Lurbinectedin – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 23 min read
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Lurbinectedin - Uses, Dosage, Side Effects, Interaction
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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...

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বাংলা রোগী নোট এখনো যোগ করা হয়নি। পোস্ট এডিটরে “RX Bangla Patient Mode” বক্স থেকে সহজ বাংলা সারাংশ যোগ করুন।

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Article Summary

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...

Key Takeaways

  • This article explains Mechanism of Action in simple medical language.
  • This article explains  Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
Educational health guideWritten for patient understanding and clinical awareness.
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  • Any symptom that feels urgent, unusual, or unsafe for the patient.
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Definition

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 bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।" data-rx-term="neutrophil" data-rx-definition="Neutrophil is a white blood cell important for fighting bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।">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 bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।" data-rx-term="neutrophil" data-rx-definition="Neutrophil is a white blood cell important for fighting bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।">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 infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">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:

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 bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।" data-rx-term="neutrophil" data-rx-definition="Neutrophil is a white blood cell important for fighting bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।">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:
bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।" data-rx-term="neutrophil" data-rx-definition="Neutrophil is a white blood cell important for fighting bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।">neutrophil count, which may increase infection risk. সহজ বাংলা: নিউট্রোফিল কম থাকা, সংক্রমণের ঝুঁকি বাড়তে পারে।" data-rx-term="neutropenia" data-rx-definition="Neutropenia means low neutrophil count, which may increase infection risk. সহজ বাংলা: নিউট্রোফিল কম থাকা, সংক্রমণের ঝুঁকি বাড়তে পারে।">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 bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।" data-rx-term="neutrophil" data-rx-definition="Neutrophil is a white blood cell important for fighting bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।">neutrophil count, which may increase infection risk. সহজ বাংলা: নিউট্রোফিল কম থাকা, সংক্রমণের ঝুঁকি বাড়তে পারে।" data-rx-term="neutropenia" data-rx-definition="Neutropenia means low neutrophil count, which may increase infection risk. সহজ বাংলা: নিউট্রোফিল কম থাকা, সংক্রমণের ঝুঁকি বাড়তে পারে।">neutropenia: Withhold therapy until resolved to Grade 1 or less; resume therapy at a reduced dose.

platelet count, which can increase bleeding risk. সহজ বাংলা: প্লাটিলেট কম।" data-rx-term="thrombocytopenia" data-rx-definition="Thrombocytopenia means low platelet count, which can increase bleeding risk. সহজ বাংলা: প্লাটিলেট কম।">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

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.
Doctor visit helper

Prepare before seeing a doctor

A simple rural-patient checklist to help you explain symptoms clearly, ask better questions, and avoid unsafe self-treatment.

Safety note: This is not a prescription or diagnosis. For severe symptoms, pregnancy danger signs, children with serious illness, chest pain, breathing difficulty, stroke-like weakness, or major injury, seek urgent care.

Which doctor may help?

Start with a registered doctor or the nearest qualified health center.

What to tell the doctor

  • Write when the problem started and how it changed.
  • Bring old prescriptions, investigation reports, and current medicines.
  • Write allergies, pregnancy status, diabetes, kidney/liver disease, and major past illnesses.
  • Bring one family member if the patient is weak, elderly, confused, or a child.

Questions to ask

  • What is the most likely cause of my symptoms?
  • Which danger signs mean I should go to hospital quickly?
  • Which tests are necessary now, and which can wait?
  • How should I take medicines safely and what side effects should I watch for?
  • When should I come for follow-up?

Tests to discuss

  • Vital signs: temperature, pulse, blood pressure, oxygen saturation
  • Basic physical examination by a clinician
  • CBC, urine test, blood sugar, or imaging only when clinically needed

Avoid these mistakes

  • Do not use antibiotics, steroid tablets/injections, or strong painkillers without proper medical advice.
  • Do not hide pregnancy, kidney disease, ulcer, allergy, or blood thinner use.
  • Do not delay emergency care when danger signs are present.

Medicine safety and first-aid guide

This section is for patient education only. It does not replace a doctor, pharmacist, or emergency care.

Safe first steps

  • Avoid heavy lifting, sudden bending, and prolonged bed rest.
  • Use comfortable posture and gentle movement as tolerated.
  • Discuss physiotherapy, X-ray, or MRI only when clinically needed.

OTC medicine safety

  • For mild back pain, pain-relief medicine may be discussed with a doctor or pharmacist.
  • Avoid repeated painkiller use if you have kidney disease, stomach ulcer, uncontrolled blood pressure, or are taking blood thinners.

Avoid these mistakes

  • Do not start antibiotics without a proper medical decision.
  • Do not use steroid tablets or injections casually for quick relief.
  • Do not delay emergency care because of home remedies.

Get urgent help if

  • Back pain with leg weakness, numbness around private area, loss of urine/stool control, fever, cancer history, or major injury needs urgent care.
Medicine names, dose, and timing must be decided by a qualified clinician or pharmacist after checking age, pregnancy, allergy, other diseases, and current medicines.

For rural patients and family caregivers

Patient health record and symptom diary

Write your symptoms, medicines already taken, test results, and questions before visiting a doctor. This note stays on your device unless you print or copy it.

Doctor to discuss: Medicine doctor / pediatrician for children / qualified clinician
Tests to discuss with doctor
  • Temperature chart and hydration assessment
  • CBC with platelet count if fever persists or dengue/other infection is possible
  • Urine test, malaria/dengue tests, chest evaluation, or blood culture only when clinically indicated
Questions to ask
  • What is the most likely cause of my symptoms?
  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Do I need antibiotics, or is this more likely viral?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Lurbinectedin – Uses, Dosage, Side Effects, Interaction

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.

RX Patient Help

Ask a health question safely

Write your symptom story. A health professional or site editor can review it before any answer is prepared. This box is not for emergency care.

Emergency first: Severe chest pain, breathing trouble, unconsciousness, stroke signs, severe injury, heavy bleeding, or rapidly worsening symptoms need urgent local medical care now.

Frequently Asked Questions

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…

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