Synvisc-One

PATIENT INFORMATION

Be sure to read the following important information carefully. This in formation 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 be obtained only by prescription.

Osteoarthritis (pronounced OS-te-o-arth-RI-tis): (OA) is a type of arthritis that involves the wearing down of cartilage (the protective covering on the ends of your bones) and loss of cushioning fluid in the joint.

Table of Contents

  • Glossary of Terms
  • Table of Contents
  • What is the Synvisc-One® (hylan g-f 20 single intra-articular injection) product?
  • How is the Synvisc-One® (hylan g-f 20 single intra-articular injection) product used? (Indications)
  • How is the Synvisc-One® (hylan g-f 20 single intra-articular injection) product given?
  • Are there any reasons why I should not receive a Synvisc-One® (hylan g-f 20 single intra-articular injection) injection? (Contraindications)
  • What should my doctor warn me about?
  • What are the risks of getting a Synvisc-One® (hylan g-f 20 single intra-articular injection) injection?
  • What are the benefits of getting a Synvisc-One® (hylan g-f 20 single intra-articular injection) injection?
  • What do I need to do after I get Synvisc-One® (hylan g-f 20 single intra-articular injection) injection?
  • What other treatments are available for OA?
    • Non-drug treatments
    • Drug therapy
  • When should you call your doctor? (Troubleshooting)
  • What adverse events were observed in the clinical study?
  • How do I get more information about the

Synvisc-One® (hylan g-f 20 single intra-articular injection) product? (User Assistance)

What is the Synvisc-One® (hylan g-f 20 single intra-articular injection) product?

Synvisc-One (hylan g-f 20 single intra-articular injection) is a gel-likemixture that comes in a syringe containing 6 mL (1 ½ teaspoon) and is injected into your knee. It is made up of hylanAfluid, hylan B gel, and salt water. Hylan A and hylan B are made from a substance called hyaluronan (pronounced hy-al-u-ROE-nan), also known as sodium hyaluronate that comes from chicken combs. Hyaluronan is a natural substance found in the body and is present in very high amounts in joints. The body's own hyaluronan acts like a lubricant and a shock absorber in the joint and is needed for the joint to work properly.

How is the the Synvisc-One® (hylan g-f 20 single intra-articular injection) product used? (Indications)

The FDA-approved indication for Synvisc-One (hylan g-f 20 single intra-articular injection) is: Synvisc-One (hylan g-f 20 single intra-articular injection) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

How is the Synvisc-One® (hylan g-f 20 single intra-articular injection) product given?

Your doctor will inject Synvisc-One (hylan g-f 20 single intra-articular injection) into your knee.

Are there any reasons why I should not receive a Synvisc-One® (hylan g-f 20 single intra-articular injection) injection? (Contraindications)

Your doctorwill determine if there is any reasonwhy you are not an appropriate candidate for Synvisc-One (hylan g-f 20 single intra-articular injection) . You should be aware that Synvisc-One (hylan g-f 20 single intra-articular injection) :

  • Should not be used in patients who have had any prior allergic reactions to SYNVISC, Synvisc-One (hylan g-f 20 single intra-articular injection) 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 are a 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-One (hylan g-f 20 single intra-articular injection) is only for injection into the knee, performed by a doctor or other qualified health care professional. Synvisc-One (hylan g-f 20 single intra-articular injection) has not been tested to show pain relief in joints other than the knee.
  • Synvisc-One (hylan g-f 20 single intra-articular injection) 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-One (hylan g-f 20 single intra-articular injection) has not been tested in pregnant women, or women who are nursing. You should tell your doctor if you think you are pregnant, or if you are nursing a child.
  • Synvisc-One (hylan g-f 20 single intra-articular injection) has not been tested in children ( ≤ 21 years of age).

What are the risks of getting a Synvisc-One® (hylan g-f 20 single intra-articular injection) injection?

The side effects (also called reactions) sometimes seen after any injection into the knee, including Synvisc-One (hylan g-f 20 single intra-articular injection) , include: pain, swelling, heat, redness, and/or fluid buildup around the knee. These reactions are generally mild and do not last long. Reactions are generally treated by resting and applying ice to the injected knee. Sometimes it is necessary to give pain relievers by mouth such as acetaminophen or NSAIDs, or to give injections of steroids, or to remove fluid from the knee joint. Patients rarely undergo arthroscopy (a surgical inspection of the knee joint) or other medical procedures related to these reactions.

