Breast cancer:
Indications for: ENHERTU
In adults 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 6 months of completing therapy. In adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Adult Dosage:
Give as IV infusion over 90mins; may give subsequent infusions over 30mins if prior infusions tolerated. 5.4mg/kg once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Prior to initiation, premedicate with prophylactic antiemetics. Dose modifications: see full labeling.
Children Dosage:
Not established.
Boxed Warning:
Interstitial lung disease. Embryo-fetal toxicity.
ENHERTU Warnings/Precautions:
Not substitutable for or with trastuzumab or ado-trastuzumab emtansine. Monitor for new or worsening respiratory symptoms; permanently discontinue if symptomatic (grade ≥2) interstitial lung disease (ILD)/pneumonitis develops. Monitor CBCs prior to initiation and each dose, then as clinically indicated; interrupt or reduce dose based on severity of neutropenia. Risk of left ventricular dysfunction. Assess LVEF prior to initiation and at regular intervals during treatment as clinically indicated; permanently discontinue if LVEF <40% or absolute decrease from baseline >20% is confirmed. Permanently discontinue in patients with symptomatic CHF or if severe infusion reactions occur. History of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment: not studied. Moderate renal (CrCl ≥30–<60mL/min) or moderate hepatic (total bilirubin >1.5–3×ULN and any AST) impairment: monitor closely. Severe renal (CrCL <30mL/min) or severe hepatic (total bilirubin >3×ULN and any AST) impairment: dosage has not been established. Embryo-fetal toxicity (oligohydramnios, others). Advise to use effective contraception during and for ≥7 months (females) or ≥4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 months after the last dose).
ENHERTU Classification:
HER2-directed antibody + topoisomerase inhibitor conjugate.
Adverse Reactions:
Nausea, decreased blood counts (WBC, hemoglobin, neutrophil, platelet, lymphocyte), increased AST/ALT, increased blood alkaline phosphatase, increased blood bilirubin, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, diarrhea, hypokalemia, cough, pyrexia, musculoskeletal pain, respiratory infection, headache, abdominal pain.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
Colorectal and other GI cancers:
Indications for: ENHERTU
In adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Adult Dosage:
Give as IV infusion over 90mins; may give subsequent infusions over 30mins if prior infusions tolerated. 6.4mg/kg once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Prior to initiation, premedicate with prophylactic antiemetics. Dose modifications: see full labeling.
Children Dosage:
Not established.
Boxed Warning:
Interstitial lung disease. Embryo-fetal toxicity.
ENHERTU Warnings/Precautions:
Not substitutable for or with trastuzumab or ado-trastuzumab emtansine. Monitor for new or worsening respiratory symptoms; permanently discontinue if symptomatic (grade ≥2) interstitial lung disease (ILD)/pneumonitis develops. Monitor CBCs prior to initiation and each dose, then as clinically indicated; interrupt or reduce dose based on severity of neutropenia. Risk of left ventricular dysfunction. Assess LVEF prior to initiation and at regular intervals during treatment as clinically indicated; permanently discontinue if LVEF <40% or absolute decrease from baseline >20% is confirmed. Permanently discontinue in patients with symptomatic CHF or if severe infusion reactions occur. History of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment: not studied. Moderate renal (CrCl ≥30–<60mL/min) or moderate hepatic (total bilirubin >1.5–3×ULN and any AST) impairment: monitor closely. Severe renal (CrCL <30mL/min) or severe hepatic (total bilirubin >3×ULN and any AST) impairment: dosage has not been established. Embryo-fetal toxicity (oligohydramnios, others). Advise to use effective contraception during and for ≥7 months (females) or ≥4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 months after the last dose).
ENHERTU Classification:
HER2-directed antibody + topoisomerase inhibitor conjugate.
Adverse Reactions:
Nausea, decreased blood counts (WBC, hemoglobin, neutrophil, platelet, lymphocyte), increased AST/ALT, increased blood alkaline phosphatase, increased blood bilirubin, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, diarrhea, hypokalemia, cough, pyrexia, musculoskeletal pain, respiratory infection, headache, abdominal pain.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
Respiratory and thoracic cancers:
Indications for: ENHERTU
In adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
Adult Dosage:
Give as IV infusion over 90mins; may give subsequent infusions over 30mins if prior infusions tolerated. 5.4mg/kg once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Prior to initiation, premedicate with prophylactic antiemetics. Dose modifications: see full labeling.
Children Dosage:
Not established.
Boxed Warning:
Interstitial lung disease. Embryo-fetal toxicity.
ENHERTU Warnings/Precautions:
Not substitutable for or with trastuzumab or ado-trastuzumab emtansine. Monitor for new or worsening respiratory symptoms; permanently discontinue if symptomatic (grade ≥2) interstitial lung disease (ILD)/pneumonitis develops. Monitor CBCs prior to initiation and each dose, then as clinically indicated; interrupt or reduce dose based on severity of neutropenia. Risk of left ventricular dysfunction. Assess LVEF prior to initiation and at regular intervals during treatment as clinically indicated; permanently discontinue if LVEF <40% or absolute decrease from baseline >20% is confirmed. Permanently discontinue in patients with symptomatic CHF or if severe infusion reactions occur. History of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment: not studied. Moderate renal (CrCl ≥30–<60mL/min) or moderate hepatic (total bilirubin >1.5–3×ULN and any AST) impairment: monitor closely. Severe renal (CrCL <30mL/min) or severe hepatic (total bilirubin >3×ULN and any AST) impairment: dosage has not been established. Embryo-fetal toxicity (oligohydramnios, others). Advise to use effective contraception during and for ≥7 months (females) or ≥4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 months after the last dose).
ENHERTU Classification:
HER2-directed antibody + topoisomerase inhibitor conjugate.
Adverse Reactions:
Nausea, decreased blood counts (WBC, hemoglobin, neutrophil, platelet, lymphocyte), increased AST/ALT, increased blood alkaline phosphatase, increased blood bilirubin, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, diarrhea, hypokalemia, cough, pyrexia, musculoskeletal pain, respiratory infection, headache, abdominal pain.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
