Synvisc (Hylan G-F 20)
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Synvisc (Hylan G-F 20)

SYNVISC®
(hylan G-F 20)

Caution: Federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

DRUG DESCRIPTION

SYNVISC® (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium hyaluronate). Hylan G-F 20 is unique in that the hyaluronan is chemically crosslinked. Hyaluronan is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-Nacetylglucosamine.

What are the possible side effects of hylan G-F 20 (Synvisc, Synvisc-One)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe pain or swelling around the knee after the injection.

Less serious side effects may include:

  • warmth, pain, stiffness, swelling, or puffiness where the medicine was injected;
  • muscle pain, trouble walking;
  • fever, chills, nausea;
  • numbness or tingly feeling;
  • headache, dizziness;
  • tired feeling; or
  • itching...

Read All Potential Side Effects and See Pictures of Synvisc »

What are the precautions when taking hylan g-f 20 (Synvisc)?

Before using hyaluronate, tell your doctor or pharmacist if you are allergic to it; or to bird proteins, feathers, or egg products; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the rubber syringe cap of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: knee joint infections, skin infections/problems in the area around the injection site, circulation problems in the legs.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk....

Read All Potential Precautions of Synvisc »

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

SYNVISC (hylan g-f 20) 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.

DOSAGE AND ADMINISTRATION

Directions For Use

SYNVISC (hylan g-f 20) is administered by intra-articular injection once a week (one week apart) for a total of three injections.

Precaution: Do not use SYNVISC (hylan g-f 20) if the package has been opened or damaged. Store in original packaging (protected from light) at room temperature below 86°F (30°C).DO NOT FREEZE.

Precaution: The syringe containing SYNVISC (hylan g-f 20) is intended for single use. The contents of the syringe must be used immediately after the syringe has been removed from its packaging.

Precaution: Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence.

SYNVISC (hylan g-f 20) is administered by intra-articular injection once a week (one week apart) for a total of three injections. Strict aseptic administration technique must be followed.

  • Using an 18- to 22-gauge needle, remove synovial fluid or effusion before each SYNVISC (hylan g-f 20) injection.
  • Do not use the same syringe for removing synovial fluid and for injecting SYNVISC (hylan g-f 20) however the same 18- to 22-gauge needle should be used.
  • Twist the tip cap before pulling it off, as this will minimize product leakage.
  • To ensure a tight seal and prevent leakage during administration, secure the needle tightly while firmly holding the luer hub.

Precaution: Do not over tighten or apply excessive leverage when attaching the needle or removing the needle guard, as this may break the syringe tip.

Inject the full 2 mL in one knee only.

HOW SUPPLIED

SYNVISC (hylan g-f 20) is supplied in a 2.25 mL glass syringe containing one 2 mL (16 mg) dose of hylan G-F 20. The contents of the syringe are sterile and nonpyrogenic.

MANUFACTURED AND DISTRIBUTED BY: Genzyme Biosurgery a division of Genzyme Corporation, 1125 Pleasant View Terrace, Ridgefield, New Jersey 07657. Telephone: 1-888-3-SYNVISC (hylan g-f 20) (1-888-379-6847).

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Potential Adverse Effects Of The Device On Health

Reported Device-Related Adverse Events

The most commonly reported adverse events associated with SYNVISC (hylan g-f 20) are the following:

  • Pain in the injected knee
  • Swelling in the injected knee
  • Joint effusion
Potential Adverse Events

The following adverse events are among those that may occur in association with intra-articular injections, including SYNVISC (hylan g-f 20) :

A summary of adverse events identified in the clinical studies is provided in the Adverse Event section below.

Post-marketing Experience

SYNVISC® (hylan g-f 20) (3-injection regimen) post-marketing experience has identified the following systemic events to occur rarely with administration: rash, hives, itching, fever, nausea, headache, dizziness, chills, muscle cramps, paresthesia, peripheral edema, malaise, respiratory difficulties, flushing and facial swelling. There have been rare reports of thrombocytopenia coincident with SYNVISC (hylan g-f 20) (3-injection regimen) injection.

Adverse Events

Adverse Events Involving the Injected Joint

Clinical Trials: A total of 511 patients (559 knees) received 1771 injections in seven clinical trials of SYNVISC (hylan g-f 20) . There were 39 reports in 37 patients (2.2% of injections, 7.2% of patients) of knee pain and/or swelling after these injections. Ten patients (10 knees) were treated with arthrocentesis and removal of joint effusion. Two additional patients (two knees) received treatment with intra-articular steroids. Two patients (two knees) received NSAIDs. One of these patients also received arthrocentesis. One patient was treated with arthroscopy. The remaining patients with adverse events localized to the knee received no treatment or only analgesics.

A total of 157 patients have received 553 injections in the three clinical trials of repeated courses of SYNVISC (hylan g-f 20) treatment. The reports in these trials describe a total of 48 reports of adverse events localized to the injected knee in 35 patients that occurred after injections that patients had received during their second course of treatment. These adverse events accounted for 6.3% of injections in 22.3% of patients as compared to 2.2% of injections in 7.2% of patients in a single course of SYNVISC (hylan g-f 20) injections. In addition, reports of two retrospective studies during the post-marketing period have described adverse events localized to the injected knee that have occurred after 4.4% and 8.5% of injections that patients had received during one or more repeated courses of SYNVISC (hylan g-f 20) treatment.

