ENHERTU

/ Astra Zeneca

Do not substitute trastuzumab deruxtecan for or with trastuzumab or ado-trastuzumab emtansine.
Premedication
Trastuzumab deruxtecan is highly emetogenic which includes delayed nausea and/or vomiting. Administer prophylactic antiemetic medications per local institutional guidelines for prevention of chemotherapy-induced nausea and vomiting.
Recommended Dosage for Metastatic Breast Cancer
The recommended dosage of this medical product is 5.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.
Recommended Dosage for Unresectable or Metastatic HER2-Mutant NSCLC
The recommended dosage of this medical product is 5.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.
Recommended Dosage for Locally Advanced or Metastatic Gastric Cancer
The recommended dosage of this medical product is 6.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.
See prescribing information for full details.

HER2-Positive Metastatic Breast Cancer
Trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive 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.
HER2-Low Metastatic Breast Cancer
Trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Unresectable or Metastatic HER2-Mutant Non-Small Cell Lung Cancer
Trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an approved test, and who have received a prior systemic therapy.
Locally Advanced or Metastatic Gastric Cancer
Trastuzumab deruxtecan is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
See prescribing information for full details

Hypersensitivity to the active substance or to any of the excipients.

Interstitial Lung Disease/Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with this medial product. A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment.
Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic (Grade 1) ILD, consider corticosteroid treatment (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). Withhold this medical product until recovery. In cases of symptomatic ILD (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (e.g., ≥1 mg/kg/day prednisolone or equivalent)) and continue for at least 14 days followed by gradual taper for at least 4 weeks. Permanently discontinue this medical product in patients who are diagnosed with symptomatic (Grade 2 or greater) ILD
Neutropenia
Severe neutropenia, including febrile neutropenia, can occur in patients treated with trastuzumab deruxtecan.
Monitor complete blood counts prior to initiation of this medical product and prior to each dose, and as clinically indicated. Based on the severity of neutropenia, Trastuzumab deruxtecan may require dose interruption or reduction.
Left Ventricular Dysfunction
Patients treated with Trastuzumab deruxtecan may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including Trastuzumab deruxtecan.
Assess LVEF prior to initiation of Trastuzumab deruxtecan and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. Permanently discontinue this medial product if LVEF of less than 40% or absolute decrease from baseline of greater than 20% is confirmed. Permanently discontinue this medical product in patients with symptomatic congestive heart failure (CHF).
Treatment with Trastuzumab deruxtecan has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.
Embryo-Fetal Toxicity
Based on its mechanism of action, the topoisomerase inhibitor component of Trastuzumab deruxtecan, can cause embryo-fetal harm when administered to a pregnant woman because it is genotoxic and targets actively dividing cells.
Verify the pregnancy status of females of reproductive potential prior to the initiation of Trastuzumab deruxtecan. Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose of Trastuzumab deruxtecan. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Trastuzumab deruxtecan and for 4 months after the last dose of Trastuzumab deruxtecan.
See prescribing information for full details

Due to the diverse conditions under which clinical trials are conducted, the rates of adverse reactions observed in the trials of one drug cannot be directly compared to those in the trials of another drug, and may not accurately represent the rates seen in real practice.
See prescribing information for full details

See prescribing information for full details.

Pregnancy: Based on its mechanism of action, Trastuzumab deruxtecan can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Trastuzumab deruxtecan in pregnant women.  
There are clinical considerations if Trastuzumab deruxtecan is used in pregnant women, or if a patient becomes pregnant within 7 months after the last dose of Trastuzumab deruxtecan.
Lactation: There is no data regarding the presence of Trastuzumab deruxtecan in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Trastuzumab deruxtecan and for 7 months after the last dose.
Females and Males of Reproductive Potential:
Females–
* Verify pregnancy status of females of reproductive potential prior to initiation of Trastuzumab deruxtecan.
* This medical product can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Trastuzumab deruxtecan and for 7 months after the last dose.
Males–
* There is a potential for genotoxicity; therefore, male patients with female partners of reproductive potential should use effective contraception during treatment with Trastuzumab deruxtecan and for 4 months following the last dose.
* Based on findings in animal toxicity studies, Trastuzumab deruxtecan may impair male reproductive function and fertility.

Please refer to the license holder for further details.