ANSWERS ABOUT TAGRISSO · 2017-05-02 · ANSWERS ABOUT TAGRISSO ™ (osimertinib) This booklet is...

ANSWERS ABOUT

TAGRISSO™

(osimertinib)This booklet is intended for people who have been prescribed TAGRISSO. It is not a substitute for the Patient Information Leaflet (PIL), which is provided with the medicine—it’s important that you read this document, too. Safety (adverse event) reporting can be found on page 13 of this booklet.

The material in this brochure was created by AstraZeneca to help patients who have been prescribed

TAGRISSO to understand important information about their treatment.

IMPORTANT: As always, please route any materials included in or developed using this document through

your internal AstraZeneca review board as well as local regulatory bodies and nominated signatories as

appropriate prior to external distribution.

Dimensions: 10’’ x 10’’ inches

©2017 AstraZeneca. All rights reserved.

Document Number: Z4-3950 Date of Prep: 04/17 Date of Expiry: 04/18

475_51318_Global_PatientStarterTreatmentBrochure_update_v06.indd 1 4/14/17 10:51 AM

Your practical

guide to using

TAGRISSO

Whatyou’ll learn

Learning that your lung cancer has progressed is difficult news to hear, and you may be worried about what’s next. But it can be reassuring to know that the treatment you have been prescribed, TAGRISSO, is designed specifically for how your cancer has changed.

This booklet has been written to help you understand why you have been prescribed TAGRISSO, how it works, and what to expect over the coming weeks.

This booklet also has space for you to write any notes or questions you may have between appointments. You may also want to bring this booklet along with you to appointments to jot down anything your nurse or doctor tells you.

Please remember to read the TAGRISSO Patient Information Leaflet (PIL) carefully, as it contains other important details about your medicine.

What is TAGRISSO?

How does TAGRISSO

work?

What should I do about side effects?(adverse events)

Who is it for?

What are the side effects of

treatment?

Words in bold/italic are defined in the glossary on pages 20–21.

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Why you are taking

TAGRISSO

TAGRISSO is the brand name of a drug called osimertinib.

TAGRISSO belongs to a class of anticancer medicines called protein kinase inhibitors (PKI) or tyrosine kinase inhibitors (TKI). It is different from chemotherapy and is sometimes called a targeted treatment, because it is designed to take advantage of some differences between normal cells and cancer cells.

When you were originally diagnosed with non-small cell lung cancer (NSCLC)…

The test of your tumour determined that you had NSCLC and that the cancer cells had the EGFR (epidermal growth factor receptor) mutation.

Your previous treatment probably included a targeted treatment—specifically, a TKI that was designed to attach to the EGFR proteins with the aim of slowing down the growth of the cancer cells and making the tumours smaller. This line of therapy may have helped your tumours to shrink, or at least not grow any larger, for a period of time.

But now your cancer cells have changed.

Despite previous treatment, the NSCLC has progressed. This means that the tumour is growing and spreading again, possibly due to additional changes in the cancer cells. In order to understand this better, you had either a tissue biopsy or a test of the cancer cells circulating in your blood (plasma ctDNA). It showed that your tumour has a secondary mutation to EGFR called T790M. Because of this change, the previous EGFR mutation–targeting medicine may no longer be working as effectively.

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4 Words in bold/italic are defined in the glossary on pages 20–21.


TAGRISSO is intended for your situation.

TAGRISSO is used when:

ProgressionEGFR T790M mutation

Your tumour tests positive for the EGFR T790M mutation.

Your cancer is advanced and is progressing despite previous treatments, including a medicine that worked to block EGFR.

You are not alone.

Studies in people with your type of cancer show that the EGFR T790M mutation

is the reason for cancer progression in

nearly 2 out of 3 cases.

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How TAGRISSO

works

TAGRISSO affects EGFR T790M.

TAGRISSO blocks both the EGFR mutation and the TKI-resistant EGFR T790M mutation. TAGRISSO may help to slow or stop your cancer from growing. It may also help to shrink the tumour.

What kind of results have people had with TAGRISSO?

TAGRISSO was studied in 419 people with your type of cancer, and it showed:

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71%had their tumours get smaller while taking

TAGRISSO.82%responded by Week 6.

Of the 197 people whose tumours responded (stopped growing or shrank),

Week 6

Words in bold/italic are defined in the glossary on pages 20–21.

Tumour Treatedtumour


Advice for taking TAGRISSO

Follow these instructions about your daily dose:

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

TAGRISSO is an 80-mg tablet that you take once a day. (If necessary, your doctor may reduce your dose to one 40-mg tablet each day.)

Take TAGRISSO every day at about the same time. Don’t worry about keeping to the exact minute.

Swallow the tablet whole with a glass of water. Don’t crush, split, or chew it.

You can take TAGRISSO with or without food. Taking it during a regular mealtime can be a good way to help you to remember to take it.

Important

If you forget a dose—take it as soon as you remember it. If it is less than 12 hours until your next dose, just skip it and take your next dose at the normal time.

Drop without crushing the tablet into a glass filled with 50 mL of still water.

Stir the water until the tablet is in small pieces—it will not completely dissolve.

