Lurbinectedin is an antineoplastic alkylating agent and synthetic derivative of trabectedin that is used to treat refractory, metastatic small-cell lung cancer. Lurbinectedin therapy is associated with a high rate of transient serum enzyme elevations during treatment and with occasional instances of clinically apparent liver injury with jaundice.
Lurbinectedin is a synthetic tetrahydropyrrolo [4, 3, 2-de]quinolin-8(1H)-one alkaloid analog with potential antineoplastic activity. Lurbinectedin covalently binds to residues lying in the minor groove of DNA, which may result in delayed progression through S phase, cell cycle arrest in the G2/M phase, and cell death.
Lurbinectedin is a DNA alkylating agent that has been investigated in the treatment of a variety of cancers, including mesothelioma, chronic lymphocytic leukemia (CLL), breast cancer, and small-cell lung cancer (SCLC). It is a derivative of the marine-derived agent ecteinascidin ([trabectedin]), an anticancer agent found in extracts of the tunicate Ecteinascidia turbinata, with the primary difference being the substitution of the tetrahydroisoquinoline with a tetrahydro β‐carboline that results in the increased antitumor activity of lurbinectedin as compared to its predecessor. On June 15, 2020, the FDA granted accelerated approval and orphan drug designation to lurbinectedin for the treatment of adult patients with metastatic SCLC who have experienced disease progression despite therapy with platinum-based agents. This accelerated approval is based on the rate and duration of therapeutic response observed in ongoing clinical trials and is contingent on the verification of these results in confirmatory trials.
Mechanism of Action
Lurbinectedin is a DNA alkylating agent. It covalently binds to guanine residues in the DNA minor groove, forming adducts that bend the DNA helix towards the major groove. This process triggers a cascade of events that affect the activity of transcription factors and impairs DNA repair pathways, ultimately leading to double-strand DNA breaks and eventual cell death. Additional mechanism(s) of action include inhibition of RNA-polymerase-II activity, inactivation of Ewing Sarcoma Oncoprotein (EWS-FL11) via nuclear redistribution, and the inhibition of human monocyte activity and macrophage infiltration into tumor tissue.
Lurbinectedin exerts its chemotherapeutic activity by covalently binding to DNA, resulting in double-strand DNA breaks and subsequent cell death. Lurbinectedin has been associated with myelosuppression, and patients receiving therapy with this agent should be closely monitored for evidence of cytopenias. Prior to beginning therapy, ensure baseline neutrophil counts are >1,500 cells/mm3 and platelet counts are >100,000/mm3. The supplementary use of granulocyte colony-stimulating factor (G-CSF) should be considered if the neutrophil count falls below 500 cells/mm3. Lurbinectedin has also been associated with hepatotoxicity. Monitor liver function tests at baseline and regular intervals throughout therapy, and consider holding, reducing, or permanently discontinuing therapy based on the severity of observed hepatotoxicity.
or
According to PharmaMar,[rx] lurbinectedin inhibits the active transcription of the encoding genes. This has two consequences. It promotes tumor cell death and normalizes the tumor microenvironment. Active transcription is the process by which there are specific signals where information contained in the DNA sequence is transferred to an RNA molecule. This activity depends on the activity of an enzyme called RNA polymerase II. Lurbinectedin inhibits transcription through a very precise mechanism. Firstly, lurbinectedin binds to specific DNA sequences. It is at these precise spots that slide down the DNA to produce RNA polymerase II that is blocked and degraded by lurbinectedin. Lurbinectedin also has an important role in the tumor microenvironment. The tumor cells act upon macrophages to avoid them from behaving like an activator of the immune system. Macrophages can contribute to tumor growth and progression by promoting tumor cell proliferation and invasion, fostering tumor angiogenesis, and suppressing antitumor immune cells.[rx][rx] Attracted to oxygen-starved (hypoxic) and necrotic tumor cells they promote chronic inflammation. So, not only that macrophages inhibit the immune system avoiding the destruction of tumor cells, but they also create tumor tissue that allows tumor growth. However, macrophages associated with tumors are cells that are addicted to the transcription process. Lurbinectedin acts specifically on the macrophages associated with tumors in two ways: firstly, by inhibiting the transcription of macrophages that leads to cell death, and secondly, by inhibiting the production of tumor growth factors. In this way, lurbinectedin normalizes the tumor microenvironment.
