Products Affected - Description

• • Hexatrione injection, Medexus Pharma, 20 mg/mL, 2 mL ampule, 1 count, NDC 59137-0570-01

Reason for the Shortage

• • Sandoz discontinued Aristospan in September 2020.

Available Products

• • There are no presentations available

• • Medexus in conjunction with FDA has had initiated a temporary importation of Triamcinolone Hexacetonide (Hexatrione 2%) injectable suspension 20 mg/mL 2 mL ampules (NDC 59137-0570-01), to the U.S. market to address drug shortage. Currently this product is unavailable to order. Once it is available again, please contact ANDA at1-855-336-3322, Option # 9. There is a side by side comparison between Aristospan and Hexatrione available at https://www.fda.gov/media/154709/download.

• • Triamcinolone hexacetonide injection is commonly used as an intraarticular injection for inflammatory joint diseases.[1]

• • Refer to Table 1 for alternative corticosteroids available as depot injections. Alternative agents may also experience supply shortages.
  • Clinical guidelines from American Academy of Orthopaedic Surgeons (AAOS), American College of Rheumatology (ACR), European League Against Rheumatism (EULAR), and do not endorse one intraarticular corticosteroid over another for short-term pain relief in inflammatory joint diseases.[2-5]

  Table 1. Recommended dosing of Corticosteroids Available as Depot Formulations[1 6 7]

  Agent	Large Joint Intraarticular Dosing	Medium Joint Intraarticular Dosing	Small Joint Intraarticular Dosing
  Triamcinolone acetonide	20 - 40 mg	20 - 30 mg	8 - 10 mg
  Triamcinolone acetonide extended-release	32 mg	32 mg	Not suitable
  Triamcinolone hexacetonide	10 - 20 mg	10 - 20 mg	2 - 6 mg
  Methylprednisolone acetate	20 - 80 mg	10 - 20 mg	4 - 10 mg
  Betamethasone sodium phosphate/acetate	6 - 12 mg	3 - 6 mg	1.5 - 3 mg

  
  

• 1. Triamcinolone. UpToDate Lexidrug, Lexi-Drugs Online. Waltham, MA, 2023.
  2. Benzon HT, Provenzano DA, Nagpal A, et al. Use and safety of corticosteroid injections in joints and musculoskeletal soft tissue: guidelines from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, the American Society of Interventional Pain Physicians, and the International Pain and Spine Intervention Society. Regional anesthesia and pain medicine 2025 doi: 10.1136/rapm-2024-105656[published Online First: Epub Date]|.
  3. Brophy RH, Fillingham YA. AAOS Clinical Practice Guideline Summary: Management of Osteoarthritis of the Knee (Nonarthroplasty), Third Edition. The Journal of the American Academy of Orthopaedic Surgeons 2022;30(9):e721-e29 doi: 10.5435/jaaos-d-21-01233[published Online First: Epub Date]|.
  4. Navani A, Manchikanti L, Albers SL, et al. Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain physician 2019;22(1s):S1-s74
  5. Uson J, Rodriguez-Garc­a SC, Castellanos-Moreira R, et al. EULAR recommendations for intra-articular therapies. Annals of the rheumatic diseases 2021;80(10):1299-305 doi: 10.1136/annrheumdis-2021-220266[published Online First: Epub Date]|.
  6. Betamethasone. UpToDate Lexidrug, Lexi-Drugs Online. Waltham, MA, 2023.
  7. Methylprednisolone. UpToDate Lexidrug, Lexi-Drugs Online. Waltham, MA, 2023.