Veterinarian FAQs

FOR PRESCRIBING VETERINARIANS.

Frequently asked questions about Adequan® i.m. (polysulfated glycosaminoglycan or PSGAG)

INDICATIONS

Adequan® i.m. (polysulfated glycosaminoglycan) is recommended for the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.

ABOUT ADEQUAN® i.m.

What is Adequan® i.m.? Arrow Up
Adequan® i.m. (polysulfated glycosaminoglycan) is the only FDA-approved PSGAG equine joint prescription available. It is recommended for intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.1
How is Adequan® i.m. packaged? Arrow Up
Adequan® i.m. Single Dose solution 500 mg/5 mL (100 mg/mL) is supplied in a single dose glass vial. The Multi-Dose solution packaging contains 5,000 mg/50 mL (100 mg/mL) in a preserved multiple-dose glass vial.1
What is the pharmacology of Adequan® i.m.?2 Arrow Up
  • Low molecular weight allows the distribution of the PSGAG from the bloodstream to the synovial fluid.
  • Distribution from the synovial fluid to the cartilage takes place by diffusion.
  • In the articular cartilage, the drug is deposited into the cartilage matrix.
  • PSGAG reaches synovial fluid within 2 hours of injection.
  • Detectable levels are maintained in synovial fluid and articular cartilage for up to 96 hours.
PSGAG improves joint function by reducing synovial fluid protein levels and increasing synovial fluid hyaluronic acid concentration in damaged equine carpal and hock joints.




MODE OF ACTION & EFFICACY

What is the mechanism of action for Adequan® i.m.? Arrow Up
In vitro research suggests polysulfated glycosaminoglycan is proven to:1,2
  • Relieve lameness caused by swelling and inflammation associated with joint disease
  • Restore synovial lubrication that facilitates movement and reduces local inflammation
  • Repair cartilage and rapidly aid in the production of new cartilage
  • Reverse the disease cycle that leads to the loss of cartilage components by inhibiting harmful enzymes that attack cartilage and synovial fluid.
What are the known pharmacokinetics of Adequan® i.m. after a single injection?2 Arrow Up
Pharmacokinetics of Adequan® i.m. 96 hours post-injection in the horse were investigated by Burba et al. Burba demonstrated that Adequan® i.m. diffused into the circulation, was transported into synovial fluid, and was absorbed by articular cartilage at therapeutic levels reported to inhibit certain cartilage degrading enzymes. These findings support the FDA approved dosing regimen for Adequan® i.m.
Summary of findings:
  • Concentrations of Adequan® i.m. peaked in serum and synovial fluid within 2 hours post-injection, then rapidly declined and remained at or above therapeutic levels for the remainder of the 96-hour test period.
  • Concentrations of hyaluronic acid nearly doubled 48 hours post-injection, with significant increases noted from 24 to 96 hours.
  • Concentrations of Adequan® i.m. at or near therapeutic levels were detected in the cartilage of all eight horses 96 hours post-injection.
Clinical significance of the above results is unknown.




