Esbriet Patient
Information
Esbriet® is used to treat idiopathic pulmonary fibrosis (IPF)
What’s Inside
Introduction
3
IPF Overview
4
Esbriet Overview
7
How effective is Esbriet?
9
Getting Started On Esbriet
10
Before Taking Esbriet
12
Things To Avoid 12
Your Questions Answered
13
Side Effects Explained
14
Important Contacts
17
Glossary of Terms
18
Notes19
1
Introduction
This booklet is for people who have been diagnosed with
a condition called Idiopathic Pulmonary Fibrosis (IPF).
It provides an overview of the disease, and also offers
important information about a treatment called Esbriet
(pronounced es-BREE-et).
Esbriet is a MEDSAFE registered prescription medicine,
which has been shown (in clinical trials) to help people with
IPF maintain their lung function and stop their disease getting
worse (slow the progression of their disease).
Some of the words used in this booklet may be new to you or seem a bit complicated.
To help you, there is a glossary of terms on page 18.
2
3
IPF Overview
What is IPF?
Idiopathic Pulmonary Fibrosis (IPF)
is a serious disease that causes
permanent scarring (fibrosis) of the
lungs. We don’t know what causes
it (hence the term ‘idiopathic’ of unknown cause), but we do
know that it’s progressive, which
means that it worsens with time.
It’s hard to predict how quickly the
condition will progress, as it differs
from person to person.
Lung
Alveoli
How does fibrosis
occur in IPF?
The damage that occurs with IPF
may result when tiny injuries in
the deepest tissues of the lungs
do not heal properly. In response
to these injuries, very small air
sacs called alveoli thicken and
stiffen, causing fibrosis (scarring).
This makes it difficult for oxygen
to enter the bloodstream. As
the disease gets worse, fibrosis
becomes more widespread.
4
What can be done to help manage IPF?
Fibrosis: In this cross-section
view of an air sac, fibrotic tissue
prevents oxygen (blue dots) from
entering the bloodstream.
Because your doctor does not know how quickly or slowly your
disease will progress, it is important to take steps to help maintain
your lung function. Talk to your doctor about ways to support a
healthy lifestyle, manage your symptoms, and treat your disease.
Why Esbriet, why now?
Starting and staying on Esbriet treatment as prescribed by your
doctor may be an important way to help maintain your lung function.
Esbriet does not improve the symptoms of IPF, but it does work in
slowing it’s progression.
5
Esbriet Overview
Here are some simple facts to help you know more about Esbriet.
What is Esbriet?
Esbriet’s active ingredient is called pirfenidone (pronounced
pir-FEN-ee-done)
Pirfenidone is a treatment that stops or slows the scarring in
the lungs - this is known as an antifibrotic
In clinical trials, it has been shown to help slow or stop the the
decline in lung fucntion
Esbriet may help you to breathe better
Outside of New Zealand, Esbriet has been available in a
number of other countries since 2011
Approximately 20,000 patients have taken Esbriet worldwide
For more information around patient support
services please go to:
www.pulmonaryfibrosis.org.nz
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7
How effective is Esbriet?
The effectiveness and safety of Esbriet has been
studied in a number of clinical trials:
Esbriet slows disease progression
1
Esbriet helps you maintain your
breathing capacity or lung function
1
Esbriet slows the decline in ability
to perform physical activities
1
The effect of Esbriet on lung function (how well the lungs work) was measured by forced
vital capacity (FVC). FVC measures the amount of air you can exhale with force after you
inhale as deeply as possible. FVC is used to help diagnose and monitor IPF during the
course of the disease.
Esbriet was compared to placebo (no treatment) in these clinical trials.
References:
1. Noble PW, et al. Eur Respir J 2016;47:243-253.
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9
Getting Started On Esbriet
When starting a new medicine, it can take time for your body to adjust.
Beginning with a small dose and slowly working up to a full dose over
time can help. This is called titration (increasing or decreasing the dose).
When you start on Esbriet, your dose will slowly increase over a twoweek period until you reach the recommended maximum daily dose of
3 capsules taken 3 times a day - i.e. 9 capsules daily.
PLEASE NOTE:
It is important to keep taking Esbriet as directed by your doctor
Your doctor may change your dosage of Esbriet if required
Always take Esbriet with food to help reduce possible side effects of
nausea and dizziness
If you miss a dose of Esbriet, take it with food as soon as you remember
Doses should be taken with food and at
the same time each day: in the morning,
afternoon, and evening.
