GLP-1 Medication Safety Information

Emergency Information

If you believe you are experiencing a medical emergency, call 911 or go to the nearest emergency room immediately. Do not wait for a reply by email, phone, chat, or through the patient portal.

For a suspected overdose or dosing error, call Poison Control at 1-800-222-1222. If the person collapses, has a seizure, has trouble breathing, or cannot be awakened, call 911.

About This Information

This page provides general safety information for adults who are prescribed a medication containing semaglutide or tirzepatide through WellMedr. It does not replace your prescription label, pharmacy instructions, medication guide, or advice from your prescribing clinician. Wellmedr LLC facilitates access to telehealth services and does not manufacture, compound, ordispense medication. A licensed clinician determines whether a prescription is medically appropriate; a prescription is not guaranteed. Medication is dispensed by the state-licensed pharmacy identified on the prescription label.

Always follow the directions on your current prescription and pharmacy label.
Formulations, ingredients, concentrations, dosage forms, syringes, storage requirements, andbeyond-use dates may differ between prescriptions and pharmacies.

Important Information About Compounded Medications

Compounded semaglutide and compounded tirzepatide are not FDA-approved. The FDAdoes not review compounded medications for safety, effectiveness, or quality before theyare marketed.

A compounded medication is not an FDA-approved generic drug and should not be assumed tobe the same as, equivalent to, or interchangeable with an FDA-approved brand medication.FDA-approved medications containing semaglutide or tirzepatide are commercially available.The FDA recommends that a compounded drug be used only when a patient's medical needscannot be met by an available FDA-approved drug.

Whether a compounded medication is appropriate and available depends on the patient'sindividual medical needs, clinician judgment, and pharmacy availability. A prescription andproduct availability are not guaranteed.

Because compounded products have not undergone FDA approval, their complete risks,side-effect frequencies, absorption, effectiveness, and quality may not be established. Some ofthe safety information below comes from FDA-approved labeling for products containingsemaglutide or tirzepatide and from FDA reports involving compounded products. This does notmean a compounded product is the same as an FDA-approved medication.

Before Starting or Continuing Treatment

Tell your prescribing clinician about all medical conditions, allergies, prescription medicines,over-the-counter medicines, vitamins, and supplements you use. In particular, tell your clinicianif you:

● You or a family member have had medullary thyroid carcinoma, or you have MultipleEndocrine Neoplasia syndrome type 2 (MEN 2);
● Have had a serious allergic reaction to semaglutide, tirzepatide, or an ingredient in yourprescribed formulation;
● Have or have had problems involving your pancreas, gallbladder, kidneys, stomach, orintestines, including severe gastroparesis;
● Have diabetes, diabetic retinopathy, changes in vision, or take insulin or a sulfonylurea;
● Use another GLP-1, semaglutide, tirzepatide, diabetes, or weight-managementmedication;
● Use oral hormonal contraceptives or another oral medicine that requires close monitoring;
● Are scheduled for surgery or a procedure involving anesthesia or deep sedation; or
● Are pregnant, may be pregnant, plan to become pregnant, or are breastfeeding.

FDA-approved products containing semaglutide or tirzepatide carry boxed warnings concerningthyroid C-cell tumors observed in rodents. It is unknown whether these medications causethyroid C-cell tumors, including medullary thyroid carcinoma, in humans. Do not use amedication containing semaglutide or tirzepatide if you or a family member have had medullarythyroid carcinoma or if you have MEN 2.

Weight-loss treatment should not be used during pregnancy. If you become pregnant, stop themedication and contact your clinician promptly. Semaglutide should be stopped at least twomonths before a planned pregnancy. Ask your clinician when tirzepatide should be stoppedbefore a planned pregnancy and whether treatment is appropriate while breastfeeding.Tirzepatide may reduce the effectiveness of oral hormonal contraceptives. Ask your clinicianabout using a non-oral contraceptive method or adding a barrier method for four weeks afterstarting tirzepatide and for four weeks after each dose increase.

Serious Symptoms

Stop using the medication and seek prompt medical advice if directed below. Call 911 for severeor life-threatening symptoms.

● Possible pancreatitis: severe, persistent abdominal pain that may spread to the back,with or without vomiting. Stop using the medication and contact a clinician immediately.
● Possible gallbladder problem: upper abdominal pain, fever, yellowing of the skin oreyes, or clay-colored stools.
● Severe dehydration or kidney problem: persistent vomiting or diarrhea, inability to keepfluids down, faintness, or reduced urination.
● Severe stomach or intestinal problem: repeated vomiting, severe or persistentabdominal pain, severe constipation, abdominal swelling, or inability to pass stool or gas.
● Serious allergic reaction: swelling of the face, lips, tongue, or throat; difficulty breathingor swallowing; severe rash; fainting; or severe dizziness. Call 911.
● Low blood sugar: sweating, shakiness, hunger, blurred vision, confusion, weakness,dizziness, slurred speech, or a fast heartbeat, particularly when used with insulin or asulfonylurea. Call 911 for loss of consciousness, seizure, or severe confusion.
● Vision changes: new or worsening changes in vision, especially if you have diabetes ordiabetic retinopathy.
● Possible thyroid tumor symptoms: a lump or swelling in the neck, persistenthoarseness, trouble swallowing, or shortness of breath.
Semaglutide and tirzepatide delay stomach emptying.Tell your surgeon, anesthesiologist,dentist, or other procedural clinician that you use one of these medications before anyprocedure involving anesthesia or deep sedation.