Postmarket Experience: The most common adverse events reported have been pain, swelling and/or effusion in the injected knee. In some cases the effusion was considerable and caused pronounced pain. In some instances, patients have presented with knees that were tender, warm and red. It is important to rule out infection or crystalline arthropathies in such cases. Synovial fluid aspirates of varying volumes have revealed a range of cell counts, from very few to over 50,000 cells/mm³. Reported treatments included symptomatic therapy (e.g., rest, ice, heat, elevation, simple analgesics and NSAIDs) and/or arthrocentesis. Intra-articular corticosteroids have been used when infection was excluded. Rarely, arthroscopy has been performed. The occurrence of post-injection effusion may be associated with patient history of effusion, advanced stage of disease and/or the number of injections or treatment courses a patient receives. Reactions generally abate within a few days. Clinical benefit from the treatment may still occur after such reactions. The clinical trials described above included 38 patients who received a second course of SYNVISC (hylan g-f 20) injections (132 injections). There were twelve reports in nine patients (9.1% of injections, 23.7% of patients) of knee pain and/or swelling after these injections. Reports of two additional clinical trials in which patients received repeated courses of SYNVISC (hylan g-f 20) treatment have appeared during the post-marketing period. One of these trials included 48 patients who received 210 injections during a second course of SYNVISC (hylan g-f 20) treatment; the other contained 71 patients who received 211 injections during a second course of SYNVISC (hylan g-f 20) treatment.

Intra-articular infections did not occur in any of the clinical trials and have been reported only rarely during clinical use of SYNVISC (hylan g-f 20) .

Other Adverse Events

Clinical Trials: In three concurrently controlled clinical trials with a total of 112 patients who received SYNVISC (hylan g-f 20) and 110 patients who received either saline or arthrocentesis, there were no statistically significant differences in the numbers or types of adverse events between the group of patients that received SYNVISC (hylan g-f 20) and the group that received control treatments.

Systemic adverse events each occurred in 10 (2.0%) of the SYNVISC (hylan g-f 20) treated patients. There was one case each of rash (thorax and back) and itching of the skin following SYNVISC (hylan g-f 20) injections in these studies. These symptoms did not recur when these patients received additional SYNVISC (hylan g-f 20) injections. The remaining generalized adverse events reported were calf cramps, hemorrhoid problems, ankle edema, muscle pain, tonsillitis with nausea, tachyarrythmia, phlebitis with varicosities and low back sprain.

Postmarket Experience: Other adverse events reported include: rash, hives, itching, fever, nausea, headache, dizziness, chills, muscle cramps, paresthesia, peripheral edema, malaise, respiratory difficulties, flushing and facial swelling. There have been rare reports of thrombocytopenia coincident with SYNVISC (hylan g-f 20) injection. These medical events occurred under circumstances where causal relationship to SYNVISC (hylan g-f 20) is uncertain. (Adverse events reported only in worldwide postmarketing experience, not seen in clinical trials, are considered more rare and are italicized.)

Read the Synvisc (hylan g-f 20) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

  • Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence.
  • Do not inject SYNVISC (hylan g-f 20) extra-articularly or into the synovial tissues and capsule. Local and systemic adverse events, generally in the area of the injection, have occurred following extra-articular injection of SYNVISC (hylan g-f 20) .
  • Intravascular injections of SYNVISC (hylan g-f 20) may cause systemic adverse events.

PRECAUTIONS

General

  • The effectiveness of a single treatment cycle of less than three injections (2 mL each) of SYNVISC (hylan g-f 20) has not been established.
  • The safety and effectiveness of SYNVISC (hylan g-f 20) in locations other than the knee and for conditions other than osteoarthritis have not been established.
  • The safety and effectiveness of the use of SYNVISC (hylan g-f 20) concomitantly with other intra-articular injectables have not been established.
  • Use caution when injecting SYNVISC (hylan g-f 20) into patients who are allergic to avian proteins, feathers, and egg products.
  • The safety and effectiveness of SYNVISC (hylan g-f 20) in severely inflamed knee joints have not been established.
  • Strict aseptic administration technique must be followed.
  • STERILE CONTENTS. The syringe is intended for single use. The contents of the syringe must be used immediately after its packaging is opened. Discard any unused SYNVISC (hylan g-f 20) .
  • Do not use SYNVISC (hylan g-f 20) if package is opened or damaged. Store in original packaging (protected from light) at room temperature below 86°F (30°C). DO NOT FREEZE.
  • Remove synovial fluid or effusion before each SYNVISC (hylan g-f 20) injection.
  • SYNVISC (hylan g-f 20) should be used with caution when there is evidence of lymphatic or venous stasis in the leg to be injected.

