Synvisc hylan gf 20 prescribing information sanofi. Synvisc and synviscone are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee. Synvisc should be used with caution when there is evidence of lymphatic or venous stasis in the leg to be injected. Synviscone hylan gf 20 is the only treatment that can give you up to six months of osteoarthritis oa knee pain relief with a single. As with any invasive joint procedure, it is recommended that patients avoid strenuous or prolonged i. Synvisc and synvisc one are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee. Nonpharmacologic modalities and conservative pharmacologic therapies are recommended for the initial treatment of oa, including acetaminophen, and topical and oral nonsteroidal antiinflammatory drugs. Your doctor will determine how many injections you should receive.
Comparative data studies have been conducted comparing either euflexxa, hyalgan, orthovisc, or supartz to synvisc. Its a simple, inoffice procedure that takes just a few minutes. Hylans are derivatives of hyaluronan sodium salt of hyaluronic acid and consist of repeating. Euflexxa 1% sodium hyaluronate is used to relieve knee pain due to osteoarthritis. Inject intraarticularly 48 mg 6 ml to affected knee once as a single injection. Durolane is a clear, transparent, viscous gel of highly purified, stabilized, nonanimalderived sodium hyaluronate that is biosynthesized using bacterial. It is usually given once a week and repeated after a week for a total of three injections. Synvisc one hylan gf 20 is a sterile, nonpyrogenic, elastoviscous fluid containing hylans. Synvisc is injected directly into the knee over the course of three doctor visits, one week apart or in one injection, synvisc one. Durolane additional information for treatment of instructions. Synvisc has not been tested in pregnant women, or women who are nursing. The following reported adverse events are among those that may occur in association with intraarticular injections, including synvisc.
Are there any reasons why i should not receive a synviscone. Orthovisc, synvisc hyaluronicacidandderivatives dosing. Osteoarthritis knee pain relief treatment synviscone. Transient pain andor swelling of the injected joint may occur after intraarticular injection of euflexxa. Synvisc which is the same material as synvisc one, only in a 3injection regimen rather than a single injection, has been commercially available for more than 10 years and is approved for sale in over 70 countries throughout the world. Aug 21, 2019 synvisc is usually given after other arthritis medications have been tried without successful treatment of symptoms. Hypersensitivity reactions including anaphylactic reaction, anaphylactoid reaction, anaphylactic shock and angioedema have been reported for both synvisc and synvisc one. Hyalgan hyaluronic acid derivative prescribing information. It primarily affects the hands, knees, and hips, severely limiting the daily activity and quality of life for many individuals in the united states us. Requests must be supported by submission of chart notes and patient specific documentation. Hylans are derivatives of hyaluronan sodium salt of hyaluronic acid and consist of repeating disaccharide units of nacetylglucosamine and sodium glucuronate. Zilretta is an extendedrelease corticosteroid approved to manage osteoarthritis knee pain.
Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Hyalgan sodium hyaluronate manufacturers full prescribing information. Synvisc is a product made to mimic the young, healthy joint fluid originally in your knee. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. Viscosupplementation is a relatively new method for the treatment of osteoarthritis oa. Please refer to most recent prescribing information. Synviscone hylan gf 20 manufacturers full prescribing information. Synvisc j7325 medical synviscone j7325 medical triluron j7332 medical trivisc j7329 medical visco3 j7321 medical. Information for patients provide patients with a copy of the patient information prior to use. Synvisc hylan gf 20 is administered by intraarticular injection once a week one. No serious adverse events were reported in clinical trials in knees injected with synviscone. The prescribing information for a drug is subject to change.
The synvisc one brand of this medicine is given only once. Jul 01, 2011 view the complete prescribing information for synvisc pdf for synviscone the most commonly reported related local adverse events were transient, mildtomoderate arthralgia, arthritis, arthropathy, injection site pain and joint effusion. View the complete prescribing information for synviscone important safety information for synviscone before trying synviscone, tell your doctor if you have had an allergic reaction, such as swelling of the face, tongue or throat, respiratory difficulty, rash, itching or hives to. Osteoarthritis oa is a common degenerative condition affecting the knees b. Aug 05, 2019 synvisc is given as a 3injection regimen. Finelli i, chiessi e, galesso d, renier d, paradossi g. Information for prescribers monovisc high molecular weight. Hylans are derivatives of hyaluronan sodium salt of hyaluronic acid and consist of repeating disaccharide units of nacetylglucosamine and. The synviscone brand of this medicine is given only once. Orthovisc hyaluronan is a nonavian sourced hyaluronic acid injection therapy which has up to six months of clinically proven efficacy with 3 or 4 injections. Before you receive a synvisc injection, tell your doctor if you have blood clots or circulation problems.
Approximately 25% of people with pain from knee oa experience difficulty performing major activities of daily living, including walking. Synvisc one hylan gf 20 prescribing information sanofi. Synvisc hylan gf 20 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 simple analgesics, e. Hyalgan is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Before trying synviscone or synvisc, tell your doctor if you are allergic to products from birdssuch as feathers, eggs or poultryor if your leg is swollen or infected.
The main goal of this project was to assess the safety and clinical utility of hylan gf20 synviscr in the treatment of pain associated with osteoarthritis of the knee. Based on the synvisc prescribing information, the safety and effectiveness of repeated treatment cycles of crosslinked hylan gf 20 has not been established. Inject intrarticularly 30 mg 2 ml to affected knee qweek for 3 weeks. Patient assistance connection eligibility requirements an application must be submitted for each patient. View the complete prescribing information for synvisc one. You should tell your doctor if you think you are pregnant, or if you are nursing a child.
