Helo Intra-articular Injection

Helo 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, e.g., acetaminophen. It may also be used as adjuvant in orthopaedic surgery.

Sodium Hyaluronate is a viscous solution consisting of a high molecular weight fraction of purified natural sodium hyaluronate in buffered physiological sodium phosphate. It has a pH of 6.8-7.5. Hyaluronic acid is an important component of the body's extracellular matrix and is present in a particularly high concentration in cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity to synovial fluid, which is fundamental for its lubricating and shock absorbing properties. It is essential for the correct structure of proteoglycans in articular cartilage. In osteoarthritis there is an insufficient amount and a change in the quality of hyaluronic acid in synovial fluid and cartilage. The intra-articular administration of hyaluronic acid into arthritic joints improves joint functions.

Sodium Hyaluronate is administered by intra-articular injection. A treatment cycle consists of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly intervals. Inject the full 2 ml in one knee only. If treatment is bilateral, a separate injection should be used for each knee. Treatment may be repeated, usually, at 6 up to 12-month interval.

Pediatrics: The safety and effectiveness of Sodium Hyaluronate have not been demonstrated in children.

Sodium Hyaluronate is for intra-articular injection and is supplied as a single use, ready to use, sterile solution in a 2 ml pre-filled syringe, and must not be diluted. The content of the syringe is sterile and must be used immediately once the syringe has been opened. Intra-articular injection of Sodium Hyaluronate should be made using precise, anatomical localization into the joint cavity of the knee to be treated. The injection site in the knee is determined by that location which is easier to reach. Usually a lateral approach can be followed, but in some cases a medial approach is preferable. Strict aseptic precautions should be observed during the administration. The solution in the prefilled syringe is ready for use and requires only a sterile disposable needle. A 20 gauge needle may be used on the syringe. To ensure sterility, the injection site must be carefully cleansed with antiseptic. Care should be taken to expel any trapped air bubbles from the syringe containing Sodium Hyaluronate prior to administration.

Joint effusion, if present, should be aspirated by arthrocentesis prior to injection of Sodium Hyaluronate. The arthrocentesis should be made using a 20 gauge needle and the joint should be aspirated to almost dryness, but not to a degree that would compromise the accuracy of the subsequent Sodium Hyaluronate injection. The intra articular injection of Sodium Hyaluronate can be given using the same needle as used for the arthrocentesis by simply detaching the aspirating syringe and attaching the syringe containing Sodium Hyaluronate. To make sure the needle is correctly positioned, some synovial fluid should be aspirated prior to the slow injection of Sodium Hyaluronate. If the patient experiences pain during injection, the procedure may need to be stopped.

For the first hours after the injection, the patient should be advised to rest the treated knee, with as little exercise as possible, avoiding any strenuous activities or prolonged weight-bearing activities such as jogging or tennis. Subsequently, they may gradually return to their normal level of activity. Discard any unused Sodium Hyaluronate.

Helo should not be intra-articularly administered simultaneously or mixed with other products. It should not be used concomitantly with disinfectants containing quaternary ammonium salts because hyaluronic acid can precipitate in their presence

The drug is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site to reduce the potential for septic arthritis.

Local reactions such as pain, swelling/effusion and warmth or redness at the injection site have been reported. Usually such symptoms are transient and disappear spontaneously within a few days by resting the affected joint and applying ice only.

The safety and effectiveness of Sodium Hyaluronate have not been established in pregnant women. It is not known if Sodium Hyaluronate is excreted in human milk. The safety and effectiveness of Sodium Hyaluronate have not been established in lactating mother.

Use caution when injecting Helo into patients who are allergic to avian proteins, feathers, and egg products. Strict aseptic administration technique must be followed. Remove joint effusion, if present, before injecting Helo. It is recommended that the patient avoid any strenuous activities or prolonged (i.e., more than 1 hour) weight-bearing activities such as jogging or tennis within 48 hours following the intra-articular injection.

Drugs for Osteoarthritis

Hyronate injection should be stored in a cool (below 25° C) and dry place and protected from light. Protect from freezing.