Important Safety Information

Archie Health offers compounded semaglutide and compounded tirzepatide only. Compounded medications are prepared by state-licensed pharmacies. They are not FDA-approved, and the FDA does not review them for safety, effectiveness, or quality. Archie Health does not prescribe or sell Wegovy^®, Ozempic^®, Zepbound^® or Mounjaro^® and is not affiliated with Novo Nordisk A/S or Eli Lilly and Company.

This page summarizes important safety information. It does not include everything you need to know and does not replace talking with your provider. Read the information that comes with your prescription each time it is filled. Archie Health serves adults 18 and older. Side effects are common, especially when starting or increasing a dose.

• Compounded semaglutide
• Compounded tirzepatide
• Using your medication safely
• Getting help and reporting side effects
• Reference: FDA-approved brand-name medications

Compounded Semaglutide

Compounded semaglutide is prepared by a state-licensed pharmacy for an individual patient under a prescription. It contains semaglutide, the active ingredient in Ozempic^® and Wegovy^®, but it is not the same product and is not FDA-approved. It is a once-weekly injection given under the skin and is used alongside a reduced-calorie diet and increased physical activity.

Do not use compounded semaglutide if:

• you or any of your family have ever had medullary thyroid carcinoma (MTC), or you have MEN 2
• you have had a serious allergic reaction to semaglutide or any of the ingredients in your medication
• you are using another semaglutide-containing product or any other GLP-1 receptor agonist medicine

Before using compounded semaglutide, tell your provider if you:

• have or have had problems with your pancreas or kidneys
• have severe stomach problems, such as slowed stomach emptying (gastroparesis) or problems digesting food
• have type 2 diabetes and a history of diabetic retinopathy
• have or have had depression, suicidal thoughts, or other mental health problems
• are pregnant or plan to become pregnant. Semaglutide may harm your unborn baby and should not be used during pregnancy. Stop using it at least 2 months before you plan to become pregnant
• are breastfeeding or plan to breastfeed. It is not known if semaglutide passes into breast milk
• are scheduled for surgery or another procedure that uses anesthesia or deep sedation
• take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements, and especially insulin or sulfonylureas. Semaglutide slows stomach emptying and can affect how some medicines taken by mouth are absorbed

Compounded semaglutide may cause serious side effects, including:

• Inflammation of the pancreas (pancreatitis). Stop using it and call your 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, including gallstones. Some may need surgery. Call your provider if you have pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.
• Low blood sugar (hypoglycemia), especially if you also take medicines for diabetes such as insulin or sulfonylureas. Signs 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). Diarrhea, nausea, and vomiting can cause a loss of fluids (dehydration), which may cause kidney problems or make them worse. Drink fluids to help reduce your chance of dehydration.
• Severe stomach problems. Tell your provider if you have stomach problems that are severe or will not go away.
• Serious allergic reactions (hypersensitivity). Stop using it and get medical help right away if you have swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
• Changes in vision (diabetic retinopathy complications) in people with type 2 diabetes. Tell your provider if you have changes in vision during treatment.
• Increased heart rate. Tell your provider if you feel your heart racing or pounding in your chest for several minutes while at rest.
• Depression or thoughts of suicide. Pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your provider right away if you have any mental changes that are new, worse, or worry you.
• Food or liquid getting into the lungs during surgery or procedures (pulmonary aspiration). Because semaglutide slows stomach emptying, tell every healthcare provider who treats you that you use it before any procedure that uses anesthesia or deep sedation.

The most common side effects include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, and heartburn. These are not all the possible side effects. Talk to your provider about any side effect that bothers you or does not go away.

Compounded Tirzepatide

Compounded tirzepatide is prepared by a state-licensed pharmacy for an individual patient under a prescription. It contains tirzepatide, the active ingredient in Mounjaro^® and Zepbound^®, but it is not the same product and is not FDA-approved. It is a once-weekly injection given under the skin and is used alongside a reduced-calorie diet and increased physical activity.

