Lurbinectedin Injection
Lurbinectedin injection (Zepzelca) is a chemotherapy used to treat small cell lung cancer, either as a maintenance therapy in extensive-stage disease or after prior platinum-based chemotherapy in metastatic disease.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Lurbinectedin Injection: Patient Information Guide
A plain-language walkthrough of Lurbinectedin Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Lurbinectedin injection (Zepzelca) is a chemotherapy approved for adults with small cell lung cancer (SCLC) in two distinct settings:
- Zepzelca is approved in combination with atezolizumab — or atezolizumab and hyaluronidase-tqjs — as maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) in adults whose disease did not progress after completing first-line induction therapy with atezolizumab (or atezolizumab and hyaluronidase-tqjs), carboplatin, and etoposide.
- Zepzelca is approved as a single-agent treatment for metastatic small cell lung cancer in adults whose disease has worsened during or after prior platinum-based chemotherapy. This use was granted accelerated approval based on tumor response rate and duration of response; continued approval depends on confirmatory trial results.
⚙️How it works▾
Lurbinectedin is an alkylating drug — a type of chemotherapy that directly attacks the DNA inside cancer cells. It binds to specific spots on the DNA strand called guanine residues, causing the DNA to bend and form abnormal structures called adducts. These structural changes disrupt proteins that normally read and repair DNA, including transcription factors that send growth signals. The result is a stalled cell cycle and eventual cancer cell death. Lurbinectedin has also been shown to reduce the activity of monocytes (a type of immune cell) and decrease the infiltration of macrophages — immune cells that can sometimes help tumors thrive — into tumor tissue.
💊How it's taken▾
Zepzelca is given as a slow intravenous (IV) infusion by a healthcare professional in a clinical setting. Each infusion takes approximately 60 minutes and is repeated once every 21 days (about once every 3 weeks) until the disease progresses or side effects become unacceptable. Dosing may be reduced or paused based on blood counts, liver function, or other side effects — your oncology team will check labs before each cycle. When used with atezolizumab or atezolizumab and hyaluronidase-tqjs, patients with moderate liver impairment receive a lower dose; patients with severe liver impairment should generally avoid Zepzelca.
- A central venous line is recommended for infusion to reduce the risk of leakage (extravasation)
- Anti-nausea medications are given before each infusion
- When combined with atezolizumab, a white blood cell booster (G-CSF) is given to help prevent severe infection
🤒Side effects — in detail▾
The most common side effects seen with Zepzelca include:
- Fatigue or weakness
- Nausea, vomiting, and constipation
- Decreased appetite
- Diarrhea
- Muscle and bone pain
- Shortness of breath (dyspnea)
- Cough
- Low blood counts: low white blood cells (leukopenia, neutropenia), low red blood cells (anemia), and low platelets (thrombocytopenia)
- Elevated liver enzymes and creatinine on blood tests
Serious reactions to report immediately include high fever or signs of infection, unusual bleeding or bruising, yellowing of the skin or eyes, severe muscle pain with dark urine, or pain and swelling at the infusion site — these need prompt medical attention.
⚠️Warnings & precautions▾
- Severe blood count suppression (myelosuppression): Zepzelca can cause dangerously low white blood cells, platelets, and red blood cells. This has led to fatal infections and sepsis. Blood counts are checked before every dose, and treatment is paused or the dose is reduced if counts fall too low. When used with atezolizumab, G-CSF (a white blood cell booster) is given routinely.
- Liver toxicity (hepatotoxicity): Zepzelca can cause serious liver damage. Liver function tests are monitored before and throughout treatment. Dose adjustments or treatment stops may be needed.
- Extravasation causing tissue necrosis: If lurbinectedin leaks out of the vein during infusion, it can destroy surrounding skin and tissue. A central venous catheter is strongly recommended. If leakage occurs, the infusion must be stopped immediately and the area monitored closely.
- Rhabdomyolysis (muscle breakdown): This rare but serious condition involves the breakdown of muscle tissue and can harm the kidneys. A muscle enzyme (CPK) is checked before and during treatment.
- Embryo-fetal toxicity: Lurbinectedin can cause the loss of a pregnancy. Females of reproductive potential must use effective contraception during treatment and for 7 months after the last dose; males must use contraception for 4 months after the last dose.
