Safety Information

Compounded medications are prepared by a state-licensed compounding pharmacy in response to an individual prescription from a licensed healthcare provider. Compounded GLP-1 medications are not reviewed by the U.S. Food and Drug Administration (FDA) for safety, efficacy, or quality before they are dispensed, and they are not FDA-approved products.

Compounded products may differ from the FDA-approved branded versions in formulation, strength, inactive ingredients, route of administration, or appearance. There is no guarantee that a compounded medication will perform the same way as an FDA-approved product.

PLX Health does not manufacture or dispense medications. Prescriptions are written by independent licensed providers and dispensed by independent licensed pharmacies.

Compounded GLP-1 medications may be prescribed by a licensed provider as an adjunct to a reduced-calorie diet and increased physical activity to support weight management in adults when clinically appropriate. Eligibility, dosing, and duration of treatment are determined by the prescribing provider based on your medical history and clinical presentation.

• Have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Have had a serious allergic reaction to semaglutide, tirzepatide, or any of the inactive ingredients in your compounded medication.
• Are pregnant, planning to become pregnant, or breastfeeding.
• Are under 18 years of age.

Before starting and during treatment, tell your provider about all of your medical conditions, including if you:

• Have or have had problems with your pancreas, kidneys, or liver.
• Have severe problems with your stomach, such as slowed emptying (gastroparesis).
• Have diabetes (type 1 or type 2) or take medications to lower blood sugar.
• Have a history of diabetic retinopathy.
• Have a history of gallbladder disease.
• Have a history of depression, suicidal thoughts, or mental health concerns.
• Plan to have surgery or a procedure requiring anesthesia or deep sedation.

Serious side effects may include:

• Inflammation of the pancreas (pancreatitis). Stop using the medication and call your provider right away if you have severe pain in your stomach area that will not go away, with or without vomiting.
• Gallbladder problems. Symptoms may include pain in the upper stomach, fever, yellowing of the skin or eyes, or clay-colored stools.
• Low blood sugar (hypoglycemia). Risk is higher when used with other diabetes medications such as insulin or sulfonylureas.
• Acute kidney injury. Often related to dehydration from nausea, vomiting, or diarrhea.
• Serious allergic reactions. Stop using the medication and seek medical help immediately if you experience swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
• Changes in vision. Tell your provider if you experience vision changes during treatment.
• Increased heart rate. Tell your provider if you feel your heart racing or pounding at rest.
• Depression or suicidal thoughts. Tell your provider, family, or caregivers about any unusual changes in mood, behavior, or thoughts of self-harm.

The most commonly reported side effects of GLP-1 medications include:

• Nausea
• Vomiting
• Diarrhea
• Constipation
• Abdominal pain
• Indigestion or heartburn
• Fatigue
• Headache
• Dizziness
• Injection site reactions (redness, itching, or discomfort)

These are not all of the possible side effects. Talk to your provider for medical advice about side effects.

Tell your provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GLP-1 medications slow stomach emptying, which can affect how other oral medications are absorbed. Special caution is needed when used with insulin, sulfonylureas, or oral contraceptives.

Compounded GLP-1 medications should not be used during pregnancy or while breastfeeding. If you are able to become pregnant, use effective contraception during treatment. Discontinue use at least two months before a planned pregnancy. Tell your provider immediately if you become pregnant while taking the medication.

Use compounded GLP-1 medications exactly as prescribed by your provider. Do not change your dose or stop treatment without talking to your provider first. Store the medication as instructed on the label, dispose of needles and syringes in an FDA-approved sharps container, and never share your medication, pen, or needles with anyone else.

If you experience a side effect or adverse event, contact your prescribing provider. You are also encouraged to report adverse events directly to the U.S. Food and Drug Administration by visiting www.fda.gov/medwatch or by calling 1-800-FDA-1088.

For non-emergency questions about your treatment, you may contact us at support@plxhealth.com. If you are experiencing a medical emergency, call 911 or go to the nearest emergency room.

This Safety Information is provided for general educational purposes and does not replace the full prescribing information for any medication or the medical judgment of your licensed healthcare provider. Always read the patient information that accompanies your medication and discuss any questions or concerns with your provider or pharmacist before starting, stopping, or changing treatment.