Do not take two doses at the same time to make up for a missed dose
Do not take more than three doses (9 capsules) in a day
If you take too many doses of Esbriet call your doctor right away
Esbriet dosing schedule
Morning
(breakfast)
Afternoon
(lunch)
Evening
(dinner)
Total pills
each day
Days 1–7
1
1
1
3
Days 8–14
2
2
2
6
Days 15 onward
3
3
3
9
Week
10
Your doctor should ask you to do blood tests before you start taking Esbriet
The information in this brochure does not replace discussions with your
doctor. Please contact your doctor with any questions about your condition
and treatment options, including Esbriet, as well as any side effects you
may experience while taking Esbriet.
11
Before Taking Esbriet
Your Questions Answered
It’s important to tell your doctor if you’re a smoker, have liver problems,
kidney problems or any other medical conditions.
How long has Esbriet been available in New Zealand?
It’s also important to tell your doctor if you are pregnant, plan to
become pregnant, are breastfeeding or plan to breastfeed, as it is not
known if Esbriet passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription
and over-the-counter medicines, vitamins and herbal supplements.
Things To Avoid
While Taking Esbriet
Sunlight. Esbriet can make your skin sensitive to UV rays. Avoid
the sun and the light from sunlamps and tanning beds while
taking Esbriet. You could get a severe sunburn. Use sunscreen
(SPF 50) and wear a hat and clothes that cover your skin if you
have to be in sunlight. Talk to your doctor if you get sunburn.
Esbriet was registered for the treatment of IPF in June 2016.
How can Esbriet help my IPF?
In clinical trials, Esbriet was shown to help slow the progression of IPF,
as measured by lung function. It is very important to continue taking
your medicine as prescribed by your doctor, even though you may not
feel different or notice a change in your IPF.
Why is staying on Esbriet treatment, as prescribed
by my doctor, important?
Because IPF is a progressive and unpredictable disease, it is important
to do everything you can to slow the decline in your lung function.
Starting and staying on Esbriet treatment as prescribed by your doctor
can be an important way to help maintain your lung function.
Esbriet does not improve IPF symptoms; Esbriet works to help slow the
progression of IPF in your lungs.
Smoking. Smoking may affect how well Esbriet works. You
should stop smoking before and during treatment with Esbriet.
Demanding activities. Esbriet may cause dizziness and
tiredness. Be careful if you have to take part in activities where
you have to be alert and co-ordinated.
12
13
Esbriet may cause dizziness and tiredness. Be careful if you have to
take part in activities where you have to be alert and co-ordinated.
Esbriet may cause other, more serious side effects, including:
Liver problems. Your doctor will do blood tests to check how your
liver is working during your treatment with Esbriet. However, call
your doctor right away if you have unexplained symptoms such as:
yellowing of your skin or the white part of your eyes (jaundice)
dark or brown (tea-coloured) urine
pain on the upper right side of your stomach area (abdomen)
bleeding or bruising more easily than normal
feeling tired
14
Side Effects Explained
Sensitivity to sunlight (photosensitivity) and rash. Refer to
“Things to avoid while taking Esbriet” on page 12.
Esbriet may have unwanted side effects in some people. Do not be
alarmed by the following list of side effects. You may not experience any
of them. If you have any questions please ask your doctor or pharmacist.
Stomach problems. Esbriet may cause stomach problems
such as nausea, vomiting, diarrhoea, indigestion, heartburn, and
stomach pain. Call your doctor immediately if you experience any
of these serious side effects.
The most common side effects of Esbriet
include feeling tired, headache, dizziness, and
decreased or loss of appetite.
In clinical trials, other reported side effects that occurred in 10%
or more of patients included throat or chest infections, sinusitis
(inflamed and/or painful nasal cavities), heartburn, sleeplessness,
weight loss, and joint pain.
15
Managing And Preventing
Side Effects
Important Contacts
Be sure to talk to your doctor immediately if you experience any
side effects while taking Esbriet.
Keep all the information about your contacts here,
so you can easily find it, in the one place.
Managing nausea
and dizziness
Preventing skin rash and sun sensitivity
Name
50
Always take Esbriet
with food as this
may reduce nausea
and dizziness.
Doctor
Phone
+
Email
Always use a broad-spectrum
(UVA/UVB) sunscreen
+ SPF 50 or higher when
with
outside. Reapply often
throughout the day.
