, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- bexarotene
bexarotene will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- bicalutamide
bicalutamide will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- bosentan
bosentan will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
lurbinectedin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brigatinib
brigatinib will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- butabarbital
butabarbital will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- butalbital
butalbital will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- carbamazepine
carbamazepine will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ceritinib
ceritinib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- chloramphenicol
chloramphenicol will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- ciltacabtagene autoleucel
lurbinectedin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- clarithromycin
clarithromycin will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- clobazam
clobazam will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- clotrimazole
clotrimazole will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- cobicistat
cobicistat will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- conivaptan
conivaptan will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- crizotinib
crizotinib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- cyclosporine
cyclosporine will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- dabrafenib
dabrafenib will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- darunavir
darunavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- diltiazem
diltiazem will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- doxycycline
doxycycline will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- dronedarone
dronedarone will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- efavirenz
efavirenz will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- elagolix
elagolix will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- encorafenib
encorafenib, lurbinectedin. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Lurbinectedin is a CYP3A4 substrate. Coadministration with encorafenib (a CYP3A4 inhibitor and inducer) may increase or decrease plasma levels. Monitor for lurbinectedin toxicities or possible decreases in efficacy.
- entacapone
entacapone will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- enzalutamide
enzalutamide will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin base
erythromycin base will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin lactobionate
erythromycin lactobionate will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin stearate
erythromycin stearate will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- etrasimod
etrasimod, lurbinectedin. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod.
- etravirine
etravirine will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fedratinib
fedratinib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fexinidazole
fexinidazole will increase the level or effect of lurbinectedin 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.
- fluconazole
fluconazole will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fluvoxamine
fluvoxamine will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fosamprenavir
fosamprenavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fosaprepitant
fosaprepitant will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fosphenytoin
fosphenytoin will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fostamatinib
fostamatinib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- grapefruit
grapefruit will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- haloperidol
haloperidol will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
lurbinectedin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idelalisib
idelalisib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- iloperidone
iloperidone will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- imatinib
imatinib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- indinavir
indinavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- isoniazid
isoniazid will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- itraconazole
itraconazole will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- ivacaftor
ivacaftor will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ivosidenib
ivosidenib will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ketoconazole
ketoconazole will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- lapatinib
lapatinib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- larotrectinib
larotrectinib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lefamulin
lefamulin will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- letermovir
letermovir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- levoketoconazole
levoketoconazole will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- lisocabtagene maraleucel
lurbinectedin, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lonafarnib
lonafarnib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- lopinavir
lopinavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- lorlatinib
lorlatinib will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lumacaftor/ivacaftor
lumacaftor/ivacaftor will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- metronidazole
metronidazole will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- mifepristone
lurbinectedin will increase the level or effect of mifepristone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
mifepristone will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration. - mitotane
mitotane will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- nafcillin
nafcillin will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- nefazodone
nefazodone will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- nelfinavir
nelfinavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- netupitant/palonosetron
netupitant/palonosetron will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- pentobarbital
pentobarbital will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- phenobarbital
phenobarbital will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- phenytoin
phenytoin will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- posaconazole
posaconazole will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- primidone
primidone will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- quinupristin/dalfopristin
quinupristin/dalfopristin will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ribociclib
ribociclib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- rifabutin
rifabutin will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- rifampin
rifampin will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- rifapentine
rifapentine will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ritonavir
ritonavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- rucaparib
rucaparib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- ruxolitinib topical
lurbinectedin will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- saquinavir
saquinavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- schisandra
schisandra will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- secobarbital
secobarbital will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- sertraline
sertraline will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- St John's Wort
St John's Wort will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- stiripentol
stiripentol will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- telotristat ethyl
telotristat ethyl will decrease the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- tetracycline
tetracycline will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- tipranavir
tipranavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- tisagenlecleucel
lurbinectedin, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tucatinib
tucatinib will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- verapamil
verapamil will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- voriconazole
voriconazole will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce lurbinectedin dose by 50%. After strong CYP3A inhibitor discontinued for 5 half-lives, increase lurbinectedin to dose used before coadministration.
- voxelotor
voxelotor will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
Monitor Closely (2)
- isavuconazonium sulfate
lurbinectedin and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lenacapavir
lenacapavir will increase the level or effect of lurbinectedin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir 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.
