Hyalgan (Hyaluronate)
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Hyalgan (Hyaluronate)

Hyalgan®
(sodium hyaluronate)

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

DRUG DESCRIPTION

Hyalgan® (hyaluronate) is a viscous solution consisting of a high molecular weight (500,000—730,000 daltons) fraction of purified natural sodium hyaluronate in buffered physiological sodium chloride, having a pH of 6.8—7.5. The sodium hyaluronate is extracted from rooster combs. Hyaluronic acid is a natural complex sugar of the glycosaminoglycan family and is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-N-acetylglucosamine.

What are the possible side effects of sodium hyaluronate (Euflexxa, Hyalgan, Supartz)?

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 a serious side effect such as:

  • severe pain or swelling around the knee after the injection;
  • fast heart rate, sweating, chills or shaking; or
  • heavy feeling, anxiety, confusion.

Less serious side effects may include:

  • warmth, pain, stiffness, swelling, or puffiness where the medicine was injected;
  • nausea,...

Read All Potential Side Effects and See Pictures of Hyalgan »

What are the precautions when taking hyaluronate (Hyalgan)?

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 Hyalgan »

Last reviewed on RxList: 12/15/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Hyalgan® (hyaluronate) 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 to simple analgesics, e.g., acetaminophen.

DOSAGE AND ADMINISTRATION

No information provided.

HOW SUPPLIED

Hyalgan® (hyaluronate) is supplied as a sterile, non-pyrogenic solution in 2 mL vials or 2 mL pre-filled syringes.

Directions for Use

Hyalgan® (hyaluronate) is administered by intra-articular injection. A treatment cycle consists of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly intervals. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.

Precaution: Do not use Hyalgan® (hyaluronate) if the package is opened or damaged. Store in the original packaging (protected from light) below 77° F (25° C). DO NOT FREEZE.

Precaution: Strict aseptic administration technique must be followed.

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

Inject subcutaneous lidocaine or similar local anesthetic prior to injection of Hyalgan® (hyaluronate) .

Precaution: Remove joint effusion, if present, before injection of Hyalgan® (hyaluronate) .

Do not use the same syringe for removing joint effusion and for injecting Hyalgan® (hyaluronate) .

Take care to remove the tip cap of the syringe and needle aseptically.

Inject Hyalgan® (hyaluronate) into the joint through a 20-gauge needle.

Precaution: The vial/syringe is intended for single use. The contents of the vial must be used immediately once the container has been opened. Discard any unused Hyalgan® (hyaluronate) . Inject the full 2 mL in one knee only. If treatment is bilateral, a separate vial should be used for each knee.

REFERENCES

Carrabba M, et al. 1991. Hyaluronic acid sodium salt (Hyalgan® (hyaluronate) ) in the treatment of patients with osteoarthritis of the knee: a controlled trial versus Orgotein, Final Report, April 1991. Data on file.

Carrabba M, Paresce E, Angelini M, Re KA, Torchiana EEM, Perbellini A. Safety and efficacy of different dose schedules of hyaluronic acid in the treatment of painful osteoarthritis of the knee with joint effusion. Eur J Rheumatol Inflamm. 1995;15:25-31.

Dougados M, Nguyen M, Listrat V, Amor B. High molecular weight sodium hyaluronate (hyalectin) in osteoarthritis of the knee: a 1 year placebo-controlled trial. Osteoarthritis Cartilage. 1993:1:97-103.

Kotz R, Kolarz G. Intra-articular hyaluronic acid: duration of effect and results of repeated treatment cycles. Am J Orthop. 1999;28(suppl 11S):5-7.

Leardini G, Franceschini M, Mattara L, Bruno R, Perbellini A. Intra-articular sodium hyaluronate (Hyalgan® (hyaluronate) ) in gonarthrosis. Clin Trials J. 1987;24:341-350.

Scali JJ. Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: a long term study. Eur J Rheumatol Inflamm. 1995;15:57-62.

MANUFACTURED BY: Fidia Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A 35031 Abano Terme, Padua (PD), Italy. DISTRIBUTED BY: Sanofi-Synthelabo Inc. 90 Park Avenue, New York, N.Y. 10016. Revised July 2001. FDA rev date: JULY 2001

Last reviewed on RxList: 12/15/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Hyalgan® (hyaluronate) was investigated in a pivotal clinical investigation conducted in the United States in which there were three arms (164 subjects treated with Hyalgan® (hyaluronate) ; 168 with placebo; and 163 with naproxen) (refer to Table 1).

