On the Front Lines of Osteoarthritis Knee Pain Physical Therapists.

On the Front Lines of Osteoarthritis Knee Pain

Physical Therapists

Please see Important Safety Information at the end of this presentation. SONE-00430.B 09/2010

The Growing Knee OA Population

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■Nearly 1 in 2 adults are at risk for developing OA of the knee1


Helping Patients Understand OA and Its Effects

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Kellgren-Lawrence Radiographic Criteria for Assessment1

GRADE 0 GRADE 1 GRADE 2 GRADE 3 GRADE 4


The Importance of an Individualized Approach

■Every patient is different:—Many have concomitant conditions requiring additional

therapies

—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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The Multimodal Approach1

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What Is Viscosupplementation?

■Nonsystemic therapy for OA kneepain relief1

■Replaces diseased, osteoarthritic synovial fluid in the knee with hyaluronan or a derivative to reduce pain1

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Treatment Options

■SYNVISC: Provides up to 6 months of OA knee pain relief with 3 injections.1

■Synvisc-One: Same formulation, provides up to 6 months of OA knee pain relief with just 1 injection.2

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Single-Injection Synvisc-One®

(hylan G-F 20)


Demonstrated Efficacy of SYNVISC

■The SYNVISC family of viscosupplements demonstrated superior OA 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.


Synvisc-One® (hylan G-F 20)

Indication

■Synvisc-One is indicated for treatment of pain in knee OA patients who have failed to respond adequately to:—Conservative non-pharmacologic therapy—Simple analgesics, e.g., acetaminophen

■Safety Profile—The side effects most commonly seen in a medical study

were knee pain, stiffness and swelling or fluid buildup in or around the knee

—Side effects were generally mild to moderate and did not last long.

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Help Patients Understand What to Expect

■Single 6-mL injection

■In-office procedure that only takes a few minutes

■After injection:—Most patients experience relief

starting one month post injection

—Patients should avoid strenuous or prolonged weight-bearing activities for 48 hours

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Part of the Multimodal Approach

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Important Safety information

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IndicationSYNVISC® (hylan G-F 20) and Synvisc-One® (hylan G-F 20) are 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.

Important Safety InformationSYNVISC and Synvisc-One are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections 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 can precipitate in their presence. Do not inject SYNVISC or Synvisc-One extraarticularly, into the synovial tissues, into the fat pad or joint capsule, or intravascularly.

The safety and efficacy of Synvisc-One in locations other than the knee, or for conditions other than osteoarthritis, or in combination with other intra-articular injectables, or in severely inflamed knee joints have not been established. Use caution when injecting SYNVISC or Synvisc-One in patients allergic to avian proteins, feathers, or egg products; who have evidence of lymphatic or venous stasis in the leg to be treated; or who have severe inflammation in the knee to be treated. Remove any synovial fluid or effusion 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 or lactating women. Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment.

For SYNVISCIn clinical trials, the most commonly reported adverse events were transient pain, swelling, and or joint effusion in the injected knee. The following reported adverse events are among those that may occur in association with intra-articular injections, including Synvisc: arthralgia, joint stiffness, joint effusion, joint swelling, joint warmth, injection site pain, arthritis, arthropathy, and gait disturbance.

For Synvisc-OneThe most commonly reported adverse events were arthralgia, arthritis, arthropathy, injection site pain, and joint effusion. The following 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 gait disturbance.

On the Front Lines of Osteoarthritis Knee Pain Physical Therapists.

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