Legend Multi Dose (20 ml) Each

Legend is the only FDA approved I.V. and intra-articular therapy to treat equine non-infectious synovitis associated with osteoarthritis. Legend is pure hyaluronate sodium, the same glycosaminoglycan present in normal joint fluid. Legend is produced by a patented biofermentation process, resulting in such purity that it can be given intravenously for immediate bioavailability.

Key Benefits:

• Helps treat joint dysfunction in horses
• Targets inflammation of the lining of the joint capsule
• Injectable form of hyaluronate reaches the problem area quickly

How It Works

The actual mechanism of action for hyaluronate sodium in the healing of degenerative joint disease is not completely understood. One major function appears to be the regulation of normal cellular constituents. This effect decreases the impact of exudation, enzyme release and subsequent degradation of joint integrity. Additionally, hyaluronate sodium exerts an anti-inflammatory action by inhibiting the movement of granulocytes and macrophages. Hyaluronate molecules are long chains which form a filter network interspersed with normal cellular fluids. It is widely accepted that injection directly into the joint pouch enhances the healing of inflamed synovium by restoring lubrication of the joint fluid. This further supplements the visco-elastic properties of normal joint fluid.

Indications

LEGEND (hyaluronate sodium) Injectable Solution and LEGEND Multi Dose (hyaluronate sodium) Injectable Solution is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis.

View Legend Drug Facts Sheet.

LEGEND Multi Dose (20 mL) and LEGEND 4 mL (40 mg) injected intravenously only. LEGEND 2 mL (20 mg) injected intravenously or intra-articularly in the carpus or fetlock. Treatment may be repeated at weekly intervals for a total of three treatments.

LEGEND Injectable Solution 2 mL: Strict aseptic technique should be observed when administering by intra-articular injection. As with any intra-articular procedure, proper injection site disinfection and animal restraint are important. Excess joint fluid should be aseptically removed prior to injection. Care should be taken to avoid scratching the cartilage surface with the tip of the injection needle. Diffuse swelling lasting 24 to 48 hours may result from movement of the needle while in the joint space.

For intravenous administration, use aseptic technique and inject slowly into the jugular vein.

Horses should be given stall rest after treatment before gradually resuming normal activity.

LEGEND Injectable Solution 2 mL and 4 mL only: Discard any unused portion of the drug and the empty vial after opening.

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Contraindications:

There are no known contraindications for the use of LEGEND Solution and LEGEND Multi Dose Injectable Solution in horses.

Residue Warning:

Do not use in horses intended for human consumption.

Human Warning:

Not for use in humans. Keep this and all other drugs out of reach of children.

Animal Safety Warning:

For 4 mL only-Not for Intra-articular use.

Multi Dose not for Intra-articular use. The Intra-articular safety of hyaluronate sodium with benzyl alcohol has not been evaluated.

Precautions:

Radiographic evaluation should be carried out in cases of acute lameness to ensure that the joint is free from serious fractures. As with any intra-articular (LEGEND Injectable Solution-2 mL only) treatment, special precautions must be followed as to injection technique and sterility for prevention of possible swelling or infection. Intra-articular injections should not be made through skin that has been recently fired or blistered, or that has excessive scurf and counterirritant on it.

The safety of LEGEND Injectable Solution and LEGEND Multi Dose Injectable Solution has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares.

Adverse Reactions:

No local or systemic side effects were observed in the LEGEND Injectable Solution clinical field trials with either intravenous or intra-articular injections.

Post-Approval Experience: While all adverse reactions are not reported, the following adverse reactions are based on voluntary post-approval reporting for LEGEND Injectable Solution:

Following Intravenous use: Occasional depression, lethargy, and fever.

Following Intra-articular (LEGEND Injectable Solution-2 mL only) use: lameness, joint effusion, joint or injection site swelling, and joint pain.

To report suspected adverse events, for technical assistance or to obtain a copy of the MSDS, contact Merial at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation.

Effectiveness:

Effectiveness studies utilizing LEGEND Multi Dose Injectable Solution were not performed. LEGEND Multi Dose Injectable Solution was approved based on the conclusion that the effectiveness of LEGEND Multi Dose Injectable Solution will not differ from that demonstrated for the original formulation of LEGEND Injectable Solution.

Forty-six horses with lameness in either the carpal or fetlock joints were treated intravenously or intra-articularly with LEGEND Injectable Solution in a well-controlled clinical study conducted at four locations. One, two or three injections were given based on clinical improvement. Overall clinical improvement was judged as excellent or good in 90% of the cases treated intravenously and 96% of those treated intra-articularly with LEGEND Injectable Solution.

Animal Safety:

Animal safety studies utilizing LEGEND Multi Dose Injectable Solution were not performed. LEGEND Multi Dose Injectable Solution was approved based on the conclusion that the safety of LEGEND Multi Dose Injectable Solution will not differ from that demonstrated for the original formulation of LEGEND Injectable Solution.

LEGEND Injectable Solution was administered to normal horses at one, three and five times the recommended intra-articular dosage of 20 mg and the intravenous dosage of 40 mg. Treatments were given once weekly for nine consecutive weeks (three times the maximum duration). No systemic clinical signs were observed nor were there any adverse effects upon hematology or clinical chemistry parameters. A transient, slight to mild post-injection swelling of the joint capsule occurred in some of the animals treated intra-articularly with LEGEND Injectable Solution-2 mL as it did in the saline treated control horses. No gross or histological lesions were observed in the soft tissues or the surface areas of the treated joint.

Storage:

Do not store above 40°C (104°F).