The FORTEO

Transcription

The FORTEO
The FORTEO
Customer Care program.
Quick Start Pen Guide.
Welcome.
Remove this card and carry it with you.
A few things to know about FORTEO:
If you have any questions, call the
FORTEO Customer Care program toll-free:
1.877.4FORTEO (1.877.436.7836).
Prefilled FORTEO® pens can be picked up directly
from your pharmacist or delivered to your home
through the FORTEO Customer Care program.
It builds new bone.
FORTEO contains teriparatide, which is the same as the
active part of the body’s natural parathyroid hormone.
It builds new bone faster than old bone is lost.
Affix card here.
It is a self-injection.
FORTEO is a once-a-day therapy you inject just under
the skin.
It is taken once a day.
FORTEO can be taken at any time of day, with or
Keep this
magnet
without
food or
drink. handy.
Throughout treatment you’ll be supported.
During your treatment with FORTEO, the FORTEO
Customer Care program will support you each step
of the way, to make sure you get the most out of
your treatment.
Affix magnet here.
What is osteoporosis?
How is bone health monitored?
With osteoporosis, old bone is removed faster than new
bone is formed. Over time, this causes bones to become
thin and weak, putting you at greater risk for a fracture.
Your bone health is measured by a bone mineral density
test (BMD).
These examples show the difference between bone with
osteoporosis and healthy bone:
Osteoporosis
Healthy
The result of this test is called a T-score. A normal
T-score is considered to be +2.5 to –1.0. The lower the
T-score, or bone mineral density, the weaker the bone is.
+2.5 +2.0 +1.5
+1.0 +0.5
Normal
Bone
0.0
T-score
–0.5 –1.0
–1.5 –2.0 –2.5 –3.0 –3.5
Weaker
Bone
Severe
Osteoporosis
Why is it important to
treat osteoporosis?
Osteoporosis makes your bones
thinner and weaker, putting
you at risk for fractures. Even
a sudden bump or fall may
cause a broken bone. Your most
vulnerable areas are your back,
hips and wrists.
Questions or comments about
osteoporosis:
Who can take FORTEO?
How does FORTEO work?
FORTEO is recommended for the treatment of
postmenopausal women with severe osteoporosis who:
It builds new bone.
FORTEO builds new bone faster than old bone is lost.
The medicinal ingredient in FORTEO is teriparatide,
which is the same as the active part of your body’s
natural hormone called parathyroid hormone or
“PTH.” Teriparatide works by increasing the activity
of the bone-building cells (osteoblasts).
• are at high risk of fracture
or
• have been unable to take other medications
or
• have not been adequately helped by other treatments.
FORTEO is also recommended for men with
(primary or hypogonadal) severe osteoporosis who:
• have been unable to take other medications
or
• have not been adequately helped by other treatments.
FORTEO is also approved for the treatment of both men
and women with severe osteoporosis related to the use of
corticosteroid medication (such as prednisone) who:
• are at high risk of fracture, including:
– those with a history of broken bones
or
– those with a low bone mineral density (BMD).
The FORTEO treatment.
What is the FORTEO treatment?
It is an injection.
FORTEO is a once-a-day therapy you inject just under
the skin.
Bone-absorbing cells cause bone
loss, like deep pits.
FORTEO increases the activity of
bone-forming cells.
FORTEO helps new bone formation,
filling in the pits.
It’s treatment with support.
The FORTEO Customer Care program is there to
support you while you’re taking FORTEO. You should
continue taking FORTEO for as long as your doctor
prescribes it for you. After that, you and your doctor can
decide on a program for your osteoporosis.
You’ll find information about the FORTEO Customer
Care program in the back of this booklet.
After FORTEO.
How can I get support?
After finishing the
FORTEO treatment, it’s
important to continue
habits that support
good bone health. Speak
with your doctor about
developing a strategy for
your osteoporosis that
includes nutrition and
exercise.
You will be contacted
regularly by a registered
nurse.
There’s no cost to register
for the FORTEO Customer
Care program. Once you
do, you’ll receive regular,
monthly calls over the
entire course of treatment
to help with:
You can also call the FORTEO Customer Care program
at 1.877.4FORTEO (1.877.436.7836) 7 days a week.