Information for Patients

  • Provide patients with a copy of the Patient Labeling prior to use.
  • Transient pain, swelling and/or effusion of the injected joint may occur after intra-articular injection of SYNVISC (hylan g-f 20) . In some cases the effusion may be considerable and can cause pronounced pain; cases where swelling is extensive should be discussed with the physician.
  • As with any invasive joint procedure, it is recommended that the patient avoid any strenuous activities (for example, highimpact sports such as soccer, tennis or jogging) or prolonged weight-bearing activities for approximately 48 hours following the intra-articular injection. The patient should consult his or her physician regarding the appropriate time to resume such activities.

Use in Specific Populations

  • Pregnancy: The safety and effectiveness of SYNVISC (hylan g-f 20) have not been established in pregnant women.
  • Nursing mothers:It is not known if SYNVISC (hylan g-f 20) is excreted in human milk. The safety and effectiveness of SYNVISC (hylan g-f 20) have not been established in lactating women.
  • Pediatrics: The safety and effectiveness of SYNVISC (hylan g-f 20) have not been established in pediatric patients. Pediatric patients are defined as patients” 21 years of age.

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

  • Do not administer to patients with known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations.
  • Do not inject SYNVISC (hylan g-f 20) in the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site.

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Clinical Studies

The safety and effectiveness of SYNVISC (hylan g-f 20) were studied in patients ≥ 40 years old in the three concurrently controlled clinical trials. The three studies investigated a total of 136 women and 81 men. The demographics of trial participants were comparable across treatment groups with regard to age, gender and duration of osteoarthritis, except that there was a significantly greater (p = 0.04) number of men in the SYNVISC (hylan g-f 20) group and women in the control group in one study (see Table 1).

One study was a multicenter study conducted at four sites in Germany. This was a randomized, double-blind prospective clinical trial with two treatment groups. The study compared the safety and effectiveness of three weekly intra-articular injections of SYNVISC (hylan g-f 20) and of physiological saline in 103 subjects (109 knees) with osteoarthritis of the knee over a 26-week period. A significantly greater number of saline-treated patients took concurrent osteoarthritis medications than did patients treated with SYNVISC (hylan g-f 20) (see Table 2). While both the SYNVISC (hylan g-f 20) and the saline-treated groups improved significantly as compared to baseline in all effectiveness measures, the SYNVISC (hylan g-f 20) group showed a significantly greater improvement in all outcome measures than did the saline-treated patients over a 26-week period (see Tables 3A and 3B).

A second study conducted at a single center in Germany was a concurrently controlled, randomized, double-blind prospective clinical trial with two treatment groups. This study compared the safety and effectiveness over a 26-week period of three weekly intra-articular injections of SYNVISC (hylan g-f 20) and of physiological saline in 29 subjects (29 knees) with osteoarthritis of the knee. The results of the study were similar to those in the German multicenter study, except that the significance levels in most comparisons were smaller (see Tables 3A and 3B). In both of these studies the most pain relief and the greatest amount of treatment success occurred 8 to 12 weeks after SYNVISC (hylan g-f 20) treatment began.

Investigators obtained data at 26 weeks by telephone interviews. A validation study suggested that the results obtained in telephone interviews are equivalent to those obtained in office visits. Since investigators did not follow patients beyond week 26, the duration of pain relief beyond 26 weeks is not known. A third study was a prospective, concurrently controlled, randomized, double-blind multicenter study conducted in 90 subjects (103 knees) at five U.S. sites. The study compared the safety and effectiveness of three weekly intra-articular injections of SYNVISC (hylan g-f 20) and of three weekly arthrocenteses in subjects with osteoarthritis of the knee over a four-week period after the first injection or arthrocentesis.

Both the SYNVISC (hylan g-f 20) -treated and the arthrocentesis-treated groups improved significantly as compared to baseline in all effectiveness measures. However, there were no significant differences between the SYNVISC (hylan g-f 20) -treated and arthrocentesis-treated patients at any time during the four-week evaluation period (see Tables 3A and 3B).

Covariate analyses with the covariates of center, presence or absence of previous treatments, baseline levels of outcome measures, age, gender, body mass, effusion, baseline X-ray score, duration of osteoarthritis, treatment of contralateral knee, and presence or absence of concurrent therapies, did not reveal any factors that significantly affected the results of any of the three studies.

The German studies and the U.S. study differed in several respects, including inclusion of patients with effusions, length of no treatment period prior to SYNVISC (hylan g-f 20) injection, nature of control treatment, final evaluation time, mean duration of disease, mean weight, prior treatments for OA, pain and X-ray inclusion criteria. Thus, the German and the U.S. studies, which gave different results, investigated different patient populations and compared SYNVISC (hylan g-f 20) with different control treatments.

Although success criteria for safety were not specified in any of the three studies, adverse events were enumerated in each study. These events are included in the “Adverse Events” section.

