Download to Hyalgan Brochure

The OsteoArthritis Support and Information
Service (OASIS) is a complimentary online
support program. If you haven’t enrolled
already, log onto www.HYALGAN.com.
By enrolling you will receive:
• The OASIS Welcome Kit • Knee Knowledge
• The OASIS Action Tracker • The OASIS Joint
Important Safety Information
You should not take this product if you have
had any previous allergic reaction to HYALGAN®
or other medications containing hyaluronan.
You should not have an injection into the knee
if you have an infection or skin disease in the
area of the injection site.
Indication
HYALGAN® is used to relieve knee pain due to
osteoarthritis. It is used for patients who do not
get adequate relief from simple painkillers or
from exercise and physical therapy.
Please see full Important Safety Information on page
12, complete Patient Information on pages 13-19, and
accompanying full Prescribing Information.
Visit www.HYALGAN.com
© 2010 sanofi-aventis U.S. LLC
US.HYA.10.06.005 July 2010 Printed in USA
Important Safety Information
You should not take this product if you have had any
previous allergic reaction to HYALGAN® or other
medications containing hyaluronan. You should not
have an injection into the knee if you have an infection
or skin disease in the area of the injection site.
Indication
HYALGAN® is used to relieve knee pain due to
osteoarthritis. It is used for patients who do not get
adequate relief from simple painkillers or from
exercise and physical therapy.
Ask your health care provider if HYALGAN® is right for you
Please see full Important Safety Information on page
12, complete Patient Information on pages 13-19,
and accompanying full Prescribing Information.
OA is a disease that affects the joints
How is it caused?
Normally, smooth cartilage covers and
protects the ends of your bones where they
meet in the knee joint. In addition, a thick and
slippery fluid in the joint provides lubrication
and extra cushioning.
The actual cause of osteoarthritis is not known.
There are many factors that are believed to
contribute to the chances of getting
osteoarthritis.
When you have osteoarthritis of the knee:
•Being overweight
•Getting older
•Joint injury
•Poorly formed joints
•Genetic factors
•Overuse from a physically active lifestyle
•The smooth cartilage gradually wears away
and becomes softer and less protective
•The joint fluid loses its lubricating and
cushioning abilities
•The resulting pain and stiffness can make
walking difficult
2
Some of these include:
3
The diagram below shows a healthy knee. You
can see the smooth cartilage that covers the
ends of the bones and the natural joint fluid
that helps lubricate and cushion the knee.
Healthy Knee
The diagram below shows a knee with
osteoarthritis. The cartilage is worn away
and the joint fluid becomes thinner and less
slippery. The result is that the bones in the
knee joint are less protected from the stresses
of use, such as walking. And the knee becomes
painful and stiff.
Knee with OA
Bone
Healthy
cartilage
Joint fluid
4
Worn-away cartilage
Joint space narrowing
Thinner; less slippery
joint fluid
5
OA can affect anyone
OA pain can be treated
Osteoarthritis is the most common form of
arthritis. It usually begins after age 40 and
is most common in people over age 65,
but people in their 20s or 30s can get
osteoarthritis too.
The treatment that’s right for you depends on
how your osteoarthritis has progressed, how
much pain you have, and what has worked
for you in the past.
Overuse of the knee joint, job- or sportsrelated injuries, being overweight, and family
history can all play a role in osteoarthritis.
If you have one or more of these symptoms
in your knee, you may have OA:
•Aches and pains, especially with motion
•Stiffness, especially in the morning and when
standing up
•“Grating” or “catching” sensations
•Limited motion
•Redness and swelling
If you experience any of the above, talk to your
health care provider.
Please see full Important Safety Information
on page 12, complete Patient Information on
pages 13-19, and accompanying full
Prescribing Information.
