What is HYALGAN®?


HYALGAN® is a solution that contains a natural substance called hyaluronate. Hyaluronate is normally found in the fluid that lubricates and cushions your knee joint. HYALGAN® is injected into your knee to relieve pain due to osteoarthritis.

HYALGAN® is a treatment option for people who do not get adequate pain relief from simple painkillers (like Tylenol® or Advil®) or from exercise and physical therapy. HYALGAN® injections can be used in addition to prescription pain relievers.

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HYALGAN® is injected directly into your knee by your health care provider.

  • HYALGAN® is a 5-injection regimen given at weekly intervals that provides long-lasting pain relief for up to 6 months
  • Some patients get benefits with 3 injections given at weekly intervals*

* Some patients may experience benefit with 3 HYALGAN® injections given at weekly intervals. This has been noted in published literature on patients receiving 3 injections who were followed for 60 days.

Individual results may vary but HYALGAN® has shown to relieve knee pain for up to 6 months.

Brands listed are the registered trademarks of their respective owners.

Indication

HYALGAN® 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, eg, acetaminophen.

Important Safety Information

HYALGAN is contraindicated in patients with known hypersensitivity to hyaluronate preparations or in cases of present infections or skin diseases in the area of the injection site. Use caution when injecting HYALGAN into patients who are allergic to avian proteins, feathers, and egg products.

What to expect with your HYALGAN® treatment

Five injections given at weekly intervals can provide most patients with long-lasting pain relief for up to 6 months. The duration of pain relief you experience may vary.

Can I get pain relief with fewer than 5 injections of HYALGAN®?

Some patients may experience benefit with 3 injections given at weekly intervals*. This has been noted in studies of published literature receiving 3 injections who were followed for 60 days.

Will treatment with HYALGAN® be all that I need to relieve osteoarthritis knee pain?

Everybody responds differently to pain. For some people, HYALGAN® may provide all the osteoarthritis knee pain relief that's needed. Other people may get the greatest pain relief by adding HYALGAN® injections to the nonprescription or prescription medicines they're already taking. HYALGAN® has no known drug interactions, but if you have questions about other medications you may be taking, talk to your health care provider.

What are the most common side effects of treatment with HYALGAN®?

Side effects sometimes seen when HYALGAN® is injected into the knee are pain, swelling, heat, and/or redness of the joint, as well as rash, itching, or bruising around the HYALGAN® injection area. These reactions were generally mild and did not last long. 14

Can treatment with HYALGAN® be repeated?

Yes. HYALGAN® has been shown to be safe for repeat treatment in a 30-month study. In clinical studies, 1 cycle (5 injections) of HYALGAN® treatment provided pain relief up to 6 months. Because osteoarthritis is a chronic and degenerative condition, you and your health care provider can decide when it's time to repeat the treatment. 9

If you have pain due to osteoarthritis of the knee, there are treatments that do not involve injections of HYALGAN® into the joint.14 These include:

Non-drug treatments:

  • Avoiding activities that cause pain in your knee
  • Physical therapy
  • Removal of excess fluid from the knee
  • Weight loss

Drug therapy:

  • Pain medication such as acetaminophen and prescription opioids
  • Drugs that reduce inflammation, such as aspirin and other non-steroidal anti-inflammatory agents (NSAIDs, such as ibuprofen and naproxen)
  • Corticosteroids that are injected directly into the knee joint

Indication

HYALGAN® 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, eg, acetaminophen.

Important Safety Information

HYALGAN is contraindicated in patients with known hypersensitivity to hyaluronate preparations or in cases of present infections or skin diseases in the area of the injection site. Use caution when injecting HYALGAN into patients who are allergic to avian proteins, feathers, and egg products.

The safety and effectiveness of HYALGAN has not been established in children or in pregnant or lactating women, for use in other joints or for concomitant use with other injectables. It is unknown whether HYALGAN® is excreted in human milk. The effectiveness of a single treatment cycle of less than 3 injections has not been established.

Transient increases in inflammation in the injected knee following HYALGAN injection have been reported in some patients with inflammatory arthritis and should not be injected if objective signs of inflammation are present. Transient pain and/or swelling of the injected joint may occur after intra-articular injection of HYALGAN®. Anaphylactoid and allergic reactions have been reported with the use of this product.

In the US clinical trial, adverse events included injection-site pain, gastrointestinal complaints, headache, local ecchymosis (bruising) and rash, local joint pain and swelling, and local pruritus (itching). In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a treatment cycle.

RX Only.

