On the Front Linesof OsteoarthritisKnee Pain
Physical Therapists
Please see Important Safety Information at the end of this presentation.
SONE-00430.B 09/2010
The GrowingKnee OA Population
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■Nearly 1 in 2 adults areat risk for developingOA of the knee1
Please see Important Safety Information at the end of this presentation.
SONE-00430.B 09/2010
Helping Patients UnderstandOA and Its Effects
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Kellgren-Lawrence RadiographicCriteria for Assessment1
GRADE 0
GRADE 1
GRADE 2
GRADE 3
GRADE 4
Please see Important Safety Information at the end of this presentation.
SONE-00430.B 09/2010
The Importance of anIndividualized Approach
■Every patient is different:
—Many have concomitant conditions requiring additionaltherapies
—Viable treatment choices are crucial
■The goal is the same:
—Relieve pain and slow disease progression
—Preserve functional independence and delay TKR
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Please see Important Safety Information at the end of this presentation.
SONE-00430.B 09/2010
The Multimodal Approach1
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Please see Important Safety Information at the end of this presentation.
SONE-00430.B 09/2010
What Is Viscosupplementation?
■Nonsystemic therapy for OA kneepain relief1
■Replaces diseased, osteoarthritic synovialfluid in the knee with hyaluronan or aderivative to reduce pain1
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Please see Important Safety Information at the end of this presentation.
SONE-00430.B 09/2010
Treatment Options
■SYNVISC: Provides up to 6 months of OAknee pain relief with 3 injections.1
■Synvisc-One: Same formulation, providesup to 6 months of OA knee pain relief withjust 1 injection.2
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Single-Injection Synvisc-One®
(hylan G-F 20)
Please see Important Safety Information at the end of this presentation.
SONE-00430.B 09/2010
Demonstrated Efficacy of SYNVISC
■The SYNVISC family of viscosupplements demonstrated superiorOA knee pain relief versus ALL of the following in separate head-to-head clinical trials:
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ICS = intra-articular corticosteroid; NSAID = non-steroidal anti-inflammatory drug.
||Pain at rest.
Please see Important Safety Information at the end of this presentation.
SONE-00430.B 09/2010
Synvisc-One® (hylan G-F 20)Indication
■Synvisc-One is indicated for treatment ofpain in knee OA patients who have failed torespond adequately to:
—Conservative non-pharmacologic therapy
—Simple analgesics, e.g., acetaminophen
■Safety Profile
—The side effects most commonly seen in a medical studywere knee pain, stiffness and swelling or fluid buildup in oraround the knee
—Side effects were generally mild to moderate and did not lastlong.
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Please see Important Safety Information at the end of this presentation.
SONE-00430.B 09/2010
Help Patients UnderstandWhat to Expect
■Single 6-mL injection
■In-office procedurethat only takes a few minutes
■After injection:
—Most patients experience reliefstarting one month post injection
—Patients should avoid strenuous orprolonged weight-bearing activitiesfor 48 hours
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Please see Important Safety Information at the end of this presentation.
SONE-00430.B 09/2010
Part of theMultimodal Approach
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Important Safety information
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Indication
SYNVISC® (hylan G-F 20) and Synvisc-One® (hylan G-F 20) are indicated for the treatment of pain in osteoarthritis (OA) of theknee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g.,acetaminophen.
Important Safety Information
SYNVISC and Synvisc-One are contraindicated in patients with known hypersensitivity to hyaluronan products or patients withinfections in or around the target knee. Hypersensitivity reactions including anaphylactic reaction, anaphylactoid reaction,anaphylactic shock and angioedema have been reported for both SYNVISC and Synvisc-One.
Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan canprecipitate in their presence. Do not inject SYNVISC or Synvisc-One extraarticularly, into the synovial tissues, into the fat pad orjoint capsule, or intravascularly.
The safety and efficacy of Synvisc-One in locations other than the knee, or for conditions other than osteoarthritis, or incombination with other intra-articular injectables, or in severely inflamed knee joints have not been established. Use caution wheninjecting SYNVISC or Synvisc-One in patients allergic to avian proteins, feathers, or egg products; who have evidence of lymphaticor venous stasis in the leg to be treated; or who have severe inflammation in the knee to be treated. Remove any synovial fluid oreffusion before injecting SYNVISC or Synvisc-One. Strict adherence to aseptic technique must be followed to avoid joint infection.
The safety and effectiveness of SYNVISC and Synvisc-One have not been established in children (≤21years old) or in pregnant orlactating women. Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hoursafter treatment.
For SYNVISC
In clinical trials, the most commonly reported adverse events were transient pain, swelling, and or joint effusion in the injectedknee. The following reported adverse events are among those that may occur in association with intra-articular injections, includingSynvisc: arthralgia, joint stiffness, joint effusion, joint swelling, joint warmth, injection site pain, arthritis, arthropathy, and gaitdisturbance.
For Synvisc-One
The most commonly reported adverse events were arthralgia, arthritis, arthropathy, injection site pain, and joint effusion. Thefollowing reported adverse events are among those that may occur in association with intra-articular injections, including Synvisc-One: arthralgia, joint stiffness, joint effusion, joint swelling, joint warmth, injection site pain, arthritis, arthropathy, and gaitdisturbance.
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