Tirzepatide for Weight Loss: Understanding the Medication and the Tirzepatide Shortage

When compared to to other GLP-1 medications (liraglutide, dulaglutide, and semaglutide), tirzepatide offers a promising alternative for those struggling to lose weight. As the demand for this innovative treatment increased, patients and healthcare providers have faced challenges with both availability and cost of branded tirzepatide, leading many to turn to compounded tirzepatide.

What happens when the branded tirzepatide shortage is resolved, though, and how will that impact access to compounded tirzepatide for the 1,000,000 + patients who are currently using it?

Staying Informed: Updates on the Tirzepatide Shortage and Availability

The remarkable efficacy of tirzepatide has led to unprecedented demand, resulting in widespread shortages of brand name tirzepatide: Mounjaro™ and Zepbound™. This has led to ~2 years of tirzepatide being classed as “in shortage” on the FDA website. On top of that, insurance coverage for Mounjaro™ and Zepbound™ is sparse, meaning out-of-pocket costs for these medications can rise up to >$1,000 each month, with cost being prohibitive for the majority of U.S. residents.

How are providers like Fella Health able to supply tirzepatide for a lower price, then? Compounding! Select compounding outsourcing facilities (503b) and direct-to-patient pharmacies(503a), like the ones that Fella is partnered with, are able to manufacture duplicate medications and fill prescriptions classed as “in shortage” on the FDA website. Once a medication shortage is officially “resolved”, though, 503b facilities have up to 60 days to stop manufacturing the medication in large, bulk quantities.

Compounded medications are nearly identical in formulation and, thus, efficacy. Our Fella patients who use compounded tirzepatide  lose up to 22.5% of their body weight in just 1 year (on average).

There has been a plethora of updates regarding the FDA and the tirzepatide shortage in October 2024. Here is everything that you need to know regarding the entire tirzepatide timeline:

• Tirzepatide has been considered “in shortage” since December 2022, allowing for compounding to take place
• On October 3, 2024, the FDA changed the status of tirzepatide from “in shortage” to “resolved” on their website. This would then mean that 503b facilities could no longer manufacture new tirzepatide from December 1, 2024.
• On October 7, 2024, the FDA was sued by the Outsourcing Facilities Association, who alleged that there was a premature resolution of the tirzepatide shortage with no due process
• On October 11, 2024, a court order remanded the FDA’s decision back to the agency for internal reevaluation, meaning compounding of tirzepatide can still take place
• As of October 22, 2024, the internal reevaluation is still ongoing. The FDA will not be taking action against compounders for continuing to manufacture compounded tirzepatide during their reevaluation
• Early reports are mentioning an FDA update on tirzepatide sometime around the end of November 2024

Navigating the Tirzepatide Shortage

While some companies that previously supplied compounded tirzepatide have already discontinued manufacture + supply, at Fella we are committed to providing compounded tirzepatide for as long as we are lawfully able to, with proactive, regular updates from Richie, our CEO, on our Fella Health subReddit and via emails to our existing customers. What should you consider as we navigate an unprecedented time in compounded pharmaceuticals? 👇

• Switch providers: You can switch providers if your current provider is not offering tirzepatide any longer. Fella ensures a seamless transition so that you don’t miss a beat if you’re wanting to continue your tirzepatide treatment for as long as possible.
• Switch to Semaglutide: Works very similarly to tirzepatide and has proven weight loss efficacy (~17% bodyweight in 1 year). The important thing is that your GLP-1 treatment is uninterrupted so that you can continue to pursue your goal weight and manage your A1C levels
• Maintenance plan: If you are on GLP-1s and have reached your weight goal, a maintenance plan could be an affordable solution for you.
• Regular provider consultation: Staying in touch with your healthcare team ensures appropriate adjustments to your treatment plan. At Fella, we’re committed to providing the high touch correspondence that you expect

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