For compounded semaglutide and compounded tirzepatide prescribed through the Healed™ program.
Read this before you start, keep it for reference, and bring anything on this page that applies to you to your prescribing clinician. It is a summary — it does not cover every risk, and it does not replace the guidance of your clinician or the information supplied with your medication.
About compounded medication
The medications prescribed through Healed™ are compounded by a state-licensed pharmacy. Compounded drugs are not FDA-approved, and the FDA does not review them for safety, effectiveness or quality before they are dispensed. The safety information on this page is drawn from the FDA-approved prescribing information for semaglutide and tirzepatide, because those are the best available data. A compounded version has not been through the same evaluation, and its risks may differ. FDA has received reports of adverse events with compounded GLP-1 medications, including reports linked to dosing errors — see “Taking your dose” below.
Boxed warning: risk of thyroid C-cell tumors
Semaglutide and tirzepatide caused thyroid C-cell tumors in rodent studies. Whether they cause thyroid C-cell tumors in people — including a type of thyroid cancer called medullary thyroid carcinoma (MTC) — is not known.
You must not use these medications if you or anyone in your family has ever had MTC, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Contact your clinician promptly if you develop a lump or swelling in your neck, a hoarse voice, difficulty swallowing, or shortness of breath.
Who should not use these medications
- Anyone with a personal or family history of MTC, or with MEN 2
- Anyone who has had a serious allergic reaction (such as anaphylaxis or angioedema) to semaglutide, tirzepatide, or any ingredient in the compounded preparation
- Anyone who is pregnant, trying to become pregnant, or breastfeeding
- Anyone under 18 or over 74 — outside the age range of the Healed™ program
- Anyone already taking another GLP-1 or GIP/GLP-1 medication
Tell your clinician before you start
Your clinician needs to know if you have now, or have ever had:
- pancreatitis (inflammation of the pancreas)
- kidney disease or kidney problems
- gallstones or other gallbladder problems
- type 1 or type 2 diabetes, or diabetic retinopathy (diabetes-related eye disease)
- severe stomach or bowel problems, including slow stomach emptying (gastroparesis)
- a heart rhythm problem or a fast resting heart rate
- an eating disorder
- surgery or a procedure with anesthesia or deep sedation planned in the coming months
And every medication, supplement and over-the-counter product you take — in particular insulin, sulfonylureas or other diabetes medication, blood thinners such as warfarin, thyroid medication, and oral contraceptives.
Serious side effects and what to watch for
- Pancreatitis. Severe, persistent pain in the stomach area, sometimes spreading to the back, with or without vomiting. Stop the medication and contact your clinician right away.
- Gallbladder problems, including gallstones. Pain in the upper right stomach, fever, nausea, yellowing of the skin or eyes, or pale stools.
- Low blood sugar (hypoglycemia). More likely if you also take insulin or a sulfonylurea. Watch for shakiness, sweating, dizziness, confusion, blurred vision, a racing heartbeat, hunger or weakness. Your diabetes medication may need adjusting.
- Dehydration and kidney injury. Nausea, vomiting and diarrhea can dehydrate you, which can strain the kidneys or worsen existing kidney disease. Keep drinking fluids, and contact your clinician if you cannot keep liquids down.
- Severe stomach and bowel problems, including severe constipation, bowel obstruction (ileus) or an impacted bowel. Contact your clinician if stomach symptoms are severe or do not settle.
- Serious allergic reactions. Swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, a severe rash, or feeling faint. Stop the medication and get emergency help.
- Vision changes in people with type 2 diabetes. Report any change in your vision.
- Increased heart rate. Report a heartbeat that feels fast or pounding while you are resting.
- Food or liquid entering the lungs during anesthesia. These medications slow stomach emptying, so food may remain in the stomach even after fasting. Tell the anesthesia team and every healthcare provider that you take a GLP-1 medication before any operation or procedure.
Common side effects
Nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, heartburn, bloating, belching, gas, reduced appetite, headache, tiredness, dizziness, hair loss, and redness, itching or swelling where you inject. Stomach-related effects are most likely when you start and after each dose increase, and usually ease over the following weeks. Tell your care team about any side effect that is severe, that worries you, or that does not go away — your dose or dose schedule can be adjusted.
Medicines and interactions
- Insulin and sulfonylureas raise the risk of low blood sugar when combined with a GLP-1 medication; the dose of those medicines may need to be lowered.
- Oral medication in general. Because stomach emptying is slowed, some oral medicines may be absorbed differently. This matters most for medicines with a narrow dosing margin, such as warfarin, and for thyroid medication (levothyroxine). Your clinician may ask for extra monitoring.
- Oral contraceptives and tirzepatide. Tirzepatide can reduce how well birth-control pills work. Use a non-oral method, or add a barrier method, for four weeks after starting tirzepatide and for four weeks after each dose increase.
Pregnancy, breastfeeding and fertility
These medications may harm an unborn baby. Do not use them if you are pregnant or breastfeeding. If you are planning a pregnancy, stop semaglutide at least two months beforehand — it stays in the body for a long time — and discuss timing for tirzepatide with your clinician. If you become pregnant during treatment, stop the medication and contact your clinician.
Taking your dose
Compounded GLP-1 medication is supplied in a vial and injected under the skin with a syringe, once a week, on the same day each week. Dosing errors are a known cause of harm with compounded GLP-1 medication, so:
- Draw up only the dose on your prescription. Doses may be written in milligrams (mg), milliliters (mL) or “units” — if the label, your syringe and your instructions do not obviously match, do not guess. Ask your care team or the pharmacy before injecting.
- Use the syringes supplied or specified by the pharmacy, and a new sterile needle and syringe for every injection. Never reuse or share needles, syringes or vials.
- Inject into the abdomen, thigh or upper arm, and rotate sites.
- Do not stop or change your dose on your own; your clinician sets each dose step.
Storage. Keep the vial in the refrigerator, do not freeze it, and follow the beyond-use date on the pharmacy label — discard the vial after that date even if medication remains. Do not use medication that arrives warm, or that looks cloudy, discolored or contains particles; contact your care team instead.
Missed dose. If you miss a dose and your next scheduled dose is more than two days away, take the missed dose as soon as you remember. If the next dose is less than two days away, skip the missed dose and carry on with your usual schedule. Never take two doses to catch up. If you miss two or more doses in a row, contact your care team before restarting — you may need to go back to a lower dose.
Too much. Taking more than prescribed can cause severe nausea and vomiting, and low blood sugar, and the effects can last for days. Contact your care team, or Poison Control at 1-800-222-1222, or seek emergency care.
Reporting side effects
Report side effects to your Healed™ care team through the patient platform at any time. You can also report to the FDA MedWatch program at www.fda.gov/medwatch or 1-800-FDA-1088, and to the dispensing pharmacy named on your label.