Visit www.HYALGAN.com
6
Treatment options may include one or more
of the following:
•Physical therapy, exercise, and weight loss
•Nonprescription pain relievers such as
acetaminophen (Tylenol®)*, aspirin,
ibuprofen (Advil®)*, and naproxen (Aleve®)*
•Prescription medicines like Celebrex®*
and Mobic®*
•Hyaluronan injections, such as HYALGAN®
•Steroid injections
•Knee surgery
Important Safety Information
• Tell your doctor if you are allergic to products
from birds, such as feathers, eggs and poultry
or if your leg is swollen or infected. Talk to
your doctor before resuming strenuous
weight-bearing activities after treatment
*Tylenol is a registered trademark of McNeil Consumer Healthcare,
a Division of MCNEIL-PPC, Inc.
Advil and Celebrex are registered trademarks of Pfizer Inc.
Aleve is a registered trademark of Bayer HealthCare LLC.
Mobic is a registered trademark of Boehringer Ingelheim Pharmaceuticals.
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HYALGAN® (HI-al-gan) contains a natural
substance called hyaluronate, and is injected
into your knee to relieve pain. Hyaluronate is
normally found in the fluid that lubricates
and cushions your knee joint. HYALGAN® is a
treatment option for people who do not get
adequate pain relief from simple painkillers
(eg, Tylenol®, Advil®) or from exercise and
physical therapy.
HYALGAN® is injected into the knee
•HYALGAN® is injected directly into your knee
by your health care provider
•Studies have shown that 5 injections given
at weekly intervals can provide long-lasting
pain relief for up to 6 months
•Some patients get benefits with just
HYALGAN® is not a drug. Its active ingredient
is a natural product that is injected directly
into the knee.
HYALGAN® works differently from pain pills
because it does not pass through your
bloodstream to work.
• HYALGAN® has no known drug interactions
• You can safely repeat your treatment
with HYALGAN®
Important Safety Information
• The most common side effects of HYALGAN®
therapy are gastrointestinal complaints,
injection-site pain, headache, rash or bruising
around the joint, local joint pain/swelling and
local itching. Cases where swelling is extensive
or painful should be discussed with your doctor
3 injections given at weekly intervals*
*This has been noted in studies reported in
the literature in which patients treated with
3 injections were followed for 60 days.
Please see full Important Safety Information
on page 12, complete Patient Information on
pages 13-19, and accompanying full
Prescribing Information.
More than 25 million injections of
HYALGAN® have been given worldwide
Ask your health care provider if HYALGAN®
is right for you.
HYALGAN® is covered by Medicare and most
managed care plans.
Visit www.HYALGAN.com
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Pain relief varies from patient to patient and
may depend on the severity of the disease and
intensity of the pain.
The chart below illustrates the pain relief
experienced by patients with OA of the knee
during HYALGAN® treatment.
Average amount of pain on visual analog scale (mm)
HYALGAN® pain relief over 6 months
with 5 injections
reduction
in pain
from beginning
of treatment
through
6 months
40
(n=103)
35
30
25
6 months
•In a large clinical study, 2 out of 3 people
using HYALGAN® reported pain relief at
6 months
HYALGAN®
67%
45
•HYALGAN® can relieve pain for up to
•You can safely repeat treatment with
55
50
HYALGAN® gives you long-lasting relief
of OA knee pain
20
15
Important Safety Information
• You should not take this product if you have
had any previous allergic reaction to HYALGAN®
or other medications containing hyaluronan.
You should not have an injection into the knee
if you have an infection or skin disease in the
area of the injection site
10
5
0
Baseline 3
4
5
9
12
Weeks
16
21
26
P=.004 at week 26
Adapted from Altman RD et al.
Osteoarthritis of the knee cannot be cured,
but the pain can be controlled. You may
want to discuss repeat treatment with your
health care provider if and when your
pain returns.
Please see full Important Safety Information
on page 12, complete Patient Information on
pages 13-19, and accompanying full
Prescribing Information.
Visit www.HYALGAN.com
10
11
•You should not take this product if you have
What is HYALGAN®?