🔀What it interacts with▾
Lurbinectedin is processed by a liver enzyme called CYP3A, so drugs and foods that affect this enzyme can significantly change how much lurbinectedin is in your body:
- Strong CYP3A inhibitors (e.g., itraconazole, certain antifungals): Can more than double lurbinectedin blood levels, increasing side effect risk — avoid if possible; if unavoidable, the dose must be reduced
- Moderate CYP3A inhibitors (e.g., verapamil, erythromycin): Also significantly raise lurbinectedin exposure — avoid or require dose reduction
- Grapefruit and Seville oranges: Contain natural CYP3A inhibitors; avoid these foods entirely during treatment
- Strong CYP3A inducers: Can lower lurbinectedin levels in the blood, potentially making the drug less effective — avoid coadministration
- Fluvoxamine (a weak CYP3A inhibitor): May modestly increase lurbinectedin exposure
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Liver impairment: Patients with moderate liver impairment require a lower dose; patients with severe liver impairment should generally not receive Zepzelca — tell your doctor about any liver problems
- Pregnancy: Zepzelca can cause complete loss of a pregnancy even at low doses; do not take it if you are pregnant unless there is no alternative, and use effective contraception during and after treatment
- Breastfeeding: Do not breastfeed during treatment or for 2 weeks after the last dose due to the risk of serious harm to the infant
- Females of reproductive potential: Use effective contraception during treatment and for 7 months after the last dose; a pregnancy test is required before starting
- Males with female partners who could become pregnant: Use effective contraception during treatment and for 4 months after the last dose
- Children: Safety and effectiveness in pediatric patients have not been established
- Older adults (age 65+): May experience more serious side effects, particularly severe blood count problems — closer monitoring is warranted
- Severe kidney impairment: The effect of severe kidney disease on lurbinectedin levels has not been studied; discuss with your prescriber
- All medications and supplements: Tell your care team about everything you take — especially antifungals, certain antibiotics, heart medications, and any herbal products that may affect liver enzymes
📡Pharmacodynamics — effects in the body▾
At higher lurbinectedin exposures, the rates of severe neutropenia (very low white blood cell counts, Grade 4) and severe low platelets (Grade 3 or higher thrombocytopenia) increase — meaning side effects on blood cells are tied to how much drug is in the body. At the recommended dose, lurbinectedin does not cause a clinically meaningful change in heart rhythm (no large QTc prolongation was detected).
🔬Pharmacokinetics — how your body processes it▾
After each intravenous infusion, lurbinectedin binds very tightly to blood proteins (about 99%), meaning very little circulates in its free form. The drug distributes widely throughout the body and has a terminal half-life of about 51 hours — meaning it takes roughly two days for blood levels to drop by half. Lurbinectedin is broken down mainly by a liver enzyme called CYP3A, and most of the drug is eliminated through the stool (about 89%), with a small amount in urine. The drug does not accumulate in the body with the every-3-week dosing schedule, and age, sex, body weight, and mild-to-moderate kidney impairment do not significantly affect how the body handles it.
📦How to store it▾
Store refrigerated at 2°C to 8°C (36°F to 46°F).
📄 Written from Lurbinectedin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Lurbinectedin Injection
156 supplements and herbal products have documented interactions with Lurbinectedin Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 5
- Moderate · 122
- Minor · 29
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Lurbinectedin Injection has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Lurbinectedin Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Zepzelca being used to treat in my situation? ▾
How will I get this medication, and how often? ▾
What side effects should I expect, and which ones should make me call my doctor right away? ▾
Are there any foods or other medications I should avoid while on Zepzelca? ▾
Is it safe to get pregnant or father a child while on this treatment? ▾
I'm older — should I be more concerned about side effects? ▾
Is Lurbinectedin Injection available over the counter? ▾
When was Lurbinectedin Injection first available? ▾
Who makes Lurbinectedin Injection? ▾
💬 Answers drafted from Lurbinectedin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Lurbinectedin Injection comes
Lurbinectedin Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Zepzelca is used in combination with atezolizumab (or atezolizumab and hyaluronidase-tqjs) as maintenance treatment for extensive-stage small cell lung cancer in adults whose disease did not progress after first-line induction therapy
- Zepzelca is used as a single agent to treat metastatic small cell lung cancer in adults whose cancer progressed on or after platinum-based chemotherapy (accelerated approval)
- Zepzelca is administered as a 60-minute intravenous infusion once every 21 days
- Zepzelca infusion via a central venous line is recommended to reduce the risk of extravasation (leakage causing tissue damage)
- When given on the same day as atezolizumab or atezolizumab and hyaluronidase-tqjs, administer that drug first, then Zepzelca
- Anti-nausea medications (a corticosteroid and a serotonin antagonist) should be given before the Zepzelca infusion to reduce nausea risk
📊 Lurbinectedin Injection across the U.S. market
How Lurbinectedin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Lurbinectedin Injection is used
A general measure of how commonly Lurbinectedin Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Lurbinectedin Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Lurbinectedin Injection prescribed? Of the 1,597 medications we measure, Lurbinectedin Injection ranks #1,260 by Medicaid prescriptions — more than 21% of them.
Utilization by Lurbinectedin Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
lurbinectedin 4 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2374733
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lurbinectedin Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Lurbinectedin Injection NDCs with Medicaid activity.
🔍 Compare Lurbinectedin Injection products
A representative set of FDA-listed product records for Lurbinectedin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 1 kg/kg | — | Apicore Pharmaceuticals Private Limited | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 0.5 mg/mL | — | Bamboo US Bidco LCC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 4 mg/8 mL | — | Gp Pharm Sa | DRUG FOR FURTHER PROCESSING | View NDC → |
| 0.5 mg/mL | Intravenous | Jazz Pharmaceuticals, Inc. × 3 listings | NDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Lurbinectedin Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Lurbinectedin Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Lurbinectedin Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Lurbinectedin Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2374729 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 2374732In current FDA listingsClinical drug / strength (SCD) 4 MGRxCUI 2374733
Look up RxCUI 2374729 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Lurbinectedin Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Lurbinectedin Injection belongs to the Alkylating Drug class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Jazz Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.