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Tirzepatide Injection Shortage

Last Updated: October 8, 2024
Status: Current

Reason for the Shortage
    • Lilly states Mounjaro and Zepbound are available.
Available Products
    • Mounjaro subcutaneous solution for injection, Lilly USA, LLC, 10 mg/0.5 mL, pen injector, 4 count, NDC 00002-1471-80
    • Mounjaro subcutaneous solution for injection, Lilly USA, LLC, 12.5 mg/0.5 mL, pen injector, 4 count, NDC 00002-1460-80
    • Mounjaro subcutaneous solution for injection, Lilly USA, LLC, 15 mg/0.5 mL, pen injector, 4 count, NDC 00002-1457-80
    • Mounjaro subcutaneous solution for injection, Lilly USA, LLC, 2.5 mg/0.5 mL, pen injector, 4 count, NDC 00002-1506-80
    • Mounjaro subcutaneous solution for injection, Lilly USA, LLC, 5 mg/0.5 mL, pen injector, 4 count, NDC 00002-1495-80
    • Mounjaro subcutaneous solution for injection, Lilly USA, LLC, 7.5 mg/0.5 mL, pen injector, 4 count, NDC 00002-1484-80
    • Zepbound subcutaneous solution for injection, Lilly USA, LLC, 10 mg/0.5 mL, pen injector, 4 count, NDC 00002-2471-80
    • Zepbound subcutaneous solution for injection, Lilly USA, LLC, 12.5 mg/0.5 mL, pen injector, 4 count, NDC 00002-2460-80
    • Zepbound subcutaneous solution for injection, Lilly USA, LLC, 15 mg/0.5 mL, pen injector, 4 count, NDC 00002-2457-80
    • Zepbound subcutaneous solution for injection, Lilly USA, LLC, 2.5 mg/0.5 mL, pen injector, 4 count, NDC 00002-2506-80
    • Zepbound subcutaneous solution for injection, Lilly USA, LLC, 5 mg/0.5 mL, pen injector, 4 count, NDC 00002-2495-80
    • Zepbound subcutaneous solution for injection, Lilly USA, LLC, 7.5 mg/0.5 mL, pen injector, 4 count, NDC 00002-2484-80

Estimated Resupply Dates

    • While doses are available, some people still may experience difficulties getting their medication from their pharmacy. This can vary by location based upon supply chain dynamics that are not controlled by Lilly.

Implications for Patient Care

    • Tirzepatide is a GIP/GLP-1 receptor agonist that increases glucose-dependent insulin secretion, decreases glucagon secretion, slows gastric emptying, and decreases food intake.[1]
    • Mounjaro is FDA-approved to improve glycemic control in type 2 diabetes patients as an adjunct to diet and exercise.[2]
    • Zepbound is FDA-approved as an adjunct to diet and exercise for chronic weight management in patients with a BMI of 30 kg/m2 or higher, or in patients with a BMI of 27 kg/m2 or higher and at least one weight-related comorbid condition.[3]

Safety

    • Lilly issued an open letter on June 20, 2024, addressing the following safety concerns:[4]
    • Tirzepatide use in people under the age of 18 is not recommended. Social media posts and ads promoting use in people under the age of 18 are inappropriate and may expose people to significant risk.
    • Lilly is the ONLY lawful supplier of FDA-approved tirzepatide medications Mounjaro and Zepbound and does not supply tirzepatide to compounding pharmacies, med spas, wellness centers, online suppliers, or other manufacturers.
    • Lilly is taking legal action against entities claiming their products contain FDA-approved tirzepatide.
    • If anyone believes to have received or used a fake version of tirzepatide, call the Lilly Answers Center (TLAC) at 1-800-LillyRx (1-800-545-5979).