• Payment
• Pen training
• Reminders
• General help
You can also call with questions at 1.877.4FORTEO
(1.877.436.7836) 7 days a week.
Your FORTEO Starter Kit.
When you join the program, you will receive information
and accessories to help make your treatment with
FORTEO as comfortable and convenient as possible.
Travel bag with gel pack:
A compact solution to help keep your FORTEO
organized and cool while travelling.
Detailed information and instructions:
These printed materials will give you information about
FORTEO, the FORTEO Customer Care program and
step-by-step instructions on the use of your FORTEO pen.
FORTEO pen:
A prefilled FORTEO pen completes your starter kit so
that you have everything you need to begin treatment.
And when it’s time to have your prescription refilled,
you have the option to get your FORTEO pen directly
from your pharmacist or have it delivered to your home.
The FORTEO Starter Kit.
Questions about the FORTEO Treatment
and Customer Care Program
Patient stories.
I learned a lot about my osteoporosis.
When I started with the FORTEO Customer Care
program, I didn’t know what to expect and was a little
anxious about my treatment. But the registered nurse
I spoke to at the FORTEO Customer Care program
was so patient; she helped me learn how to give myself
injections. And she helped me learn a lot about taking
care of myself, especially about things I can do to help
my osteoporosis.
Winnie B*
Owen Sound, ON
* Fictitious patient. May not be representative of all FORTEO patients.
Getting into a rhythm.
The biggest challenges for me were changing the way
I ate and getting enough exercise. But with the help of
the FORTEO Customer Care program, I discovered that
keeping a daily food and exercise journal made changing
my habits much easier. I don’t get overwhelmed
anymore; I just follow my daily checklist.
It also took me a while to get the hang of taking my
injections every day. I started off taking it at night, but
I’d forget it when I worked odd hours. So the nurse
suggested I take it every day, right before I brushed my
teeth. It didn’t take long before it became a part of my
morning routine.
Fred H*
Swift Current, SK
* Fictitious patient. May not be representative of all FORTEO patients.
Putting the “care” in the FORTEO
Customer Care program.
I have rheumatoid arthritis and my treatment includes
taking prednisone. When I got osteoporosis, too, from
my medication, I wondered how I would cope. But the
nurse at the FORTEO Customer Care program knew
what I needed and helped me through my FORTEO
treatment. She taught me how to do my injections and
kept in touch to make sure I was doing okay.
Marie L*
Winnipeg, MN
* Fictitious patient. May not be representative of all FORTEO patients.
I am happy to have the FCC support.
My doctor put me on tablets for my osteoporosis a few
years ago. I took them every day, but I felt like I was
alone dealing with my bone health. After I broke my
wrist, my doctor and I decided I should start FORTEO
injections. I was really happy that there was another
option for me, and that the FCC was there any time I had
questions or needed some help with my insurance issues.
It’s good to know that there is always someone to ask.
Sandra P*
Jonquière, QC
* Fictitious patient. May not be representative of all FORTEO patients.
Keeping it cool.
I have chronic respiratory problems that are pretty well
controlled with my medicine, but the medicine has made
my bones weak. When my doctor and I talked about
FORTEO injections for my osteoporosis, I wondered how
I could fit it into my schedule. I sometimes travel for
my work. But, I received a kit to carry my medication
(with a gel pack to keep it cool) and all the information I
need. I just take my whole kit with me and keep it in my
hotel room refrigerator. And, no matter where I am in
Canada, I know I can call the toll-free number if I have
any problems.
Robert M*
Edmundston, NB
* Fictitious patient. May not be representative of all FORTEO patients.
One step at a time.
My memory isn’t what it used to be, so I really appreciate
the Quick Start Injection Guide. It reminds me, stepby-step, of the correct way to give myself my FORTEO
injections. I keep it in the kitchen right next to the
refrigerator, so it’s always handy when I need it.
Agathe T*
Trois-Rivières, QC
* Fictitious patient. May not be representative of all FORTEO patients.