Indications
- Lurbinectedin is indicated for the treatment of adult patients with metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
- Lurbinectedin is a chemotherapeutic DNA alkylating agent used in the treatment of metastatic small-cell lung cancer.
- Treatment of small cell lung cancer
- Lurbinectedin is an antineoplastic alkylating agent and synthetic derivative of trabectedin that is used to treat refractory, metastatic small-cell lung cancer.
- Metastatic Lung Small Cell Carcinoma
Use in Cancer
Lurbinectedin is approved to treat:
- Small cell lung cancer that is metastatic. It is used in adults whose disease has gotten worse during or after treatment with platinum chemotherapy.
This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, a confirmatory trial(s) must show that lurbinectedin provides a clinical benefit in these patients.
Lurbinectedin is also being studied in the treatment of other types of cancer.
Contraindications
- an increased risk of bleeding
- decreased blood platelets
- low levels of a type of white blood cell called neutrophils
- liver problems
- abnormal liver function tests
- pregnancy
- a patient who is producing milk and breastfeeding
- increased creatine kinase levels
Dosage
Strengths: 4 mg
Small Cell Lung Cancer
- 3.2 mg/m2 IV over 60 minutes every 21 days until disease progression or unacceptable toxicity
- Initiate this drug only if the absolute neutrophil count (ANC) is at least 1500 cells/mm3 and the platelet count is at least 100,000/mm3.
- Consider administering pre-infusion medications for antiemetic prophylaxis: Corticosteroids (e.g., dexamethasone 8 mg IV or equivalent) and serotonin antagonists (e.g., ondansetron 8 mg IV or equivalent). For the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Dose Adjustments
DOSE REDUCTION:
- First dose reduction: 2.6 mg/m2 IV over 60 minutes every 21 days
- Second dose reduction: 2 mg/m2 IV over 60 minutes every 21 days
DOSE MODIFICATION FOR ADVERSE REACTIONS:
NEUTROPENIA (patients with isolated Grade 4 neutropenia [neutrophil count less than 500 cells/mm3] may receive G-CSF prophylaxis rather than undergo dose reduction):
- Grade 4 or any Grade febrile neutropenia: Withhold therapy until resolved to Grade 1 or less; resume therapy at a reduced dose.
THROMBOCYTOPENIA:
- Grade 3 with bleeding or Grade 4: Withhold therapy until platelet count is 100,000/mm3 or greater; resume therapy at a reduced dose.
HEPATOTOXICITY:
- Grade 2: Withhold therapy until Grade 1 or less; resume therapy at same dose.
- Grade 3 or greater: Withhold therapy until Grade 1 or greater; resume at reduced dose.
Administration advice:
- Advise patients to avoid grapefruit products during therapy with this drug.
- Read the approved patient labeling (Patient Information) before you receive this drug the first time and each subsequent dose.
- Do not become pregnant or breastfeed a child while taking this drug.
- Inform your healthcare providers of all concomitant medications, herbal. and dietary supplements.
