Important Safety Information
Your health comes first. Here's what you need to know before starting a GLP-1 with Novi.
Novi offers compounded semaglutide and compounded tirzepatide, prescribed by independent, licensed providers. Compounded medications are not FDA-approved, and the FDA has not reviewed them for safety, effectiveness or quality. The information below comes from the labels of the FDA-approved medications that contain the same active ingredients. Read it carefully, and tell your provider about your full health history before you start.
⚠️ Boxed warning: risk of thyroid C-cell tumors
In studies in rodents, semaglutide and tirzepatide caused thyroid C-cell tumors. It isn't known whether they cause these tumors in people, including a type of thyroid cancer called medullary thyroid carcinoma (MTC).
Do not use semaglutide or tirzepatide if:
• you or any family member has ever had MTC, or
• you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Tell your provider right away if you notice a lump or swelling in your neck, hoarseness, trouble 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 to semaglutide, tirzepatide or any of their ingredients
• Anyone who is pregnant. Stop treatment if you become pregnant, and talk to your provider before trying to conceive. For semaglutide, the label advises stopping at least 2 months before a planned pregnancy.
Before you start, tell your provider if you:
• have ever had pancreatitis, gallbladder disease, or kidney or liver problems
• have type 2 diabetes, diabetic eye disease (retinopathy), or take insulin or a sulfonylurea
• have a history of depression, suicidal thoughts or mental health conditions
• have severe stomach or digestive problems, such as slowed stomach emptying
• are breastfeeding, or plan to become pregnant
• are scheduled for surgery or any procedure that uses anesthesia or deep sedation
• take any other medications, vitamins or supplements, including other weight-loss products
Possible serious side effects
Stop using your medication and contact your provider right away if you have any of these:
• Pancreatitis: severe stomach pain that won't go away, with or without vomiting. The pain may spread to your back.
• Gallbladder problems: pain in your upper stomach, fever, yellowing of your skin or eyes, or clay-colored stools.
• Low blood sugar: a higher risk if you also take insulin or a sulfonylurea. Signs include dizziness, shakiness, sweating, confusion, a fast heartbeat and irritability.
• Kidney problems: vomiting, diarrhea or dehydration can lead to kidney injury. Drink plenty of fluids.
• Serious allergic reactions: swelling of the face, lips, tongue or throat, trouble breathing, a severe rash, or a racing heartbeat. Get emergency help.
• Diabetic eye changes: if you have type 2 diabetes, tell your provider about any vision changes.
• Increased heart rate: a racing or pounding heartbeat while at rest.
• Mood changes: new or worsening depression, unusual changes in mood or behavior, or thoughts of self-harm.
• Breathing problems during anesthesia: food or liquid could get into your lungs during surgery or sedation. Tell every doctor who treats you that you take a GLP-1.
Common side effects
The most common side effects are nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, heartburn, bloating, burping, headache, tiredness and dizziness. These are often worst when you start treatment or increase your dose, and they usually ease over time. If a side effect bothers you or won't go away, message your provider. They can adjust your plan.
Medication interactions
GLP-1s slow how fast your stomach empties, which can change how your body absorbs medications you take by mouth.
Tirzepatide and birth control pills: tirzepatide can make oral birth control less effective. Switch to a non-oral method, or add a barrier method such as condoms, for 4 weeks after you start and for 4 weeks after each dose increase.
Using compounded medication safely
Your medication comes in a vial, and you'll draw each dose with a syringe. Compounded medications may come in different strengths and units from the brand-name pens. The FDA has received reports of dosing errors with compounded GLP-1s.
• Follow the exact dose and instructions your provider and pharmacy give you.
• Check the units on your syringe against your dosing instructions every time.
• Use a new, sterile syringe for every injection, and never share syringes or vials.
• Never change your dose on your own.
• If anything about your dose is unclear, stop and ask your provider before injecting.
When to get help
• Questions or side effects: message your provider through the Patient Portal.
• Medical emergency: call 911 or go to the nearest emergency room. Novi does not provide emergency care.
Report side effects
You can report side effects to the FDA through MedWatch at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
This page is a summary. It doesn't cover every possible risk or replace advice from your healthcare provider. Ozempic® and Wegovy® are registered trademarks of Novo Nordisk A/S. Mounjaro® and Zepbound® are registered trademarks of Eli Lilly and Company. Novi is not affiliated with these companies.