TABLE 1
Incidence1 of Adverse Events Occuring in More Than 5% of All Subjects

Adverse Event Hyalgan®
N=164
Placebo
N=168
Gastrointestinal complaints2 48 (29%) 59 (36%)
Injection site pain3 38 (23%)4 22 (13%)
Headache 30 (18%) 29 (17%)
Local skin5 23 (14%) 17 (10%)
Local joint pain and swelling6 21 (13%) 22 (13%)
Pruritus (local) 12 (7%) 7 (4%)
1 Notes: Number and % of subjects
2
 Severe in 4 Hyalgan® (hyaluronate) -treated subjects and 4 placebo-treated subjects
3
 Severe in 5 Hyalgan® (hyaluronate) -treated subjects and 2 placebo-treated subjects
4
Statistically significant (p=0.02)
5
Includes ecchymosis and rash
6
 Severe in 2 Hyalgan® (hyaluronate) -treated subjects (1.2%) and 1 placebo-treated subject

Common adverse events reported for the Hyalgan® (hyaluronate) -treated subjects were gastrointestinal complaints, injection site pain, knee swelling/effusion, local skin reactions (rash, ecchymosis), pruritus, and headache. Swelling and effusion, local skin reactions (ecchymosis and rash), and headache occurred at equal frequency in the Hyalgan® (hyaluronate) and placebo-treated groups. Hyalgan® (hyaluronate) -treated subjects had 48/164 (29%) incidents of gastrointestinal complaints that were not statistically different from the placebo-treated group. A statistically significant difference in the occurrence of pain at the injection site was noted in the Hyalgan® (hyaluronate) -treated subjects; 38/164 (23%) in comparison to 22/168 (13%) in the placebo-treated subjects (p=0.022). There were 6/164 (4%) premature discontinuations in Hyalgan® (hyaluronate) -treated subjects due to injection site pain in comparison to 1/168 ( < 1%) in the placebo-treated subjects. These differences were not statistically significant.

Two (2/164, 1.2%) Hyalgan® (hyaluronate) -treated subjects and 3/168 (1.8%) placebo-treated subjects were reported to have positive bacterial cultures of effusion aspirated from the treated knee. The two Hyalgan® (hyaluronate) -treated subjects and two of the placebo-treated subjects did not exhibit evidence of infection clinically or subsequently and were not treated with antibiotics. One of the placebo-treated subjects was hospitalized and received presumptive treatment for septic arthritis.

Hyalgan® (hyaluronate) has been in clinical use in Europe since 1987. Analysis of the adverse events that have been reported with the use of Hyalgan® (hyaluronate) in Europe reveals that most of the events are related to local symptoms such as pain, swelling/effusion, and warmth or redness at the injection site. In the two events reported as anaphylactoid reactions, Hyalgan® (hyaluronate) treatment was discontinued and both had favorable outcomes. Three cases of allergic reactions were reported in which the patients were discontinued from Hyalgan® (hyaluronate) treatment and the incidents resolved. Seven cases of fever were reported in which three of the cases were reported to be associated with local reactions; pyogenic arthritis was reported to be ruled out in these three cases. All the fever patients were discontinued from Hyalgan® (hyaluronate) treatment and all incidents resolved. One incident of shock (which was described as a "hypotensive crisis") was reported. The incident resolved and Hyalgan® (hyaluronate) treatment was continued.

Adverse experience data from the literature contain no evidence of increased risk relating to retreatment with Hyalgan® (hyaluronate) . The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle. (Carrabba et al., 1995; Carrabba et al., 1991; Kotz and Kolarz, 1999; Scali, 1995).

Read the Hyalgan (hyaluronate) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 12/15/2008
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 hyaluronic acid can precipitate in their presence.
  • Anaphylactoid and allergic reactions have been reported with this product. See Adverse Events Section for more detail.
  • Transient increases in inflammation in the injected knee following Hyalgan® (hyaluronate) injection in some patients with inflammatory arthritis such as rheumatoid arthritis or gouty arthritis have been reported.