Other Possible Side Effects

FDA-approved products containing semaglutide or tirzepatide commonly list gastrointestinalside effects such as nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion,decreased appetite, bloating, belching, and heartburn. Other reported effects can includefatigue, headache, dizziness, hair loss, and injection-site reactions.

The complete risks and frequency of side effects for a compounded formulation may be differentor unknown. Contact your clinician about any symptom that is severe, persistent, worsening, orconcerning

Dosing and Administration Safety

Compounded medications may come in different concentrations and dosage forms. Confusingmilligrams, milliliters, and syringe “units” can cause a serious overdose.

● Use only the medication, dose, frequency, route, and syringe listed on your currentprescription and pharmacy label.
● Before every dose, confirm the medication name, concentration, prescribed dose,injection volume, and correct syringe marking.
● If any direction is missing, inconsistent, or unclear, do not take or inject the medicationuntil the prescribing clinician or dispensing pharmacy confirms it.
● Never use a universal dosing chart or copy the number of “units” used for another vial. Arefill may have a different concentration.
● Do not calculate a new dose yourself, increase the dose early, double a missed dose,change the route, or take doses more frequently than prescribed.
● Dose increases are not automatic. A clinician must determine whether an increase isappropriate based on your prescription, response, and side effects.
● Do not combine or “stack” semaglutide, tirzepatide, or another GLP-1 medication unlessyour prescribing clinician has expressly instructed you to do so.
● Never share medication, vials, pens, needles, or syringes. Use a new sterile needle andsyringe for every injection and dispose of used sharps safely.
If you may have used the wrong dose, contact your clinician and Poison Control at1-800-222-1222. Call 911 for severe symptoms.

Oral and Combination Formulations

The FDA has not approved an oral tirzepatide product. A compounded oral semaglutide product should not be assumed to be equivalent to an FDA-approved oral or injectable semaglutide product. Compounded oral, sublingual, troche, and combination formulations may have different absorption, exposure, ingredients, effectiveness, and risks.

A compounded prescription may contain an additional ingredient, such as a vitamin, amino acid,or other substance. The FDA has not determined that adding another ingredient improvesweight loss, safety, effectiveness, energy, focus, liver function, or tolerability. Added ingredients may create additional side effects, interactions, contraindications, or allergy risks. Review the complete ingredient list on your pharmacy label. If the ingredients are missing, unclear, or different from what you expected, do not use the medication until the dispensing pharmacy or your clinician provides clarification.

Do not use a product labeled as containing semaglutide sodium or semaglutide acetate. The FDA has stated that these salt forms are different active ingredients from the semaglutide used in FDA-approved products and that it is unaware of a lawful basis for their use in compounding.

Storage, Shipping, and Product Quality

● Follow the dispensing pharmacy's label for refrigeration, room-temperature limits, light protection, storage, and handling.
● Do not use medication if the pharmacy label is missing or incomplete, the seal is broken, the container is leaking or damaged, or the product appears discolored, cloudy, contaminated, frozen, or contains unexpected particles.
● Do not assume that storage guidance for a prior shipment, another pharmacy, or a brand medication applies to your current prescription.
● Keep medication and injection supplies out of the reach of children and pets.

If You Receive an FDA-Approved Brand Medication

Use the Medication Guide, Instructions for Use, prescribing information, and storage directions supplied with that exact product. FDA-approved semaglutide and tirzepatide products have different approved uses, devices, concentrations, schedules, and instructions.
Do not apply compounded-medication instructions to a branded product or instructions for one brand to another product.

Questions and Adverse-Event Reporting

For non-emergency medical questions: Message your prescribing clinician through the WellMedr patient portal.

For help reaching your care team or resolving an order issue: Call 1-888-397-6905 or emailsupport@wellmedr.com.

For questions about ingredients, concentration, preparation, storage, or the beyond-use date: Contact the dispensing pharmacy listed on your prescription label.

To report a side effect or product-quality problem to the FDA: Visit FDA MedWatch or call1-800-FDA-1088

Additional Information

This is not a complete list of warnings, risks, side effects, interactions, contraindications, or instructions. Your prescription label and the information supplied by the dispensing pharmacy control if they differ from this general summary.

For current federal information, review the FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.