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 that may be severe, life-threatening or that may lead to death

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)

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 counts (neutropenia)

Low white blood cell counts (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

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 side effects, your healthcare provider may:

Reduce
the dose

Delay
the dose

Stop
ENHERTU

What can I do to manage side effects? Tips to help:

These tips 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

  • 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 feel like vomiting, take deep, slow breaths and, if possible, get fresh air

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

  • 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 feel like vomiting, take deep, slow breaths and, if possible, get fresh air

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

For tiredness or fatigue

For tiredness or fatigue

  • Talk to your healthcare provider about what activities may be right for you
  • Meditation may help with relaxation and decrease stress
  • Plan rest time and try not to do too much
  • Try to get regular exercise during times when your energy level is high (according to your healthcare provider’s approval)
  • Let other people help you when you are feeling tired. They can assist with household chores, shopping, cooking, or driving to and from doctor's visits
  • Talk to your healthcare provider about what activities may be right for you
  • Meditation may help with relaxation and decrease stress
  • Plan rest time and try not to do too much
  • Try to get regular exercise during times when your energy level is high (according to your healthcare provider’s approval)
  • Let other people help you when you are feeling tired. They can assist with household chores, shopping, cooking, or driving to and from doctor's visits

For diarrhea

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 for how much fluid you should drink and what types of fluid might be best for you
  • 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 for how much fluid you should drink and what types of fluid might be best for you

For dealing with hair loss or thinning

For dealing with hair loss or thinning

Before hair loss or thinning:

  • Talk to your healthcare provider about the possibility of 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
  • 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
  • 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
  • If you plan on buying a wig, you should do so while you still have hair

If hair loss or thinning occurs:

  • Protect your scalp
  • Cover your head to 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 hair loss or thinning:

  • Talk to your healthcare provider about the possibility of 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
  • 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
  • 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
  • If you plan on buying a wig, you should do so while you still have hair

If hair loss or thinning occurs:

  • Protect your scalp
  • Cover your head to 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?"

ENHERTU is given as an intravenous (IV) infusion at a recommended dose of 5.4 mg/kg once every 3 weeks. There were more side effects, including serious lung problems, seen in patients with NSCLC who received a higher dose of 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
  • Diarrhea
  • Low levels of blood potassium
  • 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
  • Diarrhea
  • Low levels of blood potassium
  • 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 are encouraged to report negative side effects of ENHERTU by calling 1-877-437-7763. If you prefer to report these to the FDA, visit www.FDA.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

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

Managing side effects with ENHERTU

Let your healthcare provider know right away if you are experiencing any side effects.

Your healthcare provider may take steps to help manage your side effects, including:

  • Slowing down, interrupting, or stopping ENHERTU treatment
  • Prescribing other medicines to help lessen side effects
  • Recommending lifestyle changes

Download the Medication Guide.

View helpful resources for
patients and caregivers

SEE RESOURCES

HER2, human epidermal growth factor 2; NSCLC, non-small cell lung 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 counts (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
  • 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.

What is ENHERTU?

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

  • Non-small cell lung cancer (NSCLC) that has a certain mutation in the HER2 gene and cannot be removed by surgery or has spread to other parts of your body (metastatic), and who have received a prior treatment. Your healthcare provider will perform a test to make sure ENHERTU is right for you.

    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.

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

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