PRECAUTIONS

General

  • The effectiveness of a single treatment cycle of less than 3 injections has not been established.
  • The safety and effectiveness of the use of Hyalgan® (hyaluronate) in joints other than the knee have not been established.
  • he safety and effectiveness of the use of Hyalgan® (hyaluronate) concomitantly with other intra-articular injectables have not been established.
  • Use caution when injecting Hyalgan® (hyaluronate) into patients who are allergic to avian proteins, feathers, and egg products.
  • Strict aseptic administration technique must be followed.
  • STERILE CONTENTS. The vial/syringe is intended for single use. The contents of the vial must be used immediately once the container has been opened. Discard any unused Hyalgan® (hyaluronate) .
  • Do not use Hyalgan® (hyaluronate) if the package is opened or damaged. Store in the original packaging (protected from light) below 77° F (25°C). DO NOT FREEZE.
  • Remove joint effusion, if present, before injecting Hyalgan® (hyaluronate) .

Information for Patients

  • Provide patients with a copy of the PATIENT INFORMATION prior to use.
  • Transient pain and/or swelling of the injected joint may occur after intra-articular injection of Hyalgan® (hyaluronate) .
  • As with any invasive joint procedure, it is recommended that the patient avoid any strenuous activities or prolonged (i.e., more than 1 hour) weight-bearing activities such as jogging or tennis within 48 hours following the intra-articular injection.

Use in Specific Populations

  • Pregnancy: Teratogenic Effects- Reproductive toxicity studies, including multigeneration studies, have been performed in rats, and rabbits at doses up to 11 times the anticipated human dose (1.43 mg/kg per treatment cycle) and have revealed no evidence of impaired fertility or harm to the experimental animal fetus due to intra-articular injections of Hyalgan® (hyaluronate) . Animal reproduction studies are not always predictive of human response. The safety and effectiveness of Hyalgan® (hyaluronate) have not been established in pregnant women.
  • Nursing Mothers: It is not known if Hyalgan® (hyaluronate) is excreted in human milk. The safety and effectiveness of Hyalgan® (hyaluronate) have not been established in lactating women.
  •  Pediatrics: The safety and effectiveness of Hyalgan (hyaluronate) ® have not been demonstrated in children.

Last reviewed on RxList: 12/15/2008
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 to hyaluronate preparations.
  • Intra-articular injections are contraindicated in cases of infections or skin diseases in the area of the injection site.

Last reviewed on RxList: 12/15/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Clinical Study

The use of Hyalgan® (hyaluronate) as a treatment for pain in OA of the knee was investigated in a multicenter clinical trial conducted in the United States.

Study Design

This study was a double-masked, placebo and naproxen-controlled, multicenter prospective clinical trial with three treatment arms, as summarized in Table 2. A total of 495 subjects with moderate to severe pain was randomized (at baseline evaluation) into three treatment groups in a ratio of 1:1:1 Hyalgan® (hyaluronate) , placebo, or naproxen.

TABLE 2
STUDY DESIGN

Routes of Administration Hyalgan® Placebo Naproxen
s. c. Lidocaine (1%) Lidocaine (1%) Lidocaine (1%)
i. a.* Hyalgan® (20 mg/2 mL) Phosphate-Buffered Saline (2 mL) none
p. o. / b. i. d. Placebo for naproxen capsules Placebo for naproxen capsules Naproxen capsules (500 mg)
p. o. / p. r. n. (not to exceed 4 grams / day) Acetaminophen Acetaminophen Acetaminophen
Legend: s.c.=subcutaneous; i.a.=intra-articular; p.o.=by mouth; b.i.d.=twice a day; p.r.n.=as needed
* Synovial fluid was aspirated (when present) in the Hyalgan® (hyaluronate) and placebo groups.

Patient Population and Demographics

The demographics of trial participants were comparable across treatment groups with regard to age, sex, race, height, weight, history of osteoarthritis, prior use of NSAIDs, prior physical therapy, and use of assistive devices (refer to Table 3).

TABLE 3
Demographic Characteristics of All Randomized Subjects

DEMOGRAPHIC VARIABLE TREATMENT  
Hyalgan®
N=164
Placebo
N=168
Naproxen
N=163
TOTAL
N=495
AGE (years):
   Mean 63.5 64.3 63.2 63.7
   SD 10.1 10.0 9.2 9.8
   Range 41-90 44-85 40-80 40-90
Gender [N (%)]:
   Female 99 (60.3) 91 (54.1) 99 (60.7) 289 (58.4)
   Male 65 (39.6) 77 (45.8) 64 (39.3) 206 (41.6)
Race [N (%)]:
   Caucasian 137 (83.6) 135 (80.4) 133 (81.6) 405 (81.8)
   Black 23 (14.0) 32 (19.0) 25 (15.3) 80 (16.2)
   Other 4 (4.2) 1 (1.0) 5 (3.1) 10 (2.0)
Height (cm):
   Mean 167.8 168.6 167.6 168.0
   SD 8.8 10.7 11.9 10.5
   Range 145-190 142-193 102-198 102-198
Weight (kg):
   Mean 88.4 88.1 89.7 88.7
   SD 18.0 18.2 18.4 18.2
   Range 46-139 49-170 45-150 45-170
   NSAIDs Use 107 (65.2) 117 (69.6) 113 (69.3) 337 (68.1)
(N, %)
   Use of Assistive 35 (21.3) 34 (20.2) 32 (19.6) 101 (20.4)
Devices (N, %)
   Physical Therapy
(N, %)
20 (12.2) 17 (10.1) 25 (15.3) 62 (12.5)