Detailed Device Description

SYNVISC (hylan g-f 20) contains hylan A (average molecular weight 6,000,000) and hylan B hydrated gel in a buffered physiological sodium chloride solution, pH 7.2. SYNVISC (hylan g-f 20) has an elasticity (storage modulus G') at 2.5 Hz of 111 ± 13 Pascals (Pa) and a viscosity (loss modulus G”) of 25 ± 2 Pa (elasticity and viscosity of knee synovial fluid of 18 to 27- year-old humans measured with a comparable method at 2.5 Hz: G' = 117 ± 13 Pa; G” = 45 ± 8 Pa.) Each 2.25 mL syringe of SYNVISC (hylan g-f 20) contains:

  • Hylan polymers (hylan A + hylan B) 16 mg
  • Sodium chloride 17 mg
  • Disodium hydrogen phosphate 0.32 mg
  • Sodium dihydrogen phosphate monohydrate 0.08 mg
  • Water for injection q.s. to 2.0 mL

TABLE 1 : DEMOGRAPHIC DATA1

  DEMOGRAPHIC VARIABLE
Age Gender [N2 (%)] Duration of Osteoarthritis years
M F
German Multicenter3
  Synvisc 62.3 21 26 5.4
  (45%) (55%)  
  Saline 64.7 13 39 5.6
  (25%) (75%)  
  P (Synvisc/Saline) 0.3 0.04 0.9
German Single Center
  Synvisc 59.8 10 4 2.4
  (71%) (29%)  
  Saline 59.5 8 7 2.5
  (53%) (47%)  
  P (Synvisc/Saline) 0.9 0.3 1.0
U.S. Multicenter4
  Synvisc 62.9 17 27 8.9
  (39%) (61%)  
  Arthrocenteses 67.1 12 30 7.9
  (29%) (71%)  
  P (Synvisc/Arthrocenteses) 0.06 0.3 0.5
Footnotes: 1 Patients ≥ 40 years old and received the complete treatment course
2 N = number of patients
3 In addition, 1 male and 3 females were treated with Synvisc (hylan g-f 20) in one knee and saline in the other
4 In addition, 4 females were treated with Synvisc (hylan g-f 20) in one knee and arthrocenteses in the other

TABLE 3A : EFFECTIVENESS OF WEIGHT-BEARING PAIN1 EVALUATED BY PATIENTS

Week Base-line Improvement (Change from Baseline)
0 1 2 3 4 8 12 266
German Multicenter
Synvisc-treated
  Mean2 69.7 12.0 26.5 37.9 NA5 45.9 46.5 34.0
  P3   0.0001 0.0001 0.0001   0.0001 0.0001 0.0001
Saline-treated
  Mean 75.1 9.0 17.0 23.0 NA 16.8 16.4 19.1
  P3   0.0001 0.0001 0.0001   0.0001 0.0002 0.0001
P 4 0.1 0.3 0.01 0.0008 NA < 0.0001 < 0.0001 0.005
German Single Center
Synvisc-treated
  Mean  65.2 10.6 31.8 43.9 NA 51.7 53.5 44.5
  P3   0.02 0.0001 0.0001   0.0001 0.0001 0.0001
Saline-treated
  Mean 69.8 5.4 19.3 25.4 NA 24.4 26.8 21.2
  P3   0.01 0.0001 0.0001   0.0001 0.0001 0.002
P 4 0.4 0.2 0.03 0.01 NA 0.0001 0.0001 0.001
U.S. Multicenter
Synvisc-treated
  Mean 67.3 12.9 18.9 NA 21.3 NA NA NA
  P3   0.0002 0.0001   0.0001      
Arthrocenteses
  Mean 69.4 9.4 21.2 NA 19.1 NA NA NA
  P3   0.01 0.0001   0.0002      
P4 0.6 0.5 0.7 NA 0.7 NA NA NA
Footnotes: 1 Patients ≥ 40 years old and received the complete treatment course
2 Mean of assessments on VAS of 0 to 100 mm
3 Significance from baseline
4 Significance between Synvisc (hylan g-f 20) and control
5 NA = no measurement taken
6 Week 26 data based on patient telephone interviews rather than patient office visit

TABLE 2 : CONCURRENT OSTEOARTHRITIS THERAPIES1

CONCURRENT MEDICATIONS2 TREATED KNEES P Synvisc/ Control
TOTAL Synvisc Control
German Multicenter N3=109 N=52 N=57  
Medications [N (%)]4 27 (25%) 5 (10%) 22 (39%) 0.001
  NSAIDS 17 (16%) 4 (8%) 13 (23%) 0.03
  Acetaminophen 7 (6%) 1 (2%) 6 (11%) 0.07
  Other medications5 3 (3%) 3 (5%) 0 (0%) 0.09
German Single Center6 N=29 N=14 N=15  
Any concurrent medication [N (%)] NA7 NA NA NA
U.S. Multicenter8 N=103 N=51 N=52  
Acetaminophen [N (%)] 100 (97%) 50 (98%) 50 (96%) 0.6
Footnotes: 1 Patients ≥ 40 years old and received the complete treatment course
2 Individual patients may be represented by more than one therapy
3 N = number of knees
4 Number and percentage of subjects
5 Medications not approved in the U.S.
6 No concurrent therapies were recorded
7 Data not collected
8 Only acetaminophen was allowed

