Understanding HER2+ mBC & ENHERTU® (fam-trastuzumab deruxtecan-nxki)

What is HER2-positive metastatic breast cancer?

1

HER2 tells cells to grow

HER2 is a protein that tells cells to grow. When cells produce too much HER2, they can become cancerous.

2

Tumors form

These cancer cells grow and divide faster than healthy cells, causing tumors to form.

3

Cancer may spread

HER2-positive breast cancer can spread to other parts of the body. This is known as HER2-positive metastatic breast cancer (or HER2-positive mBC).

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What is ENHERTU?

ENHERTU is a prescription medicine used to treat adults who have:

Human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of the body (metastatic), and who have received a prior anti-HER2 breast cancer treatment:

for metastatic disease, or
have breast cancer that has come back during or within 6 months of completing treatment for their early-stage breast cancer.

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

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How is ENHERTU thought to work?

As a targeted treatment called an antibody-drug conjugate (ADC), ENHERTU is designed to work differently than traditional chemotherapies.

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ENHERTU is made up of an antibody with the chemotherapy attached

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The antibody part of ENHERTU targets and attaches to HER2 on the cancer cell

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ENHERTU enters the cancer cell and the chemotherapy is released

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The chemotherapy part of ENHERTU helps destroy the cancer cell as well as other cells nearby

Although ENHERTU is designed to target HER2 on cancer cells, it may affect some healthy cells. ENHERTU may not work for everyone.

How will I receive ENHERTU?

ENHERTU is given as an intravenous (IV) infusion. You will receive an ENHERTU infusion once every 3 weeks, either at your oncologist's office or at a nearby infusion center.

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Your healthcare provider will give you medicines before your infusion to help prevent nausea and vomiting

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The first ENHERTU infusion will take about 90 minutes so the healthcare provider can monitor any potential reactions

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Future ENHERTU infusions should take about 30 minutes if your first infusion was well tolerated

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.

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Important Safety Information

What is ENHERTU?
ENHERTU is a prescription medicine used to treat adults who have:

Human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of the body (metastatic), and who have received a prior anti-HER2 breast cancer treatment:
- for metastatic disease, or
- have breast cancer that has come back during or within 6 months of completing treatment for their early-stage breast cancer.

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

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 (such as 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 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 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 will give you medicines before your infusion to help prevent nausea and vomiting.
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 at the 5.4 mg/kg dose include:

Nausea
Low white blood cell counts
Low red blood cell counts
Feeling tired
Low platelet counts
Increased liver function tests
Vomiting

Hair loss
Constipation
Decreased appetite
Low levels of blood potassium
Diarrhea
Muscle or bone pain
Stomach-area pain

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.

Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

What is ENHERTU?
ENHERTU is a prescription medicine used to treat adults who have:

Human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of the body (metastatic), and who have received a prior anti-HER2 breast cancer treatment:
- for metastatic disease, or
- have breast cancer that has come back during or within 6 months of completing treatment for their early-stage breast cancer.

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