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Hyalgan® Indications for Use

Hyalgan® (sodium hyaluronate) is used for the treatment of osteoarthritis (OA) of the knee. It is specifically indicated for patients who have not responded adequately to conservative nonpharmacologic therapy and to simple analgesics such as acetaminophen. The product helps to relieve pain by providing lubrication and cushioning in the knee joint.

Hyalgan® Dosage Information

Hyalgan® is administered as a series of intra-articular injections:

• A typical treatment cycle consists of five injections, given once a week.
• Some patients may benefit from three injections.
• Each vial or pre-filled syringe contains 20 mg of sodium hyaluronate in 2 mL of solution.
• Inject subcutaneous lidocaine before administering Hyalgan® to reduce pain at the injection site.

Hyalgan® Side Effects and Precautions

Patients receiving Hyalgan® may experience several side effects and should be aware of precautions:

• Common adverse events include injection site pain, swelling, and gastrointestinal complaints.
• Local skin reactions such as rash, ecchymosis, and pruritus may occur.
• Anaphylactoid and allergic reactions have been reported.
• Transient increases in inflammation in patients with conditions like rheumatoid arthritis or gouty arthritis have been observed.
• To minimize the risk of infection, avoid administering to patients with infections or skin diseases at the injection site.

Precautions to follow:

• Do not use quaternary ammonium salts for skin preparation, as hyaluronic acid can precipitate in their presence.
• Aseptic technique must be followed during administration.
• Joint effusion, if present, should be removed before injection.
• Patients should avoid strenuous activities for 48 hours following the injection.

Hyalgan® Clinical Studies and Real-World Outcomes

The efficacy and safety of Hyalgan® have been established through clinical studies. One pivotal study in the United States compared Hyalgan® to placebo and naproxen:

• 495 subjects with moderate to severe knee OA pain participated.
• Patients treated with Hyalgan® showed significant improvements in pain reduction during a 50-foot walk test.
• By Week 26, a larger proportion of patients treated with Hyalgan® (56%) experienced success compared to those treated with placebo (41%) or naproxen (45%).
• The study noted that pain relief began by Week 5 and persisted until the end of the study.

Other studies showed that a three-injection course could provide significant pain relief, starting as early as Day 21 and lasting for up to 60 days. However, the benefit beyond this period remains unclear.

Hyalgan® Drug Interactions

Hyalgan® does not have well-established interactions with other intra-articular injectables. Its safety and effectiveness when used alongside other treatments for knee OA have not been confirmed. For patients allergic to avian proteins, feathers, or egg products, caution is advised due to potential allergic reactions.

Hyalgan® Adverse Events

The primary adverse events observed with Hyalgan® include:

• Injection site pain: Experienced by 23% of Hyalgan®-treated patients, compared to 13% of placebo-treated patients.
• Swelling and effusion: Typically, these symptoms resolve within a few days with rest and ice application.
• Gastrointestinal complaints were reported by 29% of Hyalgan®-treated patients.
• There have been rare cases of anaphylactic reactions, which resolved without severe complications.

Hyalgan® has been used clinically in Europe since 1987. Most adverse events are related to local symptoms at the injection site, with very rare instances of intra-articular infections reported. Systemic allergic reactions are also rare.

Hyalgan® Clinical Study Design

In the pivotal U.S. clinical trial:

• Patients were randomized into three treatment groups: Hyalgan®, placebo, or naproxen.
• The trial used a double-masked, placebo- and naproxen-controlled design.
• Patients received weekly injections for up to five weeks.
• Evaluations occurred at Week 5, Week 9, Week 12, and up to Week 26.

Success was measured by a 20 mm decrease in the Visual Analog Scale (VAS) during the 50-foot walk test. At Week 26, the success rate for Hyalgan®-treated patients was significantly higher than for placebo-treated patients.

Hyalgan® Administration Guidelines

Hyalgan® should be administered only by a healthcare professional:

• It is injected intra-articularly into the knee joint using a 20-gauge needle.
• The product is supplied in sterile vials or syringes and should be used immediately after opening.
• The product should be stored at temperatures below 77°F (25°C) and protected from light. Do not freeze the product.

Hyalgan® Adverse Event Management

After the injection, patients may experience pain or swelling in the treated joint. These effects are typically mild and resolve with rest. Patients should be instructed to avoid prolonged weight-bearing activities for 48 hours post-injection.