Enhertu 100 mg/5mL
fam-trastuzumab deruxtecan-nxki · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Daiichi Sankyo Inc.
Enhertu is a prescription injection used to treat certain types of breast cancer that have specific genetic markers. It works by combining an antibody with a chemotherapy agent to target and destroy cancer cells.
Key Facts
- Brand Name
- Enhertu
- Generic Name
- fam-trastuzumab deruxtecan-nxki
- NDC Code (Product)
65597-406- Manufacturer
- Daiichi Sankyo Inc.
- Strength
- 100 mg/5mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761139
- Marketing Start
- 12/20/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ENHERTU 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. ( 1.1 ) HER2-Positive Metastatic Breast Cancer in combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test. ( 1.2 ) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. ( 1.2 ) HER2-Low and HER2-Ultra…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Do not substitute ENHERTU for or with trastuzumab or ado-trastuzumab emtansine. ( 2.2 , 2.4 ) For intravenous infusion only . Do not administer as an intravenous push or bolus. DO NOT use Sodium Chloride Injection, USP. ( 2.4 ) Premedicate for prevention of chemotherapy-induced nausea and vomiting. ( 2.2 ) HER2-Positive Early Breast Cancer Neoadjuvant: ENHERTU 5.4 mg/kg every 3 weeks for 4 cycles, followed by THP regimen for 4 cycles. ( 2.2 , 2.3 ) Post Neoadjuvant: ENHERTU 5.4 mg/kg every 3 weeks for 14 cycles unless disease recurrence or unacceptable toxicity. ( 2.2 , 2.3 ) HER2-Positive, HER2-Low, or HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and HER2-Positive (IHC 3+) Solid Tumors: ENHERTU 5.4 mg/kg every 3 weeks until disease progression or unacceptable toxicity. ( 2.2 , 2.3 ) HER2-Positive First-line Metastatic Breast Cancer: ENHERTU 5.4 mg/kg every 3 weeks in combination with pertuzumab until disease progression or unacceptable toxicity. Cycle 1, Day 1: ENHERTU 5.4 mg/kg followed by pertuzumab 840 mg. ( 2.2 , 2.3 ) Subsequent cycles, Day 1: ENHERTU 5.4 mg/kg followed by pertuzumab 420 mg. ( 2.2 , 2.3 ) HER2-Positive Gastric Cancer: 6.4 mg/kg …
Contraindications
4 CONTRAINDICATIONS None . None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1) ] Neutropenia [see Warnings and Precautions (5.2) ] Left Ventricular Dysfunction [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥20%), including laboratory abnormalities, in patients with: HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and HER2-Positive (including IHC 3+) Solid Tumors are decreased white blood cell count, nausea, decreased hemoglobin, decreased neutrophil count, decreased lymphocyte count, fatigue, decreased platelet count, increased aspartate aminotransferase, increased alanine aminotransferase, increased blood alkaline phosphatase, vomiting, alopecia, constipation, decreased blood potassium, decreased appetite, diarrhea, and musculoskeletal pain. ( 6.1 ) HER2-Positive Early Breast Cancer are decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, decreased white blood cell count, nausea, peripheral neuropathy, diarrhea, decreased neutrophil count, alopecia, fatigue, decreased lympho…
Frequently Asked Questions
What is Enhertu used for?
Enhertu is a prescription injection used to treat certain types of breast cancer that have specific genetic markers. It works by combining an antibody with a chemotherapy agent to target and destroy cancer cells.
Is Enhertu a controlled substance?
Enhertu is not classified as a controlled substance by the DEA.
What is the generic name for Enhertu?
The generic name for Enhertu is fam-trastuzumab deruxtecan-nxki. There are no other listed brand versions of fam-trastuzumab deruxtecan-nxki.
What is the NDC code for Enhertu 100 mg/5mL?
The NDC (National Drug Code) for Enhertu 100 mg/5mL is 65597-406, listed by Daiichi Sankyo Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)