DOSING AND ADMINISTRATION

What is the dosing regimen for a patient starting Adequan® i.m.? Arrow Up
The recommended dose of Adequan® i.m. in horses is 500 mg every 4 days for 28 days intramuscularly.1 The injection site must be thoroughly cleansed prior to injection. Do not mix Adequan® i.m. with other drugs or solvents.
Why is Adequan® i.m. administered every 4 days?2 Arrow Up
Pharmacokinetics of Adequan® i.m. 96 hours post-injection in the horse were investigated by Burba et al.1 Burba et al demonstrated that Adequan® i.m. diffused into the circulation, was transported into synovial fluid, and was absorbed by articular cartilage at therapeutic levels reported to inhibit certain cartilage degrading enzymes.1 These findings supported the FDA-Approved dosing regimen for Adequan® i.m.
Summary of findings:
  • Concentrations of Adequan® i.m. peaked in serum and synovial fluid within 2 hours post-injection, then rapidly declined and remained at or above therapeutic levels for the remainder of the 96-hour test period
  • Concentrations of hyaluronic acid nearly doubled 48 hours post-injection, with significant increases noted from 24 to 96 hours
  • Concentrations of Adequan® i.m. at or near therapeutic levels were detected in the cartilage of all eight horses 96 hours post-injection
Clinical significance of the above results is unknown.
What is the recommendation for Adequan® i.m. for “prophylactic” or “maintenance” use? Is there a “loading” dose? Arrow Up
Adequan® i.m. is recommended for the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses. Our recommendation is to repeat the label dose upon recurrence of clinical signs of degenerative joint disease (DJD). The label dose is 500 mg every 96 hours/4 days for seven treatments (28 days) in the horse. There is no data with accompanying label verbiage to support ‘prophylactic’, ‘loading,’ or ‘maintenance’ dosing regimens. The prescribing veterinarian, in the context of the veterinarian-client-patient relationship (VCPR), may determine individual treatment. Thus, there are no prophylactic, loading, or maintenance dosing recommendations for Adequan® i.m. There is ONLY ONE FDA APPROVED DOSING REGIMEN for Adequan® i.m., listed on the package insert.1
Is the Adequan® i.m. Single Dose vial or Adequan® i.m Multi-Dose vial labeled for intravenous (IV) or subcutaneous (SQ) administration? Arrow Up
No. The only recommended dosing regimen for Adequan® i.m. in horses is the label dose of 500 mg every 4 days for 28 days intramuscularly (i.m.). Alternative routes of administration of Adequan® i.m. have not been studied for safety or efficacy.1
Is there a recommendation as to where in the muscle Adequan® i.m. should be administered? Arrow Up
Adequan® i.m. is labeled for intramuscular use only. Injection location is not specified on the package insert.1 The location should be determined by the prescribing veterinarian based on his/her clinical judgment.




FORMULATION AND PACKAGING

Is Adequan® i.m. available in a multiple-use vial? Arrow Up
Yes, Adequan® i.m. Multi-Dose contains a preservative (Benzyl Alcohol 0.9% v/v) which allows multiple punctures of an individual vial. Practice aseptic techniques in withdrawing each dose to decrease the possibility of post-injection bacterial infections. Adequately clean and disinfect the stopper prior to entry with a sterile needle and syringe. Use only sterile needles and use each needle only once. Use within 28 days of first puncture and puncture a maximum of 10 times.1
What are the differences in ingredients between Adequan® i.m. Single Dose Vial versus the Adequan® i.m. Multi-Dose Vial? Arrow Up
Single-Dose Vial (SDV)
Each 5 mL of Adequan® i.m. SDV contains 500 mg of Polysulfated Glycosaminoglycan and Water for injection q.s. Sodium Hydroxide and/or Hydrochloric Acid added when necessary to adjust pH. Sodium Chloride may be added to adjust tonicity.

Multi-Dose Vial (MDV)
Each mL of Adequan® i.m. MDV contains 100 mg of Polysulfated Glycosaminoglycan, 0.9% v/v Benzyl Alcohol as a preservative, and Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid added when necessary to adjust pH.

Therefore, the key difference in ingredients between the SDV and MDV is the addition of a preservative in the MDV, Benzyl Alcohol.
My Adequan® i.m. used to be clear or colorless. I’ve noticed it is now light yellow. Should I return it? Arrow Up
Adequan® i.m. is normally a clear, colorless to slightly yellow solution. Adequan® i.m. is known to become yellow over time, and this is normal for the product. It may be used through the expiration date listed on the vial label. If you are uncomfortable using the product, you may request a return via customer service.
What is the shelf life of Adequan® i.m. SDV and MDV? Arrow Up
All product should be used by the expiration date printed on the vial and carton labeling. If product is expired, please contact Customer Service for return procedures.
My Adequan® i.m. was not shipped or received in optimal conditions for an extended or unknown period. Is it still safe and effective? Arrow Up
Label storage conditions are: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).1

If you are uncomfortable using the product, please contact customer service for return procedures.

Best Practices:
There is no guarantee of safety or efficacy outside of label storage conditions. If you have received product that has been exposed to temperature extremes (extreme heat or freezing) outside of the label conditions, or the glass vial has been compromised, you are advised to return the product. Additionally, there are no label recommendations on use of ice packs in warmer climates and this may be a shipping protocol used by some third-party suppliers. Please contact our customer service team to address additional questions and concerns. Customer service hours are 8:30am to 6:00pm EST Monday-Thursday, and 8:30am to 5:00pm EST on Friday. Customers should be advised to plan strategically around inclement weather when ordering product.




