Enhertu fam-trastuzumab deruxtecan-nxki

Get an overview of ENHERTU (fam-trastuzumab deruxtecan-nxki injection, powder, lyophilized, for solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Enhertu can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Enhertu.

Drug Basics

Brand Name: Enhertu

Generic Name: FAM-TRASTUZUMAB DERUXTECAN-NXKI

Drug Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS

Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Packager: Daiichi Sankyo Inc.

Data Current As Of: 2021-03-25

Indications and Usage (1.2) 01/2021
Dosage and Administration (2.1, 2.2, 2.3) 01/2021
Warnings and Precautions (5.1, 5.2, 5.3) 01/2021

Indications & Usage

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:

  • adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. (1.1)
    •  This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (1.1, 14.1)
  • adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. (1.2)

metastatic breast cancer

ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

locally advanced or metastatic gastric cancer

ENHERTU 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.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Interstitial Lung Disease

  • Inform patients of the risks of severe or fatal ILD. Advise patients to contact their healthcare provider immediately for any of the following: cough, shortness of breath, fever, or other new or worsening respiratory symptoms [see Warnings and Precautions (5.1)].

Neutropenia

  • Advise patients of the possibility of developing neutropenia and to immediately contact their healthcare provider should they develop a fever, particularly in association with any signs of infection [see Warnings and Precautions (5.2)].

Left Ventricular Dysfunction

Embryo-Fetal Toxicity

Lactation

Infertility

Manufactured by:
Daiichi Sankyo, Inc., Basking Ridge, NJ 07920

U.S. License No. 2128

Marketed by:
Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 and AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

ENHERTU® is a registered trademark of Daiichi Sankyo Company, Ltd.
© 2021 Daiichi Sankyo Co., Ltd.

USPI-ENH-C4-0121-r002

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 01/2021
Medication Guide
ENHERTU® (en-HER-too)
(fam-trastuzumab deruxtecan-nxki) for injection
What is the most important information I should know about ENHERTU?
ENHERTU can cause serious side effects, including:
Lung problems that may be severe, life-threatening or that may lead to death.
If you develop lung problems your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you get any of the following signs and symptoms:

Low white blood cell count (neutropenia). Low white blood cell counts are common with ENHERTU and can sometimes be severe. Your healthcare provider will check your white blood cell counts before starting ENHERTU and before starting each dose. Tell your healthcare provider right away if you develop any signs or symptoms of an infection or have fever or chills during treatment with ENHERTU.
Heart problems that may affect your heart's ability to pump blood. Your healthcare provider will check your heart function before starting treatment with ENHERTU. Tell your healthcare provider right away if you get any of the following signs and symptoms:

Your healthcare provider will check you for these side effects during your treatment with ENHERTU. Your healthcare provider may reduce your dose, delay treatment or completely stop treatment with ENHERTU if you have severe side effects.
Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with ENHERTU.
  • If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with ENHERTU.
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment with ENHERTU and for at least 7 months after the last dose.
  • Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with ENHERTU and for at least 4 months after the last dose.

See "What are the possible side effects of ENHERTU?" for more information about side effects.

What is ENHERTU?
ENHERTU is a prescription medicine used in adults to treat human epidermal growth factor receptor 2 (HER2)-positive
  • breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received two or more prior anti-HER2 breast cancer treatments.
  • stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma that has spread to areas near your stomach (locally advanced) or that has spread to other parts of your body (metastatic), and who have received a prior trastuzumab-based regimen.

It is not known if ENHERTU is safe and effective in children.

Before you receive ENHERTU, tell your healthcare provider about all of your medical conditions, including if you:
  • have lung or breathing problems.
  • have signs or symptoms of an infection.
  • have or have had any heart problems.
  • are breastfeeding or plan to breastfeed. It is not known if ENHERTU passes into your breast milk. Do not breastfeed during treatment with ENHERTU and for 7 months after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive ENHERTU?
  • You will receive ENHERTU into your vein through an intravenous (IV) line by your healthcare provider.
  • ENHERTU is given 1 time every three weeks (21-day treatment cycle).
  • Your healthcare provider will decide how many treatments you need.
  • Your healthcare provider may slow down or temporarily stop your infusion of ENHERTU if you have an infusion-related reaction, or permanently stop ENHERTU if you have severe infusion reactions.
  • If you miss a planned dose of ENHERTU, call your healthcare provider right away to schedule an appointment. Do not wait until the next planned treatment cycle.
What are the possible side effects of ENHERTU?
ENHERTU can cause serious side effects. See "What is the most important information I should know about ENHERTU?"
The most common side effects of ENHERTU, when used in people with breast cancer, include:
  • nausea
  • low white blood cell counts
  • low red blood cell counts
  • feeling tired
  • vomiting
  • hair loss
  • increased liver function tests
  • low platelet counts
  • constipation
  • decreased appetite
  • diarrhea
  • low levels of blood potassium
  • cough
The most common side effects of ENHERTU, when used in people with stomach cancer, include:
  • low red blood cell counts
  • low white blood cell counts
  • low platelet counts
  • nausea
  • decreased appetite
  • increased liver function tests
  • feeling tired
ENHERTU may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.
These are not all of the possible side effects of ENHERTU. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ENHERTU.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about ENHERTU that is written for healthcare professionals.
What are the ingredients in ENHERTU?
Active Ingredient: fam-trastuzumab deruxtecan-nxki.
Inactive Ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and sucrose.
Manufactured by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920
U.S. License No. 2128
Marketed by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 and AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
ENHERTU® is a registered trademark of Daiichi Sankyo Company, Ltd.
© 2021 Daiichi Sankyo Co., Ltd.
USMG-ENH-C4-0121-r002
For more information, call 1-877-437-7763 or go to https://www.ENHERTU.com
This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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