Hyruan One

Cross-linked hyaluronic acid.

Each 1 mL of Hyruan ONE (3 mL/syringe) contains: Cross-linked hyaluronic acid 20 mg, Phosphate buffered saline q.s.
Hyruan ONE is a milestone viscosupplementation treatment used to relieve pain associated with osteoarthritis of the knee. Hyruan ONE is presented in a prefilled syringe filled with 3.0 mL of colorless clear and viscous gel. The gel is composed of cross-linked hyaluronic acid.

Mode of Action: Naturally-occurring hyaluronic acid in the various part of the body acts in the joints as a shock absorber, protects cartilage, and relieves pain associated with osteoarthritis.

For use as a symptomatic treatment of osteoarthritis of the knee.

Dosage: Hyruan ONE is a single dose for single injection, and should only be injected once per treatment course. The recommended dose is 3 mL for the knee joint.

Hyruan ONE should not be injected: To patients who are known to be sensitive to the product or its ingredient(s); To patients with an infection or severe inflammation at joint cavity; To patients with a disease or infection of skin near the injection site.
Hyruan ONE should be injected with caution: In patients with hypersensitivity to other substances; In patients with liver disease or prior history of liver disease.

General precaution: Administration of Hyruan ONE to severely inflamed joints caused by deformative osteoarthritis can lead to exacerbation of local inflammation symptoms. Thus, Hyruan ONE is desired to be given after the removal of existing inflammation symptoms.
Administration of Hyruan ONE may occasionally cause local pain or swelling. Thus, patients should be informed to avoid strenuous exercise or actions leading joint pain of knee up to 48 hours after administration, and action such as local relaxation should be guided after injection.
Leakage of Hyruan ONE outside the articular cavity might cause pain. Thus, Hyruan ONE should be accurately injected into the articular cavity.
Precaution in use: Hyruan ONE should be administered by a doctor fully trained for the treatment.
Since Hyruan ONE is injected directly into the joints, administration should be performed under intact sterilization status.
In case of retention of articular fluid, the fluid should be removed by puncturing prior to administration of Hyruan ONE.
Intravascular injection, extra-articular injection, or injection into the synovial tissues should be avoided.
It is desirable to administer the product using an enclosed needle.
Care should be taken with a disinfectant quaternary ammonium salt such as benzalkonium chloride and chlorhexidine which may induce precipitation of hyaluronic acid.
Hyruan ONE is intended for single use only. Re-use or re-sterilization of the product is prohibited since the sterility will be compromised which may lead to adverse events.
The injection site must be sterilized either by alcohol or other disinfecting solution prior to administration.
Used syringe, needle, and unused materials all need to be discarded after administration.
In case Hyruan ONE is administered into both knees a separate product should be applied for each administration.
Clinical safety and effectiveness for pregnancy, nursing mothers, and pediatrics have not been established.
Since a physiological function of geriatrics has generally declined, treatment should be made carefully.

Serious adverse events: Shock: since symptoms of shock (frequency unknown) may occur, careful observation should be made. In case abnormalities are noticed, administration should be discontinued and proper measures should be taken.
Reported adverse events in clinical investigations: In a pivotal clinical trial of Hyruan ONE in patients with knee osteoarthritis (a total of 285 subjects), the occurrence rate of local reaction at the injection site after injection into the articular cavity was 48.9% (68/139 subjects) in the study group and 49.3% (72/146 subjects) in the control group. The reported adverse events are shown in Table 1. The serious adverse events were reported in the decreasing order of pain (7.2% of the study group, 6.2% of the control group), redness (5.0% of the study group, 2.1% of the control group), and so on. Adverse events lasting over a week were pain 5.3%, redness 1.4%, swelling and warmth each accounting for 1.0%, yet all of them completely resolved in two weeks without any special treatment. (See Table 1.)


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Of the patients with knee osteoarthritis (285 subjects), the occurrence rate of the adverse events excluding ones that occurred at the injection site is 34.5% (48/139, 73 cases) for the study group and 28.8% (42/146, 63 cases) for the control group. Most of them were mild to moderate. Table 2 indicates the adverse events that occurred in more than 1% of the study group. (See Table 2.)


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Precautions in handling: Hyruan ONE should be kept in its original packaging; storing Hyruan ONE in a different packaging can cause misuse of product or decline in product quality.
Incompatibilities: Incompatibilities of Hyruan ONE with other intra-articular injectables have not been established.

Store at 2-25°C free from light, in a hermetic container.
Shelf Life: 24 months.

Other Drugs Acting on Musculo-Skeletal System

M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.

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