PATIENT
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Here are answers to some commonly asked questions about treatment with HYMOVIS® ONE.
If you have a specific question about treatment or about knee pain, please speak with your health care provider.
HYMOVIS® ONE is a viscous (thick), gel-like sterile solution made from highly purified, chemically modified hyaluronan, supplied in a pre-filled syringe. The syringe contains 4 mL (less than 1 teaspoon) of HYMOVIS® ONE. It is injected into the knee by a trained clinical professional in a single-injection regimen. Hyaluronan is a substance naturally present in the body and is found in high amounts in the fluid that fills the joints. The body's own hyaluronan acts as a lubricant and shock absorber in the joint, which is essential for proper joint function. In osteoarthritis, the quality of hyaluronan may differ from normal. If you do not understand this information or want to know more, consult your healthcare professional.
HYMOVIS® ONE is used to temporarily relieve knee pain caused by osteoarthritis. It is intended for patients who do not get adequate pain relief from simple pain relievers like acetaminophen or from exercise and physical therapy.5
Your doctor will inject HYMOVIS® ONE (4 mL) into your knee in a single injection.5
Some side effects (also called reactions) may occur with the use of HYMOVIS® ONE, including symptoms such as knee pain, inflammation, reddening, and swelling at the injection site. If any of these symptoms appear after you are given HYMOVIS® ONE, or if you experience any other problems, you should call your doctor. Occurrences of rash, headache, dizziness, chills, hives, nausea, muscle cramps, peripheral edema (fluid buildup), and malaise (feeling of discomfort) have also been reported in association with intra-articular injections of hyaluronic acid in the knee. Temporary increases in inflammation (redness and swelling) following injections have occurred in some patients with inflammatory joint conditions.
In patients treated with HYMOVIS® ONE in a clinical study, a low number of anticipated side effects were reported, including joint swelling (1 event), as well as a low number of unanticipated events, such as pain/inflammation in the ball of the foot (metatarsalgia, 1 event), neck pain (1 event), and headache (1 event). Patients treated with a different hyaluronic acid injection in the same clinical study, MONOVISC®, experienced side effects including discomfort (1 event), thirst (1 event), joint contracture (1 event), muscle aches and pains (myalgia).
A clinical trial conducted using HYMOVIS® ONE demonstrated that HYMOVIS® ONE provides temporary pain relief to patients with osteoarthritis of the knee. The patients in the study had been diagnosed with OA of the knee associated with pain and did not obtain sufficient relief from simple analgesics (e.g., acetaminophen) taken orally. A total of 347 patients in the study were randomly assigned to receive either a single intra-articular injection of HYMOVIS® ONE or the same treatment with a comparator hyaluronic acid, MONOVISC®. Neither the patients nor the doctors evaluating them knew which treatment they received. Patients were observed by their doctor over 6 months. HYMOVIS® ONE demonstrated comparable safety and effectiveness to MONOVISC® when injected in the knee.5
Your doctor will determine if there is any reason why you should not be treated with HYMOVIS® ONE. You should be aware that HYMOVIS® ONE:
The following are important considerations to discuss with your doctor:
The side effects sometimes seen after any joint injection, including HYMOVIS® ONE, may include: pain, swelling, warmth, and redness. These symptoms are generally mild and do not last long. If needed, your doctor will recommend appropriate treatment. If any of these symptoms or signs appear after you are given HYMOVIS® ONE, or if you have any other problems, you should call your doctor.5
It is recommended to avoid strenuous activities, such as high-impact sports (e.g., tennis and jogging) or prolonged weight-bearing activities for approximately 48 hours following the injection. You should talk to your doctor regarding the appropriate time to resume such activities.5
HYMOVIS® ONE is covered by Medicare, Tricare, and most insurance plans. However, insurance coverage can vary from plan to plan, even within the same insurer. Your provider can verify your insurance coverage through the Fidia Complete program by visiting www.fidiacomplete.com or by calling 866-749-2542, option 2, or by contacting your insurance provider.
Yes, patients can call their insurance company asking them to use HYMOVIS® ONE. Additionally, patients can contact their employer insurance benefits coordinator and ask for HYMOVIS® ONE.
HYMOVIS® ONE 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 or simple analgesics (e.g., acetaminophen).
HYMOVIS® ONE is contraindicated in patients with known hypersensitivity (allergy) to hyaluronate preparations or gram-positive bacterial proteins. Do not administer
HYMOVIS® ONE to patients with infections or skin diseases in the area of the injection site or joint. The safety and effectiveness of HYMOVIS® ONE have not been established in
pregnant women, nursing mothers, or children, or for use in joints other than the knee, or for concomitant use with other intra-articular (IA) injections. The effectiveness of
repeat treatment cycles of HYMOVIS® ONE has not been established. No serious adverse events or pseudoseptic reactions were reported in the HYMOVIS® ONE clinical study.
The adverse events experienced and reported in the HYMOVIS® ONE clinical study were joint swelling, metatarsalgia, neck pain, and headache.
Rx Only. See package insert for full prescribing information, including indications, contraindications, adverse events, warnings, precautions, and side effects.
References:
5. HYMOVIS® ONE Patient Information, FIDIA FARMACEUTICI S.P.A., ITALY.