The FORTEO Customer Care program
helped me with my treatment.
Yesterday, I gave myself my last injection after 24 months
of treatment. When I started, the thought of giving
myself a daily shot seemed daunting. But I learned a lot
with the help of the FORTEO Customer Care program,
and I’m proud that I was able to complete my treatment.
Margaret E*
New Westminster, BC
* Fictitious patient. May not be representative of all FORTEO patients.
Discuss your treatment goals with
your doctor.
Changes are easier to make when you have a clear idea of
what your goals are. Discuss with your doctor where you
see yourself after your treatment with FORTEO. Then
your doctor can suggest steps to take, in addition to
treatment with FORTEO, to help you get there.
Information
and support.
How do I take FORTEO?
Getting into a rhythm.
For instructions on how to use the pen, see the Quick Start Pen Guide
in the front pocket of this booklet. If you are injecting for the first time
or are unsure, please call 1.877.4FORTEO (1.877.436.7836).
Especially if you are taking more than one medication,
it can be hard to get into a routine. If you link your
FORTEO injection to something you do every day, like
brushing your teeth or making a cup of tea, it may help
you to remember.
FORTEO is stored in the refrigerator (2°C – 8°C).
It is a good idea to try to take it each day at about the
same time.
When you start out, read all the materials given to you,
and refer to the Quick Start Pen Guide in this booklet.
Give yourself as much time as you need to go through
all of the materials.
Over time, your FORTEO injection may become part of
your daily routine.
For example:
11
• Use each pen for 28 days only.
• For simple troubleshooting solutions, check the
back of your FORTEO Pen Quick Start Injection Guide.
1
10
3
Morning: Some people take
FORTEO when they go to the
refrigerator after getting up.
3
Evening: Other people take
FORTEO just before a favourite
television program or as they
are getting ready for bed.
2
9
8
4
7
FORTEO Quick Tips
• Always check the expiry date before using a new
FORTEO pen.
12
11
6
12
5
1
10
2
9
8
4
7
6
5
What else should I do?
Calcium
It is still important to get a good amount of calcium to help
strengthen your bones. You can take supplements and eat a
diet that is high in calcium. Some foods high in calcium are:
Dairy products: Dairy products, such as milk, cheese
and yogurt contain high amounts of calcium that is easily
absorbed.
Calcium-fortified beverages: Fortified soy beverages and
orange juices may contain as much calcium as milk (check
the labels).
Vegetables and fish: Vegetables, lentils, beans and canned
fish also have some calcium.
Exercise
Exercise is important to help strengthen your bones. Be sure
to talk to your doctor about exercises that are right for you,
such as:
Weight-bearing exercises: Any exercise where your
feet and legs carry your weight, such as walking, jogging,
aerobics, stair climbing and dancing.
Resistance exercises: Exercises that involve moving
objects or your own weight, such as free weights,
weight-training machines or exercise bands.
Exercise and nutrition considerations:
Some useful resources:
Osteoporosis Canada
www.osteoporosis.ca
Tel: 1.800.463.6842
This well-organized site features high-calcium recipes,
free publications, exercise information, and diagnosis and
treatment discussions.
Active Living Coalition for Older Adults
www.alcoa.ca
Tel: 1.800.549.9799
This group is a partnership of organizations and
individuals dedicated to the promotion of active living
and quality of life for older adults. The site features
information about projects, as well as resources and
publications.
The Canadian Orthopaedic Foundation
www.canorth.org
Tel: 1.800.461.3639
The Foundation is a registered Canadian charity
dedicated solely to helping people maintain and restore
their bone and joint health. The site features patient
stories, education information and resources.
www.menopauseandu.ca
This website is managed by the Society of Obstetricians
and Gynaecologists of Canada. It provides science-based,
easy-to-understand information about menopause and
osteoporosis, including videos and answers to frequently
asked questions.
Frequently asked questions.
What happens if I miss a dose?
You should take your dose every
day on a regular schedule. But if
you miss once, don’t worry. Take
the next dose at the usual time
the next day. Do not take more
than one injection in the same
day. If you miss more doses, talk
to your doctor.