See the package insert section of this website for full prescribing information.

Product Information

1. What is Hyalgan® (sodium hyaluronate)?

HYALGAN® is a product based on a class of products known as hyaluronic acid, sodium hyaluronate, or hyaluronans.1

It is approved for the treatment of pain due to osteoarthritis of the knee in patients who do not get adequate relief from simple

painkillers or from exercise and physical therapy.2

2. How is HYALGAN® administered?

HYALGAN® is administered by your health care provider as an intra-articular injection into the knee joint.

3. How does HYALGAN® work?

The precise mechanism by which HYALGAN® works is unknown. The fluid (synovial fluid) in your knee helps to lubricate and cushion

the joint during movement. The major component in the synovial fluid is hyaluronic acid. One of the early effects of osteoarthritis

(OA) is the breakdown of this fluid, making it less effective. It is thought that HYALGAN® injection helps restore the synovial fluid

back to a more healthy state, thereby reducing the pain of OA.1,3

4. Why is my doctor recommending I receive HYALGAN®?

HYALGAN® is indicated for patients with osteoarthritis knee pain who do not obtain adequate relief from simple painkillers,

(Tylenol® or Advil®), or from exercise and physical therapy.2

Ask your doctor for additional information and discuss your treatment options.

5. Is HYALGAN® approved for use in the U.S.?

HYALGAN® was the first hyaluronic acid to be approved in the United States in 1997.4

It has a long history of use worldwide with a very favorable safety profile, with over 30 million doses administered since launch, and

has been studied in 110 clinical trials.4

6. What is HYALGAN® made from?

Hyaluronic acid is naturally present in the body and its composition is almost exactly the same in all animal species – including human.

It is particularly in high amounts in joint tissues and in the fluid that fills the knee joint (synovial fluid).1,3 HYALGAN® is made from an

extraction and purification of hyaluronic acid from rooster combs, where it is also found in particularly high amounts.

7. Will my insurance cover HYALGAN®?

Most insurance carriers and Medicare cover HYALGAN®. The process of obtaining reimbursement varies from plan to plan so talk

with your doctor’s office and your insurance provider before you begin treatment to find out if HYALGAN® is covered.

Treatment

8. Why are three or more injections required?

Clinical investigations with HYALGAN® have demonstrated that three*5

 to five6

 injections one week apart provide significant pain

relief and restoration of joint mobility. Completion of the full injection treatment course is recommended to achieve the greatest

therapeutic benefit.2

9. How do I know if HYALGAN® is right for me?

A doctor is the best person to advise you on any course of treatment. HYALGAN® is approved for the treatment of pain due to

osteoarthritis of the knee in patients who do not get adequate relief from simple painkillers or from exercise and physical therapy.2

10. Am I too old for HYALGAN® injections?

There are no specific precautions or contraindications regarding the use of HYALGAN® in older patients. During clinical trials, the

safety profile of HYALGAN® was well established in older patients (greater than 50 years old).7

11. Can I take other medications with HYALGAN®?

Because HYALGAN® is injected directly into the joint and not administered systemically and there are no known drug interactions,8

you may be able to take other medications as well. It is not known to interfere with other pain relievers and anti-inflammatory drugs.

The safety and effectiveness of the use of HYALGAN® concomitantly with other intra-articular injections, such as steroids, have not

been established. You should discuss all of your current medications and vitamin supplements with your physician

on a periodic basis.

12. Can I receive HYALGAN® in both knees?

Yes, if both knees have pain. HYALGAN® treatment may be given in both knees simultaneously or separately, according to your

physician’s recommendations. Because HYALGAN® is only injected locally into the knee joint and not administered systemically, it is

not likely that injections into one knee will have an effect on both knees. Please consult with your physician on his/her recommendation.

13. Should I avoid strenuous activities after receiving HYALGAN® treatment?

It is recommended that you avoid strenuous activities such as jogging, tennis, and heavy lifting or standing on your feet for a long time

for at least 48 hours after receiving an injection.2

Your doctor will advise about what level of activity is right for you, but in general, patients are able to maintain their normal daily

activities after receiving HYALGAN® treatment.

14. How often can HYALGAN® be injected into my knee?

The number of courses/injections is a decision you and your doctor need to make. Your doctor may recommend three*

 or five

HYALGAN® injections and repeat treatment based upon their clinical assessment and discussions with you. Studies show that

retreatment with HYALGAN® is safe following the initial treatment period.2,7 Some insurance plans restrict the frequency at

which you can receive additional injections. Consult your doctor’s office or insurance provider to find out about coverage for any

retreatments you may receive.