•Tell your doctor if you are allergic to products
• HYALGAN® has not been tested in children,
HYALGAN® is a sterile mixture that is made up
of natural, highly purified sodium hyaluronate
that comes from rooster combs. Hyaluronate
is a natural chemical found in the body, and it
is present in a particularly high amount in joint
tissues and in the fluid that fills the joints. The
body’s own hyaluronate acts like a lubricant and
a shock absorber in the joint, and it is needed
for the joint to work properly. In osteoarthritis,
there may not be enough hyaluronate, and
there may be a change in the quality of the
hyaluronate in joint fluid and tissues.
•The most common side effects of HYALGAN®
HYALGAN® is available in either 2-mL glass
containers or 2-mL prefilled syringes.
HYALGAN® is given in a shot directly into
your knee.
had any previous allergic reaction to HYALGAN®
or other medications containing hyaluronan.
You should not have an injection into the knee
if you have an infection or skin disease in the
area of the injection site
from birds, such as feathers, eggs and poultry
or if your leg is swollen or infected. Talk to
your doctor before resuming strenuous
weight-bearing activities after treatment
pregnant women or women who are nursing.
You should tell your doctor if you think you
are pregnant or if you are nursing a child
therapy are gastrointestinal complaints,
injection-site pain, headache, rash or bruising
around the joint, local joint pain/swelling
and local itching. Cases where swelling is
extensive or painful should be discussed with
your doctor
What is HYALGAN® used for?
HYALGAN® is used to relieve knee pain due to
osteoarthritis. It is used for patients who do not
get adequate relief from simple painkillers or
from exercise and physical therapy.
Visit www.HYALGAN.com
12
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What are the benefits of HYALGAN®?
A study involving 495 patients with knee pain
due to osteoarthritis was performed in the
United States.
This study investigated the safety and
effectiveness of HYALGAN®. The patients were
placed in one of three groups.
One group was given an injection of HYALGAN®
into one knee joint once a week for 5 weeks.
The second group was given an injection of
saltwater into one knee joint once a week
for 5 weeks. The third group received two
naproxen tablets every day for 6 months. Joint
pain was measured in all patients throughout
the 6 months. Patients with osteoarthritic knee
joint pain, who did not get relief from simple
painkillers or from exercise and physical therapy,
got pain relief from the HYALGAN® injections
into the knee joint. Pain relief was not seen in
some patients until after the fifth injection.
Three additional studies were conducted to
establish the efficacy of HYALGAN® after just
3 injections.* Although it is a 5-injection course
of therapy, pain relief can be achieved with
3 injections,* giving you and your physician the
flexibility to determine which treatment regimen
is best for your needs. HYALGAN® is the only
hyaluronan with 3-injection efficacy proven in
3 placebo-controlled trials.
Visit www.HYALGAN.com
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What other treatments are available
for OA?
If you have osteoarthritis, there are several
things you can do that do not involve
HYALGAN® injections. These include
the following:
Non-drug treatments
–Avoiding activities that cause excess pain
in your joints
–Exercise
–Physical therapy
Drug therapy
–Painkillers such as acetaminophen
and narcotics
–Drugs that reduce inflammation such
as aspirin, and other nonsteroidal
anti-inflammatory agents (NSAIDs)
such as ibuprofen and naproxen
–Corticosteroids that are injected directly
into the joint
*Some patients may experience benefit with
3 injections given at weekly intervals. This has
been noted in studies reported in the literature
in which patients treated with 3 injections were
followed for 60 days.
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Are there any reasons why I should not
take HYALGAN®?
–You should not take this product if you
have had any previous allergic reaction
to HYALGAN® or similar material, ie,
hyaluronate products
–You should not have an injection into the
knee if you have infections or skin diseases
around the injection site
Things I should know about HYALGAN®
–HYALGAN® is only for injection into the knee,
performed by a qualified physician
–Consult your physician if you are allergic to
products from birds such as feathers, eggs,
and poultry
–Immediately after you have the injection and
for the next 48 hours, you may need to avoid
activities such as jogging, tennis, heavy lifting,
or standing on your feet for a long time
–Although results of studies in rats and rabbits
with HYALGAN® did not suggest that it could
affect your ability to have children or cause
harm to your child if you are pregnant or
nursing, HYALGAN® has not been tested in
pregnant women, or women who are
nursing. You should tell your doctor if you
think you are pregnant, or if you are nursing
a child
–The safety and effectiveness of HYALGAN®
has not been shown in children
Possible complications
–HYALGAN® has been used in a number of
countries in Europe, South America, and
Asia since 1987. During this time, two cases
of serious, allergic-type events were reported
right after the patients received the injection.
