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Author: Muhammad Qureshi

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IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Therapy with Reltone is for patients with specific situations and gallstone types. Dissolving a gallstone with Reltone takes months of therapy. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. Your healthcare provider should check liver enzyme levels when you start and continue taking Reltone. Do not use Reltone if you have a strong medical reason to have surgery to remove the gallbladder or if you have an allergy to bile acids.

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WHAT IS RELTONE?

Reltone (ursodiol capsules) is an FDA-approved prescription medicine for people with certain types of gallstones. 

1. Reltone may be used to dissolve gallstones in people who cannot or choose not to have surgery to remove the gallbladder (elective cholecystectomy). They may not be able to have surgery because of higher risk due to disease, age, or reaction to anesthesia. Reltone may be used to dissolve gallstones that are:

  • Made up of cholesterol
  • Not visible with x-ray (radiolucent)
  • Not hardened (noncalcified)
  • Smaller than 20 mm in diameter


2. Reltone is also used to prevent gallstones from forming in patients with body mass index (BMI) ≥ 30 experiencing rapid weight loss from either surgery or dieting.


IMPORTANT SAFETY INFORMATION

Therapy with Reltone is for patients with specific situations and gallstone types, and other therapies should be considered when selecting treatment. Dissolving a gallstone with Reltone takes months of therapy. In some patients, the gallstone is not completely dissolved. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. It is not known if Reltone is safe to use for longer than 24 months.

Your healthcare provider should check the levels of certain liver enzymes when you first start taking Reltone and at times as you continue taking it. Tell your healthcare provider if you have liver disease.

Reltone will not dissolve gallstones that are

  • Made up of hardened (calcified) cholesterol
  • Visible with x-ray (radiopaque)
  • Made up of bile pigments and invisible with x-ray (radiolucent)


Reltone should not be used by people who have a strong medical reason to have surgery to remove the gallbladder. These reasons may include sudden, persistent swelling of the gallbladder (unremitting acute cholecystitis); infected bile ducts (cholangitis); blocked bile ducts (biliary obstruction); inflamed pancreas caused by gallstones (gallstone pancreatitis); or an abnormal connection between organs (biliary-gastrointestinal fistula).


Do not use Reltone if you have an allergy to bile acids.

When Reltone is used for dissolving gallstones, the most common side effects (more frequent than placebo by ≥3%) include diarrhea, indigestion, inflamed throat (pharyngitis), and arthritis. When Reltone is used for preventing gallstones, the most common side effects (more frequent than placebo by ≥3%) include back pain, diarrhea, constipation, nausea, and dizziness.

Using Reltone when pregnant is not recommended. Using the correct dose of Reltone is important, especially for elderly people. It is unknown if Reltone is safe or effective in children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information enclosed.

*Eligibility requirements and program restrictions may apply.

References

  1. Reltone. Prescribing information. Intra-Sana Laboratories LLC; 2024.

     

  2. Stokes CS, Gluud LL, Casper M, Lammert F. Ursodeoxycholic acid and diets higher in fat prevent gallbladder stones during weight loss: a meta-analysis of randomized controlled trials. Clin Gastroenterol Hepatol. 2014;12(7):1090-e61. doi:10.1016/j.cgh.2013.11.031

     

  3. European Association for the Study of the Liver (EASL). EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016;65(1):146-181. doi:10.1016/j.jhep.2016.03.005

     

  4. Mechanick JI, Apovian C, Brethauer S, et al. Clinical practice guidelines for the perioperative nutrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures – 2019 update: cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, The Obesity Society, American Society for Metabolic & Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists – executive summary. Endocr Pract. 2019;25(12):1346-1359. doi:10.4158/GL-2019-0406

     

  5. He L, Wang J, Ping F, et al. Association of glucagon-like peptide-1 receptor agonist use with risk of gallbladder and biliary diseases: a systematic review and meta-analysis of randomized clinical trials. JAMA Intern Med. 2022;182(5):513-519. doi:10.1001/jamainternmed.2022.0338

     

  6. Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012;6(2):172-187. doi:10.5009/gnl.2012.6.2.172

     

  7. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205-216. doi:10.1056/NEJMoa2206038

