UNDERSTANDING POTENTIAL RISKS

What is the most important information I should know about ENHERTU?

ENHERTU can cause side effects

Some serious or life-threatening side effects may affect your lungs, heart, or white blood cell count, affecting your ability to fight infection.

Pay special attention to new or worsening symptoms as they may be related to:

Lung problems, like interstitial lung disease/pneumonitis, that may be severe, life-threatening, or that may lead to death

Call or see your healthcare provider right away if you develop any of the following signs and symptoms or if these symptoms get worse:

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

If lung problems develop, your healthcare provider may treat you with corticosteroid medicines.

Call or see your healthcare provider right away if you develop any of the following signs and symptoms or if these symptoms get worse:

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

If lung problems develop, your healthcare provider may treat you with corticosteroid medicines.

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

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 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

Harm to your unborn baby

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.

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.

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.

Contact your healthcare provider right away if you develop any of these side effects, experience new symptoms, or if your current symptoms get worse.

Will my healthcare provider adjust my dose if I have side effects?

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

Delay
your dose

Reduce
your dose

Stop
ENHERTU

Tips for managing common side effects that may happen during treatment

The tips below are not intended to take the place of your healthcare team’s advice. Always talk to your healthcare provider first.

For nausea and vomiting

For nausea and
vomiting

Talk to your healthcare team if your nausea or vomiting is not controlled. Additionally, these tips may help:

Try to eat 5 or 6 small meals and snacks each day instead of 3 large meals
Eat bland, easy-to-digest food and drinks
Avoid food and drinks that are too hot or too cold
Avoid strong smells, if possible
If you are vomiting, take deep, slow breaths and, if possible, get fresh air

Talk to your healthcare team if your nausea or vomiting is not controlled. Additionally, these tips may help:

Try to eat 5 or 6 small meals and snacks each day instead of 3 large meals
Eat bland, easy-to-digest food and drinks
Avoid food and drinks that are too hot or too cold
Avoid strong smells, if possible
If you are vomiting, take deep, slow breaths and, if possible, get fresh air

For diarrhea

Try to eat 5 or 6 small meals and snacks each day instead of 3 large meals
Eat foods that are low in fiber
Drink clear liquids to replace lost fluids. Check with your healthcare provider to figure out how much and what types of fluid might be best

Try to eat 5 or 6 small meals and snacks each day instead of 3 large meals
Eat foods that are low in fiber
Drink clear liquids to replace lost fluids. Check with your healthcare provider to figure out how much and what types of fluid might be best

For tiredness or fatigue

Try activities such as meditation, which helps with relaxation and decreases stress
Plan rest time and try not to do too much
Try regular exercise during times when your energy level is high (according to your healthcare provider’s approval)
Let other people help you with everyday tasks

Try activities such as meditation, which helps with relaxation and decreases stress
Plan rest time and try not to do too much
Try regular exercise during times when your energy level is high (according to your healthcare provider’s approval)
Let other people help you with everyday tasks

For dealing with hair thinning or hair loss (alopecia)

Before thinning or hair loss:

Talk to your healthcare provider about the possibility of hair thinning or hair loss
Consider cutting your hair short to feel more in control of hair loss
Be gentle when you wash your hair. Use a mild shampoo, such as baby shampoo
Avoid items such as electric hair dryers, hairspray, hair dyes, products to perm or relax hair, hair bands, and/or clips that can hurt your scalp
Consider asking your healthcare provider about cold caps or scalp cooling systems. These may help reduce hair loss by narrowing the blood vessels beneath your scalp
If you plan on buying a wig, do so while you still have hair

If hair thinning or loss occurs:

Protect your scalp by wearing a hat or head covering, applying sunscreen, and avoiding very hot or sunny places when possible
Cover your head to help stay warm. You may feel colder if you lose your hair
Sleep on a satin pillowcase. Satin creates less friction and may be more comfortable

Before thinning or hair loss:

Talk to your healthcare provider about the possibility of hair thinning or hair loss
Consider cutting your hair short to feel more in control of hair loss
Be gentle when you wash your hair. Use a mild shampoo, such as baby shampoo
Avoid items such as electric hair dryers, hairspray, hair dyes, products to perm or relax hair, hair bands, and/or clips that can hurt your scalp
Consider asking your healthcare provider about cold caps or scalp cooling systems. These may help reduce hair loss by narrowing the blood vessels beneath your scalp
If you plan on buying a wig, do so while you still have hair

If hair thinning or loss occurs:

Protect your scalp by wearing a hat or head covering, applying sunscreen, and avoiding very hot or sunny places when possible
Cover your head to help stay warm. You may feel colder if you lose your hair
Sleep on a satin pillowcase. Satin creates less friction and may be more comfortable

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
Muscle or bone pain

Decreased appetite
Low levels of blood potassium
Diarrhea
Cough

Nausea
Low white blood cell counts
Low red blood cell counts
Feeling tired
Low platelet counts
Increased liver function tests
Vomiting
Hair loss
Constipation
Muscle or bone pain
Decreased appetite
Low levels of blood potassium
Diarrhea
Cough

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.

Before you receive ENHERTU, tell your healthcare provider about all of your medical conditions, including if you:

Have lung or breathing problems.
Have kidney problems. Your healthcare provider may follow you more closely. In clinical trials, more serious lung problems were seen in patients with certain kidney problems.
Have liver problems. Your healthcare provider may follow you more closely.
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.

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.