Other side effects seen with SYNVISC or Synvisc-One (hylan g-f 20 single intra-articular injection) are: rashes, hives, itching, muscle pain/cramps, flushing and/or swelling of your face, fast heartbeat, nausea (or feeling sick to your stomach), dizziness, fever, chills, headache, difficulty breathing, swelling in your arms and/or legs, prickly feeling of your skin, and in rare cases a low number of platelets in the blood (platelets are a type of blood cell that are needed to help your blood clot when you are cut or injured). Rare cases of knee joint infection have been reported. If any of the above side effects or symptoms appear after you are given Synvisc-One (hylan g-f 20 single intra-articular injection) , or if you have any other problems, you should call your doctor.

What are the benefits of getting a Synvisc-One® (hylan g-f 20 single intra-articular injection) injection?

As shown in a medical study of 253 patients with osteoarthritis (OA) of the knee, where approximately half received either a single injection of Synvisc-One (hylan g-f 20 single intra-articular injection) or an injection of the same volume of salt water (a “Saline Control” injection), the major benefits of Synvisc-One (hylan g-f 20 single intra-articular injection) 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-One® (hylan g-f 20 single intra-articular injection) injection?

It is recommended you avoid strenuous activities (for example, high-impact sports such as tennis or jogging) or prolonged weight-bearing activities for approximately 48 hours following the injection. You should consult your doctor regarding the appropriate time to resume such activities.

What other treatments are available for OA?

If you have OA, there are other things you can do besides getting Synvisc-One (hylan g-f 20 single intra-articular injection) . 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 non-steroidal anti-inflammatory drugs (NSAIDs, for example ibuprofen and naproxen)
  • Steroids that are injected directly into your knee

When should I call my doctor? (Troubleshooting)

If any of the side effects or symptoms described above appear after you are given Synvisc-One (hylan g-f 20 single intra-articular injection) , or if you have any other problems, you should call your doctor.

What did the clinical studies show?

A study was conducted in 6 countries outside the United States with 21 physicians. The patients in the study had mild to moderate knee OA, moderate to severe pain, and did not have sufficient relief of their pain and symptoms with medications taken by mouth.

A total of 253 patients in the study were assigned by chance to receive either a single injection of Synvisc-One (hylan g-f 20 single intra-articular injection) (n=123 patients), or an injection of the same volume of salt water (a “Saline Control” injection) (n=130 patients). Neither the patients nor the doctors evaluating them knew which treatment they received. Any fluid that was present in the patient's knee was removed before the injection. The patients were seen by their doctor at standard times over 6 months. Information was collected about how much pain they were experiencing doing various types of activities, how much they were limited in their daily activities by their OA, and on their overall condition. Their doctor also provided an overall rating of their OA.

The main measure of the study was how much pain the subjects had doing five common types of activities over the 6 months duration of the study. Daily activity limitations and overall evaluations were also compared between the group of patients receiving Synvisc-One (hylan g-f 20 single intra-articular injection) injection and the group receiving salt water injection. The study showed that patients receiving Synvisc-One (hylan g-f 20 single intra-articular injection) had significantly less pain over 6 months, and felt significantly better than the patients who received the salt water injections. The difference in pain score reduction from baseline to 6 months between the Synvisc-One (hylan g-f 20 single intra-articular injection) and salt water control injection was 0.15 out of a 5 point scale for the measurement of OA pain in the knee.

What adverse events were observed in the clinical study?

The following are the most common adverse events that occurred during the clinical trial of Synvisc-One (hylan g-f 20 single intra-articular injection) :

  • Pain in the knee or at the injection site
  • Stiffness, swelling or warmth in or around the knee
  • Changes in the way that you walk (e.g., limping)

Severe adverse events were not observed in the Synvisc-One (hylan g-f 20 single intra-articular injection) trial. Joint infections did not occur in the injected knee in the Synvisc-One (hylan g-f 20 single intra-articular injection) clinical trial. The most commonly occurring adverse events outside of the injected knee were headache, back pain, sore throat and the flu. One patient had a single episode of feeling faint.

How do I get more information about the Synvisc-One® (hylan g-f 20 single intra-articular injection) product? (User Assistance)

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

Last reviewed on RxList: 7/29/2010
This monograph has been modified to include the generic and brand name in many instances.

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