May 25, 2016
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Synvisc-One

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Synvisc-One




PATIENT INFORMATION

SYNVISC ONE®
(Hylan G-F 20)

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 work properly.

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 prescription.

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? (User Assistance)

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., acetaminophen.

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 Synvisc-One:

  • 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 be given.

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® injection?

The side effects (also called reactions) sometimes n 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 these reactions.

Other side effects n 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® injection?

It is recommended you avoid strenuous activities (for example, highimpact 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:

Non-drug treatments

  • Avoiding activities that cause knee pain
  • Exercise or physical therapy
  • Weight loss
  • Removal of excess fluid from your knee

Drug therapy

  • Pain relievers such as acetaminophen and narcotics
  • Drugs that reduce inflammation (signs of inflammation are swelling, pain or redness), such as aspirin and other nonsteroidal 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 n 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 study?

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? (User Assistance)

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.

Table 1: Summary of Demographic and Baseline Characteristics

Parameter/Category Synvisc-One®
(N=124)*
Saline Control
(N=129)*
Total
(N=253)
Age, n * 124 129 253
  Mean (SD) 63.6 (9.6) 62.5 (9.2) 63.0 (9.4)
  Range 42, 83 43, 84 42, 84
Sex, n * 124 129 253
  Female, n (%) 92 (74%) 88 (68%) 180 (71%)
Race, n * 124 129 253
  Caucasian, n (%) 118 (95%) 125 (97%) 243 (96%)
  Non-Caucasian, n (%) 6 (5%) 4 (3%) 10 (4%)
Body Mass Index (kg/m²), n* 123 129 252
  Mean (SD) 29.1 (4.8) 29.8 (5.7) 29.4 (5.4)
  Range 20.7, 46.0 19.5, 52.4 19.5, 52.4
Prior Corticosteroids In Target Knee, n† 123 130 253
  Yes - n (%) 40 (32%) 31 (24%) 71 (28%)
Prior Arthroscopy In Target Knee, n† 123 130 253
  Yes - n (%) 26 (21%) 28 (22%) 54 (21%)
Tibio-Femoral Joint Modified Kellgren-Lawrence Numerical Grading System†
Grade II 63 (51%) 51 (39%) 114 (45%)
Grade III 60 (49%) 78 (60%) 138 (55%)
Grade IV 0 1 (1%) 1 (0%)
Total WOMAC Score (096); Mean (SD) * 55.1 (10.5) 54.8 (9.4)  
WOMAC A Score (0-4); Mean (SD) * 2.30 (0.43) 2.25 (0.41)  
PTGA - Mean (SD) (0-4) * 2.57 (0.67) 2.50 (0.64)  
COGA - Mean (SD) (0-4) * 2.44 (0.76) 2.49 (0.75)  
*ITT Population
†Safety Population

Table 2: Patients with Adverse Events in the Injected Knee Regardless of Relatedness

MedDRA Preferred Term Synvisc-One®
N=123 n (%)
Saline Control
N=130 n (%)
Any Treatment-Emergent Adverse Event 44 (35.8%) 44 (33.8%)
Arthralgia 31 (25.2%) 28 (21.5%)
Joint stiffness 10 (8.1%) 13 (10.0%)
Joint effusion 7 (5.7%) 7 (5.4%)
Joint swelling 5 (4.1%) 7 (5.4%)
Joint warmth 2 (1.6%) 5 (3.8%)
Post-traumatic pain 0 3 (2.3%)
Injection site pain 1 (0.8%) 1 (0.8%)
Synovial cyst 0 2 (1.5%)
Arthritis 1 (0.8%) 0
Arthropathy 1 (0.8%) 0
Gait disturbance 1 (0.8%) 0
Joint range of motion decreased 0 1 (0.8%)
Ostheoarthritis 0 1 (0.8%)
Note: Patients are counted once for each unique AE regardless of device relatedness, and may have had more than one unique

Table 3: Patients with Device-Related Adverse Events in the Injected Knee

MedDRA Preferred Term Synvisc-One®
N=123 n (%)
Saline Control
N=130 n (%)
Any Device-Related Adverse Event 7 (5.7%) 4 (3.1%)
Arthralgia 2 (1.6%) 3 (2.3%)
Arthritis 1 (0.8%) 0
Arthropathy 1 (0.8%) 0
Injection site pain 1 (0.8%) 1 (0.8%)
Joint effusion 2 (1.6%) 0
Note: Patients are counted once for each unique AE, and may have had more than one unique AE.

