Safety Information1

Toxicity: In a subacute toxicity study, 32 adult beagle dogs (4 males and 4 females per treatment group) received either 0.9% saline solution or PSGAG at a dose of 5 mg, 15 mg, or 50 mg per kg of body weight (approximately 2.3, 6.8, or 22.7 mg/lb), via intramuscular injection twice weekly for 13 weeks. PSGAG doses represent approximately 1X, 3X, and 10X the recommended dosage of 2 mg/lb, and more than 3 times the recommended 4-week duration of treatment. Necropsies were performed 24 hours after the final treatment. During week 12, one dog in the 50 mg/kg dosage group developed a large hematoma at the injection site which necessitated euthanasia. No other mortalities occurred during the treatment period. Statistically significant changes in the 50 mg/kg group included increased prothrombin time, reduced platelet count, an increase in ALT and cholesterol, and increased liver and kidney weights. Increased cholesterol and kidney weights were also noted in the 15 mg/kg group. Microscopic lesions were noted in the liver (Kupffer cells containing eosinophilic foamy cytoplasm), kidneys (swollen, foamy cells in the proximal convoluted tubules), and lymph nodes (macrophages with eosinophilic foamy cytoplasm) in the 15 mg/kg and 50 mg/kg groups. Intramuscular inflammation, hemorrhage, and degeneration were seen in all 3 PSGAG treated groups; the incidence and severity appeared dose related.

Contraindications: Do not use in dogs showing hypersensitivity to PSGAG. PSGAG is a synthetic heparinoid; do not use in dogs with known or suspected bleeding disorders.

Precautions: The safe use of Adequan® Canine used in breeding, pregnant, or lactating dogs has not been evaluated. Use with caution in dogs with renal or hepatic impairment.

Adverse Reactions: In the clinical efficacy trial, 24 dogs were treated with Adequan® Canine twice weekly for 4 weeks. Possible adverse reactions were reported after 2.1% of the injections. These included transient pain at the injection site (1 incident), transient diarrhea (1 incident each in 2 dogs), and abnormal bleeding (1 incident). These effects were mild and self-limiting and did not require interruption of therapy.

Post Approval Experience (2014)

The following adverse events are based on voluntary, post-approval reporting. Not all adverse reactions are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The signs reported are listed in decreasing order of reporting frequency.
Vomiting, anorexia, depression/lethargy, diarrhea.
In some cases, death has been reported.
To report suspected adverse drug events, contact American Regent, Inc. at 1-800-458-0163. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth .

Warnings: Not for use in humans. Keep this and all medications out of reach of children.

For the Adequan® Canine full prescribing information, click here.

To view the Safety Data Sheet, click here.

For more frequently asked questions:

VETERINARIAN FAQs DOG OWNER FAQs


Adequan® Canine brand of polysulfated glycosaminoglycan (PSGAG)
INDICATIONS Adequan® Canine is recommended for intramuscular injection for the control of signs associated with non-infectious degenerative and/or traumatic arthritis of canine synovial joints.
IMPORTANT SAFETY INFORMATION Adequan® Canine should not be used in dogs who are hypersensitive to PSGAG or who have a known or suspected bleeding disorder. It should be used with caution in dogs with renal or hepatic impairment. Adverse reactions in clinical studies (transient pain at injection site, transient diarrhea, and abnormal bleeding) were mild and self-limiting. In post approval experience, death has been reported in some cases; vomiting, anorexia, depression/lethargy and diarrhea have also been reported. The safe use of PSGAG in breeding, pregnant or lactating dogs has not been evaluated. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For additional safety information, please see Full Prescribing Information.
1. Adequan® Canine Package Insert, Rev 1/19.

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