Side Effects
The Most Common
- fatigue
- nausea
- vomiting
- constipation
- diarrhea
- loss of appetite
- muscle pain
- headache
- tingling, numbness, and pain in the hands and feet
- chest pain
- shortness of breath
- light-colored bowel movements, yellowing of the skin or eyes, loss of appetite, unusual bleeding or bruising, dark yellow or brown urine, or pain in the upper right part of the stomach
- fever, cough, chills, or other signs of infection
- tiredness or pale skin
More common
- Black, tarry stools
- bleeding gums
- bloody urine
- bone, joint, or muscle pain
- chest pain or tightness
- chills
- dark urine
- difficult or labored breathing
- fever
- the general feeling of discomfort or illness
- hoarseness
- loss of appetite
- lower back or side pain
- nausea
- painful or difficult urination
- pale skin
- pale stools
- pinpoint red spots on the skin
- sneezing
- sore throat
- stomach pain or tenderness
- thickening of bronchial secretions
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
Rare
- Swelling of the feet or lower legs
- Muscle cramps, spasms, or stiffness
- pain, discomfort, itching, redness, or swelling at the injection site
- Burning, numbness, tingling, or painful sensations
- change in or loss of taste
- constipation
- diarrhea
- headache
- unsteadiness or awkwardness
Drug Interactions
DRUG | INTERACTION |
---|---|
Abametapir | The serum concentration of Lurbinectedin can be increased when it is combined with Abametapir. |
Amiodarone | The serum concentration of Lurbinectedin can be increased when it is combined with Amiodarone. |
Amprenavir | The serum concentration of Lurbinectedin can be increased when it is combined with Amprenavir. |
Apalutamide | The serum concentration of Lurbinectedin can be decreased when it is combined with Apalutamide. |
Aprepitant | The serum concentration of Lurbinectedin can be increased when it is combined with Aprepitant. |
Articaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Articaine. |
Atazanavir | The serum concentration of Lurbinectedin can be increased when it is combined with Atazanavir. |
Avanafil | The serum concentration of Avanafil can be increased when it is combined with Lurbinectedin. |
Benzocaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Benzocaine. |
Benzyl alcohol | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Benzyl alcohol. |
Berotralstat | The serum concentration of Lurbinectedin can be increased when it is combined with Berotralstat. |
Bexarotene | The serum concentration of Lurbinectedin can be decreased when it is combined with Bexarotene. |
Boceprevir | The serum concentration of Lurbinectedin can be increased when it is combined with Boceprevir. |
Bosentan | The serum concentration of Lurbinectedin can be decreased when it is combined with Bosentan. |
Bupivacaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Bupivacaine. |
Butacaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Butacaine. |
Butamben | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Butamben. |
Capsaicin | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Capsaicin. |
Carbamazepine | The serum concentration of Lurbinectedin can be decreased when it is combined with Carbamazepine. |
Cenobamate | The serum concentration of Lurbinectedin can be decreased when it is combined with Cenobamate. |
Chloroprocaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Chloroprocaine. |
Cinchocaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Cinchocaine. |
Ciprofloxacin | The serum concentration of Lurbinectedin can be increased when it is combined with Ciprofloxacin. |
Clarithromycin | The serum concentration of Lurbinectedin can be increased when it is combined with Clarithromycin. |
Clozapine | The serum concentration of Lurbinectedin can be increased when it is combined with Clozapine. |
Cobicistat | The serum concentration of Lurbinectedin can be increased when it is combined with Cobicistat. |
Cocaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Cocaine. |
Conivaptan | The serum concentration of Lurbinectedin can be increased when it is combined with Conivaptan. |
Crizotinib | The serum concentration of Lurbinectedin can be increased when it is combined with Crizotinib. |
Curcumin | The serum concentration of Lurbinectedin can be increased when it is combined with Curcumin. |
Cyclosporine | The serum concentration of Lurbinectedin can be increased when it is combined with Cyclosporine. |
Dabrafenib | The serum concentration of Lurbinectedin can be decreased when it is combined with Dabrafenib. |
Danazol | The serum concentration of Lurbinectedin can be increased when it is combined with Danazol. |
Darbepoetin alfa | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Lurbinectedin. |
Darunavir | The serum concentration of Lurbinectedin can be increased when it is combined with Darunavir. |