Table 4: Primary Efficacy Results: WOMAC A (Pain) Score Overall Change from Baseline over 26 Weeks – ITT Population

  Baseline Mean (SE) (0-4 Scale) Mean Post treatment (SE) (0-4 Scale) Estimated Change (SE) Estimated Difference from Saline Contol (95% CI) p-value (ancova)
Synvisc- One® (n=124) 2.30 (0.04) 1.43 (0.06) -0.84 (0.06) 0.15 (-0.302, -0.002) 0.047
Saline Control (n=129) 2.25 (0.04) 1.59 (0.06) -0.69 (0.06)
WOMAC A scale using 5 point Likert scale, where 0 = no pain and 4 = extreme pain Repeated measures Analysis of Covariance was used for the WOMAC A pain score change from the baseline.

Table 5: Clinical Meaning of Secondary Efficacy Endpoints

  Odds Ratio* Definition Explanation
Generalized Estimating Equation for categorical data
WOMAC A1 Over 26 weeks 0.64† The odds (probability [Worse] / Probability [Better]) for Synvisc-One for over 26 weeks and at 26 weeks is approximately 64%, and 56%, respectively, to the odds for control. Synvisc-One patients were 1.56 times more likely to self-report pain relief while walking on a flat surface compared to those patients treated with saline control over 26 weeks and 1.79 times more likely to selfreport pain relief while walking on a flat surface compared to those patients treated with saline control at 26 weeks.
At week 26 0.56†
PTGA Over 26 weeks 0.69† The odds (probability [Worse] / Probability [Better]) for Synvisc-One for over 26 weeks and at 26 weeks is approximately 69% and 51%, respectively, to the odds for control. PTGA: Patient Global Assessment has 5 scales (Very well, Well, Fair, Poor, Very poor) Synvisc-One patients were 1.45 times more likely to self-report improvement in overall health status compared to those patients treated with saline control over 26 weeks and 1.96 times more likely to selfreport improvement in overall health status compared to those patients treated with saline control at 26 weeks.
At week 26 0.51†
COGA Over 26 weeks 0.71† The odds (probability [Worse] / Probability [Better]) for Synvisc-One for over 26 weeks and at 26 weeks is approximately 71%, and 56%, respectively, to the odds for control. COGA: Clinical Observer Global Assessment has 5 scales (Very well, Well, Fair, Poor, Very poor) Blinded clinical observers were 1.41 times more likely to assess patients treated with Synvisc-One as showing overall improvement in disease status compared to those patients treated with saline control over 26 weeks and 1.79 times more likely to assess patients treated with Synvisc-One as showing overall improvement in disease status compared to those patients treated with saline control at 26 weeks.
At week 26 0.56†
OMERACT-OARSI Over 26 weeks 0.66 This response analysis did not reach statistical significance between, the treatment groups.  
At week 26 0.69
Estimate of Treatment Difference (Analysis of Covariance)
WOMAC C Over 26 weeks -0.18 The study did not show a statistically significant difference in functional improvement between the treatment groups.  
At week 26 -0.11
Odds ratio = (Probability [Worse] / Probability [Better]) for Synvisc-One / Probability [Worse]/ Probability [Better]) for Control If odds ratio < 1, then in favor of Synvisc-One
*Odds ratio = Odds for Synvisc-One/Odds for control
†Statistically significant at the 5% significance level; not adjusted for multiplicity

Figure 1: Plot for Categorical Secondary Endpoints - ITT Population

Plot for Categorical Secondary Endpoints - Illustration

Figure 2: Patient Responder Rate on WOMAC A1 (Walking Pain) -ITT Population

Patient Responder Rate on WOMAC A1 (Walking Pain) - Illustration

 

Last reviewed on RxList: 5/6/2016
This monograph has been modified to include the generic and brand name in many instances.

Synvisc-One - User Reviews

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