SYNVISCÆ (Hylan G-F 20) is an FDA-approved therapy that
provides lubrication for your knee. It also acts as a "shock
absorber" to cushion your knee joint.
SYNVISCÆ is an elastic and viscous fluid that is made from a
substance called hyaluronan that is found in normal joint fluid. Hyaluronan
acts as a "shock absorber" and lubricant in your knee joint and is
needed for your joint to work properly. SYNVISCÆ is indicated for the treatment
of pain in osteoarthritis (OA) of the knee in patients who have failed to
respond adequately to conservative nonpharmacologic therapy, and simple
analgesics, e.g., acetaminophen.
SYNVISCÆ is not a drug. It is made from a substance that is
found in normal joint fluid and is injected directly into the knee joint.
How does Synvisc work?
In knees with osteoarthritis, normal joint fluid,
called synovial fluid, becomes thinner and loses its elasticity and viscosity
(ability to lubricate). The osteoarthritic synovial fluid cannot provide
"cushioning" in your knee joint. Without this cushioning, the
cartilage in your knee joint may be more likely to wear down over time. This
deterioration along with the loss of cushioning can contribute to pain and
stiffness in your knee.
SYNVISCÆ (Hylan G-F 20) is injected directly into your knee
joint by a qualified health care professional to help restore the cushioning
effect and lubrication of normal, healthy synovial fluid. This treatment is
called viscosupplementation.
Successful treatment with SYNVISCÆ can help reduce knee pain
from osteoarthritis, allowing you to return to a more comfortable, active life.
Your doctor may ask you to temporarily avoid strenuous activity after treatment
with SYNVISCÆ.
What is viscosupplementation?
Viscosupplementation: a procedure that restores
the shock-absorbing and lubricating properties of the synovial fluid in people
with osteoarthritis of the knee.
Viscosupplementation is a procedure that can help restore
and increase the cushioning and lubrication of osteoarthritic synovial, or
joint, fluid. Viscosupplementation has been studied as a treatment for
osteoarthritis since the 1970s. This procedure is not a cure for osteoarthritis
of the knee; it is a treatment that may reduce or eliminate pain that occurs
with this condition.
With viscosupplementation, your health care
professional injects a gel that is similar to healthy synovial fluid into your
knee joint. The goals of viscosupplementation are to
… restore the properties of shock absorption and lubrication to
diseased synovial fluid.
… reduce or stop the pain from osteoarthritis of the knee.
… improve mobility.
The success of viscosupplementation may depend on
how well the fluid restores the elasticity and lubrication of the synovial
fluid. Individual results may vary. SYNVISCÆ (Hylan G-F 20) is a viscosupplementation product
that has been proven to provide pain relief from osteoarthritis of the knee for
up to 6 months. The elastic and lubrication properties of SYNVISCÆ are similar to those of
synovial fluid from healthy joints in 18- to 27-year-old
How is Synvisc given?
A health care professional injects SYNVISCÆ (Hylan G-F 20) directly into
your knee joint three times, 7 days apart, over a 15-day period (days 1, 8, and
15). To get the best results from SYNVISCÆ therapy, your health care professional will remove
the diseased osteoarthritic synovial fluid from your knee before the injection
of SYNVISCÆ.
Completion of the full three-injection treatment
course is necessary to achieve the greatest benefit. Most patients feel the
greatest pain relief 8 to 12 weeks after beginning treatment.
Benefits of Synvisc therapy.
There are many benefits of using SYNVISCÆ (Hylan G-F 20) to treat
osteoarthritis of the knee:
… Successful treatment can help reduce or stop pain in an
osteoarthritic knee, allowing increased mobility and a higher and more
comfortable level of activity.*
… Pain relief can last for up to 6 months: you may begin to feel
relief after the first injection, but maximum results usually occur 8 to 12
weeks after the first injection. Individual results may vary.
… Because SYNVISCÆ is not a drug and is injected directly into the knee, it should
not interfere with any other medications you are taking, including pain
relievers and/or anti-inflammatory drugs; be sure to talk to your doctor about
any medications you are taking.
… SYNVISCÆ treatment can be given in both knees at the same time or at
different times.
… SYNVISCÆ is given in only three injections; other viscosupplementation
treatments usually require five injections.
*Your doctor may ask you to temporarily avoid
strenuous activity after treatment.
Who is a candidate for Synvisc therapy?
SYNVISCÆ (Hylan G-F 20) is used for the treatment of pain
from osteoarthritis of the knee in people who have not found pain relief using
the following treatments:
… exercise
… physical therapy
… the use of heat (e.g., a heating pad) and cold (e.g., ice packs)
… acetaminophen (a pain reliever like TylenolÆ*)
Examples of people who might consider SYNVISCÆ include people who:
… are not receiving adequate pain relief from current treatment.
… cannot take aspirin or other anti-inflammatory drugs like
ibuprofen.
… are already taking multiple oral medications.
… are not appropriate candidates for knee surgery.
SYNVISCÆ has been shown to be effective in all stages of
osteoarthritis, although it is most effective in the less severe stages of this
disease.
SYNVISCÆ (Hylan G-F 20) is considered to be a device rather
than a drug. Insurers typically cover devices that meet the following criteria:
… The device is medically necessary to treat your condition.
… The device is used according to the labeled uses approved by the
U.S. Food and Drug Administration.
Insurance coverage, however, is never a guarantee of
payment, and insurers vary widely in the services that they cover. Benefits
also vary according to the specific plan under which you're covered. For these
reasons, your health care professional should determine the extent to which an
insurer will cover SYNVISCÆ
and what, if anything, patients and providers must do to follow coverage
guidelines.
Specific reimbursement rates for SYNVISCÆ vary across insurers. Many patients
share the cost of medical care through co-payments and deductibles.
For information about insurance coverage for SYNVISCÆ, please call your insurance
carrier.
The most commonly reported adverse events are
transient local pain, swelling, and/or effusion in the injected knee (2.2% of
injections in 7 pivotal clinical trials). In some cases, these symptoms have
been extensive. Other side effects such as rash have been reported rarely.
SYNVISCÆ is contraindicated in
patients with known hypersensitivity to hyaluronan products or patients with
infections in or around the knee. Use caution when using SYNVISCÆ in patients allergic to
avian proteins, feathers, or egg products; who have evidence of venous or
lymphatic stasis in the leg to be treated; or who have severe inflammation in
the knee joint to be treated. The results of repeat use have not been
established. Strict adherence to aseptic technique must be followed to avoid
joint infection.