Full prescribing information for synvisc one important safety information synvisc and synvisc one are contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee. Inject 2 ml intraarticularly into the knee once a week for 3 weeks. Zilretta is not for people allergic to corticosteroids, triamcinolone acetonide or any other component of the product. Synvisc hylan gf 20 is a sterile, nonpyrogenic, elastoviscous fluid containing hylans. Synvisc one has not been tested to show pain relief in joints other than the knee. Indicated for treatment of pain in osteoarthritis of the knee. Synvisc one is only for injection into the knee, performed by a doctor or other qualified health care professional. The program will triage the prescription to the most costeffective specialty pharmacy in order to dispense synvisc to the above named patient. Synviscone and synvisc are only for injection into the knee, performed by a. Call your doctor for instructions if you miss an appointment for your synvisc injection.
Information for patients transient pain or swelling may occur after the intraarticular ia injection. Jun 26, 2017 the synvisc brand of hylan gf 20 is usually given once every week until you have received 3 injections. Inject intraarticularly 16 mg 2 ml to affected knee qweek for 3 weeks. Please for full prescribing information for synvisc.
Hypersensitivity reactions including anaphylactic reaction, anaphylactoid reaction, anaphylactic shock. Synviscone is indicated for the treatment of pain in osteoarthritis oa of the knee in patients who have failed to respond adequately to. Osteoarthritis knee pain relief treatment synviscone official site. Synvisc package insert ce description synvisc hylan gf 20 is a sterile, nonpyrogenic, elastoviscous fluid containing hylans. Synvisc hylan gf 20 has not been tested to show pain relief in joints other than the knee. Federal law restricts this device to sale by or on the order of a physician or licensed practitioner. In clinical trials, the most commonly reported adverse events were transient pain, swelling, and or joint effusion in the injected knee. Synviscone and synvisc are only for injection into the knee, performed by a doctor or other qualified health care professional.
The synvisc brand of hylan gf 20 is usually given once every week until you have received 3 injections. R12 a number of reports of pseudosepsis, also known as severe acute inflammatory reaction, have been reported in literature for synvisc. You should not receive synvisc if you have an infection in your knee or in the skin around your knee. A new viscosupplement based on partially hydrophobic hyaluronic acid. Synvisc patient handout 1015 twin cities orthopedics. The side effects sometimes seen after synvisc one include synvisc one. The following are hyaluronate derivatives requiring prior authorization. Sanofi is a leader in the global pharmaceutical market, with an extensive line of prescription medicines. It is used for patients who do not get enough relief from simple pain medications such as acetaminophen or.
Synvisc dosage information in more detail what happens if i miss a dose. As with any invasive joint procedure, it is recommended that thepatient avoid any strenuous activities. Osteoarthritis oa constitutes a growing public health burden and the most common cause of disability in the united states. Pseudoseptic reactions to hylan viscosupplementation. Pharmacy prior authorization viscosupplements clinical.
It is characterized by deterioration and loss of the articular cartilage, subchondral sclerosis and osteophyte formation, and is often accompanied by inflammation of the synovium. Synvisc, the incidence of joint effusions was significantly higher in the synvisc group vs. Highlights of prescribing information major surgery. Synvisc is indicated for the treatment of pain in osteoarthritis oa of the knee in patients who have failed to respond adequately to conservative. Additional information for treatment of synovial joints requiring image guidance the intraarticular injection in the hip should be given under fluoroscopic control preferably with a contrast medium or ultrasonographic control in order to assure correct location of the needle in the joint cavity. Instructions for use synvisc hylan gf 20 description. Policy and procedure ambetter from coordinated care. Addressing fundamental health issues, sanofi us strives to make major therapeutic solutions available for patients. This medicine usually comes with patient information insert. Hyaluronans, viscosupplementation for osteoarthritis of the knee. Synvisc one has not been tested to show better pain relief when combined with other injected medicines. Read the information carefully and make sure you understand it efore receiving this medicine. Hayes directory of new medical technologies status evaluation.
View the complete prescribing information for synvisc one important safety information for synvisc one before trying synvisc one, tell your doctor if you have had an allergic reaction, such as swelling of the face, tongue or throat, respiratory difficulty, rash, itching or hives to synvisc or any hyaluronanbased products. Osteoarthritis oa is a chronic condition that causes pain and substantial disability. It is used for patients who do not get enough relief from simple pain medications such as acetaminophen or from exercise and physical therapy. Orthovisc high molecular weight hyaluronan is a fda approved treatment made from ultrapure hyaluronan, a naturally occurring lubricant found in healthy knee joints. See important reminder at the end of this policy for important regulatory and legal information. The benefits and risks of repeat injections have not been demonstrated. Please see important safety information and full prescribing information 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. Synvisc hylan gf 20 has not been tested to show better pain relief when combined with other injected medicines. View the complete prescribing information for synvisc pdf for synviscone the most commonly reported related local adverse events were transient, mildtomoderate arthralgia, arthritis, arthropathy, injection site pain and joint effusion. Jun 26, 2017 synvisc hylan gf 20 is only for injection into the knee, performed by a doctor or other qualified health care professional. Synviscone hylan gf 20 is a sterile, nonpyrogenic, elastoviscous fluid containing hylans.
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