GELSYN-3 is a next-generation hyaluronic acid (HA) that provides long-lasting relief of osteoarthritis (OA) knee pain for your patients1,2

GELSYN-3 utilizes next-generation biofermentation technology2

  • Fully automated production methods virtually eliminate contamination and human error3

  • Low level of impurities, including proteins and bacterial endotoxins4

  • GELSYN-3 is a biofermentation-based formulation of HA that may diminish the risk of avian allergies and sensitivities2

  • Bacterial fermentation of Streptococcus
    equi     is safe and nongenetically modified
    (non-GMO)3,5

  • Fully automated production methods virtually eliminate contamination and human error3

  • Low level of impurities, including proteins and bacterial endotoxins4

  • GELSYN-3 is a biofermentation-based formulation of HA that may diminish the risk of avian allergies and sensitivities2

  • Bacterial fermentation of Streptococcus equi is safe and nongenetically modified (non-GMO)3,5

GELSYN-3 has effective
viscosupplement performance for
improved outcomes1

Study background1

  • A 3-injection series of GELSYN-3* (0.8% highly purified, hyaluronic acid of biofermentation origin) or Synvisc® (0.8% hylan G-F20)
  • Patients (N = 380) were observed for a period of 26 weeks
  • Primary outcome measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score at 26 weeks
    • Non-inferiority margin = WOMAC pain score difference of 8 mm at 26 weeks
* Sinovial® is branded as GELSYN-3 for the US market.

Efficacy endpoints at Week 12

  • A decrease in Lequesne pain scores compared to Synvisc
  • Patients in the GELSYN-3 study arm had a 37% reduction in pain medication use

37% REDUCTION IN PAIN MEDICATION USE IN THE GELSYN-3 STUDY ARM

GELSYN-3 provides long-lasting positive outcomes1

WOMAC = Western Ontario and McMaster Universities Arthritis Index.
GELSYN-3 performed as well as Synvisc in terms of effectiveness and safety, providing patients
with long-lasting, clinically relevant pain relief1

Efficacy endpoints at Week 26

  • Patients given GELSYN-3 had a 32.5-mm reduction in WOMAC pain scores1
  • 93% to 97% of patients and investigators scored global tolerability as good or very good at 26 weeks1
  • There were 5 treatment-related adverse events in the Synvisc treatment group vs 1 in the GELSYN-3 treatment group
  • May delay the need for total knee replacement6,*
*Although not specifically studied in the Altman R et al analysis, GELSYN-3 belongs in the HA class and has been found to perform similarly to Synvisc, which was included in the HA brands analyzed.
GELSYN-3 is reimbursed on Medicare
Fee-for-Service, Medicare Advantage,* Medicare Supplemental, and Open Access Commercial
insurance plans.

Billing and Ordering

  • GELSYN-3 has a dedicated J code of J7328
  • Providers should bill 168 units of HCPCS code J7328 for the single injection of GELSYN-3, as J7328 reimburses per 0.1 mg
GELSYN-3 Wholesaler and Specialty Distributor Item Numbers
National
Drug Code
(NDC)		 Wholesaler Specialty
Distributor
McKesson®
(Economist #)		 AmerisourceBergen®
(ABC)		 Cardinal®
(CIN #)		 HD Smith® Besse®
Medical
89130-3111-01 3566213 10167262 5264056 5593843 47226

For specific payer information in your area, contact your local Bioventus representative or request information at www.GELSYN3.com, including a reimbursement guide.

*May require additional prescribing requirements, such as prior authorization. Check with your Medicare Advantage beneficiaries’ individual plan(s).
COMPANY:
Bioventus LLC
DEVICE CLASS:
Hyaluronic acid for injection.
ACTIVE INGREDIENT:
Sodium hyaluronate
INDICATION:
Treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics (eg, acetaminophen).
ADULTS:
Remove synovial fluid or effusion before injection. Give as a single intra-articular injection, 2 mL in one knee only once weekly for 3 weeks.
CHILDREN:
Not established.
CONTRAINDICATIONS:
Allergies or sensitivities to sodium hyaluronate. Knee joint infections. Skin diseases or infections in area of the injection site.
WARNINGS/
PRECAUTIONS:
Do not inject by intravascular route. Do not inject outside of synovial space or into the synovial tissue or capsule. Advise patients to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours following injection. Pregnancy, nursing mothers: not established.
INTERACTIONS:
Avoid use of disinfectants containing quaternary ammonium salts; hyaluronan can precipitate in their presence. Concomitant use with other intra-articular injections: not studied.
ADVERSE
REACTIONS:
Treatment-related Reactions: Injection site pain (0.5%).
Intra-articular Injection Reactions: Arthralgia, joint effusion/warmth/stiffness/swelling, arthritis, gait disturbance, arthropathy.
HOW
SUPPLIED:
Single-use, prefilled syringe—1 (with needle)
REFERENCES
  1. Pavelka K, Uebelhart D. Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial®*) vs hylan G-F20 (Synvisc®) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study. Osteoarthritis Cartilage. 2011;19(11):1294-1300.
  2. Gelsyn-3. [Prescribing Information]. Durham, NC: Bioventus LLC; 2016.
  3. Institut Biochimque SA. Innovation in healthcare and research. www.ibsa-international.com/innovation. Accessed November 17, 2016.
  4. HTL Biotechnology. Safety by design. www.htl-bio.com/products/304/safety_by_design.php. Accessed November 17, 2016.
  5. RPT-000529 Data on File. DOF Sinovial Sales Data.
  6. Altman R, Lim S, Steen RG, Dasa V. Hyaluronic acid injections are associated with delay of total knee replacement surgery
    in patients with knee osteoarthritis: evidence from a large U.S. health claims database. PLoS One. 2015;10(12):e0145776. doi: 10.1371/journal.pone.0145776.
* Sinovial® is branded as GELSYN-3 for the US market.
  • GELSYN-3 is a trademark of Bioventus LLC.
  • Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
  • Synvisc is a registered trademark of Sanofi.

©2017 Bioventus. All rights reserved. SMK-001948 1/17

This MPR Prescribing Alert is produced as a basic reminder of important information for healthcare professionals. Readers are advised to consult manufacturers and specialists if questions arise about specific products, treatments, or diseases. The publisher and editors do not assume liability for any errors or omissions. MPR and MPR Prescribing Alert are registered trademarks of Haymarket Media, Inc.

© 2017 Haymarket Media, Inc.

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Summary of Indications for Use:

IMPORTANT SAFETY INFORMATION

Summary of Indications for Use:

GELSYN-3 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., acetaminophen. Do not administer to patients with known hypersensitivity (allergy) to sodium hyaluronate preparations. Do not inject GELSYN-3 into the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site. 

GELSYN-3 is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found in product labeling, at www.GELSYN3.com or by contacting customer service at 1-800-836-4080.

Please see full Prescribing Information for more information.

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