Delavirdine | The serum concentration of Lurbinectedin can be increased when it is combined with Delavirdine. |
Desvenlafaxine | The serum concentration of Lurbinectedin can be increased when it is combined with Desvenlafaxine. |
Dexamethasone | The serum concentration of Lurbinectedin can be decreased when it is combined with Dexamethasone. |
Dexamethasone | The serum concentration of Lurbinectedin can be decreased when it is combined with Dexamethasone acetate. |
Diltiazem | The serum concentration of Lurbinectedin can be increased when it is combined with Diltiazem. |
Diphenhydramine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Diphenhydramine. |
Dronedarone | The serum concentration of Lurbinectedin can be increased when it is combined with Dronedarone. |
Dyclonine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Dyclonine. |
Echinacea | The serum concentration of Lurbinectedin can be decreased when it is combined with Echinacea. |
Econazole | The serum concentration of Lurbinectedin can be increased when it is combined with Econazole. |
Efavirenz | The serum concentration of Lurbinectedin can be decreased when it is combined with Efavirenz. |
Elvitegravir | The serum concentration of Lurbinectedin can be increased when it is combined with Elvitegravir. |
Enzalutamide | The serum concentration of Lurbinectedin can be decreased when it is combined with Enzalutamide. |
Ergotamine | The serum concentration of Lurbinectedin can be increased when it is combined with Ergotamine. |
Erythromycin | The serum concentration of Lurbinectedin can be increased when it is combined with Erythromycin. |
Erythropoietin | The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Lurbinectedin. |
Ethyl chloride | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Ethyl chloride. |
Etidocaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Etidocaine. |
Etravirine | The serum concentration of Lurbinectedin can be decreased when it is combined with Etravirine. |
Fluconazole | The serum concentration of Lurbinectedin can be increased when it is combined with Fluconazole. |
Fluvoxamine | The serum concentration of Lurbinectedin can be increased when it is combined with Fluvoxamine. |
Fosnetupitant | The serum concentration of Lurbinectedin can be increased when it is combined with Fosnetupitant. |
Fosphenytoin | The serum concentration of Lurbinectedin can be decreased when it is combined with Fosphenytoin. |
Fusidic acid | The serum concentration of Lurbinectedin can be increased when it is combined with Fusidic acid. |
Haloperidol | The serum concentration of Lurbinectedin can be increased when it is combined with Haloperidol. |
Indinavir | The serum concentration of Lurbinectedin can be increased when it is combined with Indinavir. |
Isavuconazole | The serum concentration of Lurbinectedin can be increased when it is combined with Isavuconazole. |
Isavuconazonium | The serum concentration of Lurbinectedin can be increased when it is combined with Isavuconazonium. |
Isoniazid | The serum concentration of Lurbinectedin can be increased when it is combined with Isoniazid. |
Isradipine | The serum concentration of Lurbinectedin can be increased when it is combined with Isradipine. |
Itraconazole | The serum concentration of Lurbinectedin can be increased when it is combined with Itraconazole. |
Ivosidenib | The metabolism of Lurbinectedin can be increased when combined with Ivosidenib. |
Ketoconazole | The serum concentration of Lurbinectedin can be increased when it is combined with Ketoconazole. |
Levobupivacaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Levobupivacaine. |
Levoketoconazole | The serum concentration of Lurbinectedin can be increased when it is combined with Levoketoconazole. |
Lidocaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Lidocaine. |
Linagliptin | The serum concentration of Lurbinectedin can be increased when it is combined with Linagliptin. |
Lonafarnib | The serum concentration of Lurbinectedin can be increased when it is combined with Lonafarnib. |
Lopinavir | The serum concentration of Lurbinectedin can be increased when it is combined with Lopinavir. |
Lovastatin | The serum concentration of Lurbinectedin can be increased when it is combined with Lovastatin. |
Luliconazole | The serum concentration of Lurbinectedin can be increased when it is combined with Luliconazole. |
Lumacaftor | The serum concentration of Lurbinectedin can be decreased when it is combined with Lumacaftor. |
Mavacamten | The serum concentration of Lurbinectedin can be decreased when it is combined with Mavacamten. |
Meloxicam | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Meloxicam. |
Mepivacaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Mepivacaine. |
Methimazole | The serum concentration of Lurbinectedin can be increased when it is combined with Methimazole. |
Methoxy poly | The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Lurbinectedin. |
