Understanding HER2+ mBC and ENHERTU brush

Understanding HER2+brush mBC and ENHERTU brush

Couple - wife in chair husband on floor - happily looking at each other Couple - wife in chair husband on floor - happily looking at each other

What is HER2+ unresectable or metastatic breast cancer?

Number one - part of graphic explaining HER2 positive metastatic breast cancer and ENHERTU Number one - part of graphic explaining HER2 positive metastatic breast cancer and ENHERTU
HER2 tells cells to grow
HER2 is a protein that tells cells to grow. In HER2+ breast cancer, the cancer cells have too much HER2, which leads to cancer growth.
Number two - part of graphic explaining HER2 positive metastatic breast cancer and ENHERTU Number two - part of graphic explaining HER2 positive metastatic breast cancer and ENHERTU
Tumors form
These cancer cells grow and divide faster than healthy cells, causing tumors to form.
Number three - part of graphic explaining HER2 positive metastatic breast cancer and ENHERTU Number three - part of graphic explaining HER2 positive metastatic breast cancer and ENHERTU
Cancer may spread
HER2+ breast cancer can spread to other parts of the body. This is known as HER2+ metastatic breast cancer (or HER2+ mBC). HER2+ unresectable breast cancer means it cannot be removed by surgery.

What is ENHERTU?

ENHERTU is a prescription drug for people with:

  • HER2+ breast cancer that has spread to other parts of your body or cannot be removed by surgery, and
  • Have already received at least 2 other prior treatments for HER2+ breast cancer

ENHERTU was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. ENHERTU is still being studied to confirm these results.

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

ENHERTU was studied in many types of people, including those with different:

  • Ages
  • Hormone receptor (HR) status
  • Tumors that had spread (metastasized) to other parts of the body, including the liver, lungs, and bone
  • Tumors that had spread to the brain and were stable

How is ENHERTU thought to work?

ENHERTU is made up
of an antibody with a
chemotherapy attached
ENHERTU medical graphic - showing how ENHERTU is supposed to work
The antibody part of
ENHERTU targets and attaches
to the HER2+ cancer cell
ENHERTU medical graphic - showing how ENHERTU is supposed to work
ENHERTU enters
the cancer cell and the
chemotherapy is released
ENHERTU medical graphic - showing how ENHERTU is supposed to work
The chemotherapy part
of ENHERTU helps
destroy the cancer cell

Although ENHERTU is designed to target HER2+ cancer cells, it may affect some healthy cells.

ENHERTU may not work for everyone.

How will I receive ENHERTU?

ENHERTU is taken alone, without the need for other medicines, to treat breast cancer

ENHERTU is given as an intravenous infusion (IV) once every 3 weeks

1st Infusion graphic - IV bag with 90 minutes written on it to show that a patient's 1st infusion with ENHERTU will last for 90 minutes
The first infusion will take about 90 minutes so the doctor can see if there are any side effects or problems
The first infusion will take about 90 minutes so the doctor can see if there are any side effects or problems
1st Infusion graphic - IV bag with 90 minutes written on it to show that a patient's 1st infusion with ENHERTU will last for 90 minutes
2nd Infusion graphic - IV bag with 30 minutes written on it to show that a patient's 2nd infusion with ENHERTU will last for 30 minutes
Future infusions should only take about 30 minutes, if your first infusion was well tolerated
Future infusions should only take about 30 minutes, if your first infusion was well tolerated
2nd Infusion graphic - IV bag with 30 minutes written on it to show that a patient's 2nd infusion with ENHERTU will last for 30 minutes

Your healthcare provider can adjust your dose if you experience side effects with ENHERTU.

To help manage your side effects, your healthcare provider may:

Lower your dose icon: white arrow pointing down against orange background Lower your dose icon: white arrow pointing down against orange background

Lower your dose

Delay your dose icon: white clock against green background Delay your dose icon: white clock against green background

Delay your dose

Stop ENHERTU Icon: white octagon (stop sign) against dark blue background Stop ENHERTU Icon: white octagon (stop sign) against dark blue background

Stop ENHERTU

Review study results icon

Ready to see the results?

See Study Results
Would you like us to send you information about ENHERTU when it becomes available?

HER2, human epidermal growth factor 2; mBC, metastatic breast cancer.

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:

  • Cough
  • Trouble breathing or shortness of breath
  • Fever
  • Other new or worsening breathing symptoms (e.g., chest tightness, wheezing)

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:

  • New or worsening shortness of breath
  • Coughing
  • Feeling tired
  • Swelling of your ankles or legs
  • Irregular heartbeat
  • Sudden weight gain
  • Dizziness or feeling light-headed
  • Loss of consciousness

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.

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
  • Diarrhea
  • Low levels of blood potassium
  • Vomiting
  • Constipation
  • Fever
  • Hair loss

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 Daiichi Sankyo at 1-877-437-7763 or to FDA at 1-800-FDA-1088.

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.

    ENHERTU was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. ENHERTU is still being studied to confirm these results.
  • 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.

Please click here for full Prescribing Information, including Boxed WARNINGS, and click here for Medication Guide.

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