What is the most important information I
should know about TAGRISSO?
TAGRISSO may cause serious side
• heart problems, including heart failure.
TAGRISSO may cause heart problems that
may lead to death. Your doctor should check
your heart function before you start taking
TAGRISSO and during treatment as needed.
Tell your doctor right away if you have any of
the following signs and symptoms of a heart
problem: feeling like your heart is pounding or
racing, shortness of breath, swelling of your
ankles and feet, feeling lightheaded.
• eye problems. TAGRISSO may cause eye
problems. Tell your doctor right away if you
have symptoms of eye problems which may
include watery eyes, sensitivity to light, eye
pain, eye redness, or vision changes. Your
doctor may send you to see an eye specialist
(ophthalmologist) if you get eye problems
See “What are the possible side effects
of TAGRISSO?” for more information about
What is TAGRISSO?
TAGRISSO is a prescription medicine used to treat
non-small cell lung cancer (NSCLC) that has spread
to other parts of the body (metastatic):
• as your ;rst treatment if your tumor has a
certain abnormal epidermal growth factor
receptor (EGFR) gene(s)
• if you have a certain type of EGFR gene and
had previous treatment with an EGFR tyrosine
kinase inhibitor (TKI) medicine that did not
work or is no longer working.
Your doctor will perform a test to make sure that
TAGRISSO is right for you.
It is not known if TAGRISSO is safe and effective
Before taking TAGRISSO, tell your doctor
about all of your medical conditions,
including if you:
have lung or breathing problems.
have heart problems, including a condition
called long QTc syndrome.
have problems with your electrolytes, such as
sodium, potassium, calcium or magnesium.
have a history of eye problems.
are pregnant or plan to become pregnant.
TAGRISSO can harm your unborn baby.
Tell your doctor right away if you become
pregnant during treatment with TAGRISSO or
think you may be pregnant.
° Females who are able to become pregnant
should use effective birth control during
treatment with TAGRISSO and for 6 weeks
after the final dose of TAGRISSO.
° Males who have female partners that are
able to become pregnant should use
effective birth control during treatment with
TAGRISSO and for 4 months after the final
dose of TAGRISSO.
• are breastfeeding or plan to breastfeed. It is
not known if TAGRISSO passes into your
breast milk. Do not breastfeed during
treatment with TAGRISSO and for 2 weeks
after your final dose of TAGRISSO. Talk to
your doctor about the best way to feed your
baby during this time.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter
medicines, vitamins, or herbal supplements.
Especially tell your doctor if you take a heart or
blood pressure medicine.
How should I take TAGRISSO?
• Take TAGRISSO exactly as your doctor tells
you to take it.
• Your doctor may change your dose,
temporarily stop, or permanently stop
treatment with TAGRISSO if you have side
• Take TAGRISSO 1 time each day.
• You can take TAGRISSO with or without food.
• If you miss a dose of TAGRISSO, do not make
up for the missed dose. Take your next dose
at your regular time.
• If you cannot swallow TAGRISSO
° place your dose of TAGRISSO in a container
that contains 60 mL ( 2 ounces) of water.
Do not use carbonated water or any
° stir the TAGRISSO tablet and water until the
TAGRISSO tablet is in small pieces (the
tablet will not completely dissolve). Do not
crush, heat, or use ultrasound to prepare
° drink the TAGRISSO and water mixture
° add 120 mL to 240 mL ( 4 to 8 ounces)
of water into the container and drink to
make sure that you take your full dose
What are the possible side effects of
TAGRISSO may cause serious side
See “What is the most important information
I should know about TAGRISSO?”
The most common side effects of TAGRISSO
• dry skin
• changes in your nails, including: redness,
tenderness, pain, inflammation, brittleness,
• decreased appetite
Tell your doctor if you have any side effect that
bothers you or that does not go away.
These are not all the possible side effects of
TAGRISSO. For more information, ask your doctor
Call your doctor for medical advice about side
effects. You may report side effects to FDA at
How should I store TAGRISSO?
Store TAGRISSO at room temperature
between 68°F to 77°F ( 20°C to 25°C).
Safely throw away medicine that is out of
date or that you no longer need.
Keep TAGRISSO and all medicines out of
the reach of children.
General information about the safe and
effective use of TAGRISSO.
Medicines are sometimes prescribed for
purposes other than those listed in a Patient
Information leaflet. Do not use TAGRISSO for
a condition for which it was not prescribed.
Do not give TAGRISSO to other people, even
if they have the same symptoms you have. It
may harm them. You can ask your doctor or
pharmacist for information about TAGRISSO
that is written for a healthcare professional.
What are the ingredients in TAGRISSO?
Active ingredient: osimertinib
Inactive ingredients: mannitol, microcrystalline
cellulose, low-substituted hydroxypropyl cellulose,
and sodium stearyl fumarate. Tablet coating
contains: polyvinyl alcohol, titanium dioxide,
macrogol 3350, talc, ferric oxide yellow, ferric
oxide red and ferric oxide black.
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: April 2018
For more information, go to Tagrisso.com or
Distributed by: AstraZeneca Pharmaceuticals LP,
Wilmington, DE 19850
TAGRISSO is a registered trademark of the
AstraZeneca group of companies.
©2018 AstraZeneca. All rights reserved.
lung problems. TAGRISSO may cause lung
problems that may lead to death. Symptoms
may be similar to those symptoms from lung
cancer. Tell your doctor right away if you have
any new or worsening lung symptoms,
including trouble breathing, shortness of
breath, cough, or fever.