metreleptin | The metabolism of Lurbinectedin can be increased when combined with metreleptin. |
Miconazole | The serum concentration of Lurbinectedin can be increased when it is combined with Miconazole. |
Midostaurin | The serum concentration of Lurbinectedin can be decreased when it is combined with Midostaurin. |
Milnacipran | The serum concentration of Lurbinectedin can be increased when it is combined with Milnacipran. |
Mitotane | The serum concentration of Lurbinectedin can be decreased when it is combined with Mitotane. |
Modafinil | The serum concentration of Lurbinectedin can be decreased when it is combined with Modafinil. |
Nafcillin | The serum concentration of Lurbinectedin can be decreased when it is combined with Nafcillin. |
Nefazodone | The serum concentration of Lurbinectedin can be increased when it is combined with Nefazodone. |
Nelfinavir | The serum concentration of Lurbinectedin can be increased when it is combined with Nelfinavir. |
Netupitant | The serum concentration of Lurbinectedin can be increased when it is combined with Netupitant. |
Nicardipine | The serum concentration of Lurbinectedin can be increased when it is combined with Nicardipine. |
Nilotinib | The serum concentration of Lurbinectedin can be increased when it is combined with Nilotinib. |
Nilvadipine | The serum concentration of Lurbinectedin can be increased when it is combined with Nilvadipine. |
Oxetacaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Oxetacaine. |
Oxybuprocaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Oxybuprocaine. |
Peginesatide | The risk or severity of Thrombosis can be increased when Peginesatide is combined with Lurbinectedin. |
Pentobarbital | The serum concentration of Lurbinectedin can be decreased when it is combined with Pentobarbital. |
Phenobarbital | The serum concentration of Lurbinectedin can be decreased when it is combined with Phenobarbital. |
Phenol | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Phenol. |
Phenytoin | The serum concentration of Lurbinectedin can be decreased when it is combined with Phenytoin. |
Pitolisant | The serum concentration of Lurbinectedin can be decreased when it is combined with Pitolisant. |
Posaconazole | The serum concentration of Lurbinectedin can be increased when it is combined with Posaconazole. |
Pramocaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Pramocaine. |
Prilocaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Prilocaine. |
Primaquine | The serum concentration of Lurbinectedin can be increased when it is combined with Primaquine. |
Primidone | The serum concentration of Lurbinectedin can be decreased when it is combined with Primidone. |
Procaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Procaine. |
Proparacaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Proparacaine. |
Propoxycaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Propoxycaine. |
Ribociclib | The serum concentration of Lurbinectedin can be increased when it is combined with Ribociclib. |
Rifampicin | The serum concentration of Lurbinectedin can be decreased when it is combined with Rifampicin. |
Rifamycin | The serum concentration of Lurbinectedin can be decreased when it is combined with Rifamycin. |
Rifapentine | The serum concentration of Lurbinectedin can be decreased when it is combined with Rifapentine. |
Rimexolone | The serum concentration of Lurbinectedin can be decreased when it is combined with Rimexolone. |
Ritonavir | The serum concentration of Lurbinectedin can be increased when it is combined with Ritonavir. |
Ropivacaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Ropivacaine. |
Saquinavir | The serum concentration of Lurbinectedin can be increased when it is combined with Saquinavir. |
Satralizumab | The serum concentration of Lurbinectedin can be decreased when it is combined with Satralizumab. |
Simeprevir | The serum concentration of Lurbinectedin can be increased when it is combined with Simeprevir. |
Somatrogon | The metabolism of Lurbinectedin can be increased when combined with Somatrogon. |
Sotorasib | The serum concentration of Lurbinectedin can be decreased when it is combined with Sotorasib. |
St. John’s Wort | The serum concentration of Lurbinectedin can be decreased when it is combined with St. John’s Wort. |
Stiripentol | The serum concentration of Lurbinectedin can be increased when it is combined with Stiripentol. |
Telaprevir | The serum concentration of Lurbinectedin can be increased when it is combined with Telaprevir. |
Telithromycin | The serum concentration of Lurbinectedin can be increased when it is combined with Telithromycin. |
Telotristat ethyl | The serum concentration of Lurbinectedin can be decreased when it is combined with Telotristat ethyl. |
Terfenadine | The serum concentration of Lurbinectedin can be increased when it is combined with Terfenadine. |