Alternative Agents & Management

    • The American Diabetes Association (ADA) describes pharmacologic therapy in adults with type 2 diabetes in section 9 of the standards of care in diabetes.[5] The ADA lists tirzepatide, semaglutide, and high-dose dulaglutide as very effective GLP agents in glucose-lowering. The ADA lists semaglutide and tirzepatide as very effective GLP agents for weight loss in patients with type 2 diabetes. Alternative agents that can have moderate effects on glucose-lowering and aid in weight loss are dulaglutide and liraglutide.
    • The American Gastroenterological Association (AGA) guideline on pharmacological interventions for adults with obesity lists the following as agents that can treat obesity in adjunct with lifestyle interventions.[6] Examples of dosing schedules are included below: Semaglutide 2.4 mg subcutaneous injection[7] Weeks 1-4: 0.25 mg subcutaneously weekly Weeks 5-8: 0.5 mg subcutaneously weekly Weeks 9-12: 1 mg subcutaneously weekly Weeks 13-16: 1.7 mg subcutaneously weekly Week 17 and therafter (maintenance): 2.4 mg subcutaneously weekly (Preferred; may use 1.7 mg weekly if 2.4 mg not tolerated) Liraglutide 3.0 mg subcutaneous injection[8] Initial dose: 0.6 mg subcutaneously once daily for one week Increase dose at weekly intervals to a target dose of 3 mg once daily If a dose is not tolerated, delay increase for 1 additional week May continue on maximum tolerated dose if weight loss is achieved on that dose Evaluate weight loss after 12 weeks at maximum tolerated dose; discontinue if 4-5% of baseline weight loss has not been achieved Phentermine-topiramate ER oral capsule[9] Initial: phentermine 3.75 mg/topiramate 23 mg by mouth once daily for 14 days Increase dose as tolerated to phentermine 7.5 mg/topiramate 46 mg by mouth once daily for 12 weeks, then evaluate weight loss May discontinue if at least 3% of baseline body weight was not lost w/ gradual taper OR increase dose based on tolerability May escalate dose to phentermine 11.25mg/topiramate 69 mg by mouth once daily for 14 days, then to a max dose of phentermine 15 mg/topiramate 92 mg by mouth once daily If at least 5% of baseline body weight is not lost, discontinue with a gradual taper Naltrexone-bupropion ER oral tablet[10] (one tablet = naltrexone 8 mg/bupropion 90 mg) Initial: One tablet by mouth once daily in the morning for 1 week Increase dose in weekly intervals One tablet by mouth twice daily for one week 2 tablets by mouth in the morning and one tablet by mouth in the evening for 1 week 2 tablets by mouth twice daily Max dose 4 tablets/day (naltrexone 32 mg/bupropion 360 mg per day) Discontinue if weight loss is not at least 4-5% of baseline after 3 months

References

    1. Tirzepatide (Lexi-Drugs) - UpToDate® LexidrugTM. Accessed July 26, 2024. https://online-lexi-com.ezproxy.lib.utah.edu/lco/action/doc/retrieve/docid/patch_f/7224042?cesid=3zD85waaxdt&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dtirzepatide%26t%3Dname%26acs%3Dtrue%26acq%3Dtirzep#
    2. DailyMed - MOUNJARO- tirzepatide injection, solution. Accessed July 26, 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0#boxedwarning
    3. DailyMed - ZEPBOUND- tirzepatide injection, solution ZEPBOUND- tirzepatide injection, solution. Accessed July 26, 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b
    4. An Open Letter From Eli Lilly and Company Regarding Certain Practices Related to Mounjaro® and Zepbound® | Eli Lilly and Company. Accessed July 26, 2024. https://investor.lilly.com/news-releases/news-release-details/open-letter-eli-lilly-and-company-regarding-certain-practices
    5. American Diabetes Association Professional Practice Committee. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes2024. Diabetes Care. 2023;47(Supplement_1):S158-S178. doi:10.2337/dc24-S009
    6. Grunvald E, Shah R, Hernaez R, et al. AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity. Gastroenterology. 2022;163(5):1198-1225. doi:10.1053/j.gastro.2022.08.045
    7. Semaglutide (Lexi-Drugs) - UpToDate® LexidrugTM. https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/6577162?cesid=9q9iZIs4obk&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dsemaglutide%26t%3Dname%26acs%3Dtrue%26acq%3Dsemag
    8. Liraglutide (Lexi-Drugs) - UpToDate® LexidrugTM. https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/2144379?cesid=3kwsWdTtb3h&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dliraglutide%26t%3Dname%26acs%3Dtrue%26acq%3Dliragl
    9. Phentermine and topiramate (Lexi-Drugs) - UpToDate® LexidrugTM. https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/3832942?cesid=71Z3CHXJTil&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dphentermine%2Btopiramate%26t%3Dname%26acs%3Dtrue%26acq%3Dphenterm
    10. Naltrexone and bupropion (Lexi-Drugs) - UpToDate® LexidrugTM. https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/5338462?cesid=7VNb07A2ee1&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dnaltrexone%2Band%2BbuPROPion%26t%3Dname%26acs%3Dtrue%26acq%3Dnaltre

Updated

Updated October 8, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created July 20, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.