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The OsteoArthritis Support and Information Service (OASIS) is a complimentary online support program. If you haven’t enrolled already, log onto www.HYALGAN.com. By enrolling you will receive: • The OASIS Welcome Kit • Knee Knowledge • The OASIS Action Tracker • The OASIS Joint Important Safety Information You should not take this product if you have had any previous allergic reaction to HYALGAN® or other medications containing hyaluronan. You should not have an injection into the knee if you have an infection or skin disease in the area of the injection site. Indication HYALGAN® is used to relieve knee pain due to osteoarthritis. It is used for patients who do not get adequate relief from simple painkillers or from exercise and physical therapy. Please see full Important Safety Information on page 12, complete Patient Information on pages 13-19, and accompanying full Prescribing Information. Visit www.HYALGAN.com © 2010 sanofi-aventis U.S. LLC US.HYA.10.06.005 July 2010 Printed in USA Important Safety Information You should not take this product if you have had any previous allergic reaction to HYALGAN® or other medications containing hyaluronan. You should not have an injection into the knee if you have an infection or skin disease in the area of the injection site. Indication HYALGAN® is used to relieve knee pain due to osteoarthritis. It is used for patients who do not get adequate relief from simple painkillers or from exercise and physical therapy. Ask your health care provider if HYALGAN® is right for you Please see full Important Safety Information on page 12, complete Patient Information on pages 13-19, and accompanying full Prescribing Information. OA is a disease that affects the joints How is it caused? Normally, smooth cartilage covers and protects the ends of your bones where they meet in the knee joint. In addition, a thick and slippery fluid in the joint provides lubrication and extra cushioning. The actual cause of osteoarthritis is not known. There are many factors that are believed to contribute to the chances of getting osteoarthritis. When you have osteoarthritis of the knee: •Being overweight •Getting older •Joint injury •Poorly formed joints •Genetic factors •Overuse from a physically active lifestyle •The smooth cartilage gradually wears away and becomes softer and less protective •The joint fluid loses its lubricating and cushioning abilities •The resulting pain and stiffness can make walking difficult 2 Some of these include: 3 The diagram below shows a healthy knee. You can see the smooth cartilage that covers the ends of the bones and the natural joint fluid that helps lubricate and cushion the knee. Healthy Knee The diagram below shows a knee with osteoarthritis. The cartilage is worn away and the joint fluid becomes thinner and less slippery. The result is that the bones in the knee joint are less protected from the stresses of use, such as walking. And the knee becomes painful and stiff. Knee with OA Bone Healthy cartilage Joint fluid 4 Worn-away cartilage Joint space narrowing Thinner; less slippery joint fluid 5 OA can affect anyone OA pain can be treated Osteoarthritis is the most common form of arthritis. It usually begins after age 40 and is most common in people over age 65, but people in their 20s or 30s can get osteoarthritis too. The treatment that’s right for you depends on how your osteoarthritis has progressed, how much pain you have, and what has worked for you in the past. Overuse of the knee joint, job- or sportsrelated injuries, being overweight, and family history can all play a role in osteoarthritis. If you have one or more of these symptoms in your knee, you may have OA: •Aches and pains, especially with motion •Stiffness, especially in the morning and when standing up •“Grating” or “catching” sensations •Limited motion •Redness and swelling If you experience any of the above, talk to your health care provider. Please see full Important Safety Information on page 12, complete Patient Information on pages 13-19, and accompanying full Prescribing Information. Visit www.HYALGAN.com 6 Treatment options may include one or more of the following: •Physical therapy, exercise, and weight loss •Nonprescription pain relievers such as acetaminophen (Tylenol®)*, aspirin, ibuprofen (Advil®)*, and naproxen (Aleve®)* •Prescription medicines like Celebrex®* and Mobic®* •Hyaluronan injections, such as HYALGAN® •Steroid injections •Knee surgery Important Safety Information • Tell your doctor if you are allergic to products from birds, such as feathers, eggs and poultry or if your leg is swollen or infected. Talk to your doctor before resuming strenuous weight-bearing activities after treatment *Tylenol is a registered trademark of McNeil Consumer Healthcare, a Division of MCNEIL-PPC, Inc. Advil and Celebrex are registered trademarks of Pfizer Inc. Aleve is a registered trademark of Bayer HealthCare LLC. Mobic is a registered trademark of Boehringer Ingelheim Pharmaceuticals. 