Be sure to read the following important information
carefully. This information does not take the place of your doctor's advice. If
you do not understand this information or want to know more, ask your doctor.
Glossary of Terms
Hyaluronan (pronounced hy-al-u-ROE-nan): is a
natural substance that is present in very high amounts in joints. It acts like
a lubricant and a shock absorber in the joint and is needed for the joint to
Non-steroidal anti-inflammatory drugs: also known
as “NSAIDs”; medication used to treat pain or swelling. There are many
examples of NSAIDs, including (but not limited to) aspirin and ibuprofen. Some
of these are over-the-counter drugs, and some can only be obtained by
Osteoarthritis (pronounced OS-te-o-arth-RI-tis):
(OA) is a type of arthritis that involves the wearing down of cartilage (the protective
covering on the ends of your bones) and loss of cushioning fluid in the joint
Table of Contents
- Glossary of Terms
- Table of Contents
- What is the Synvisc-One® product?
- How is the Synvisc-One product ® used? (Indications)
- How is the Synvisc-One® product given?
- Are there any reasons why I should not receive a Synvisc-
- One® injection? (Contraindications)
- What should my doctor warn me about?
- What are the risks of getting a Synvisc-One® injection?
- What are the benefits of getting a Synvisc-One® injection?
- What do I need to do after I get Synvisc-One® injection?
- What other treatments are available for OA?
- Non-drug treatments
- Drug therapy
- When should I call my doctor? (Troubleshooting)
- What adverse events were observed in the clinical study?
- How do I get more information about the Synvisc-One® product?
What is the Synvisc-One product?
Synvisc-One is a gel-like mixture that comes in a syringe
containing 6 mL (1 ½ teaspoon) and is injected into your knee. It is made up of
hylan A fluid, hylan B gel, and salt water. Hylan A and hylan B are made from a
substance called hyaluronan (pronounced hy-al-u-ROE-nan), also known as sodium hyaluronate
that comes from chicken combs. Hyaluronan is a natural substance found in the
body and is present in very high amounts in joints. The body's own hyaluronan
acts like a lubricant and a shock absorber in the joint and is needed for the joint
to work properly.
How is the Synvisc-One® product used? (Indications)
The FDA-approved indication for Synvisc-One is:
Synvisc-One is indicated for the treatment of pain in osteoarthritis
(OA) of the knee in patients who have failed to respond adequately to
conservative non-pharmacologic therapy and simple analgesics, e.g.,
How is the Synvisc-One® product given?
Your doctor will inject Synvisc-One into your knee.
Are there any reasons why I should not receive a
Synvisc- One® injection? (Contraindications)
Your doctor will determine if there is any reason why you
are not an appropriate candidate for Synvisc-One. You should be aware that
- Should not be used in patients who have had any prior allergic
reactions to SYNVISC, Synvisc-One or any hyaluronan-based products. Signs of an
allergic reaction may include swelling of your face, tongue, or throat; difficulty
breathing or swallowing; shortness of breath; wheezing; chest pain; a tightness
in your throat; sleepiness; rash; itching; hives; flushing; and/or fever.
- Should not be used in patients with a knee joint
infection, skin disease or infection around the area where the injection will
What should my doctor warn me about?
The following are important treatment considerations for
you to discuss with your doctor and understand in order to help avoid unsatisfactory
results and complications:
- Synvisc-One is only for injection into the knee,
performed by a doctor or other qualified health care professional. Synvisc-One
has not been tested to show pain relief in joints other than the knee.
- Synvisc-One has not been tested to show better pain relief
when combined with other injected medicines.
- Tell your doctor if you are allergic to products from
birds such as feathers, eggs, and poultry.
- Tell your doctor if you have significant swelling or
blood clots in the leg.
- Synvisc should be used with caution when there is evidence
of lymphatic or venous stasis in the leg to be injected.
- Synvisc-One 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.
- Synvisc-One has not been tested in children ( ≤ 21
years of age).