     

  8. Garvey WT, Batterham RL, Bhatta M, et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022;28(10):2083-2091.doi:10.1038/s41591-022-02026-4

     

  9. Mounjaro. Prescribing information. Eli Lilly and Company; 2023.

     

  10. Ozempic. Prescribing information. Novo Nordisk; 2023.

     

  11. Rybelsus. Prescribing information. Novo Nordisk; 2024. 12.

  12. Saxenda. Prescribing information. Novo Nordisk; 2023.

     

  13. Victoza. Prescribing information. Novo Nordisk; 2023.

     

  14. Wegovy. Prescribing information. Novo Nordisk; 2024.

     

  15. Zepbound. Prescribing information. Eli Lilly and Company; 2024.

     

  16. Garvey WT, Frias JP, Jastreboff AM, et al. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo- controlled, phase 3 trial. Lancet. 2023;402(10402):613-626. doi:10.1016/S0140-6736(23)01200-X

     

  17. Morris-Stiff G, Sarvepalli S, Hu B, et al. The natural history of asymptomatic gallstones: a longitudinal study and prediction model. Clin Gastroenterol Hepatol. 2023;21(2):319-327.e4. doi:10.1016/j.cgh.2022.04.010

     

  18. Jones MW, Weir CB, Ghassemzadeh S. Gallstones (Cholelithiasis). In: StatPearls [Internet]. StatPearls Publishing; 2024. Accessed July 3, 2024.https://www.ncbi.nlm.nih.gov/books/NBK459370/

     

  19. Schreuder AM, Busch OR, Besselink MG, et al. Long-term impact of iatrogenic bile duct injury. Dig Surg. 2020;37(1):10-21. doi:10.1159/000496432

     

  20. Pucher PH, Brunt LM, Davies N, et al. Outcome trends and safety measures after 30 years of laparoscopic cholecystectomy: a systematic review and pooled data analysis. Surg Endosc. 2018;32(5):2175-2183. doi:10.1007/s00464-017-5974-2

Important Safety Information

Please read this important safety information carefully. This page contains essential information about Reltone (ursodiol) that you should discuss with your healthcare provider.
Important Considerations Before Using Reltone

Therapy with Reltone is for patients with specific situations and gallstone types, and other therapies should be considered when selecting treatment. Dissolving a gallstone with Reltone takes months of therapy. In some patients, the gallstone is not completely dissolved. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. It is not known if Reltone is safe to use for longer than 24 months.

Liver Monitoring & Treatment Limitations

Your healthcare provider should check the levels of certain liver enzymes when you first start taking Reltone and at times as you continue taking it. Tell your healthcare provider if you have liver disease.

Made up of hardened (calcified) cholesterol
Visible with x-ray (radiopaque)
Made up of bile pigments and invisible with x-ray (radiolucent)
Who Should Not Use Reltone

Patients Requiring Gallbladder Surgery

Reltone should not be used by people who have a strong medical reason to have surgery to remove the gallbladder. These reasons may include sudden, persistent swelling of the gallbladder (unremitting acute cholecystitis); infected bile ducts (cholangitis); blocked bile ducts (biliary obstruction); inflamed pancreas caused by gallstones (gallstone pancreatitis); or an abnormal connection between organs (biliarygastrointestinal fistula).

Allergy to Bile Acids

Do not use Reltone if you have an allergy to bile acids.

Common Side Effects

When Used for Dissolving Gallstones

When Reltone is used for dissolving gallstones, the most common side effects (more frequent than placebo by ≥3%) include diarrhea, indigestion, inflamed throat (pharyngitis), and arthritis.

When Used for Preventing Gallstones

When Reltone is used for preventing gallstones, the most common side effects (more frequent than placebo by ≥3%) include back pain, diarrhea, constipation, nausea, and dizziness.

Special Populations & Important Information
Using Reltone when pregnant is not recommended.
Using the correct dose of Reltone is important, especially for elderly people.
It is unknown if Reltone is safe or effective in children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information enclosed.

Reltone®
(200mg & 400mg ursodiol capsules, USP)

Proven therapy for preventing gallstone formation during rapid weight loss

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