lurbinectedin (Rx)

Brand and Other Names:Zepzelca
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Dosing & Uses

AdultPediatric

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

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

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Interactions

Interaction Checker

and lurbinectedin

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (105)

              • abametapir

                abametapir will increase the level or effect of lurbinectedin 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 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.

              • 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.

              • 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.

              • 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.

              • clozapine

                clozapine 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.

              • conivaptan

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

              • 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.

              • desipramine

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

              • 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.

              • 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.

              • 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.

              • 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.

              • 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.

              • 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.

              • 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.

              • 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.

              • lisocabtagene maraleucel

                lurbinectedin, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • lopinavir

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

              • 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.

              • 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.

              • nelfinavir

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

              • netupitant/palonosetron

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

              • 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.

              • 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.

              • 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.

              • 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, lurbinectedin. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Lurbinectedin is a CYP3A4 substrate. Coadministration with stiripentol (a CYP3A4 inhibitor and inducer) may increase or decrease plasma levels. Monitor for lurbinectedin toxicities or possible decreases in efficacy.

              • 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.

              • 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.

              • voxelotor

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

              Monitor Closely (1)

              • isavuconazonium sulfate

                lurbinectedin and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              Minor (0)

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                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

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                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
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                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.

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                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)

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                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
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                Images

                No images available for this drug.
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                Additional Offers
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.