Legend: cm=centimeters; kg=kilograms; SD=standard deviation

Evaluation Schedule

After meeting initial screening requirements NSAID therapy was discontinued. After 2 weeks, all subjects returned for baseline evaluations. The baseline evaluation included assessment of three primary effectiveness criteria; measurement of pain during a 50-foot walk test using a 100 mm Visual Analog Scale (VAS), a categorical assessment (0=none to 5=disabled) of pain, as assessed by a masked evaluator, during the 48 hours preceding the visit, and a categorical assessment (0=none to 5=disabled) of pain, as assessed by the subject, during the 48 hours preceding the visit.

All subjects who completed the NSAID washout period and met all entry requirements received their first injection after randomization. All subjects received subcutaneous lidocaine injections. Intra-articular injections (Hyalgan® (hyaluronate) , placebo) were administered weekly for a total of 5 injections (Weeks 0—4). The naproxen group received 500 mg of naproxen to be taken b.i.d. for 26 weeks.

Subsequent visits and evaluations took place at Weeks 5, 9, 12, 16, 21, and 26. Safety and effectiveness criteria were assessed and recorded at these time periods.

Clinical Results

For this trial, overall success for effectiveness was defined as meeting all four of the success criteria listed in Table 4 using scores from week 26. The criteria were met (refer to Tables 4 through 8).

TABLE 4
Clinical Results

Evaluation Success Criteria Results
100 mm VAS for pain during 50 foot walk. A statistically significant (alpha=0.05) reduction on mean VAS for Hyalgan® when compared to placebo at Week 26. This difference was also to exceed one fourth of the Standard Deviation of the mean change from baseline. At Week 26, the difference between the Hyalgan®-treated group and the placebo-treated group adjusted means was 8.85 mm (p=0.0043), which is a difference of approximately one-third of a standard deviation (Table 5).
Masked Evaluator Categorical Assessment of subject pain (0=none to 5=disabled) during the 48 hours preceding visits. The number of Hyalgan®-treated subjects showing improvement at Week 26 was to be concordant with the VAS results, however, not required to be independently statistically significant. At Week 26 the masked evaluator's categorical assessment of pain indicated that the Hyalgan®-treated subjects experienced less pain than the placebo-treated subjects (Table 6).
Subjects' Categorical Assessment of pain (0=none to 5=disabled) during the 48 hours preceding visits. The number of Hyalgan®-treated subjects showing improvement at Week 26 was to be concordant with the VAS results; however, not required to be independently statistically significant. At Week 26 the subjects' categorical assessment of pain indicated that the Hyalgan®-treated subjects experienced less pain than the placebo-treated subjects (Table 7).
Magnitude of the observed effect for Hyalgan® versus placebo on both the VAS and the categorical pain assessments. At Week 26 the magnitude of the observed effect for Hyalgan® versus placebo on both the VAS and the categorical pain assessments were to be at least 50% of those observed for the naproxen group. The improvement in pain on the VAS exhibited by the Hyalgan® (hyaluronate) -treated group relative to the placebo-treated group were at least 50% of the benefits exhibited by the naproxen-treated group relative to the placebo-treated group.
The results of the categorical assessments by the masked evaluator and the subject indicated that improvement of the Hyalgan® (hyaluronate) -treated group relative to the placebo-treated group was at least 50% of the benefits exhibited by the naproxen-treated group relative to the placebo-treated group (Table 8).

