ElixaMD

Important Savety Information

Please see Important Safety Information below for intended use, potential risks and side effects, use in specific populations, and drug interactions of advertised prescription treatments.

ElixaMD encourages the reporting of any adverse side effects of medications to the medical professional and the distributing pharmacy. Additionally, to report suspected adverse reactions to acarbose contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In case of emergencies, please call 911 or go seek care at the nearest emergency room.

Personalized Semaglutide, and Personalized Tirzepatide—have been prescribed (on-and-off label) for weight management, including obesity, along with a reduced caloric diet and increased physical activity. Take precaution with, and read all warnings concerning, GLP-1s, as they may cause serious side effects, including a risk of thyroid c-cell tumors. Do not use if you or your family have a history of a type of thyroid cancer called MTC (medullary thyroid carcinoma) or MEN 2 (multiple endocrine neoplasia syndrome). See important warnings & safety info about these medications. As an alternative to FDA-approved branded products, where appropriate, a provider may prescribe a GLP-1 compounded drug that is effective when prescribed off label for weight loss, which is prepared by a state-licensed sterile compounding pharmacy partner. Although GLP-1 compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Thoroughly review all warnings and essential safety information regarding these drugs. Important safety information may be found below.

Personalized Semaglutide (Injection) - Important Safety Information

Last Updated: 19 March 2025

BLACK BOX WARNING
Warning: Risk of Thyroid C-Cell Tumors
See full prescribing information for complete boxed warning.

* As an alternative to FDA-approved branded products, where appropriate, a provider may prescribe a compounded drug, which is prepared by a state-licensed sterile compounding pharmacy partner. Although compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your provider may recommend certain doses of compounded semaglutide based on your medical evaluation. FDA-approved medicines containing semaglutide are available.

What is the most important information I should know about Semaglutide?
Semaglutide may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Semaglutide and medicines that work like Semaglutide caused thyroid tumors, including thyroid cancer. It is not known if Semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
- Do not use Semaglutide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Do not use Semaglutide if:
- you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- you have had a serious allergic reaction to semaglutide or any of the ingredients in Semaglutide.

Before using Semaglutide, tell your healthcare provider if you have any other medical conditions, including if you:
- have or have had problems with your pancreas or kidneys
- have type 2 diabetes and a history of diabetic retinopathy
- have or have had depression, suicidal thoughts, or mental health issues
- are pregnant or plan to become pregnant. Semaglutide may harm your unborn baby. You should stop using Semaglutide 2 months before you plan to become pregnant
- are breastfeeding or plan to breastfeed. It is not known if Semaglutide passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Semaglutide may affect the way some medicines work and some medicines may affect the way Semaglutide works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Semaglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

What are the possible side effects of Semaglutide?

Semaglutide may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using Semaglutide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
- gallbladder problems. Semaglutide may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
- increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Semaglutide. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery
- kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
serious allergic reactions. Stop using Semaglutide and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat - change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Semaglutide
- increased heart rate. Semaglutide can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes
- depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you

The most common side effects of Semaglutide may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu, heartburn, and runny nose or sore throat.

Semaglutide is a prescription medication.

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.

This summary provides basic information about compounded semaglutide but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about compounded semaglutide and how to take it. Your healthcare provider is the best person to help you decide if compounded semaglutide is right for you.

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

You are encouraged to report negative side effects of compounded semaglutide to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. In case of emergencies, please call 911 or go to the nearest emergency room.

Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.


Personalized Tirzepatide (Injection) - Important Safety Information

Last Updated: 19 March 2025

BLACK BOX WARNING
Warning: Risk of Thyroid C-Cell Tumors
See full prescribing information for complete boxed warning.


* As an alternative to FDA-approved branded products, where appropriate, a provider may prescribe a compounded drug, which is prepared by a state-licensed sterile compounding pharmacy partner. Although compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your provider may recommend certain doses of compounded Tirzepatide based on your medical evaluation. FDA-approved medicines containing Tirzepatide are available.