15. Can HYALGAN® be used in joints other than the knee?

The U.S. Food and Drug Administration has only approved HYALGAN® for use in the treatment of OA of the knee.2

The FDA has not approved or made an evaluation regarding the safety and effectiveness in other joints.

16. Can HYALGAN® alleviate the signs and symptoms of osteoarthritis of the knee?

There is no cure for osteoarthritis. HYALGAN® is a treatment for the symptoms of knee pain in osteoarthritis, with long-lasting

benefit.2

Benefits

17. When can I expect to experience pain relief?

Each patient’s response to HYALGAN® may vary, depending on severity of your OA, degree of pain, and pre-existing medical

conditions. In some patients, successful treatment may reduce pain within the first week after treatment begins. However, based upon

clinical trials, patients may experience pain relief after their third injection of HYALGAN®.

6

18. Is HYALGAN® treatment effective in knees with advanced osteoarthritis and loss of cartilage?

Clinical studies with HYALGAN® have been primarily done in patients with mild to moderate OA.6

19. What are the benefits of receiving HYALGAN® treatment?

Successful treatment with HYALGAN® should reduce pain in an osteoarthritic knee, resulting in increased mobility and recovery of

joint function.6

Because it is a local treatment, HYALGAN® should not interfere with any concomitant medicine that the patient may take. Please

seek advice from your physician.

20. How long can I expect the benefits of HYALGAN® to last?

Each patient reacts differently to HYALGAN® treatment. Five injections given at weekly intervals can provide most patients with

long-lasting pain relief for up to 6 months. The duration of pain relief you experience may vary.

Some patients may experience benefit with three injections given at weekly intervals.*

 This has been noted in published literature of

patients receiving three injections who were followed for 60 days.

Safety

21. How safe is HYALGAN®?

Extensive safety and toxicity tests were performed on HYALGAN® before the first clinical trials. HYALGAN® has been in use since

1987 in Europe and 1997 in the U.S., with 50 million injections given worldwide since launch.4

In clinical trials, transient local pain or swelling occurred with some patients with injections of HYALGAN®.

2,6

22. What are the side effects of HYALGAN®?

Because HYALGAN® is injected directly into the joint, some patients may feel localized discomfort after treatment.2,6,8 Transient pain,

swelling, and effusion may occur in and around the knee, which usually go away within a short period and do not interfere with the

success of the treatment. If you continue to feel discomfort or notice other problems, you should consult your physician.

23. Are there any allergies that may affect HYALGAN® treatment?

Consult with your doctor if you have a history of allergy, especially if you have had a reaction to intra-articular hyaluronic acid

preparations or are allergic to avian proteins, feathers, and egg products. There are rare reports of patients reporting allergic

reactions to HYALGAN® injections.2

* Some patients may experience benefits with 3 injections, 1 injection per week for 3 weeks. This has been noted in published literature.

Brands listed are the registered trademarks of their respective owners.

References:

1. Greene GW, Banquy X, Lee DW, Lowrey DD, Yu J, Israelachvili JN. Adaptive mechanically controlled lubrication mechanism found in

articular joints. Proc Natl Acad Sci USA. 2011;108:5255-5259.

2. Hyalgan (sodium hyaluronate) [prescribing information]. Fidia Farmaceutici S.p.A.; 2011.

3. Smith MM, Ghosh P. The synthesis of hyaluronic acid by human synovial fibroblasts is influenced by the nature of the hyaluronate in

the extracellular environment. Rheumatol Int. 1987;7:113-122.

4. Hyalgan (sodium hyaluronate). Data on file, Fidia Farmaceutici S.p.A., P950027 and Fidia Farmaceutici S.p.A.

5. Carrabba M, Paresce E, Angelini M, Re KA, Torchiana EEM, Perbellini A. The 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.

6. Altman RD, Moskowitz R, and the HYALGAN® Study Group. Intraarticular sodium hyaluronate (HYALGAN®) in the treatment of

patients with osteoarthritis of the knee: a randomized clinical trial. J Rheumatol. 1998;25:2203-2212.

7. Scali JJ. Intra-articular sodium hyaluronic acid in the treatment of osteoarthritis of the knee: a long term study.

Eur J Rheumatol Inflamm. 1995;15:57-62.

8. Hammesfahr JF, Knopf AB, Stitik T. Safety of intra-articular hyaluronates for pain associated with osteoarthritis of the knee.

Am J Orthop. 2003;32:277-283.

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