GLP-1 Medical Disclaimer

This disclaimer applies to compounded GLP-1 receptor agonist therapy (including compounded semaglutide and compounded tirzepatide) prescribed by Align Integrative Wellness, LLC (“Align”). Please read carefully before initiating GLP-1 therapy.

Compounded medications are not FDA-approved

The FDA-approved branded versions of semaglutide and tirzepatide are manufactured by major pharmaceutical companies and have undergone the FDA’s formal new-drug approval process.

Compounded versions of semaglutide and tirzepatide are prepared by licensed U.S. compounding pharmacies under 503A or 503B regulations. Compounded medications are not FDA-approved. While they contain the same active pharmaceutical ingredient as the brand-name medications, they have not undergone the FDA’s formal new-drug approval process.

Compounded medications are prescribed when:

• The brand-name product is not commercially available or is in shortage
• The patient requires a customized dose, formulation, or strength not available commercially
• There is a documented clinical need for a compounded preparation

Your provider will discuss whether brand-name or compounded medication is appropriate for your specific situation. Brand-name medications may be covered by insurance for diagnosed obesity or type 2 diabetes; compounded medications generally are not covered by insurance.

Eligibility requires clinical evaluation

GLP-1 therapy is not appropriate for everyone. Eligibility depends on a clinical evaluation by your provider, including review of your weight history, current health, lab work, and any contraindications.

GLP-1 therapy is generally not appropriate for patients with:

• Personal or family history of medullary thyroid carcinoma
• Multiple endocrine neoplasia syndrome type 2 (MEN-2)
• Pregnancy or active plans to become pregnant
• Active eating disorder
• History of pancreatitis
• Known hypersensitivity to GLP-1 receptor agonists
• Patients under 18 years old

Other contraindications and precautions may apply. Your provider will conduct the full eligibility evaluation.

Side effects and risks

Common side effects

The most common side effects of GLP-1 therapy are gastrointestinal:

• Nausea (most common, especially during dose increases)
• Mild constipation
• Reduced appetite (often the desired effect, but can be uncomfortable)
• Occasional vomiting
• Mild fatigue, especially during dose changes

Most patients describe these as “noticeable but manageable.” They typically appear in the first 2 to 4 weeks and improve as the body adjusts. Your provider will start at a low dose and titrate slowly to minimize side effects.

Less common side effects

• Vomiting (especially with rapid dose increases)
• Diarrhea
• Acid reflux
• Headaches
• Feeling unusually full after small meals

Serious but rare side effects

• Pancreatitis (severe abdominal pain that radiates to the back)
• Gallbladder issues (gallstones, cholecystitis)
• Severe hypoglycemia (especially when combined with insulin or sulfonylureas)
• Allergic reaction
• Acute kidney injury (related to dehydration from severe vomiting)

If you experience symptoms of any serious side effect, stop the medication and seek immediate medical attention.

Individual results vary

Patient response to GLP-1 therapy varies considerably based on starting weight, metabolic rate, lifestyle, dose, and individual physiology. Most patients in our 90-day metabolic protocol experience 15 to 25 lbs of weight change*, but individual results differ. Some patients experience more, some less. Some patients are non-responders.

*Internal data based on patients completing our 90-day protocol. Individual results vary. Eligibility and outcomes depend on clinical evaluation. Not a guarantee of weight loss.

Long-term considerations

GLP-1s work for as long as you take them. Studies show meaningful weight regain after stopping if no other lifestyle, hormonal, or metabolic changes are addressed. We treat GLP-1 as part of a longer-term metabolic protocol, not a 90-day weight-loss product.

Your provider will discuss long-term planning with you, including possible step-down dosing, maintenance dosing, or transition to other interventions.

What this is not

This service is not a substitute for emergency medical care. If you are experiencing a medical emergency, call 911 or go to your nearest emergency department.

This information is not personalized medical advice. The content of this disclaimer is for general informational purposes only. Your provider will discuss the specifics of your treatment plan, risks, and contraindications during your consultation.

Pharmacy partner

Compounded GLP-1 medications prescribed by Align are dispensed by Mountain View Pharmacy, Bountiful, Utah, a licensed U.S. 503A compounding pharmacy. Medications are shipped directly to you in temperature-controlled packaging.

Acknowledgment

By initiating GLP-1 therapy with Align Integrative Wellness, LLC, you acknowledge that you have read this disclaimer, understand the risks and limitations of compounded GLP-1 therapy, and have had the opportunity to discuss any questions with your provider.

A signed copy of this disclaimer (in combination with your treatment plan) will be obtained at intake and stored in your medical record.

Contact

Questions about GLP-1 therapy or this disclaimer:
Align Integrative Wellness, LLC
Mailing address available on request
care@alignintegrative.com
(385) 316-1345

Align Integrative Wellness, LLC is not affiliated with, endorsed by, or sponsored by the manufacturers of the FDA-approved branded versions of semaglutide or tirzepatide. References to branded medications are for informational comparison only.