TABLE 3B : EFFECTIVENESS OF NIGHT PAIN1 EVALUATED BY PATIENTS

Week Base-line Improvement (Changefrom Baseline)
0 1 2 3 4 8 12 266
German Multicenter
Synvisc-treated
  Mean2 41.6 9.2 20.0 26.4 NA5 28.3 29.8 24.3
  P3   0.0001 0.0001 0.0001   0.0001 0.0001 0.0001
Saline-treated
  Mean 45.7 9.5 15.2 21.2 NA 18.4 17.3 12.8
  P3   0.0001 0.0001 0.0001   0.0001 0.0001 0.002
P 4 0.5 0.9 0.2 0.3 NA 0.05 0.02 0.03
German Single Center
Synvisc-treated
  Mean 31.8 8.4 17.7 24.8 NA 28.9 29.5 25.4
  P3   0.04 0.005 0.004   0.005 0.005 0.004
Saline-treated
  Mean 33.3 4.5 13.1 16.1 NA 16.1 17.9 14.9
  P3   0.1 0.001 0.0007   0.0001 0.0001 0.01
P 4 0.9 0.4 0.4 0.3 NA 0.1 0.2 0.2
U.S. Multicenter
Synvisc-treated
  Mean 61.0 19.0 17.9 NA 22.8 NA NA NA
  P3   0.0001 0.0001   0.0001      
Arthrocenteses
  Mean 76.0 23.3 36.3 NA 29.8 NA NA NA
  P3   0.0001 0.0001   0.0001      
P 4 0.002 0.5 0.004 NA 0.3 NA NA NA
Footnotes: 1 Patients ≥ 40 years old and received the complete treatment course
2 Mean of assessments on VAS of 0 to 100 mm
3 Significance from baseline
4 Significance between Synvisc (hylan g-f 20) and control
5 NA = no measurement taken
6 Week 26 data based on patient telephone interviews rather than patient office visit

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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® (hylan g-f 20) product?
  • How is the SYNVISC® (hylan g-f 20) product used? (Indications)
  • How is the SYNVISC® (hylan g-f 20) product given?
  • Are there any reasons why I should not receive SYNVISC® (hylan g-f 20) injections? (Contraindications)
  • What should my doctor warn me about?
  • What are the risks of getting SYNVISC® (hylan g-f 20) injections?
  • What are the benefits of getting SYNVISC® (hylan g-f 20) injections?
  • What do I need to do after I get a SYNVISC® (hylan g-f 20) injection?
  • What other treatments are available for OA?
    • Non-drug treatments
    • Drug therapy
  • What adverse events were observed in the clinical studies?
  • How do I get more information about the SYNVISC® (hylan g-f 20) product? (User Assistance)

What is the SYNVISC® (hylan g-f 20) product?

SYNVISC (hylan g-f 20) is a gel-like mixture that 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. Osteoarthritis (pronounced os-TE-o-ar-THRI-tis) (OA) is a type of arthritis that involves the wearing down of cartilage (the protective covering on the ends of your bones). In OA, there may not be enough hyaluronan, and there may be a decrease in the quality of the hyaluronan in the joint. SYNVISC (hylan g-f 20) comes in syringes containing 2 mL (half a teaspoon) of product. SYNVISC (hylan g-f 20) is injected directly into your knee.

How is the SYNVISC® (hylan g-f 20) product used? (Indications)

The FDA-approved indication for SYNVISC (hylan g-f 20) is:

SYNVISC (hylan g-f 20) 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® (hylan g-f 20) product given?

Your doctor will inject SYNVISC (hylan g-f 20) into your knee.

Are there any reasons why I should not receive SYNVISC® (hylan g-f 20) injections? (Contraindications)

Your doctor will determine if there is any reason why you are not an appropriate candidate for SYNVISC (hylan g-f 20) . You should be aware that SYNVISC (hylan g-f 20) :

  • Should not be used in patients who have had any prior allergic reactions to SYNVISC (hylan g-f 20) , Synvisc (hylan g-f 20) -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, or circulatory problems in the legs.

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 (hylan g-f 20) is only for injection into the knee, performed by a doctor or other qualified health care professional. SYNVISC (hylan g-f 20) has not been tested to show pain relief in joints other than the knee.
  • SYNVISC (hylan g-f 20) 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 (hylan g-f 20) 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 (hylan g-f 20) has not been tested in children ( ≤ 21 years of age).

What are the risks of getting SYNVISC® (hylan g-f 20) injections?

The side effects (also called reactions) sometimes seen when SYNVISC (hylan g-f 20) is injected into the knee as a first or repeat set of injections were pain, swelling, heat, redness, and/or fluid build-up around the knee. These reactions were generally mild and did not last long. If you have a reaction where the swelling is extensive and painful you should notify your doctor. The reactions seemed to occur more often when SYNVISC (hylan g-f 20) was injected into the knee as a repeat set of injections than when SYNVISC (hylan g-f 20) was injected as a first set of injections. 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 less common side effects have been: 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 clot your blood when you are cut or injured). Before you are given SYNVISC (hylan g-f 20) , tell your doctor if something like this has ever happened to you after receiving an injection of SYNVISC (hylan g-f 20) or other hyaluronan products. If any of the above symptoms or signs appear after you are given SYNVISC (hylan g-f 20) , or if you have any other problems, you should call your doctor. Rare cases of knee joint infection have been reported after SYNVISC (hylan g-f 20) injections.

