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.⁸

Your doctor will inject HYMOVIS^® ONE (4 mL) into your knee in a single injection.⁸

Some side effects (also called reaction) may occur with the use of HYMOVIS^® ONE. Include symptoms such as knee pain, inflammation, reddening, and swelling appearing at the injection site. If any of these symptoms or signs appear after injection of HYMOVIS^® ONE, or if you have 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 who were treated with HYMOVIS^® ONE in a clinical study, there were reported a low number of anticipated side effects, joint swelling (1 event), as well as a low number of unanticipated events, including pain/inflammation in the back of the foot (metatarsalgia, 1 event), neck pain (1 event) and headache (1 event). Furthermore, patients who were treated with a different hyaluronic acid injection in this clinical study, MONOVISC^®, experienced some side effects such as discomfort (1 event), thirst (1 event), joint contracture (1 event), muscle aches and pain (myalgia, 2 events), headache (2 events), redness (erythema, 1 event) and immune sensitivity (1 event).

A clinical trial showed that HYMOVIS^® ONE demonstrated that HYMOVIS^® ONE provides temporary pain relief to patients with osteoarthritis of the knee. The patients in the study had had good response on OARSI clinical guidelines or had not received adequate pain relief from current analgesics (e.g., acetaminophen) taken by mouth. A total of 239 patients in the study were assigned by chance to receive either a single intra-articular injection of HYMOVIS^® ONE or to receive 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 the same benefit in terms of safety and effectiveness as MONOVISC^® when injected into the knee.⁸

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:

• Should not be used in patients who have had any prior allergic reactions to any hyaluronan-based products or have an allergy to gram positive bacterial proteins. Signs of an allergic reaction may include swelling of your face, tongue; airway difficulty; breathing or swallowing; shortness of breath; wheezing; chest pain; tightness in your throat.
• Should not be used in patients with a knee joint infection, skin disease or infection around the area where the injection will be given. If you have circulatory problems in your legs, be sure to talk to your doctor about them.

Important considerations to discuss with your doctor:

• HYMOVIS^® ONE should be injected in the knee by a qualified physician or properly licensed practitioner.
• HYMOVIS^® ONE should not be tested in combination with other products.
• Tell your physician if you are allergic to hyaluronan products or have an allergy to gram positive bacterial proteins.
• HYMOVIS^® ONE should not be tested in pregnant or nursing women. Please inform your physician if you are pregnant or nursing a child.
• HYMOVIS^® ONE was not tested in children (21 years of age or younger).
• Safety and effectiveness of HYMOVIS^® ONE in joints other than the knee has not been demonstrated in U.S. studies.
• The effectiveness of repeat treatments of HYMOVIS^® ONE has not been demonstrated in U.S. studies.⁸

The side effects sometimes seen after any joint injections- 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.⁸

It is recommended to avoid strenuous activities, such as high-impact sports (such as tennis and jogging) or prolonged weight bearing activities for approximately 48 hours period following the injection. You should talk to your doctor regarding the appropriate time to resume such activities.⁸

If any of the side effects or symptoms described above are noticed after you are injected with HYMOVIS^® ONE.

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 fdia complete program by visiting www.fidiacomplete.com or by calling 1-866-749-2542 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.