+
50
50
Wear a hat and clothing
that covers your skin,
including your face,
arms, and legs.
Nurse
Name
Phone
Email
Your doctor may need to reduce your dose or ask you to stop taking
Esbriet for a short time to help manage side effects. If you stop
taking Esbriet for 14 or more days, you will need to restart treatment
with a low dose, and then slowly increase to the maximum dose.*
Other healthcare providers
Your doctor may also ask you to permanently stop taking Esbriet.
Remember, take Esbriet exactly as your doctor tells you to take it.
Email
Name
Service
Phone
Pharmacy
For further information on side effects, please view the Consumer Medicines Information
at www.medsafe.govt.nz/consumers/cmi/e/esbriet.pdf
* Refer to “Getting Started on Esbriet” on page 10.
16
Name
Phone
Email
17
Glossary of Terms
Notes
Alveoli: tiny sacs within our lungs that allow oxygen and carbon dioxide to move between
the lungs and bloodstream.
Antifibrotic: an agent that blocks or prevents tissue scarring.
Clinical Trials: carefully controlled studies to provide data and information about how well the
treatment works and its side effects.
Diarrhoea: watery stools.
Dose: a specified quantity of a medicine, prescribed to be taken at one time or at stated intervals.
Idiopathic: of unknown cause.
Indigestion: pain or discomfort in the stomach associated with difficulty in digesting food.
Fibrosis: the thickening and scarring of connective tissue, usually as a result of injury.
FVC (forced vital capacity): measures how much air a person can exhale during a forced breath.
Heartburn: a burning sensation in the chest, caused by acid reflux into the oesophagus
(digestive tract).
Jaundice: yellowing of the skin and eyes. This condition forms when there is too much bilirubin (a
yellow substance) in the system.
Nausea: is an uneasiness of the stomach that often comes before vomiting.
Placebo: a substance that has no medical effect, used as a control in testing new medicines.
Progressive: happening or developing slowly or in stages.
Pulmonary: relating to the lungs.
Respiratory Tract: the passage formed by the mouth, nose, throat, and lungs, through which air
passes during breathing.
Sinusitis: inflammation of a nasal sinus.
Titration: increasing or decreasing medicine dosage.
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19
Notes
20
21
Roche Products (New Zealand) Ltd.
PO Box 109113, Newmarket, Auckland 1149
Ph: 0800 656 464
www.roche.co.nz
Esbriet® (pirfenidone), 267 mg hard capsules, is a Prescription Medicine used to treat idiopathic pulmonary
fibrosis (IPF).
Do not take Esbriet if: you have an allergy to any medicine containing pirfenidone or any of the ingredients;
you are pregnant and/or breast feeding; you are under 18 years of age; you are taking fluvoxamine (used to
treat depression and obsessive compulsive disorder); you have experienced angioedema when previously
taking pirfenidone. Tell your doctor if: you have kidney or liver problems; you are a smoker; you are pregnant
or breast-feeding, or planning to become pregnant or breast-feed; you are going to have surgery; you are
taking, or about to start taking any other medicines.
Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you notice any
of the following: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea coloured)
urine, pain in the upper right side of your stomach area (abdomen), bleeding or bruising more easily than
normal; swelling of face, lips and/or tongue, difficulty breathing or wheezing. Serious side effects may
include: infection of the throat or of the airways going into the lungs and/or sinusitis; weight loss; difficulty
sleeping; dizziness; feeling sleepy; changes in taste; stomach problems such as acid reflux, vomiting,
feeling bloated, abdominal pain and discomfort, heart burn, feeling constipated and passing wind. Possible
common side effects may also include: sensitivity to sunlight, skin reactions after going out in the sun or
using sun lamps or tanning beds; rash or itching; feeling sick (nausea); tiredness; diarrhea; indigestion or
stomach upset; loss of appetite; headache; muscle aches or pain.
Esbriet has risks and benefits. Ask your doctor if Esbriet is right for you. Use strictly as directed. If symptoms
continue or you have side effects, see your healthcare professional. For further information on Esbriet, please
talk to your health professional or visit www.medsafe.govt.nz for Esbriet Consumer Medicine Information.
Esbriet is a funded medicine for patients with idiopathic pulmonary fibrosis who meet pre-defined
criteria. Prescription and normal doctors’ fees may apply.
Consumer Panel based on CMI dated 17 June 2016.
All trademarks mentioned herein are protected by law.
SAP37558182/TAPSNA8718/2016DEC