What are the benefits of getting SYNVISC® (hylan g-f 20) injections?

As shown in medical studies of patients with osteoarthritis (OA) of the knee, where approximately half received a single injection of SYNVISC (hylan g-f 20) and the other half either had fluid removed from the knee and/or received injections of the same volume of salt water (a “Saline Control” injection), the major benefits of SYNVISC (hylan g-f 20) are pain relief and improvement in other symptoms related to OA of the knee.

What do I need to do after I get a SYNVISC® (hylan g-f 20) injection?

It is recommended you avoid strenuous activities (for example, highimpact sports such as soccer, tennis or jogging) or prolonged weightbearing 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 (hylan g-f 20) . 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.

What did the clinical studies show?

Two medical studies involving a total of 132 patients were done in Germany. The patients in these studies were at least 40 years old and had knee pain due to OA. The patients were placed in one of two groups. One group was given an injection of SYNVISC (hylan g-f 20) into one or both knees once a week for three weeks. The second group was given an injection of salt water once a week for three weeks. As part of the study, knee joint pain was measured for 26 weeks. Also, patients and doctors were asked to judge the success of the treatment for 26 weeks. Patients with OA knee pain, who did not get pain relief with other medicines, got pain relief with SYNVISC (hylan g-f 20) . The patients given SYNVISC (hylan g-f 20) had more pain relief than the patients given salt water. Some patients started to feel pain relief after the first week of SYNVISC (hylan g-f 20) treatment. The most pain relief and the greatest amount of treatment success was seen 8 to 12 weeks after SYNVISC (hylan g-f 20) treatment started.

A medical study done in the United States involved 90 patients. The patients were at least 40 years old and had knee pain due to OA. Patients were placed into one of two groups. One group was given SYNVISC (hylan g-f 20) once a week for three weeks. The second group had a needle inserted into the knee to have any fluid removed (this procedure is called arthrocentesis [pronounced AR-thro-sen-TEE-sis]) once a week for three weeks.

Patients improved after SYNVISC (hylan g-f 20) treatment, but not more than patients who had arthrocentesis. This study was different from the German studies because the last time the two groups were compared was only two weeks after the last SYNVISC (hylan g-f 20) injection. The study was also different in other ways, including length of time that patients had to stop taking medicines before they could start treatment. The length of time patients had to stop taking medicines was two weeks in the German studies and four weeks in the U.S. study.

What adverse events were observed in the clinical studies?

The side effects (also called reactions) sometimes seen when SYNVISC (hylan g-f 20) is injected into the knee as a first or repeat set of injections were pain, swelling, heat, redness, and/or fluid build-up around the knee. These reactions were generally mild and did not last long.

How do I get more information about the SYNVISC® (hylan g-f 20) product? (User Assistance)

If you have any questions or would like to find out more about SYNVISC (hylan g-f 20) , you may call Genzyme Biosurgery at 1-888-3-SYNVISC (hylan g-f 20) (1-888-379-6847) or visit www.synvisc (hylan g-f 20) .com.

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

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® (hylan g-f 20) product?
  • How is the SYNVISC® (hylan g-f 20) product used? (Indications)
  • How is the SYNVISC® (hylan g-f 20) product given?
  • Are there any reasons why I should not receive SYNVISC® (hylan g-f 20) injections? (Contraindications)
  • What should my doctor warn me about?
  • What are the risks of getting SYNVISC® (hylan g-f 20) injections?
  • What are the benefits of getting SYNVISC® (hylan g-f 20) injections?
  • What do I need to do after I get a SYNVISC® (hylan g-f 20) injection?
  • What other treatments are available for OA?
    • Non-drug treatments
    • Drug therapy
  • What adverse events were observed in the clinical studies?
  • How do I get more information about the SYNVISC® (hylan g-f 20) product? (User Assistance)

What is the SYNVISC® (hylan g-f 20) product?

SYNVISC (hylan g-f 20) is a gel-like mixture that 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. Osteoarthritis (pronounced os-TE-o-ar-THRI-tis) (OA) is a type of arthritis that involves the wearing down of cartilage (the protective covering on the ends of your bones). In OA, there may not be enough hyaluronan, and there may be a decrease in the quality of the hyaluronan in the joint. SYNVISC (hylan g-f 20) comes in syringes containing 2 mL (half a teaspoon) of product. SYNVISC (hylan g-f 20) is injected directly into your knee.

How is the SYNVISC® (hylan g-f 20) product used? (Indications)

The FDA-approved indication for SYNVISC (hylan g-f 20) is:

SYNVISC (hylan g-f 20) 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® (hylan g-f 20) product given?

Your doctor will inject SYNVISC (hylan g-f 20) into your knee.

