Prescription medicine
Trastuzumab deruxtecan Brand names: Enhertu
Trastuzumab deruxtecan (Enhertu) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the trastuzumab deruxtecan FDA label on DailyMed (effective May 15, 2026); every trastuzumab deruxtecan label on DailyMed.
Highlights of the record
FDA label of May 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
INTERSTITIAL LUNG.
DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including severe, life-threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and the need to immediately report symptoms [see Dosage and Administration (2.3), Warnings and Precautions (5.1) ]. Embryo-Fetal Toxicity: Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.4), Use in Specific Populations (8.1 , 8.3) ]. WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Interstitial lung disease (ILD) and pneumonitis, including severe, life threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms. […]
Used for
From the label: indications and usageENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP).
Forms and strengths
- 100 mg/5ml
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 10,021 through July 30, 2026
What is trastuzumab deruxtecan used for?
From the label: indications and usageENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP). ( 1.1 ) as adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment. […]
Conditions named in the indications of trastuzumab deruxtecan's FDA labels, with every medicine labeled for each:
From other trastuzumab deruxtecan labelsLung cancer: … adjuvant chemotherapy. ( 1.3 ) HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have …
Source: FDA drug label (Enhertu), Daiichi Sankyo Inc., effective May 15, 2026 (SPL set 7e67e73e-ddf4-4e4d-8b50-09d7514910b6), via openFDA; the full label on DailyMed
What does the patient leaflet for trastuzumab deruxtecan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ENHERTU?ENHERTU can cause serious side effects, including: Lung problems that may be severe, life-threatening or that may lead to death. If you develop lung problems your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you get any of the following signs and symptoms: cough trouble breathing or shortness of breath fever other new or worsening breathing symptoms (such as chest tightness, wheezing) Low white blood cell count (neutropenia). Low white blood cell counts are common with ENHERTU and can sometimes be severe. Your healthcare provider will check your white blood cell counts before starting ENHERTU and before starting each dose. Tell your healthcare provider right away if you develop any signs or symptoms of an infection or have fever or chills during treatment with ENHERTU. Heart problems that may affect your heart's ability to pump blood. Your healthcare provider will check your heart function before starting treatment with ENHERTU and during treatment if needed. Tell your healthcare provider right away if you get any of the following signs and symptoms: new or worsening shortness of breath coughing feeling tired swelling of your ankles or legs irregular heartbeat sudden weight gain dizziness or feeling light-headed loss of consciousness Your healthcare provider will check you for these side effects during your treatment with ENHERTU. Your healthcare provider may reduce your dose, delay treatment or completely stop treatment with ENHERTU if you have severe side effects. Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with ENHERTU. […]
Source: FDA drug label (Enhertu), Daiichi Sankyo Inc., effective May 15, 2026 (SPL set 7e67e73e-ddf4-4e4d-8b50-09d7514910b6), via openFDA; the full label on DailyMed
Is there a generic for trastuzumab deruxtecan (Enhertu)?
No generic trastuzumab deruxtecan is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the trastuzumab deruxtecan label say about other medicines?
The trastuzumab deruxtecan label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Pertuzumab | warnings and precautions | ENHERTU in Combination with Pertuzumab In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), decreased neutrophil count occurred in 79% of patients. |
| Prednisolone | warnings and precautions | For asymptomatic (Grade 1) ILD, consider corticosteroid treatment (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). |
Source: FDA drug label (Enhertu), Daiichi Sankyo Inc., effective May 15, 2026 (SPL set 7e67e73e-ddf4-4e4d-8b50-09d7514910b6), via openFDA; the full label on DailyMed
What do FAERS reports show for trastuzumab deruxtecan?
The FDA Adverse Event Reporting System holds 10,021 reports that list trastuzumab deruxtecan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,575 are coded as a death and 2,439 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,248, against a median of 380 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as trastuzumab deruxtecan?
14 other medicines are given the same way (intravenous) and in the same FDA class as trastuzumab deruxtecan or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Docetaxel | Breast cancer, Lung cancer | 14 labelers | n/a | A presentation being discontinued |
| Paclitaxel | Breast cancer, Lung cancer | 20 labelers | n/a | No current entry |
| Gemcitabine | Breast cancer, Lung cancer | 10 labelers | n/a | No current entry |
| Eribulin | Breast cancer | 14 labelers | n/a | No current entry |
| Trastuzumab | Breast cancer | none listed | n/a | No current entry |
| Margetuximab | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab emtansine | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab-strf | Breast cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as trastuzumab deruxtecan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to trastuzumab deruxtecan
- 14 medicines for the same use
- Trastuzumab deruxtecan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other