7 HYALGAN® (HI-al-gan) contains a natural substance called hyaluronate, and is injected into your knee to relieve pain. Hyaluronate is normally found in the fluid that lubricates and cushions your knee joint. HYALGAN® is a treatment option for people who do not get adequate pain relief from simple painkillers (eg, Tylenol®, Advil®) or from exercise and physical therapy. HYALGAN® is injected into the knee •HYALGAN® is injected directly into your knee by your health care provider •Studies have shown that 5 injections given at weekly intervals can provide long-lasting pain relief for up to 6 months •Some patients get benefits with just HYALGAN® is not a drug. Its active ingredient is a natural product that is injected directly into the knee. HYALGAN® works differently from pain pills because it does not pass through your bloodstream to work. • HYALGAN® has no known drug interactions • You can safely repeat your treatment with HYALGAN® Important Safety Information • The most common side effects of HYALGAN® therapy are gastrointestinal complaints, injection-site pain, headache, rash or bruising around the joint, local joint pain/swelling and local itching. Cases where swelling is extensive or painful should be discussed with your doctor 3 injections given at weekly intervals* *This has been noted in studies reported in the literature in which patients treated with 3 injections were followed for 60 days. Please see full Important Safety Information on page 12, complete Patient Information on pages 13-19, and accompanying full Prescribing Information. More than 25 million injections of HYALGAN® have been given worldwide Ask your health care provider if HYALGAN® is right for you. HYALGAN® is covered by Medicare and most managed care plans. Visit www.HYALGAN.com 8 9 Pain relief varies from patient to patient and may depend on the severity of the disease and intensity of the pain. The chart below illustrates the pain relief experienced by patients with OA of the knee during HYALGAN® treatment. Average amount of pain on visual analog scale (mm) HYALGAN® pain relief over 6 months with 5 injections reduction in pain from beginning of treatment through 6 months 40 (n=103) 35 30 25 6 months •In a large clinical study, 2 out of 3 people using HYALGAN® reported pain relief at 6 months HYALGAN® 67% 45 •HYALGAN® can relieve pain for up to •You can safely repeat treatment with 55 50 HYALGAN® gives you long-lasting relief of OA knee pain 20 15 Important Safety Information • You should not take this product if you have had any previous allergic reaction to HYALGAN® or other medications containing hyaluronan. You should not have an injection into the knee if you have an infection or skin disease in the area of the injection site 10 5 0 Baseline 3 4 5 9 12 Weeks 16 21 26 P=.004 at week 26 Adapted from Altman RD et al. Osteoarthritis of the knee cannot be cured, but the pain can be controlled. You may want to discuss repeat treatment with your health care provider if and when your pain returns. Please see full Important Safety Information on page 12, complete Patient Information on pages 13-19, and accompanying full Prescribing Information. Visit www.HYALGAN.com 10 11 •You should not take this product if you have What is HYALGAN®? •Tell your doctor if you are allergic to products • HYALGAN® has not been tested in children, HYALGAN® is a sterile mixture that is made up of natural, highly purified sodium hyaluronate that comes from rooster combs. Hyaluronate is a natural chemical found in the body, and it is present in a particularly high amount in joint tissues and in the fluid that fills the joints. The body’s own hyaluronate acts like a lubricant and a shock absorber in the joint, and it is needed for the joint to work properly. In osteoarthritis, there may not be enough hyaluronate, and there may be a change in the quality of the hyaluronate in joint fluid and tissues. •The most common side effects of HYALGAN® HYALGAN® is available in either 2-mL glass containers or 2-mL prefilled syringes. HYALGAN® is given in a shot directly into your knee. had any previous allergic reaction to HYALGAN® or other medications containing hyaluronan. You should not have an injection into the knee if you have an infection or skin disease in the area of the injection site from birds, such as feathers, eggs and poultry or if your leg is swollen or infected. Talk to your doctor before resuming strenuous weight-bearing activities after treatment 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 therapy are gastrointestinal complaints, injection-site pain, headache, rash or bruising around the joint, local joint pain/swelling and local itching. Cases where swelling is extensive or painful should be discussed with your doctor What is HYALGAN® used for? HYALGAN® is used to relieve knee pain due to osteoarthritis. It is used for patients who do not get adequate relief from simple painkillers or from exercise and physical therapy. Visit www.HYALGAN.com 12 13 What are the benefits of HYALGAN®? A study involving 495 patients with knee pain due to osteoarthritis was performed in the United States. This study investigated the safety and effectiveness of HYALGAN®. The patients were placed in one of three groups. One group was given an injection of HYALGAN® into one knee joint once a week for 5 weeks. The second group was given an injection of saltwater into one knee joint once a week for 5 weeks. The third group received two naproxen tablets every day for 6 months. Joint pain was measured in all patients throughout the 6 months. Patients with osteoarthritic knee joint pain, who did not get relief from simple painkillers or from exercise and physical therapy, got pain relief from the HYALGAN® injections into the knee joint. Pain relief was not seen in some patients until after the fifth injection. Three additional studies were conducted to establish the efficacy of HYALGAN® after just 3 injections.