Are there any reasons why I should not receive SYNVISC® (hylan g-f 20) injections? (Contraindications)

Your doctor will determine if there is any reason why you are not an appropriate candidate for SYNVISC (hylan g-f 20) . You should be aware that SYNVISC (hylan g-f 20) :

  • Should not be used in patients who have had any prior allergic reactions to SYNVISC (hylan g-f 20) , Synvisc (hylan g-f 20) -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, or circulatory problems in the legs.

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 (hylan g-f 20) is only for injection into the knee, performed by a doctor or other qualified health care professional. SYNVISC (hylan g-f 20) has not been tested to show pain relief in joints other than the knee.
  • SYNVISC (hylan g-f 20) 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 (hylan g-f 20) 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 (hylan g-f 20) has not been tested in children ( ≤ 21 years of age).

What are the risks of getting SYNVISC® (hylan g-f 20) injections?

The side effects (also called reactions) sometimes seen when SYNVISC (hylan g-f 20) is injected into the knee as a first or repeat set of injections were pain, swelling, heat, redness, and/or fluid build-up around the knee. These reactions were generally mild and did not last long. If you have a reaction where the swelling is extensive and painful you should notify your doctor. The reactions seemed to occur more often when SYNVISC (hylan g-f 20) was injected into the knee as a repeat set of injections than when SYNVISC (hylan g-f 20) was injected as a first set of injections. 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 less common side effects have been: 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 clot your blood when you are cut or injured). Before you are given SYNVISC (hylan g-f 20) , tell your doctor if something like this has ever happened to you after receiving an injection of SYNVISC (hylan g-f 20) or other hyaluronan products. If any of the above symptoms or signs appear after you are given SYNVISC (hylan g-f 20) , or if you have any other problems, you should call your doctor. Rare cases of knee joint infection have been reported after SYNVISC (hylan g-f 20) injections.

What are the benefits of getting SYNVISC® (hylan g-f 20) injections?

As shown in medical studies of patients with osteoarthritis (OA) of the knee, where approximately half received a single injection of SYNVISC (hylan g-f 20) and the other half either had fluid removed from the knee and/or received injections of the same volume of salt water (a “Saline Control” injection), the major benefits of SYNVISC (hylan g-f 20) are pain relief and improvement in other symptoms related to OA of the knee.

What do I need to do after I get a SYNVISC® (hylan g-f 20) injection?

It is recommended you avoid strenuous activities (for example, highimpact sports such as soccer, tennis or jogging) or prolonged weightbearing 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 (hylan g-f 20) . 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.

What did the clinical studies show?

Two medical studies involving a total of 132 patients were done in Germany. The patients in these studies were at least 40 years old and had knee pain due to OA. The patients were placed in one of two groups. One group was given an injection of SYNVISC (hylan g-f 20) into one or both knees once a week for three weeks. The second group was given an injection of salt water once a week for three weeks. As part of the study, knee joint pain was measured for 26 weeks. Also, patients and doctors were asked to judge the success of the treatment for 26 weeks. Patients with OA knee pain, who did not get pain relief with other medicines, got pain relief with SYNVISC (hylan g-f 20) . The patients given SYNVISC (hylan g-f 20) had more pain relief than the patients given salt water. Some patients started to feel pain relief after the first week of SYNVISC (hylan g-f 20) treatment. The most pain relief and the greatest amount of treatment success was seen 8 to 12 weeks after SYNVISC (hylan g-f 20) treatment started.

A medical study done in the United States involved 90 patients. The patients were at least 40 years old and had knee pain due to OA. Patients were placed into one of two groups. One group was given SYNVISC (hylan g-f 20) once a week for three weeks. The second group had a needle inserted into the knee to have any fluid removed (this procedure is called arthrocentesis [pronounced AR-thro-sen-TEE-sis]) once a week for three weeks.

Patients improved after SYNVISC (hylan g-f 20) treatment, but not more than patients who had arthrocentesis. This study was different from the German studies because the last time the two groups were compared was only two weeks after the last SYNVISC (hylan g-f 20) injection. The study was also different in other ways, including length of time that patients had to stop taking medicines before they could start treatment. The length of time patients had to stop taking medicines was two weeks in the German studies and four weeks in the U.S. study.

What adverse events were observed in the clinical studies?

The side effects (also called reactions) sometimes seen when SYNVISC (hylan g-f 20) is injected into the knee as a first or repeat set of injections were pain, swelling, heat, redness, and/or fluid build-up around the knee. These reactions were generally mild and did not last long.

How do I get more information about the SYNVISC® (hylan g-f 20) product? (User Assistance)

If you have any questions or would like to find out more about SYNVISC (hylan g-f 20) , you may call Genzyme Biosurgery at 1-888-3-SYNVISC (hylan g-f 20) (1-888-379-6847) or visit www.synvisc (hylan g-f 20) .com.

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Synvisc Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

HYALURONATE - INJECTION

(HYE-a-loo-RON-ate)

COMMON BRAND NAME(S): Hyalgan, Synvisc

USES: This medication is used to treat knee pain in patients with joint inflammation (osteoarthritis). It is usually used in patients who have not responded to other treatments such as acetaminophen, exercise, or physical therapy. Hyaluronate (also known as hyaluronan) is similar to a substance that occurs naturally in the joints. It may work by acting as a lubricant and shock absorber in the joint, helping the knee to move smoothly, thereby lessening pain.

