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 in people with HER2-positive gastric or GEJ adenocarcinoma, 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.
Please see full Prescribing Information, including Boxed WARNINGS, and
Medication
Guide.