* Although it is a 5-injection course of therapy, pain relief can be achieved with 3 injections,* giving you and your physician the flexibility to determine which treatment regimen is best for your needs. HYALGAN® is the only hyaluronan with 3-injection efficacy proven in 3 placebo-controlled trials. Visit www.HYALGAN.com 14 What other treatments are available for OA? If you have osteoarthritis, there are several things you can do that do not involve HYALGAN® injections. These include the following: Non-drug treatments –Avoiding activities that cause excess pain in your joints –Exercise –Physical therapy Drug therapy –Painkillers such as acetaminophen and narcotics –Drugs that reduce inflammation such as aspirin, and other nonsteroidal anti-inflammatory agents (NSAIDs) such as ibuprofen and naproxen –Corticosteroids that are injected directly into the joint *Some patients may experience benefit with 3 injections given at weekly intervals. This has been noted in studies reported in the literature in which patients treated with 3 injections were followed for 60 days. 15 Are there any reasons why I should not take HYALGAN®? –You should not take this product if you have had any previous allergic reaction to HYALGAN® or similar material, ie, hyaluronate products –You should not have an injection into the knee if you have infections or skin diseases around the injection site Things I should know about HYALGAN® –HYALGAN® is only for injection into the knee, performed by a qualified physician –Consult your physician if you are allergic to products from birds such as feathers, eggs, and poultry –Immediately after you have the injection and for the next 48 hours, you may need to avoid activities such as jogging, tennis, heavy lifting, or standing on your feet for a long time –Although results of studies in rats and rabbits with HYALGAN® did not suggest that it could affect your ability to have children or cause harm to your child if you are pregnant or nursing, HYALGAN® 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 –The safety and effectiveness of HYALGAN® has not been shown in children Possible complications –HYALGAN® has been used in a number of countries in Europe, South America, and Asia since 1987. During this time, two cases of serious, allergic-type events were reported right after the patients received the injection. For example, one patient experienced sweating, paleness, and a feeling of pressure in the chest and stomach. The patient’s skin turned slightly blue, and blood pressure dropped. You should tell your doctor before you are given HYALGAN® if something like this has ever happened to you after receiving an injection of HYALGAN® or a similar material, ie, hyaluronate products –Six cases of allergic reactions were reported in people outside the United States after they had been given HYALGAN®. These people Visit www.HYALGAN.com 16 17 reported that their pulse became quicker, they had a heavy feeling, there were changes in their blood pressure and circulation, and they shivered, had a fever, and sweated. You should tell your doctor before you are treated with HYALGAN® if something like this has ever happened to you after receiving an injection of HYALGAN® or a similar material, ie, hyaluronate products –Seven cases of fever were reported How is HYALGAN® given? Your doctor will give you an injection of HYALGAN® (20 mg/2 mL) into your knee. A treatment cycle consists of 5 injections given at weekly intervals. Some patients may experience benefit with 3 injections given at weekly intervals. This has been noted in studies reported in the literature in which patients treated with 3 injections were followed for 60 days. –One case of abnormally low blood pressure was reported –One episode of fainting occurred –Side effects sometimes seen when HYALGAN® is injected into the knee are gastrointestinal complaints, injection-site pain, headache, rash or bruising around the joint, local joint pain/swelling and local itching where HYALGAN® is injected. These reactions were generally mild and did not last long –If any of the above symptoms or signs appear after you are given HYALGAN®, or if you have any other problems, you should call your doctor DISTRIBUTED BY sanofi-aventis U.S. LLC 55 Corporate Drive Bridgewater, NJ 08807 MANUFACTURED BY FIDIA Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A 35031 Abano Terme, Padua (PD), Italy 07241190 Visit www.HYALGAN.com 18 19 The OsteoArthritis Support and Information Service (OASIS) is a complimentary online support program. If you haven’t enrolled already, log onto www.HYALGAN.com. By enrolling you will receive: • The OASIS Welcome Kit • Knee Knowledge • The OASIS Action Tracker • The OASIS Joint Important Safety Information You should not take this product if you have had any previous allergic reaction to HYALGAN® or other medications containing hyaluronan. You should not have an injection into the knee if you have an infection or skin disease in the area of the injection site. Indication HYALGAN® is used to relieve knee pain due to osteoarthritis. It is used for patients who do not get adequate relief from simple painkillers or from exercise and physical therapy. Please see full Important Safety Information on page 12, complete Patient Information on pages 13-19, and accompanying full Prescribing Information. Visit www.HYALGAN.com © 2010 sanofi-aventis U.S. LLC US.HYA.10.06.005 July 2010 Printed in USA Important Safety Information You should not take this product if you have had any previous allergic reaction to HYALGAN® or other medications containing hyaluronan. You should not have an injection into the knee if you have an infection or skin disease in the area of the injection site. Indication HYALGAN® is used to relieve knee pain due to osteoarthritis. It is used for patients who do not get adequate relief from simple painkillers or from exercise and physical therapy. Ask your health care provider if HYALGAN® is right for you Please see full Important Safety Information on page 12, complete Patient Information on pages 13-19, and accompanying full Prescribing Information.