Do not use compounded tirzepatide if:

• you or any of your family have ever had medullary thyroid carcinoma (MTC), or you have MEN 2
• you have had a serious allergic reaction to tirzepatide or any of the ingredients in your medication
• you are using another tirzepatide-containing product or any GLP-1 receptor agonist medicine

Before using compounded tirzepatide, tell your provider if you:

• have or have had problems with your pancreas or kidneys
• have severe stomach problems, such as slowed stomach emptying (gastroparesis) or problems digesting food
• have type 2 diabetes and a history of diabetic retinopathy
• have or have had depression, suicidal thoughts, or other mental health problems
• are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. Tirzepatide may harm your unborn baby and should not be used during pregnancy. It is not known if it passes into breast milk
• take birth control pills by mouth. They may not work as well while using tirzepatide. Your provider may recommend another type of birth control for 4 weeks after you start and for 4 weeks after each dose increase
• are scheduled for surgery or another procedure that uses anesthesia or deep sedation
• take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements, and especially insulin or sulfonylureas

Compounded tirzepatide may cause serious side effects, including:

• Inflammation of the pancreas (pancreatitis). Stop using it and call your 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. Tell your provider right away if you have pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.
• Low blood sugar (hypoglycemia). Your risk may be higher if you also take medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.
• Kidney problems (kidney failure). Diarrhea, nausea, and vomiting can cause a loss of fluids (dehydration), which may cause kidney problems. Drink fluids to help reduce your chance of dehydration.
• Severe stomach problems. Tell your provider if you have stomach problems that are severe or will not go away.
• Serious allergic reactions (hypersensitivity). Stop using it and get medical help right away if you have swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
• Changes in vision (diabetic retinopathy complications) in people with type 2 diabetes. Tell your provider if you have changes in vision during treatment.
• Depression or thoughts of suicide. Pay attention to changes in your mood, behaviors, feelings, or thoughts. Call your provider right away if you have any mental changes that are new, worse, or worry you.
• Food or liquid getting into the lungs during surgery or procedures (pulmonary aspiration). Because tirzepatide slows stomach emptying, tell every healthcare provider who treats you that you use it before any procedure that uses anesthesia or deep sedation.

The most common side effects include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects. Talk to your provider about any side effect that bothers you or does not go away.

Using your medication safely

• Follow the dosing instructions from your provider and the pharmacy label exactly. Do not change your dose on your own.
• Compounded medication comes in a vial. Measure each dose carefully with the syringe supplied. Dosing errors have been reported when people measured the wrong amount from a vial; ask your care team if you are unsure.
• Inject under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm once each week, on the same day each week.
• Change (rotate) your injection site each week. Never share needles or syringes.
• Store your medication as described on the pharmacy label.
• If you miss a dose or take too much, contact your provider for advice.

Getting help and reporting side effects

• If you have a medical emergency, call 911.
• If you think you have taken too much medication, contact Poison Control at 1-800-222-1222 or poison.org.
• For questions about side effects or your treatment, message your care team anytime; clinical questions are typically answered within 48 hours, Monday–Friday.
• You are encouraged to report side effects of prescription drugs to the FDA through MedWatch or by calling 1-800-FDA-1088.

Reference: FDA-approved brand-name medications (not offered by Archie Health)

Ozempic^® and Wegovy^® (semaglutide) are made by Novo Nordisk. Mounjaro^® and Zepbound^® (tirzepatide) are made by Eli Lilly and Company. These are FDA-approved brand-name medications. Each has its own FDA-approved Prescribing Information and Medication Guide, which you can find on the FDA's Drugs@FDA database.

Archie Health does not prescribe or sell these brand-name medications. We offer compounded semaglutide and compounded tirzepatide, which are not FDA-approved. Archie Health is not affiliated with Novo Nordisk A/S or Eli Lilly and Company. All brand names are trademarks of their respective owners.