What is the most important information I should know about compounded Tirzepatide?
Tirzepatide may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats, Tirzepatide and medicines that work like Tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if Tirzepatide will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not use Tirzepatide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Inflammation of the pancreas (pancreatitis). Stop using Tirzepatide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Tirzepatide with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.
- Serious allergic reactions. Stop using Tirzepatide and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.
- Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
- Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Tirzepatide. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
- Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Tirzepatide.
- Gallbladder problems. Gallbladder problems have happened in some people who use Tirzepatide. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.

Common side effects
The most common side effects of Tirzepatide include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Tirzepatide. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

DRUG INTERACTIONS
As with other medications, compounded Tirzepatide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Tirzepatide delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Tirzepatide, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (i.e., warfarin) should be monitored closely while on Tirzepatide.

This summary provides basic information about compounded Tirzepatide but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about compounded Tirzepatide and how to take it. Your healthcare provider is the best person to help you decide if compounded Tirzepatide is right for you.

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

You are encouraged to report negative side effects of compounded Tirzepatide to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. In case of emergencies, please call 911 or go to the nearest emergency room.

Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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*The assessment made available on the ElixaMD website does not create a doctor-patient relationship between the individual completing the assessment and ElixaMD. OpenLoop Health, a network of US-licensed doctors that adhere to rigorous medical protocols designed for patient safety, has established exclusionary criteria to determine if an individual does not qualify for GLP-1s. The answers an individual provides to the ElixaMD assessment consequently determine if the individual is screened out of eligibility for GLP-1 medication, and an OpenLoop Health clinician will meet with an individual after checkout to determine if they qualify for a prescription. OpenLoop Health clinicians retain the decision to prescribe compounded GLP-1s to patients.

All claims and benefits on this website refer to self-reported data from GLP-1 customers on a treatment plan that includes compounded GLP-1 medications and consultations with medical professionals. Customers reported their weight on their initial medical intake questionnaire every 3-4 weeks thereafter. Results from compounded medications found on the ElixaMD platform may vary and be affected by an individual's adherence to the program and their clinician's recommendations. Compounded GLP-1s are produced in FDA-regulated facilities. Although these facilities are highly regulated, the medications are not FDA-approved or evaluated for safety, efficacy, or quality. The decision to use compounded drugs is guided by the licensed provider's medical judgment, which is informed by a telehealth consultation and medical history. We encourage all prospective users of compounded medications to speak with their provider about the specific risks and benefits that may come with the use of compounded medication. ElixaMD does not produce compounded medications, and individuals may receive medication that looks different than what is portrayed on the website

Pharmacy Providers
We are partnered with multiple USA certified pharmacies to bring the best product and overall experience to our membership. Our team meets regularly with pharmacies to discuss any product shortages, shipping delays, and get updated reports on their medication testing.

*Results vary based on starting weight and program adherence. Inches lost from hips, waist, chest, thighs and arms in the first month. Patients exercised daily and ate a reduced-calorie diet. Their fat loss is not typical. Results may vary. Medication prescriptions are at the discretion of medical providers and may not be suitable for everyone. ElixaMD patients typically result in 1-2 lbs per week weight loss after 4 weeks, involving a healthy diet and exercise changes. Consult a healthcare professional before using medication or starting any weight loss program. *Based on the average weight loss as reported by patients without diabetes who reached and maintained a dose of 2.4 mg/week of GLP-1 treatment, along with a reduced-calorie diet and increased physical activity.

Medication is included in the cost of the ElixaMD Program. Wegovy® is FDA-approved for weight loss. Ozempic® is FDA-approved for type 2 diabetes treatment but may be prescribed for weight loss. The trademarks, service marks, trade names (Wegovy® ,Ozempic®), and products displayed on this Internet site are protected and belong to their respective owners. Medical treatment is provided by “OpenLoop Health", affiliated networks for medical professional corporations and associations. No data, photos, claims or any other information is associated with results derived from clinical trials, studies or public information and is always representative of ElixaMD patient experience.