Select therapeutic use:

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

Pricing for ENHERTU

100mg vial (Qty: 1)
Appx. price $2443
GoodRx

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

Pricing for ENHERTU

100mg vial (Qty: 1)
Appx. price $2443
GoodRx

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

Pricing for ENHERTU

100mg vial (Qty: 1)
Appx. price $2443
GoodRx