Enhertu
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Black Box Warning
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Interstitial Lung Disease and Embryo-Fetal Toxicity
See full prescribing information for complete Boxed Warning.
Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with Enhertu. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue Enhertu in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and the need to immediately report symptoms. Exposure to Enhertu during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.
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Overview
Enhertu is an Anti-HER2 antibody that is FDA approved for the treatment of Unresectable or metastatic HER2-positive and HER2-low breast cancer. Also for treating Unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC) and Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Nausea, Fatigue, Vomiting, Alopecia, Constipation, Decreased appetite, Anemia, Neutropenia, Diarrhea, Leukopenia, Cough, and Thrombocytopenia..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
HER2-Positive Breast Cancer: 5.4 mg/kg intravenously every 3 weeks
HER2-Low Breast Cancer: 5.4 mg/kg intravenously every 3 weeks
HER2-Mutant NSCLC: 5.4 mg/kg intravenously every 3 weeks
HER2-Positive Gastric/GEJ Adenocarcinoma: 6.4 mg/kg intravenously every 3 weeks
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Enhertu in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Enhertu in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness have not been established in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Enhertu in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Enhertu in pediatric patients.
Contraindications
There is limited information regarding Enhertu Contraindications in the drug label.
Warnings
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Interstitial Lung Disease and Embryo-Fetal Toxicity
See full prescribing information for complete Boxed Warning.
Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with Enhertu. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue Enhertu in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and the need to immediately report symptoms. Exposure to Enhertu during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.
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Interstitial Lung Disease/Pneumonitis: Monitor for and promptly investigate signs and symptoms. Permanently discontinue in all patients with Grade 2 or higher ILD/pneumonitis.
Neutropenia: Monitor complete blood counts prior to initiation and prior to each dose. Manage with dose modifications or treatment interruption.
Left Ventricular Dysfunction: Assess left ventricular ejection fraction (LVEF) prior to initiation and at regular intervals. Discontinue in patients with symptomatic congestive heart failure.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Adverse Reactions
Clinical Trials Experience
Common Adverse Reactions (≥20%):
Nausea
Fatigue
Vomiting
Alopecia
Constipation
Decreased appetite
Anemia
Neutropenia
Diarrhea
Leukopenia
Cough
Thrombocytopenia
Postmarketing Experience
There is limited information regarding Enhertu Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Enhertu Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Enhertu in women who are pregnant.
Pregnancy Category (AUS): D
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Enhertu in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Enhertu during labor and delivery.
Nursing Mothers
Advise lactating women not to breastfeed during treatment and for 7 months after the last dose.
Pediatric Use
There is no FDA guidance on the use of Enhertu in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Enhertu in geriatric settings.
Gender
There is no FDA guidance on the use of Enhertu with respect to specific gender populations.
Race
There is no FDA guidance on the use of Enhertu with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Enhertu in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Enhertu in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Enhertu in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Enhertu in patients who are immunocompromised.
Administration and Monitoring
Administration
Administer Enhertu as an intravenous infusion over 90 minutes for the first infusion. If well tolerated, subsequent infusions may be administered over 30 minutes.
Do not administer as an intravenous push or bolus.
Dilute Enhertu in 100 mL of 5% Dextrose Injection, USP.
Monitoring
Monitor for signs and symptoms of interstitial lung disease (ILD) or pneumonitis.
Perform complete blood counts prior to each dose.
Assess left ventricular ejection fraction (LVEF) prior to initiation and at regular intervals during treatment.
IV Compatibility
There is limited information regarding the compatibility of Enhertu and IV administrations.
Overdosage
There is limited information regarding Enhertu overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Enhertu Pharmacology in the drug label.
Mechanism of Action
Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. The antibody component binds to HER2, and the topoisomerase inhibitor is released inside the cell, causing DNA damage and cell death.
Structure
There is limited information regarding Enhertu Structure in the drug label.
Pharmacodynamics
The pharmacodynamic effects of Enhertu include inhibition of tumor growth in HER2-expressing cancer cells.
Pharmacokinetics
Absorption: Not applicable (intravenous administration).
Distribution: The volume of distribution of trastuzumab deruxtecan is approximately 5.3 L.
Metabolism: The drug is expected to be metabolized into small peptides and amino acids via catabolic pathways.
Elimination: The terminal half-life is approximately 5.7 days.
Nonclinical Toxicology
There is limited information regarding Enhertu Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Enhertu Clinical Studies in the drug label.
How Supplied
Form: Lyophilized powder for injection
Strength: 100 mg per vial
Packaging: Single-dose vial
Storage
Unopened Vials:
Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Do not freeze.
Do not shake.
Reconstituted Solution:
If not used immediately, store in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours, protected from light.
Do not freeze.
Discard any unused portion after 24 hours.
Diluted Solution:
If not used immediately, store at room temperature (20°C to 25°C or 68°F to 77°F) for up to 4 hours, including preparation and infusion time, or in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours, protected from light.
Do not freeze.
Discard any unused portion left in the vial.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Interstitial Lung Disease (ILD)/Pneumonitis:
Advise patients to immediately report symptoms such as cough, shortness of breath, fever, or other new or worsening respiratory symptoms.
Neutropenia:
Inform patients about the risk of low white blood cell counts and the importance of reporting signs of infection, such as fever or chills.
Left Ventricular Dysfunction:
Advise patients to report symptoms indicative of heart problems, including shortness of breath, fatigue, swelling in the ankles or legs, and irregular heartbeat.
Embryo-Fetal Toxicity:
Warn female patients of reproductive potential about the potential risk to a fetus.
Advise the use of effective contraception during treatment and for 7 months after the last dose. Enhertu HCP
Male patients with female partners of reproductive potential should use effective contraception during treatment and for 4 months after the last dose.
Breastfeeding:
Advise women not to breastfeed during treatment and for 7 months after the last dose.
Precautions with Alcohol
Alcohol-Enhertu interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Enhertu
Manufactured by Daiichi Sankyo, Inc.
Look-Alike Drug Names
There is limited information regarding Enhertu Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.