Breast cancer:
Indications for ENHERTU:
Treatment in patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti-HER2-based regimens in the metastatic setting.
Adult:
Give by IV infusion over 90mins. 5.4mg/kg once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Subsequent infusions may be given over 30mins if previously tolerated. Dose modifications: see full labeling.
Children:
Not established.
Boxed Warning:
Interstitial lung disease. Embryo-fetal toxicity.
Warnings/Precautions:
Monitor for new or worsening respiratory symptoms; permanently discontinue if 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. Moderate hepatic impairment: monitor closely. Severe renal or hepatic impairment: no data. 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).
Pharmacologic Class:
HER2-directed antibody + topoisomerase inhibitor conjugate.
Adverse Reactions:
Nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, neutropenia, diarrhea, leukopenia, cough, thrombocytopenia.
Generic Availability:
NO
How Supplied:
Single-dose vial—1