For example, one patient experienced
sweating, paleness, and a feeling of pressure
in the chest and stomach. The patient’s skin
turned slightly blue, and blood pressure
dropped. You should tell your doctor before
you are given HYALGAN® if something like this
has ever happened to you after receiving an
injection of HYALGAN® or a similar material,
ie, hyaluronate products
–Six cases of allergic reactions were reported
in people outside the United States after they
had been given HYALGAN®. These people
Visit www.HYALGAN.com
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reported that their pulse became quicker,
they had a heavy feeling, there were changes
in their blood pressure and circulation, and
they shivered, had a fever, and sweated.
You should tell your doctor before you are
treated with HYALGAN® if something like this
has ever happened to you after receiving an
injection of HYALGAN® or a similar material,
ie, hyaluronate products
–Seven cases of fever were reported
How is HYALGAN® given?
Your doctor will give you an injection of
HYALGAN® (20 mg/2 mL) into your knee.
A treatment cycle consists of 5 injections
given at weekly intervals. Some patients
may experience benefit with 3 injections
given at weekly intervals. This has been noted
in studies reported in the literature in which
patients treated with 3 injections were
followed for 60 days.
–One case of abnormally low blood pressure
was reported
–One episode of fainting occurred
–Side effects sometimes seen when
HYALGAN® is injected into the knee are
gastrointestinal complaints, injection-site
pain, headache, rash or bruising around
the joint, local joint pain/swelling and local
itching where HYALGAN® is injected. These
reactions were generally mild and did not
last long
–If any of the above symptoms or signs
appear after you are given HYALGAN®, or if
you have any other problems, you should
call your doctor
DISTRIBUTED BY
sanofi-aventis U.S. LLC
55 Corporate Drive
Bridgewater, NJ 08807
MANUFACTURED BY
FIDIA Farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
35031 Abano Terme, Padua (PD), Italy
07241190
Visit www.HYALGAN.com
18
19
The OsteoArthritis Support and Information
Service (OASIS) is a complimentary online
support program. If you haven’t enrolled
already, log onto www.HYALGAN.com.
By enrolling you will receive:
• The OASIS Welcome Kit • Knee Knowledge
• The OASIS Action Tracker • The OASIS Joint
Important Safety Information
You should not take this product if you have
had any previous allergic reaction to HYALGAN®
or other medications containing hyaluronan.
You should not have an injection into the knee
if you have an infection or skin disease in the
area of the injection site.
Indication
HYALGAN® is used to relieve knee pain due to
osteoarthritis. It is used for patients who do not
get adequate relief from simple painkillers or
from exercise and physical therapy.
Please see full Important Safety Information on page
12, complete Patient Information on pages 13-19, and
accompanying full Prescribing Information.
Visit www.HYALGAN.com
© 2010 sanofi-aventis U.S. LLC
US.HYA.10.06.005 July 2010 Printed in USA
Important Safety Information
You should not take this product if you have had any
previous allergic reaction to HYALGAN® or other
medications containing hyaluronan. You should not
have an injection into the knee if you have an infection
or skin disease in the area of the injection site.
Indication
HYALGAN® is used to relieve knee pain due to
osteoarthritis. It is used for patients who do not get
adequate relief from simple painkillers or from
exercise and physical therapy.
Ask your health care provider if HYALGAN® is right for you
Please see full Important Safety Information on page
12, complete Patient Information on pages 13-19,
and accompanying full Prescribing Information.