HOW TO USE: Read the Patient Information Leaflet provided by your health care professional before you start using hyaluronate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Your doctor will give this medication by injection into the affected joint, usually once a week. Skin disinfectants that contain ammonium salts (such as benzalkonium chloride) should not be used to prepare the injection site. Your doctor may need to remove extra fluid from the joint before injecting the medicine. Dosage is based on your medical condition and response to treatment.

Hyaluronate should not be injected into a vein or artery because increased side effects may occur.

After receiving an injection of hyaluronate, you should avoid any activities that put stress on your knee (such as jogging, tennis, heavy lifting, standing on your feet for more than an hour) for 48 hours.

Also, after the injection, you may experience increased pain and swelling in the knee at first. If the pain or swelling continues or worsens, talk to your doctor promptly.

It is important to have this medication injected on schedule. It may take up to 3 injections before the full benefits of this medication occur.

Tell your doctor if your condition persists or worsens.

Disclaimer

Synvisc Consumer (continued)

SIDE EFFECTS: See also How to Use section.

Pain, swelling, redness/warmth/bruising at the injection site, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: back pain, severe headache, fast/pounding heartbeat, fever, tingling skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Synvisc (hylan g-f 20) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using hyaluronate, tell your doctor or pharmacist if you are allergic to it; or to bird proteins, feathers, or egg products; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the rubber syringe cap of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: knee joint infections, skin infections/problems in the area around the injection site, circulation problems in the legs.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Synvisc Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Non-drug treatments for osteoarthritis include exercising, doing physical therapy, losing weight, having extra fluid removed from the knee, and avoiding activities that cause pain in your knee.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

Information last revised January 2011. Copyright(c) 2011 First Databank, Inc.

Synvisc Patient Information Including Side Effects

Brand Names: Synvisc, Synvisc-One

Generic Name: hylan G-F 20 (Pronunciation: HI lan G F 20)

What is hylan G-F 20 (Synvisc)?

Hylan G-F 20 is similar to the fluid that surrounds the joints in your body. This fluid acts as a lubricant and shock absorber for the joints.

Hylan G-F 20 is used to treat knee pain caused by osteoarthritis.

Hylan G-F 20 is usually given after other arthritis medications have been tried without successful treatment of symptoms.

Hylan G-F 20 may also be used for purposes not listed in this medication guide.

What are the possible side effects of hylan G-F 20 (Synvisc)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe pain or swelling around the knee after the injection.

Less serious side effects may include:

  • warmth, pain, stiffness, swelling, or puffiness where the medicine was injected;
  • muscle pain, trouble walking;
  • fever, chills, nausea;
  • numbness or tingly feeling;
  • headache, dizziness;
  • tired feeling; or
  • itching or skin irritation around the knee.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Synvisc (hylan g-f 20) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about hylan G-F 20 (Synvisc)?

You should not receive hylan G-F 20 if you are allergic to it, or if you have an infection in your knee or in the skin around your knee.

Before you receive a hylan G-F 20 injection, tell your doctor if you have blood clots or circulation problems in your legs, or an allergy to birds, feathers, or egg products.

For at least 48 hours after your injection, avoid jogging, strenuous activity, high-impact sports, or standing for longer than 1 hour at a time.

Call your doctor at once if you have severe pain or swelling around the knee after the injection.

Side Effects Centers

Synvisc Patient Information including How Should I Take

What should I discuss with my health care provider before receiving hylan G-F 20 (Synvisc)?

You should not receive hylan G-F 20 if you are allergic to it, or if you have an infection in your knee or in the skin around your knee.

To make sure you can safely receive hylan G-F 20, tell your doctor if you have:

  • blood clots or circulation problems in your legs; or
  • an allergy to birds, feathers, or egg products.

It is not known whether hylan G-F 20 will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether hylan G-F 20 passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Hylan G-F 20 is generally not used in anyone younger than 21 years old.

How is hylan G-F 20 given (Synvisc)?

Hylan G-F 20 is injected directly into your knee joint. A healthcare provider will give you this injection.

Hylan G-F 20 is usually given once every week for 3 weeks. Follow your doctor's dosing instructions very carefully.

To prevent pain and swelling, your doctor may recommend resting your knee or applying ice for a short time after your injection.

Side Effects Centers

Synvisc Patient Information including If I Miss a Dose

What happens if I miss a dose (Synvisc)?

Call your doctor for instructions if you miss an appointment for your hylan G-F 20 injection.

What happens if I overdose (Synvisc)?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving hylan G-F 20 (Synvisc)?

For at least 48 hours after your injection, avoid jogging, strenuous activity, or high-impact sports such as soccer or tennis. Also avoid weight-bearing activity or standing for longer than 1 hour at a time. Ask your doctor how long to wait before you resume these activities.

What other drugs will affect hylan G-F 20 (Synvisc)?

There may be other drugs that can interact with hylan G-F 20. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor can provide more information about hylan G-F 20.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01. Revision date: 1/5/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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