HOW DOES ADEQUAN® i.m. COMPARE?

What is the difference between FDA-Approved prescription Adequan® i.m. and other over-the-counter products? Arrow Up
There are many supplements, medical devices and over-the-counter products making claims similar to Adequan® i.m. However, most of these products are only supported by testimonial statements and do not have the structured and qualified product testing and trials Adequan® i.m. completed to obtain FDA-Approval.




SAFETY & APPROVED USES

Are there any age or breed restrictions for Adequan® i.m.? Arrow Up
There are no age or breed restrictions.1
Are there any contraindications? Arrow Up
There are no known contraindications to the use of intramuscular Polysulfated Glycosaminoglycan. Do not use in horses showing a hypersensitivity to PSGAG.1
Are there any side effects that may be observed? Arrow Up Are there precautions for the use of Adequan® i.m.? Arrow Up
The safe use of Adequan® i.m. in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated.1
Are there any warnings? Arrow Up
Adequan® i.m. should not be used in horses intended for human consumption. Not for use in humans. Keep this and all medications out of the reach of children.1
Is Adequan® i.m. approved for use in pregnant or lactating mares, or in breeding stallions? Arrow Up
No. The safe use of Adequan® i.m. in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated.1
Is Adequan® i.m. approved for use in horses with insulin dysregulation (ID), insulin resistance (IR), Equine Metabolic Syndrome (EMS), or Pituitary Pars Intermedia Dysfunction (PPID)? Arrow Up
No. Studies to establish the safety of Adequan® i.m. in horses suffering from these conditions have not been conducted by American Regent, Inc.1,4
Is Adequan® i.m. approved for use in foals, minis, drafts, or aged horses? Arrow Up
No. Adequan® i.m. has not been studied for safety or efficacy in foals, minis, drafts, or aged horses.1 Pivotal approval studies were conducted in Quarter or Thoroughbred-type horses. Safety studies specifically included male and female horses ranging in weight 600 to 972 lbs., aged 2 to 10 years.1,3




CONCURRENT USE WITH OTHER PRODUCTS

Is Adequan® i.m. approved for concurrent use with other products for joint disease? Arrow Up
No. Adequan® i.m. is an FDA-Approved drug for the treatment of degenerative joint disease and is not approved for concurrent use with any product.1
Are oral glucosamine and chondroitin sulfate products suggested to be utilized while a horse is using Adequan® i.m.? Arrow Up
Adequan® i.m. is an FDA-Approved drug for the treatment of DJD and traumatic joint dysfunction. As required by FDA, safety and efficacy studies for Adequan® i.m. were conducted without the concomitant use of additional products. Adequan® i.m. successfully achieved FDA approval without use of additional oral joint health (OJS) products.1
Can I give Adequan® i.m. to a horse that is also taking NSAIDS (Non-steroidal anti-inflammatory drugs)? Arrow Up
American Regent Animal Health (ARAH) has not completed any trials or studies identifying the combination use of NSAIDs and Adequan® i.m.




ABOUT AMERICAN REGENT ANIMAL HEALTH

Who is the manufacturer of Adequan® i.m.? Arrow Up



HOW TO PURCHASE

How can I order Adequan® i.m.? Arrow Up
INDICATIONS
Adequan® i.m. (polysulfated glycosaminoglycan) is recommended for the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.
IMPORTANT SAFETY INFORMATION There are no known contraindications to the use of intramuscular Polysulfated Glycosaminoglycan. Studies have not been conducted to establish safety in breeding horses. WARNING: Do not use in horses intended for human consumption. Not for use in humans. Keep this and all medications out of the reach of children. CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For full prescribing information, click here.
1. Adequan® i.m. Package Insert, Rev 1/19.
2. Burba DJ, Collier MA, DeBault LE, Hanson-Painton O, Thompson HC, Holder CL: In vivo kinetic study on uptake and distribution of intramuscular tritium-labeled polysulfated glycosaminoglycan in equine body fluid compartments and articular cartilage in an osteochondral defect model. J Equine Vet Sci 1993; 13: 696-703.
3. Freedom of information Summary, Adequan® i.m. NADA 140-901
4. Tadros EM, Frank N. Equine Veterinary Education, Equine vet. Educ. (2013) 25 (3) 152-162, doi: 10.1111/j.2042-3292.2011.00327.x

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