Minor (0)
Adverse Effects
>10%
All grades
- Decreased leukocytes (79%)
- Decreased lymphocytes (79%)
- Fatigue (77%)
- Decreased hemoglobin (74%)
- Decreased neutrophils (71%)
- Increased creatinine (69%)
- Increased ALT (66%)
- Increased glucose (52%)
- Decreased platelets (37%)
- Nausea (37%)
- Musculoskeletal pain (33%)
- Decreased appetite (33%)
- Decreased albumin (32%)
- Dyspnea (31%)
- Constipation (31%)
- Decreased sodium (31%)
- Increased AST (26%)
- Decreased magnesium (22%)
- Vomiting (22%)
- Cough (20%)
- Diarrhea (20%)
- Respiratory tract infection (18%)
- Pyrexia (13%)
- Abdominal pain (11%)
- Peripheral neuropathy (11%)
Grade 3-4
- Decreased neutrophils (46%)
- Decreased lymphocytes (43%)
- Decreased leukocytes (29%)
- Fatigue (12%)
1-10%
All grades
- Chest pain (10%)
- Pneumonia (10%)
- Headache (10%)
Grade 3-4
- Decreased hemoglobin (10%)
- Decreased platelets (7%)
- Pneumonia (7%)
- Decreased sodium (7%)
- Dyspnea (6%)
- Respiratory tract infection (5%)
- Increased glucose (5%)
- Musculoskeletal pain (4%)
- Increased ALT (4%)
- Diarrhea (4%)
- Increased AST (2%)
- Abdominal pain (1%)
- Decreased appetite (1%)
- Headache (1%)
- Peripheral neuropathy (1%)
- Decreased albumin (1%)
Postmarketing Reports
Rhabdomyolysis
Tumor lysis syndrome
Warnings
Contraindications
None
Cautions
May cause myelosuppression; monitor blood cell counts, including neutrophil count and platelet count, before each administration
Hepatotoxicity reported; monitor liver function tests before initiating therapy, periodically during treatment, and as clinically indicated
Based on animal data and mechanism of action, fetal harm may occur when administered to pregnant females
Rhabdomyolysis reported; monitor creatine phosphokinase (CPK) before initiating and periodically during treatment as clinically indicated; withhold or reduce dose based on severity
Extravasation
- Extravasation resulting in skin and soft tissue injury, including necrosis requiring debridement, can occur
- Consider using a central venous catheter to reduce extravasation risk, particularly in patients with limited venous access; monitor for signs and symptoms of extravasation during infusion
- If extravasation occurs, immediately discontinue infusion, remove infusion catheter, and monitor for signs and symptoms of tissue necrosis; the time to onset of necrosis after extravasation may vary
- Administer supportive care and consult with appropriate medical specialist as needed for signs and symptoms of extravasation; administer subsequent infusions at site that was not affected by extravasation
Drug interaction overview
- Substrate of CYP3A4
-
Strong or moderate CYP3A4 inhibitors
- Avoid coadministration
- Strong or moderate CYP3A inhibitor increases systemic exposure and risk of adverse reactions to lurbinectedin
-
Strong or moderate CYP3A4 inducers
- Avoid coadministration
- Strong or moderate CYP3A4 inducer decreases systemic exposure to and efficacy of lurbinectedin
Pregnancy & Lactation
Pregnancy
Based on animal data and mechanism of action, fetal harm may occur when administered to pregnant females
No data are available regarding risk in pregnant females
Advise pregnant females of potential risk to a fetus
Verify pregnancy status of females of reproductive potential before initiating treatment
Contraception
- Females of reproductive potential: Use effective contraception during treatment and for 6 months after final dose
- Males with a female sexual partner of reproductive potential: Use effective contraception during treatment and for 4 months after final dose
Animal data
- IV administration of a single lurbinectedin dose (~0.2x the 3.2 mg/m2 clinical dose) to pregnant rats during organogenesis caused embryolethality
Lactation
There are no data on presence of in human milk, effects on breastfed children, or on milk production
Advise lactating females not to breastfeed during treatment and for 2 weeks after final dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
An alkylating drug; it binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove
Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA-binding proteins, including some transcription factors, and DNA repair pathways
Absorption
Peak plasma concentration: 107 mcg/mL
AUC: 551 mcg⋅hr/L
Distribution
Vd (steady-state): 504 L
Protein bound: ~99%
Metabolism
Primarily metabolized by CYP3A4
Elimination
Half-life: 51 hr
Clearance: 11 L/hr
Excretion: Feces (89%; <0.2% unchanged), urine (6%; 1% unchanged)
Administration
IV Incompatibilities
Do not coadminister with other IV drugs concurrently within same IV line
Do not use inline nylon membrane filters when diluent is 0.9% NaCl; drug adsorption to these filters observed when 0.9% NaCl is the diluent
IV Compatibilities
0.9% NaCl
D5W
Compatibility with other IV administration materials and diluted solution
- Polyolefin containers (polyethylene, polypropylene, and mixtures)
- Polyvinyl chloride (non-DEHP-containing), polyurethane and polyolefin infusion sets (polyethylene, polypropylene, and polybutadiene)
- Implantable venous access systems with titanium and plastic resin ports and with polyurethane or silicone intravenous catheters
Premedication
Consider antiemetic prophylaxis before infusing
Corticosteroids (dexamethasone 8 mg IV or equivalent)
Serotonin antagonists (ondansetron 8 mg IV or equivalent)
IV Preparation
Reconstitute each vial with 8 mL of sterile water for injection, resulting in a 0.5 mg/mL diluted solution
Visually inspect solution for particulate matter and discoloration; solution is clear, colorless, or slightly yellowish, and free of visible particles
Calculate the required drug volume and withdraw volume for reconstituted vials; infusion bag volume is dependent infusion line
Central line: Add drug volume to at least 100-mL infusion bag of 0.9% NaCl or D5W
Peripheral line: Add drug volume to 250-mL infusion bag of 0.9% NaCl or D5W
IV Administration
Visually inspect for particulate matter and discoloration; discard if particulate matter appears
Infuse over 60 min with or without an inline filter
If using inline filters, use 0.22-micron polyethersulfone inline filters
Storage
Hazardous drug; follow applicable special handling and disposal procedures
Unused vials
- Refrigerate at 2-8ºC (36-46ºF)
Reconstituted vials or diluted solutions
- Use immediately
- If not used immediately after reconstitution or dilution, refrigerate at 2-8ºC (36-46ºF) or store at room temperature for up to 24 hr following reconstitution, including infusion time
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