TABLE 5
ANCOVA of 50-Foot Walk Test (mm) VAS by Week for All Completed Subjects

  Week
3 4 5 9 12 16 21 26
Adjusted Means Hyalgan® 27.23 21.54 19.29 20.04 20.26 20.83 18.44 17.88
Placebo 32.35 28.57 25.67 24.28 26.66 25.44 24.77 26.73
Hyalgan® versus Placebo 5.13 7.03 6.39 4.24 6.40 4.61 6.33 8.846
p-value 0.06 0.01 0.01 0.1 0.03 0.1 0.02 0.004

TABLE 6
Masked Evaluators' Categorical Assessments of Pain for Completed Subjects in Prior 48 Hours: Level of Pain by Treatment Group at Baseline and Week 26

  NUMBER (%) OF SUBJECTS IN CATEGORY
Hyalgan® Placebo Naproxen
Baseline Week 26 Baseline Week 26 Baseline Week 26
None (0) 0 (0.0) 27 (25.7) 0 (0.0) 15 (13.0) 0 (0.0) 17 (15.0)
Slight (1) 1 (1.0) 23 (21.9) 0 (0.0) 27 (23.5) 0 (0.0) 32 (28.3)
Mild (2) 2 (1.9) 24 (22.9) 2 (1.7) 29 (25.2) 2 (1.8) 27 (23.9)
Moderate (3) 69 (65.7) 26 (24.8) 85 (73.9) 34 (29.6) 79 (70.5) 28 (24.8)
Marked (4) 33 (31.4) 5 (4.8) 28 (24.3) 10 (8.7) 31 (27.7) 9 (8.0)
TOTAL 105 (100) 105 (100) 115 (100) 115 (100) 112* (100) 113 (100)
One Naproxen treated subject was missing a balance assessment.

TABLE 7
Subjects' Categorical Assessments of Pain For Completed Subjects in Prior 48 Hours: Level of Pain by Treatment Group at Baseline and Week 26

  NUMBER (%) OF SUBJECTS IN CATEGORY
Hyalgan® Placebo Naproxen
Baseline Week 26 Baseline Week 26 Baseline Week 26
None (0) 1 (1.0) 23 (21.9) 0 (0.0) 14 (12.2) 0 (0.0) 13 (11.5)
Slight (1) 2 (1.9) 27 (25.7) 0 (0.0) 24 (20.9) 1 (0.9) 31 (27.4)
Mild (2) 6 (5.7) 19 (18.1) 8 (7.0) 24 (20.9) 7 (6.2) 26 (23.0)
Moderate (3) 62 (59.0) 26 (24.8) 78 (67.8) 40 (34.8) 72 (63.7) 31 (27.4)
Marked (4) 34 (32.4) 10 (9.5) 29 (25.2) 13 (11.3) 33 (29.2) 12 (10.6)
TOTAL 105 (100) 105 (100) 115 (100) 115 (100) 113 (100) 113 (100)

TABLE 8
Hyalgan® (hyaluronate) Effect as a Percentage of the Naproxen-Placebo Difference

Assessment Hyalgan®
(HYL)
Placebo
(PLA)
Naproxen
(NAP)
HYL-PLA NAP-HYL NAP- PLA (HYL-PLA) % of (NAP-PLA)
VAS for 50 footWalk Baseline Adjusted Mean Effect SizesFrom ANCOVA       -8.85 mm on a 100 mm VAS 4.12 mm on a 100 mm VAS -4.73*mm on a 100 mm VAS 187 %
% of Subjects Improved by Masked Evaluators 78.1 69.6 73.2 8.5 -4.9 3.6 236 %
% of Subjects Improved by Subjects 73.3 62.6 67.3 10.7 -6.0 4.7 228 %
*Imputed as (NAP-HYL)+(HYL-PLA).
Note that Effectiveness Success Criterion D is satisfied since ((HYL-PLA) % of (NAP-PLA)) > 50% for all three of the above pain assessments.

Additional Analyses

a . An analysis of study completers was performed as follows: Success was defined as 1) achieving a 20 mm decrease in the VAS for the 50-foot walk test by Week 5, and 2) maintaining this improvement through Week 26. In this analysis greater proportions of Hyalgan® (hyaluronate) -treated subjects (59/105, 56%) than either placebo- (47/115, 41%) or naproxen-treated subjects (51/113, 45%) were successful under this definition. The Hyalgan® (hyaluronate) -placebo comparison was statistically significant (p=0.031, Fisher's Exact Test).

Since patients were not followed beyond Week 26, it is unknown how long pain relief continued. There are reports in the literature of some patients experiencing benefit beyond 26 weeks.

b . Categorical Assessment of Pain - Subjects: A longitudinal analysis of categorical assessment of pain by the subject, which analyzed the percentage of subjects who attained success, revealed that a significantly higher percentage of Hyalgan® (hyaluronate) -treated subjects as compared to the placebo-treated subjects (55/105, 52% vs 43/115, 37%, p=0.030, Fisher's Exact Test) achieved success (an improvement of greater than or equal to one point on the five-point scale) and maintained this success from Week 5 until Week 26.