Drink

the liquid straight away.

Refill

the glass with another 50 mL of water and drink it.

Do not

use any other liquids.

WITH

OR WITHOUT

If you have trouble

swallowing TAGRISSO…

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AZ 80


Reporting the side effects of TAGRISSO

Important Note: Patients should always ask their doctors for medical advice about adverse events/side effects.

After a drug is approved by regulatory agencies and made available for prescribing, the safety of the product continues to be monitored by both the manufacturer of the product as well as by regulatory agencies who initially approved the product. As side effects are reported to the manufacturer, this safety information is monitored regularly to continuously assess the safety profile of the drug. This information, after evaluated, may result in updated prescribing information which provides health care professionals with the benefit/risk information they need to make appropriate prescribing decisions for their patients.

Countries worldwide may have specific processes in place to handle reports of adverse events. To report an adverse event, ask your health care provider for more information or contact your local health authority.

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in the package leaflet.

You can report side effects by asking your healthcare provider for more information, or consulting your local health authority.

By reporting side effects, you can help provide more information on the safety of this medicine so that new safety information can be quickly identified.

Potential side effects

of TAGRISSO

Like all medicines, TAGRISSO may cause side effects (adverse events), although not everybody gets them.

Serious side effects: sudden difficulty in breathing with a cough or fever This may be a sign of inflamed lungs, a condition called interstitial lung disease. Tell your doctor straight away if you notice this side effect.

Watery eyes, sensitivity to light, eye pain, eye redness, or vision changes.

Tell your doctor straight away if you notice these serious side effects.

Other side effects that occur in more than 1 in 10 people:• Diarrhoea that may come and go during treatment• Skin and nail problems, such as itching, dry skin,

rash, redness around the fingernails • Stomatitis, or the inflammation of the inner lining of

the mouth• Reduction in the number of types of white

blood cells in the blood• Reduction in the number of platelets in the blood

Tell your doctor if you experience any side effect, even if it’s not on this list.

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What to do about

side effects

(adverse events)

If you get diarrhoea: If you have skin or nail problems:

Avoid the sun—sunlight seems to trigger rashes in some people.

Use sunscreen. Wear a hat. Use moisturisers regularly on your skin and nails.

Drink plenty of water. It is important to stay hydrated if you have

diarrhoea.

Tell your doctor if your diarrhoea gets worse or does not go away

after a few days.

You may discuss antidiarrhoea medicine and how to manage your symptoms with

your doctor.

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Questions for your doctor

If you aren’t clear on anything, just ask.

Your lung cancer care team is there to help you during your treatment. They will do all they can to make sure you have the information you need.

Here are a few questions you might want to ask:

What can I expect from TAGRISSO?

What can I do about a

particular side effect?

What is the timeline for my appointments

and tests?

What does my latest x-ray, CT scan, or other

test show? Can I look at it?

Write your own questions here:

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More space for your questions and notes:

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Glossary

Here are definitions of some terms used in this brochure.

Adverse eventAn unexpected or undesirable experience during treatment with a medicine or therapy.

EGFREpidermal growth factor receptor is a protein that may be found on the surface of non-small cell lung cancer cells. When mutated, EGFR plays a role in causing cancer cells to grow and spread as tumours.

Interstitial lung diseaseA condition that damages the lungs with swelling (inflammation) and scarring, causing shortness of breath and/or difficult breathing, cough, and fever.

Plasma ctDNA (circulating tumour DNA) testA blood test that can detect tumour cells that may be circulating in your blood.

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ProgressionWhen cancer cells grow or spread.

Protein kinase inhibitor (PKI) or tyrosine kinase inhibitor (TKI)A PKI is a substance that inhibits some of the signals involved with the function of cells in the body. A TKI is one type of PKI. It is a substance that prevents enzymes called tyrosine kinases from working. These enzymes are involved in the growth and division of cancer cells. TKIs are one kind of targeted therapy.

Secondary mutationA new type of mutation that develops at a different place on the gene within an existing type of mutation.

T790MA secondary mutation that happens in tumours that are EGFR mutation positive. When T790M is present, the cells develop resistance to the TKI or PKI being used as a treatment.

Targeted treatment, targeted therapyA cancer treatment that is designed to affect a specific activity in the cells.

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Please keep the attached

TAGRISSO card with

you.

It can be used to keep important information about your medicine and your treatment team close at hand in your wallet or purse.

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Keep in touch about Tagrisso,

visit Tagrisso.com

Key things to note about

TAGRISSOThis card is intended for people who have

been prescribed TAGRISSO.


Front

Mock-up of TAGRISSO Patient Card 6

BackMiddle fold-out


Provided as a service to medicine by

©2017 AstraZeneca. All rights reserved.

Document Number: Z4-3950 Date of Prep: 04/17 Date of Expiry: 04/18

475_51318_Global_PatientStarterTreatmentBrochure_update_v06.indd 26 4/14/17 10:52 AM

ANSWERS ABOUT TAGRISSO · 2017-05-02 · ANSWERS ABOUT TAGRISSO ™ (osimertinib) This booklet is...

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