Tetracaine | The risk or severity of methemoglobinemia can be increased when Lurbinectedin is combined with Tetracaine. |
Tioconazole | The serum concentration of Lurbinectedin can be increased when it is combined with Tioconazole. |
Tipranavir | The serum concentration of Lurbinectedin can be increased when it is combined with Tipranavir. |
Troleandomycin | The serum concentration of Lurbinectedin can be increased when it is combined with Troleandomycin. |
Tucatinib | The metabolism of Tucatinib can be decreased when combined with Lurbinectedin. |
Venetoclax | The serum concentration of Lurbinectedin can be increased when it is combined with Venetoclax. |
Verapamil | The serum concentration of Lurbinectedin can be increased when it is combined with Verapamil. |
Viloxazine | The metabolism of Lurbinectedin can be decreased when combined with Viloxazine. |
Voriconazole | The serum concentration of Lurbinectedin can be increased when it is combined with Voriconazole. |
Zimelidine | The serum concentration of Lurbinectedin can be increased when it is combined with Zimelidine. |
Ziprasidone | The serum concentration of Lurbinectedin can be increased when it is combined with Ziprasidone. |
Pregnancy and Lactation
Pregnancy
Based on animal data and its mechanism of action, ZEPZELCA can cause fetal harm when administered to a pregnant woman. There are no
available data to inform the risk of ZEPZELCA use in pregnant women. Intravenous administration of a single lurbinectedin dose (approximately 0.2 times the 3.2 mg/m2 clinical dose) to pregnant rats during the period of organogenesis caused embryo lethality. Advise pregnant women of the potential risk to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth
defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Lactation
There are no data on the presence of lurbinectedin in human milk or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions from ZEPZELCA in breastfed children, advise women not to breastfeed during treatment with
ZEPZELCA and for 2 weeks after the final dose.
Why is this medication prescribed?
Lurbinectedin injection is used to treat small cell lung cancer (SCLC) that has spread to other parts of the body and did not improve during or after treatment with platinum chemotherapy. Lurbinectedin injection is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.
How should this medicine be used?
Lurbinectedin injection comes as powder to be mixed with liquid to be injected intravenously (into a vein) over 60 minutes by a doctor or nurse in a hospital or medical facility. It is usually given once every 21 days. Your doctor will decide how often you are to receive lurbinectedin based on your body’s response to this medication.
Your doctor may need to temporarily or permanently stop your treatment or decrease your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with lurbinectedin injection. Your doctor will give you medication to prevent nausea and vomiting before you receive each dose of lurbinectedin.
Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before receiving lurbinectedin injection,
- tell your doctor and pharmacist if you are allergic to lurbinectedin, any other medications, or any of the ingredients in lurbinectedin injection. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, or nutritional supplements you are taking or plan to take. Be sure to mention any of the following: antifungal medications such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); clarithromycin (Biaxin, Prevpac); diltiazem (Cardizem, Dilacor, Tiazac, others); erythromycin (E-mycin, Ery-Tab, others); certain HIV medications such as efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); nefazodone; pioglitazone (Actos, in Oseni); rifabutin (Mycobutin); prednisone; rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol, others), phenobarbital, and phenytoin (Dilantin, Phenytek); and verapamil (Calan, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may interact with lurbinectedin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
- tell your doctor what herbal products you are taking, especially St. John’s wort.
- tell your doctor if you have or have ever had liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving lurbinectedin injection. Your doctor may perform a pregnancy test to be sure that you are not pregnant before you receive lurbinectedin injection. If you are female, you should use birth control during your treatment and for 6 months after your final dose. If you are male, you and your female partner should use birth control during your treatment and for 4 months after your final dose. If you or your partner become pregnant while receiving lurbinectedin injection, call your doctor. Lurbinectedin injection may harm the fetus.
- tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving lurbinectedin injection and for at least 2 weeks after your final dose.