What are the risks of getting a Synvisc-One®
The side effects (also called reactions) sometimes seen
after any injection into the knee, including Synvisc-One, include: pain, swelling,
heat, redness, and/or fluid build-up around the knee. These reactions are
generally mild and do not last long. Reactions are generally treated by resting
and applying ice to the injected knee. Sometimes it is necessary to give pain relievers
by mouth such as acetaminophen or NSAIDs, or to give injections of steroids, or
to remove fluid from the knee joint. Patients rarely undergo arthroscopy (a
surgical inspection of the knee joint) or other medical procedures related to
Other side effects seen with SYNVISC or Synvisc-One are:
rashes, hives, itching, muscle pain/cramps, flushing and/or swelling of your
face, fast heart beat, nausea (or feeling sick to your stomach), dizziness,
fever, chills, headache, difficulty breathing, swelling in your arms and/or
legs, prickly feeling of your skin, and in rare cases a low number of platelets
in the blood (platelets are a type of blood cell that are needed to help your
blood clot when you are cut or injured). Allergic reactions, some which can be potentially
severe, were observed during the use of Synvisc-One.
Rare cases of knee joint infection have been reported
after SYNVISC injections. If any of the above side effects or symptoms appear
after you are given Synvisc-One, or if you have any other problems, you should
call your doctor.
What are the benefits of getting a Synvisc-One® injection?
As shown in a medical study of 253 patients with
osteoarthritis (OA) of the knee, where approximately half received either a single
injection of Synvisc-One or an injection of the same volume of salt water (a
“Saline Control” injection), the major benefits of Synvisc-One are
pain relief and improvement in other symptoms related to OA of the knee.
What do I need to do after I get Synvisc-One®
It is recommended you avoid strenuous activities (for
example, high-impact sports such as tennis or jogging) or prolonged weight-bearing
activities for approximately 48 hours following the injection. You should
consult your doctor regarding the appropriate time to resume such activities.
What other treatments are available for OA?
If you have OA, there are other things you can do besides
getting Synvisc-One. These include:
- Avoiding activities that cause knee pain
- Exercise or physical therapy
- Weight loss
- Removal of excess fluid from your knee
- Pain relievers such as acetaminophen and narcotics
- Drugs that reduce inflammation (signs of inflammation are
swelling, pain or redness), such as aspirin and other non-steroidal
anti-inflammatory drugs (NSAIDs, for example ibuprofen and naproxen)
- Steroids that are injected directly into your knee.
When should I call my doctor? (Troubleshooting)
If any of the side effects or symptoms described above
appear after you are given Synvisc-One, or if you have any other problems, you
should call your doctor.
What did the clinical studies show?
A study was conducted in 6 countries outside the United
States with 21 physicians. The patients in the study had mild to moderate knee
OA, moderate to severe pain, and did not have sufficient relief of their pain
and symptoms with medications taken by mouth.
A total of 253 patients in the study were assigned by
chance to receive either a single injection of Synvisc-One (n=123 patients), or
an injection of the same volume of salt water (a “Saline Control”
injection) (n=130 patients). Neither the patients nor the doctors evaluating
them knew which treatment they received. Any fluid that was present in the
patient's knee was removed before the injection. The patients were seen by
their doctor at standard times over 6 months. Information was collected about how
much pain they were experiencing doing various types of activities, how much
they were limited in their daily activities by their OA, and on their overall
condition. Their doctor also provided an overall rating of their OA.
The main measure of the study was how much pain the
subjects had doing five common types of activities over the 6 months duration
of the study. Daily activity limitations and overall evaluations were also
compared between the group of patients receiving Synvisc-One injection and the
group receiving salt water injection. The study showed that patients receiving Synvisc-One
had significantly less pain over 6 months, and felt significantly better than
the patients who received the salt water injections. The difference in pain
score reduction from baseline to 6 months between the Synvisc-One and salt
water control injection was 0.15 out of a 5 point scale for the measurement of OA
pain in the knee.
What adverse events were observed in the clinical
The following are the most common adverse events that occurred
during the clinical trial of Synvisc-One:
- Pain in the knee or at the injection site
- Stiffness, swelling or warmth in or around the knee
- Changes in the way that you walk (e.g., limping)
Severe adverse events were not observed in the
Synvisc-One trial. Joint infections did not occur in the injected knee in the Synvisc-One
clinical trial. The most commonly occurring adverse events outside of the
injected knee were headache, back pain, sore throat and the flu. One patient
had a single episode of feeling faint.
How do I get more information about the Synvisc-One® product?
If you have any questions or would like to find out more
about Synvisc-One, you may call Genzyme Biosurgery at 1-888-3-SYNVISC
(1-888-379-6847) or visit www.synvisc.com.