How do I know I did the
injection correctly?
If you injected correctly, the black
injection button should be all the
way down, and the yellow shaft
should not be seen. If you are in
doubt, please call 1.877.4FORTEO
(1.877.436.7836).
What if there is liquid left in the pen after
28 injections?
You should not use it. The pen should be properly
disposed of after 28 days of first use, even if it is not
completely empty.
How many pens will I need for my treatment?
For the full treatment period of 24 months, you will need
26 pens. Each pen contains enough FORTEO for 28 days,
taking one injection every day.
Why do I have to count 5 seconds when I inject?
FORTEO injections are given
with a small needle. So it’s
important to count to 5 slowly
as it may take this long for all
of the medication to be released
through the needle.
What are the side effects of FORTEO?
Most of the side effects of FORTEO are mild. The most
common side effects are dizziness and leg cramps.
Your doctor and pharmacist need this information to
help keep you from taking a combination of products
that may harm you.
If you become dizzy, do not drive or operate machinery;
you should sit or lie down until the symptoms go away.
If they continue or get worse, you should call your
doctor before continuing treatment.
You should not take FORTEO if you:
• Have had an allergic reaction to teriparatide or any of
its ingredients.
You should also call a healthcare provider if you have
continuing nausea, vomiting, constipation, low energy
or muscle weakness. These may be signs of too much
calcium in your blood.
• Have kidney problems (severe renal impairment).
If you have any problems or questions while taking
FORTEO, ask your doctor, nurse or pharmacist for
more information.
Do any medications interact with FORTEO?
Tell your healthcare provider and pharmacist about
all the medicines you are taking when you start taking
FORTEO, and if you start taking a new medicine after
you start FORTEO treatment. Tell them about all the
medicines you take, with prescriptions and without
prescriptions, as well as herbal or natural remedies.
• Have high levels of calcium (pre-existing
hypercalcemia) or alkaline phosphatase.
• Have other bone diseases, or have had radiation therapy
involving your bones.
• Have ever been diagnosed with bone cancer or other
cancers that have spread to your bones.
• Are a child, growing adult, or if you are pregnant or
breastfeeding.
• Have trouble injecting yourself and do not have
someone who can help you.
Serious Warnings and Precautions
As part of drug testing, teriparatide, the active
ingredient in FORTEO, was given to rats for a
significant part of their lifetime. In these studies,
teriparatide caused some rats to develop
osteosarcoma, a bone cancer. The potential to
cause osteosarcoma in rats was increased with
higher doses and longer periods of treatment.
Osteosarcoma in humans is a serious but very rare
cancer. Osteosarcoma occurs in about 4 out of every
million people each year. None of the patients in the
clinical trials or post-treatment follow-up developed
osteosarcomas, but it is not known whether humans
treated with FORTEO would have an increased
chance of getting osteosarcoma. You should discuss
any safety concerns you have about the use of
FORTEO with your doctor.
Notes:
The FORTEO
Customer
Care
program.
Quick
Start Pen
Guide.
This section contains your membership card for the
FORTEO Customer Care program. You should carry
this card with you, should you need to contact us with
questions. This section also contains a magnet, so you
can keep the FORTEO Customer Care program number
in an easy-to-find place.
Remove this card and carry it with you.
FORTEO
Customer Care
Call toll-free 1.877.4FORTEO
Affix 7card
here.
(1.877.436.7836) Call
days
a week.
® Registered trademark owned by Eli Lilly and Company;
used under license.
© 2010 Eli Lilly Canada Inc. Toronto, Ontario M1N 2E8.
Keep this magnet handy.
FORTEO
Customer Care
Call toll-free 1.877.4FORTEO
x magnet
(1.877.436.7836)Affi
Call
7 days here.
a week.
® Registered trademark owned by Eli Lilly and Company;
used under license.
© 2010 Eli Lilly Canada Inc. Toronto, Ontario M1N 2E8.
® Registered trademark owned by Eli Lilly and Company; used under license.
© 2010 Eli Lilly Canada Inc. Toronto, Ontario M1N 2E8.
www.lilly.ca
FTCAD02320210S(R)