Supplementary Clinical Information

Three randomized, controlled clinical investigations were performed that provide information about a three-injection treatment course of Hyalgan® (hyaluronate) . In all of the studies the patients were followed for 60 days. Two studies provided a comparison to placebo. One of the placebo-controlled studies evaluated two treatment doses of Hyalgan® (hyaluronate) , 20 mg/2 mL and 40 mg/2 mL. The 20 mg/2 mL treatment arm included 19 knees, the 40 mg/2 mL included 20 knees, and the placebo arm included 18 knees. The other placebo study included 20 knees in the treatment group and 18 knees in the placebo-treatment group. The third study provided a comparison between patients treated with three weekly injections of Hyalgan® (hyaluronate) followed by 2 weekly treatments with arthrocentesis with patients treated with arthrocentesis for five weeks, and arthrocentesis and placebo injections for five weeks. Additional arms of this study assessed different treatment regimens. Statistical evaluation of the data was performed at day 60. In this study only patients considered to be a success were followed beyond day 60. These patients were followed for 180 days; however, due to the number of dropouts, statistical evaluation was not performed on data at time points beyond day 60. The results of these investigations reported that the three-injection Hyalgan® (hyaluronate) treated patients experienced pain relief beginning at day 21 and continuing throughout the 60-day observation period.

Safety

In order for the product to be considered safe, the incidence of severe swelling and pain consequent to intra-articular injection should be less than 5%. This criterion was met as indicated in Table 1. See the Adverse Events Section.

Detailed Device Description

Each vial or syringe contains:

   Sodium Hyaluronate 20.0 mg
   Sodium chloride 17.0 mg
   Monobasic sodium phosphate • 2H2O 0.1 mg
   Dibasic sodium phosphate • 12H2O 1.2 mg
   Water for injection q.s.* to 2.0 mL

*q.s. = up to

Last reviewed on RxList: 12/15/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 12/15/2008
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 12/15/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Hyalgan 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

Hyalgan 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 Hyalgan (hyaluronate) 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

Hyalgan 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.

Hyalgan Patient Information Including Side Effects

Brand Names: Euflexxa, Hyalgan, Supartz

Generic Name: sodium hyaluronate (injection) (Pronunciation: SO dee um HYE al yoo RON ate)

What is sodium hyaluronate (Hyalgan)?

Sodium hyaluronate is similar to the fluid that surrounds the joints in your body. This fluid acts as a lubricant and shock absorber for the joints.

Sodium hyaluronate is used to treat knee pain caused by osteoarthritis.

Sodium hyaluronate is usually given after other arthritis medications have been tried without successful treatment of symptoms.

Sodium hyaluronate may also be used for purposes not listed in this medication guide.

What are the possible side effects of sodium hyaluronate (Hyalgan)?

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 a serious side effect such as:

  • severe pain or swelling around the knee after the injection;
  • fast heart rate, sweating, chills or shaking; or
  • heavy feeling, anxiety, confusion.

Less serious side effects may include:

  • warmth, pain, stiffness, swelling, or puffiness where the medicine was injected;
  • nausea, stomach pain;
  • headache;
  • back pain;
  • numbness or tingly feeling;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • 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 Hyalgan (hyaluronate) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about sodium hyaluronate (Hyalgan)?

You should not receive sodium hyaluronate 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 sodium hyaluronate 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

Hyalgan Patient Information including How Should I Take

What should I discuss with my health care provider before receiving sodium hyaluronate (Hyalgan)?

You should not receive sodium hyaluronate 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 sodium hyaluronate, 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 sodium hyaluronate 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 sodium hyaluronate 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.

How is sodium hyaluronate given (Hyalgan)?

Sodium hyaluronate is injected directly into your knee joint. A healthcare provider will give you this injection.

Sodium hyaluronate is usually given once every week for 3 to 5 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

Hyalgan Patient Information including If I Miss a Dose

What happens if I miss a dose (Hyalgan)?

Call your doctor for instructions if you miss an appointment for your sodium hyaluronate injection.

What happens if I overdose (Hyalgan)?

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 sodium hyaluronate (Hyalgan)?

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 sodium hyaluronate (Hyalgan)?

There may be other drugs that can interact with sodium hyaluronate. 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 sodium hyaluronate.


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.

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